2015 AER Conference Guide by Anne Meade

Schedule at a Glance Thursday, November 12 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 7:00 AM-6:00 PM Registration Open 8:30 AM Pre-Conference Programs 4:30-6:00 PM Pre-Conference Programs Networking Reception

Pre-Function Hall C See schedule for room locations Boylston Hallway, Level Two

7:00-5:30 PM Registration Open 7:00-8:00 AM Continental Breakfast to Welcome First-Time Attendees 7:00-8:00 AM Affinity Group Peer-to-Peer Networking Continental Breakfast 8:00-8:15 AM Welcome from the Conference Co-Chairs 8:15-8:30 AM Welcome from PRIM&R’s Executive Director 8:30-9:15 AM Keynote Address: Boghuma K. Titanji, MD, MSc, PhD 9:15-9:30 AM Break 9:30-10:45 AM Panels I, II, III 10:45-11:15 AM Coffee break 11:15 AM-12:30 PM Innovations in… Series 12:45-1:45 PM Common Ground Networking Lunch 12:45-1:45 PM Research Ethics Book Group Lunch and Book Signing 1:15 PM-1:35 PM Demonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC) 1:40 PM-2:00 PM Demonstration of PRIM&R’s Knowledge Center 1:45-2:15 PM Meet the 2015 AER Conference Poster Authors 1:45-2:15 PM Meet the 2015 AER Supporters and Exhibitors 1:45-2:15 PM FDA Office Hours 2:30-3:45 PM Didactic Sessions and Workshops Series A 3:45-4:00 PM Coffee break 4:00-5:15 PM Didactic Sessions and Workshops Series B 5:15-6:30 PM 2015 AER Welcome Reception with the Supporters and Exhibitors 7:00-9:00 PM Young Professionals Networking Reception

Pre-Function Hall C Room 210 Ballroom A Veterans Memorial Auditorium Veterans Memorial Auditorium Veterans Memorial Auditorium See schedule for room locations Exhibit Hall C See schedule for room locations Exhibit Hall D Ballroom A Exhibit Hall C Exhibit Hall C Exhibit Hall C See schedule for room locations Exhibit Hall C See schedule for room locations Exhibit Hall C Back Bay Social Club

Saturday, November 14 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Boston, MA

7:00 AM-12:00 PM Registration Open Pre-Function Hall C 8:00-8:15 AM Welcome from the Conference Co-Chairs Veterans Memorial Auditorium 8:15-8:30 AM PRIM&R Membership Update Veterans Memorial Auditorium 8:30-9:30 AM Keynote Address: Robert K. Massie, IV, MDiv, DBA Veterans Memorial Auditorium 9:30-9:45 AM Break 9:45-11:00 AM Panels VII, VIII, IX See schedule for room locations 11:00-11:15 AM Coffee Break Exhibit Hall C 11:15 AM-12:30 PM Didactic Sessions and Workshops Series E See schedule for room locations 12:45-1:45 PM Lunch Exhibit Hall D 2:00-3:15 PM Closing General Session: Could this Happen to You? Lessons Learned from the University of Minnesota Reports Veterans Memorial Auditorium

November 12-15

Sunday, November 15 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

7:00 AM-5:00 PM Registration Open Pre-Function Hall C 7:00-8:00 AM CIP® Continental Breakfast Ballroom A 8:00-8:15 AM Welcome from the Conference Co-Chairs Veterans Memorial Auditorium 8:15-8:30 AM Presentation of PRIM&R’s ARENA Legacy Award and Pillars of PRIM&R Award Veterans Memorial Auditorium 8:30-9:15 AM Keynote Address: Sendhil Mullainathan, PhD Veterans Memorial Auditorium 9:15-9:30 AM Break 9:30-10:45 AM Panels IV, V, VI See schedule for room locations 10:45-11:15 AM Coffee break Exhibit Hall C 11:15 AM-12:30 PM Didactic Sessions and Workshops Series C See schedule for room locations 12:45-1:45 PM Lunch Exhibit Hall D 2:00-3:15 PM Didactic Sessions and Workshops Series D See schedule for room locations 3:30-4:45 PM Town Hall Meeting: The NPRM and the Future of Human Subjects Protections Veterans Memorial Auditorium 5:00-6:00 PM Networking Reception with the Supporters, Exhibitors, and Poster Presentation Authors Exhibit Hall C 5:00-6:00 PM AER Conference Group Mentoring Exhibit Hall D 5:00-6:00 PM FDA Office Hours Exhibit Hall C 5:00 PM-5:15 PM Demonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC) 5:15 PM-5:30 PM Demonstration of PRIM&R’s Knowledge Center 5:45 PM-6:05 PM Demonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC) 6:00-7:00 PM DNA in Play: The ABC’s of Assent, Blurred Boundaries, Capacity, Disclosure, Ethics, Families... Ballroom B 6:05 PM-6:25 PM Demonstration of PRIM&R’s Knowledge Center

PRIM&R’s 2015 Advancing Ethical Research Conference

Friday, November 13 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

THANK YOU . . . to our Conference Planning Committee members who made this conference possible. CORE CONFERENCE PLANNING COMMITTEE Co-Chairs

Members

Director Human Research Affairs Partners HealthCare System, Inc.; Associate Professor of Pediatrics, Harvard Medical School

Senior Medical Fellow, Bioethics and Pediatric Capabilities Eli Lilly and Company

P. Pearl O’Rourke, MD

Laura Odwazny, JD, MA

Senior Attorney Office of the General Counsel US DHHS

Albert J. Allen, MD, PhD

Dean R. Gallant, AB

Consultant HRP Consulting Group, Inc.

Leonard Glantz, JD David A. Borasky, Jr., MPH, CIP Professor Emeritus of Health Law, Vice President Quality Management Copernicus Group IRB

Bioethics, and Human Rights Boston University School of Public Health

Alexander M. Capron, LLB

Celia B. Fisher, PhD

University Professor; Scott H. Bice Chair in Healthcare Law, Policy, and Ethics; Co-Director, Pacific Center for Health Policy and Ethics University of Southern California

Marie Ward Doty Endowed University Chair and Professor of Psychology; Founding Director, Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute Fordham University

Susan Z. Kornetsky, MPH Director Clinical Research Compliance Boston Children’s Hospital

Robert J. Levine, MD

Professor of Internal Medicine; Chair, Executive Committee of the Center for Bioethics Yale University

David H. Strauss, MD

Director of Psychiatric Research, New York State Psychiatric Institute; Vice Chair for Research Administration, Ethics, and Policy Department of Psychiatry Columbia University

Elyse I. Summers, JD President and CEO AAHRPP, Inc.

Ivor A. Pritchard, PhD

Senior Advisor to the Director OHRP

WORKSHOP DIDACTIC SUBCOMMITTEE Co-Chairs

Members

Susie R. Hoffman, RN, BSN, CIP Jeremy N. Block, PhD, MPP

Janet C. Donnelly, RAC, CIP

Eric Mah, MHS, CIP

Scott J. Lipkin, DPM, CIP

Michelle Feige, MSW, LCSW-C

Greg E. Manship, D.Bioethics, MDiv, CIP, CIM

Sharon Freitag

Megan Kasimatis Singleton, JD, MBE

Director IRB for Health Sciences Research University of Virginia Managing Director Health Solutions FTI Consulting

IRB Chair Mount Sinai Health System; Assistant Professor Department of Population Health Science and Policy Icahn School of Medicine at Mount Sinai

Kristina C. Borror, PhD

Director Division of Compliance Oversight OHRP

Elizabeth A. Buchanan, PhD Endowed Chair and Director Center for Applied Ethics University of Wisconsin-Stout

Policy Analyst Office of Good Clinical Practice FDA Executive Vice President AAHRPP, Inc.

Director, Research Ethics Office St. Michael’s Hospital

George Gasparis, CIP

President The PEER Consulting Group

Shannon L. Harr, CIM, EdD

Director Research Integrity and Compliance Morehead State University

Executive Director Clinical Research Operations University of California, San Diego IRB Director and Human Protections Administrator University of Indianapolis Associate Director Human Research Protections University of Pennsylvania

Susan Brown Trinidad, MA

Research Scientist Department of Bioethics and Humanities University of Washington

POSTER ABSTRACT SUBCOMMITTEE Co-Chairs

Members

Susan S. Fish, PharmD, MPH

Hila F. Berger, MPH, CIP

Professor Biostatistics and Epidemiology Boston University School of Public Health

Nancy A. Olson, JD

Director Human Research Office and IRBs University of Mississippi Medical Center

Research Compliance Administrator Montclair State University

Stacey A. Donnelly, MPA Director, Sponsored Research Broad Institute

Patricia A. MacCubbin, MS President and CEO Research Ethics Group

Okyere “Boat” Boateng, MSc, MHSc Samantha M. Ferrante, MS, CIP Cynthia R. Pearson, PhD IRB Chair Noguchi Memorial Institute for Medical Research

Warren Capell, MD

IRB Analyst II Children’s Hospital of Philadelphia

Karen N. Hale, RPh, MPH, CIP

Director Clinician-Scientist, CPC Clinical Research; Office of Responsible Associate Professor of Medicine, Division Research Practices The Ohio State University of Endocrinology, Metabolism, and Diabetes University of Colorado Denver

Neha Kaul, MS, MA, MPH

Susan Corl, MSW, MPH, CIP, CCRP Director Education and QI Specialist Boston Children’s Hospital

Human Subjects Administration New York Medical College

Michele Kennett, JD, RN, CIP Assistant Vice Chancellor for Research University of Missouri Columbia

Director of Research Policy and Methods; Assistant Professor University of Washington

Lauren B. Solberg, JD, MTS Assistant Professor Program in Bioethics, Law, and Medical Professionalism University of Florida College of Medicine

Holly A. Taylor, PhD, MPH

Associate Professor Berman Institute of Bioethics Johns Hopkins Bloomberg School of Public Health

Cheryl A. Savini, CIP Principal, COO HRP Consulting Group, Inc. Alan Teller

Assistant Director of IRB Operations Columbia University

Ilene Frances Wilets, PhD, CIP Executive Director, IRB New York State Pyschiatric Institute

Rachel Zand, PhD

Director Office of Research Ethics University of Toronto

60 68

FACULTY Faculty List Keynote and Plenary Biographies

SUPPORTERS & EXHIBITORS

98 99 100 101 102

About PRIM&R Board of Directors Staff Thanks to Committee Members CIP® In Memoriam

104

MAPS

122

NOTES

posters

SCHEDULES Your Guide to the Pre-Conference Program Your Guide to the Conference Schedule Your Guide to the Conference Tracks Schedule: November 13-15 CME Accreditation Statement

POSTERS Posters Selected for Presentation Posters Selected for Innovations in… Series

faculty

14 15 16 18 59

78 84

schedules

11 12

CONFERENCE INFORMATION Welcome from PRIM&R’s Executive Director Welcome from the Conference Co-Chairs Announcements Affinity Groups Certificates of Attendance and Continuing Education Credit Scholarships ARENA Legacy Award

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Contents

Common Abbreviations and Acronyms IOM Institute of Medicine

AAHRPP, Inc. Association for the Accreditation of Human Research Protection Programs, Inc.

NAS National Academies of Science

AER PRIM&R’s Advancing Ethical Research Conference

CBPR Community-Based Participatory Research CCPC Core Conference Planning Committee CDC US Centers for Disease Control and Prevention CIP® Certified IRB Professional CME Continuing Medical Education DOC Department of Commerce DOD US Department of Defense

NCI National Cancer Institute mHealth Mobile Health NIH National Institutes of Health NIST The National Institute of Standards and Technology NSF National Science Foundation NPRM Notice of Proposed Rulemaking OHRP Office for Human Research Protections OIG Office of Inspector General ORI Office of Research Integrity PRIM&R Public Responsibility in Medicine and Research

DHHS US Department of Health and Human Services

QA Quality Assurance

E-ROC PRIM&R’s Ethical Research Oversight Course

maps

DOE US Department of Energy EPA US Environmental Protection Agency

about PRIM&R

ARENA Applied Research Ethics National Association, PRIM&R’s former membership division

IRB Institutional Review Board

supporters & exhibitors

AAALAC Association for Assessment and Accreditation of Laboratory Animal Care International

QI Quality Improvement SACHRP Secretary’s Advisory Committee on Human Research Protections

HRPP Human Research Protections Program

SBER Social, Behavioral, and Educational Research

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notes

FDA US Food and Drug Administration

conference information

Welcome from PRIM&R’s Executive Director Dear Friends, Thank you for joining us at PRIM&R’s 2015 AER: Continuity and Change in Human Research Protections. All of us at PRIM&R are pleased to welcome you to our hometown of Boston for this opportunity to learn and connect around our shared goal of advancing the highest ethical standards in human subjects research.

This year’s meeting comes at an especially exciting time— albeit one of heighted uncertainty—with the release of the NPRM. As you know, these proposals represent what could be the first changes to the Common Rule since it was published in 1991. To help you understand the potential impact of the proposals on your work, your institution, and on the research enterprise more generally, we’ll be examining elements of the NPRM across the conference schedule, including in special sessions dedicated to the most significant changes and a Town Hall meeting (see more details in the Co-Chairs Welcome on the next page). As is our AER tradition, this year’s program is packed with a variety of opportunities for you to hear from experts, network with and learn from peers, talk to those who regulate the field, and get help in answering your toughest questions. We’ll bring you a research subject’s perspective in what promises to be an enlightening keynote address. We’ll broach timely issues related to mhealth research, germline editing, the use biomedical technologies in social science research, privacy research, precision medicine, global health research, and more, and offer you 127 practical breakout sessions on a range of topics germane to all aspects of the research enterprise. And, of course, we’ll have a bit of fun alongside our learning, with our traditional musical and dramatic performances. Such content diversity wouldn’t be possible without the many partners, volunteers, and professionals who contributed to this endeavor. I’d like to thank Boston University School of Medicine and the Association of American Medical Colleges for their ongoing support of this meeting. We appreciate their assistance in making this learning experience possible for our community. I also want to thank our three volunteer planning committees who worked tirelessly over many months to craft this exceptional program. They did so under the wise and capable leadership of our six co-chairs: Pearl O’Rourke and Laura Odwazny (Core Conference Planning Committee),

Susie Hoffman and Scott Lipkin (Workshop Didactic Sub-committee), and Susan Fish and Nancy Olson (Poster Abstract Sub committee). We couldn’t have asked for more dedicated stewards of the planning process. Thanks, too, to nearly 300 conference faculty members, more than 63 poster presenters, and 17 Affinity Group facilitators who will spend the next three days providing you with the most current information, the newest and best practices, and their professional expertise and wisdom, so that you might return to your institutions ready and able to strengthen your research programs. We’re grateful for their leadership and many hours of careful preparation. I’d also like to thank our Platinum supporters: the CITI Program at the University of Miami, Evisions, Schulman IRB, and WIRB. You can read more about them on page 92. Finally, thank you for being here and demonstrating your commitment to advancing ethical research. Over the next three days, you’ll have many opportunities to attend thought-provoking and hands-on sessions, browse posters, visit with exhibitors, network with colleagues, and seek expert advice. I encourage you to find the combination of activities that best addresses the challenges you face. And if you have an idea for something you’d like to see at a future conference, please let us know by filling out your conference evaluation. I look forward to meeting many more of you over the next few days, and hearing about how PRIM&R can continue to support you. Please introduce yourself when you see me out and about! Again, welcome to Boston. I hope you leave armed with new colleagues and friends, fresh ideas, and a renewed sense of purpose. My best, Elisa A. Hurley, PhD Executive Director

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Welcome to the 2015 AER Conference and to Boston – PRIM&R’s hometown. As your conference co-chairs, we are pleased you could join us during this exciting time in our field to take part in an incredible conference schedule developed by this year’s planning committees with your input.

This year, we’ll examine the challenges that shape our future, and how a series of proposed changes to the Common Rule could impact research protections and the field’s daily work. While the conference will explore the larger ethical, social, and scientific context in which our work occurs, it will also offer essential tools to deepen knowledge and enhance skills. And, of course, there will be ample opportunity for networking. Each year, the planning committees strive to create a conference schedule that provides attendees with a forum to exchange ideas, discuss best practices, and grapple with complex ethical issues. The crafting of this year’s schedule was a collaboration of more than 50 volunteers (see the list on the inside front cover of this guide) who selected three keynote speakers, designed 14 plenary sessions, planned 127 breakout sessions, identified nearly 300 faculty members, and reviewed 101 poster submissions. It was an enormous undertaking, but one that paid off with a conference that is timely and robust. Highlights of this year’s schedule include three keynote speakers: Robert K. Massie, IV, MDiv, DBA, author of A Song in the Night: A Memoir of Resilience, who will share his experience as a research subject; Sendhil Mullainathan, PhD, a professor of economics at Harvard University, who will talk about how big data applies to questions of human behavior; and Boghuma Kabisen Titanji, MD, MSc, PhD, a physician and clinical researcher with the Ministry of Public Health in Cameroon, who will discuss the ethical riddles of doing research abroad. You can read more about these outstanding professionals beginning on page 70. In addition, our plenary sessions were designed to speak to the diversity of interests and institutions our conference attendees represent, and address timely issues related to global health research, mhealth research, germline gene modification, risks and benefits, privacy research, precision medicine, and more. This year, we will host two unopposed plenary sessions on late-breaking topics in the field. On November 14 from 3:30 to 4:45 PM, join your peers and experts in the field for a Town Hall Meeting: The NPRM and the Future of Human Subjects Protections during which representatives of PRIM&R’s Public Policy Committee and other stakeholders will share their perspectives on areas of the NPRM that merit attention, as well as invite audience members to participate in a wide-ranging discussion about the proposed revisions and the ethical considerations underlying the stated goals of the NPRM.

And, on November 15 from 2:00 to 3:15 PM, join us for a living room conversation on how we can all learn from the lessons that arise out of specific institutional cases around research culture, compliance, ethics and organizational systems, and how we might think about our respective research programs moving forward. The schedule also features 127 breakout sessions on a broad variety of topics related to human subjects protections and best practices, including several sessions specifically devoted to address complex issues in the NPRM. Attendees find these sessions particularly useful in getting answers to their most pressing questions, obtaining insight on complex topics, and networking with their peers. And, finally, this year’s Poster Presentation Program will include 63 posters displayed in The Conference Connection, nine of which will be highlighted during our “Innovations in…” panel series on November 13 from 11:15 AM to 12:30 PM. Please also join us on this same day from 1:45 to 2:15 PM in The Conference Connection to talk with all the poster authors about their important work. Thank you for contributing your ideas, feedback, and perspectives; it makes this conference stronger. This year’s meeting was shaped by your suggestions and proposals. We received 89 submissions through our Call for Session Proposals and Speaker Suggestions, 22 of which were accepted as sessions (these are represented by a star icon on the program). Don’t forget to submit a session proposal or poster abstract for the 2016 AER Conference. Visit www.primr.org/aer16 for more details. Welcome, again, to the 2015 AER Conference. We are confident you will enjoy the meeting and a schedule that is content-rich, current, and exciting. We expect you will return to your institutions inspired by novel ideas and innovative strategies, as well as better connected with others in the field who share your passion for human subjects protections. Warmly, P. Pearl O’Rourke, MD Director, Human Research Affairs, Partners HealthCare System, Inc.; Associate Professor of Pediatrics, Harvard Medical School Laura Odwazny, JD, MA Senior Attorney, Office of the General Counsel, DHHS n ove m b e r 12- 15 , b os t on , m a

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Welcome from the Co-Chairs

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Announcements Bookstore

Spotlighting books and other reference materials on human subjects protections, research ethics, and IRB management, the onsite Bookstore will offer the latest resources to those working in research oversight. The Bookstore is located in Pre-Function Hall C on Level Two and will be open during the following hours: • November 13: 7:00 AM-5:30 PM • November 14: 7:00 AM-5:00 PM • November 15: 7:00 AM-2:00 PM PRIM&R would like to thank CITI for supporting the Bookstore.

Certificate of Attendance

A certificate of attendance for the 2015 AER Conference will be provided to attendees who complete the online conference evaluation sent on day three of the conference, November 15. Please note that attendees will be emailed an evaluation at the conclusion of each conference day. Certificates of attendance will also be provided for each of the pre-conference programs on November 12, and will be accessible upon completion of the course evaluation sent at the end of the day. Certificates of attendance are useful for obtaining continuing education credits from various professional associations. Association guidelines will vary; please consult the appropriate association representative for information as to whether, and how many, credits from PRIM&R conferences may be used.

Charging Lounge

Is your tablet or smart phone running low on charge? Feel free to visit the charging lounge, located in The Conference Connection, to charge your phone, laptop, iPad, or other electronic devices. PRIM&R would like to thank Evisions for supporting the charging lounge.

Coat and Luggage Storage

There will be an unattended coat and luggage storage area to the left of the auditorium doors on Level Two. PRIM&R assumes no liability for the items stored in this area, you can also check your luggage at the bell stand of your hotel and plan to return there prior to your departure.

Conference Blog Squad

Meet the 2015 AER Conference Blog Squad! • Mina Busch, MS, CCRP, CIP, program manager for research education and outreach, Cincinnati Children’s Hospital Medical Center • Dahron Johnson, community member non-scientist, Veteran Affairs’ Tennessee Valley Healthcare System IRB •M ichael Kraten, PhD, MPPM, BBA, associate professor of accountancy, IRB chair; Providence College p rim&r’ s 20 1 5 adv anci ng e th i cal re se a rc h c on f e r e n c e

•J acqueline Tulksy, MD, professor of clinical medicine, emeritus; University of California, San Francisco • Courtney Zwieg, MLIS, IRB administrator, NorthShore University HealthSystem These Blog Squad members will be covering sessions, events, and the 2015 AER Conference at large for PRIM&R’s Blog, Ampersand, online at www.primr.org/ampersand.

Conference Mobile App

Enhance your conference experience with the 2015 AER Conference app: • Access the conference schedule, session materials, and exhibitor and speaker profiles. • Use the My Planner function to select the sessions you don’t want to miss. • Take notes directly on slides while watching presentations live. • Connect with other attendees who are using the app. • Get conference updates and announcements Download the free app in the iTunes app store or Google Play store—just search for PRIM&R 2015 AER Conference app. Visit www.primr.org/aer15/app to learn more.

Courtesy Reminder

As a courtesy to speakers and other attendees, please turn off or silence all cell phones and electronic devices during sessions.

First-Time Attendees

Please help us welcome first-time attendees! You can recognize them by the rainbow-colored ribbons attached to their name badges.

Guest Services Associates (Red Coats)

The Hynes Convention Center’s guest service associates are available to assist you with questions about the facility and the city of Boston. Guest services associates are easily distinguished by their red blazers and are stationed throughout the facility.

Help Us Improve

Our goal is to make each AER Conference a positive experience for all who attend, but we can’t do it without you. We want to hear your thoughts on what we did well and what could be better. Please use the notepaper in the back of this guide to capture your thoughts, and then take a few minutes to complete the daily evaluations, which will be emailed to you at the end of each day. Thank you in advance for your feedback.

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In Case of Emergency

Please call the Hynes Public Safety Command Center at 617.954.2111 to report all emergencies. The Command Center is in direct contact with all local emergency services and will call 911 on your behalf. Failure to contact the Command Center may result in a significant delay in the response time of emergency personnel. If friends or family need to contact you and cannot reach you directly, they should call the Hynes Public Safety Command Center, which is staffed 24 hours a day, seven days a week at 617.954.2111.

Internet Café and Wireless Internet

Want to check email, access the conference app from your mobile device, or review the conference handouts electronically? Use one of the computers in the Internet Café, located in The Conference Connection on November 13-15, or connect your own device wirelessly on November 12-15. To access the Hynes free Wi-Fi, open your wireless network connection on any device and click on Hynes Wireless Network. No password is required. PRIM&R would like to thank HRP Consulting Group for their support of the Internet Café.

Lead Retrieval

In an effort to help facilitate connections between our attendees and supporters and exhibitors, PRIM&R offers these vendors a lead retrieval system for use in

their exhibit booth(s). While you’re in The Conference Connection, participating supporters and exhibitors may ask to collect your contact information by scanning the quick response (QR) code that appears on your name badge. The QR code stores your name, title, institution, email, and mailing address as it appears in our database. This service is optional and meant to be helpful to those looking to exchange information. If you do not wish to share your information, you may decline to have your badge scanned. Please visit the Help Desk in the Registration Area if you have questions.

Lost and Found

To inquire about a lost item or report a found item, please visit the Hynes Public Safety Command Center or contact 617.954.2111. You may also go to the following website, http://signatureboston.com/Attendee/Lost-and-Found.aspx.

“M” on Badges

The letter “M” on your badge designates your status as a member of PRIM&R. If there is no “M” on your badge and you would like to become a member, please visit the Help Desk.

Name Badges and Agendas

Please wear your name badge at all times. Visit the Personalized Agenda kiosk in the Registration Area to pick up a copy of your conference schedule (based on your selections at the time you registered).

an archive of stories from the research community

The People & Perspectives digital storytelling library includes video interviews, audio interviews, written narratives, and archived conference excerpts. The stories in this dynamic, growing collection cover the development of the eld of research ethics, as well as insight on speciic cases and projects.

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Announcements Networking Ribbons

Are you a first-time attendee, IRB administrator, IRB chair, IRB member, researcher, institutional official, university faculty member, or research subject/advocate? Then don’t forget to pick up these name badge ribbons in the Registration Area. Networking ribbons are designed to enhance community building and to help you connect with colleagues who share similar professional experiences.

Nursing Mothers

For those requiring a quiet and private space to pump during our conference, PRIM&R has set aside a room for your convenience. Please visit the Help Desk to obtain access to this room.

Onsite Photography

A professional photographer will be onsite to capture images from this event. Photos taken at this year’s conference may be used on our website and/or for other promotional purposes. If you do not wish to have your photograph taken and used by PRIM&R, please alert the photographer. The photographer has been instructed to honor the request of anyone not wishing to be photographed.

Personalized Conference Schedules

Visit the Personalized Agenda kiosk in the Registration Area to pick up a copy of your conference schedule (based on your selections at the time you registered). The Registration Area is located in Pre-Function Hall C on Level Two.

PRIM&R’s “Green” Initiatives

We’re doing our best to make the 2015 AER Conference another green PRIM&R meeting, and hope you’ll join us in our efforts! PRIM&R’s environmentally conscious initiatives include: using an electronic evaluation; providing a reusable tote bag; printing this guide using soy-based ink; and using a printer for this guide that runs entirely on wind energy. The Hynes uses only green cleaning products, recycled restroom paper products, and HEPA filters to contain dust particles. Their CONVENTIONS C.A.R.E. donation program allows event hosts to leave unused materials at designated locations after their event – diverting 73,000 lbs. of waste (2010), and benefiting charitable organizations.

Principles and Expectations for Participation at PRIM&R Conferences

The objective of PRIM&R’s educational programs and conferences is to provide a safe and respectful environment for attendees to increase their knowledge and understanding of ethical and regulatory requirements, learn best practices, grapple with both late-breaking

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and longstanding challenges, and confer with peers and experts in the research ethics field in a constructive way. PRIM&R is committed to being an impartial convener within the research ethics field, which encompasses people with a range of differing opinions. PRIM&R values freedom of expression, constructive and respectful dialogue, and spirited discussion, as these are essential to finding common ground and advancing the goal of responsible, ethical conduct of research with human subjects and animals. To preserve the objectives and integrity of its educational programming and conferences, PRIM&R will not tolerate the disruption of conference sessions that results in: • The inability for the learning objectives of sessions to be met • The inability for dialogue, discussion, debate, learning, and/or networking to take place • Harassment, badgering, or verbal threats • The use or threat of physical force by any individual or group of individuals against another • Destruction of property In the interest of promoting learning for all participants when asked on making comments, please keep as brief and on-point to them as possible, identify yourself when you speak, and be mindful of others who wish to participate in the discussion.

Registration Area Registration and the Help Desk are located in PreFunction Hall C on Level Two, and will be open during the following hours: • November 11: 3:00 PM-7:00 PM • November 12: 7:00 AM-6:00 PM • November 13: 7:00 AM-5:30 PM • November 14: 7:00 AM-5:00 PM (the Help Desk will remain open until 6:00 PM) • November 15: 7:00 AM-12:00 PM (the Help Desk will remain open until 3:00 PM) Also in this area is a kiosk where you can get a copy of your personalized conference schedule (based on your selections at the time you registered). Please stop by the Help Desk with questions, and a PRIM&R staff member will be happy to assist you.

Religious Observance and Prayer

For those requiring a quiet space to pray and/or observe other religious practices during our conference, PRIM&R has set aside Room 307 on the Level Three for this purpose. This room will remain open to all throughout the conference.

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Sessions

To keep the conference running on time, please familiarize yourself with the location of the sessions you plan to attend, so you can arrive promptly at the session’s start time. Maps are included in this guide, and our staff and Hynes Center Red Coats are ready to help with directions or with any questions you might have. Also, it’s important that you attend the sessions for which you pre-registered, as space is limited. Please refer to the schedule in this guide for more information

Session Materials To access session materials using the interactive schedule: 1. Visit bit.ly/aer15schedule. 2. L ocate the specific session on the full schedule by scrolling or using the search field. You can also search by clicking on the Conference Schedule, which allows you to browse by date, title, target audience, track, Affinity Group, or keyword. 3. If materials are available for a session, a document icon will appear next to or below the title of the session. 4. Click on the session title to access the materials. 5. You will need to enter the handout code found on your personalized schedule (this was also emailed to you before the conference). Alternatively, you can access conference handouts using the conference app: 1. Search for PRIM&R 2015 AER Conference in the iTunes app store or Google Play store. 2. Download the app. 3. Once you have set up your app account, click on the Presentations icon. 4. Browse by day, session title, speaker, or track to find the session you are looking for. Click on the session. 5. Sessions with materials available have either a Handout button or a View Slides button available. Please check the interactive schedule and conference app periodically, as additional materials are posted as they are received. Please note that not all sessions have handouts. You may print materials for any and all of the sessions that interest you. After the conference, audio and video recordings for designated presentations will be accessible through the interactive schedule.

Shipping, Fax, and Photocopy Services

FedEx Office, located in the Main Lobby on the Plaza Level, offers shipping, mailing, faxing, and photocopying services. The FedEx Office will be open 9:00 AM to 5:00 PM on November 12-15.

Special Meal Tickets

If you indicated a specific dietary request that requires a special meal, you should have received special meal tickets when you picked up your name badge. During lunch, please alert a server and turn in a ticket to ensure you receive your meal. If you lost or did not receive special meal tickets, or you forgot to include a dietary request during registration, please visit the PRIM&R Help Desk and we are happy to help.

The Conference Connection Join us in The Conference Connection—home to conference supporters and exhibitors, posters presentations, the charging lounge, internet café, the PRIM&R booth, coffee breaks, and receptions. The Conference Connection is located in Exhibit Hall C on the Second Level and will be open during the following hours: • November 13: 7:00 AM - 6:30 PM • November 14: 7:00 AM - 6:00 PM • November 15: 7:00 AM - 1:45 PM A map of The Conference Connection can be found on page 109 of this guide.

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conference information

Affinity Groups To help you connect with colleagues with similar responsibilities and interests at the 2015 AER Conference, PRIM&R hosts Affinity Groups (AGs). These small groups share areas of specialized professional interest, and are designed to foster networking and community building before, during, and after the conference. Color-coded networking ribbons are available to help members identify one another, based on the color of the AG titles below. 2015 AER Conference AGs Diversity: This AG is for individuals who are responsible for addressing the issue of diversity at their institution and in the research being conducted at that institution, who are interested in addressing the lack of diversity in the human research protections professions, and/or who want to engage around the question of why diversity is not directly addressed in the federal regulations governing human subjects research. Facilitators: Dorotha Love Hall, PhD, MPA, CIP; and Eric C. Mah, MHS, CIP Sessions: A3, A5, A13, A19, B6, B9, B10, B13, B19, B25, C9, C19, C20, C25, D3, D7, D19, E9, E17, E19, Innovations A, Panel I, Panel II, Panel VII Tracks: Advanced Forum for IRB Professionals, Educating and Training, IRB Chairs, Populations Requiring Additional Protections, Empirical Research Ethics, Global Research, Hot Topics, SBER II - Advanced, Potpourri, Ethical Issues, Non-Scientist IRB Members Global Research: This AG is for non-US-based research professionals and US-based professionals working outside North America who are interested in the conduct of ethical research across geographic and cultural borders. Facilitators: Karen M. Hansen; Samia Rizk, MD, MPH, MSc, CIP; and Henry Silverman, MD, MA Sessions: A9, A19, B9, B10, B19, B25, C9, D9, E9, Innovations A, Panel I, Panel II, Panel VII Tracks:Global Research, Populations Requiring Additional Protections, Hot Topics, SBER II - Advanced IRB Administrators/Coordinators: This AG is for IRB administrators and coordinators interested in networking with one another to discuss best practices, challenges, and solutions; share resources and strategies; and learn more about career development. Facilitators: Ashley Kuniholm, CIP, and James E. McNerney, JD, CIP, RAC Sessions: A1-A9, A12-A16, A18-A25, B1, B2, B4-B25, C1-C6, C8, C9, C11, C12, C14-C25, D1, D3-D9, D11, D12, D14-D25, E1-E9, E12, E14-E25, Innovations B, All Panels Tracks: All tracks IRB Chairs: This AG is for IRB chairs interested in engaging with each other about “hot button” issues and everyday aspects of their jobs. Facilitators: J. Andrew Bertolatus, MD; Julie M. Burgess, BA, CIP; and Patience Stevens, MD, MPH, CIP Sessions: A1-A9, A11-A16, A18-A25, B1, B2, B4-B19, B21-B25, C1-C6, C8, C9, C11-C25, D1, D3-D9, D11-D25, E1-E9, E11-E25, all Innovations, all Panels Tracks: All tracks Non-Scientist IRB Members: This AG is for non-scientist IRB members interested in discussing essential, basic scientific topics and strategies for IRB review, as well as connecting with others in this role. Facilitators: Dahron A. Johnson, BA, and Heather Carson Pearcy, JD Sessions: A1-A3, A6-A9, A12, A15-A19, A22, A24, A25, B1, B2, B4, B5, B7-B10, B12, B15-B17, B19, B20, B22-B25, C1, C2, C4-C6, C9, C12, C15, C16, C19, C20, C22, C24, C25, D1, D3, D4, D6, D7, D12, D16-D20, D22, D24, D25, E1, E2, E5, E17, E19, E20, E25, Innovations B, Innovations C, All Panels

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conference conference information information

Tracks: A Dialogue with the Feds I, A Dialogue with the Feds II, Advanced Forum for IRB Professionals, Empirical Research Ethics, Ethical Issues, FDA Regulations, Global Research, IRB Boot Camp, Issues Pharma/ Biotech, Legal, Non-Scientist IRB Members, Out-of-Body Experiences: Research Involving Tissue and Data, Populations Requiring Additional Protections, Research Involving the Internet and Social Networking, SBER I – Basic, SBER II – Advanced, Boundaries and Balance, Educating and Training, Hot Topics, Potpourri Small Research Programs: This AG is geared toward those working in small research programs, recognizing that “small” is typically a self-imposed designation, and may be used on one or more of the following bases: protocol workload, number of full-time equivalent (FTE) IRB staff, research budget, number of IRB members, and the character of the institution/researcher community. As a general guideline, a “small” research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff. Facilitators: Robert S. Bienkowski, PhD, CIP, CHRC; Greg E. Manship, D. Bioethics, MDiv, CIP, CIM; and Erica W. Tauriello, BA, CIP Sessions: A1-A6, A11, A12, A14-A16, A18-A23, B1, B2, B4-B13, B15-B19, B21, B23, C1-C6, C8, C9, C11, C14-C24, D1, D3-D9, D11-D14, D16-D23, E1-E4, E6, E9, E11-E17, E19-E21, E23, All Innovations, Panel I, Panel II, Panel IVPanel IX Tracks: A Dialogue with the Feds I, A Dialogue with the Feds II, Advanced Forum for IRB Professionals, Boundaries and Balance, Educating and Training, Empirical Research Ethics, Institutional Officials and HRPP Leadership, IRB Boot Camp, IRB Operations and Toolkit, Issues Pharma/ Biotech, Legal, Out-of-Body Experiences: Research Involving Tissue and Data, Populations Requiring Additional Protections, Potpourri, QA/QI and Post-Approval Monitoring, Research Involving the Internet and Social Networking, Small Research Programs, Ethical Issues, FDA Regulations, Global Research, Hot Topics, IRB Chairs, Non-Scientist IRB Members, SBER I – Basic Social, Behavioral, and Educational Research (SBER): This AG is for those involved and/or interested in the conduct and review of SBER. Facilitators: Candice M. Loeb, BA, CIP; and Katherine Lerner, JD, CIP Sessions: A3-A7, A9, A12, A16, A19, A22-A25, B2, B4-B6, B9, B12, B15-B17, B19, B24, B25, C4- C6, C19, C20, C22, C24, C25, D1, D7, D22, D24, D25, E1, E2, E17, E20, E24, E25, All Innovations, Panel III, Panel IV, Panel VI-Panel IX Tracks: Advanced Forum for IRB Professionals, Boundaries and Balance, Educating and Training, Empirical Research Ethics, Ethical Issues, Global Research, IRB Boot Camp, Legal, Populations Requiring Additional Protections, Research Involving the Internet and Social Networking, Small Research Programs, SBER I – Basic, SBER II – Advanced, A Dialogue with the Feds II, Issues Pharma/Biotech, Non-Scientist IRB Members, Potpourri, A Dialogue with the Feds I

2015 AER Conference AG Onsite Activities

Members of the AGs have access to the following onsite activities: • One-on-one meetings with AG facilitators (dependent on facilitator availability; please see your AG Facilitator welcome letter for information) • AG Peer-to-Peer Networking Continental Breakfast on November 13, 7:00-8:00 AM in Ballroom A • AER Conference Group Mentoring on November 14, 5:00-6:00 PM in Exhibit Hall D

Interested in participating in an AG at the 2015 AER Conference?

Visit the Help Desk located in the Registration Area and a PRIM&R staff member will happily assist you.

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conference information

Certificates of Attendance and Continuing Education Credit A certificate of attendance for the 2015 AER Conference will be distributed to those who complete the online conference evaluation, distributed via email at the end of each day. The certificate will be included on the final day’s evaluation, sent on November 15. Certificates of attendance for the pre-conference programs will also be distributed upon completion of the online evaluation for those programs. These will be sent on November 12. Certificates of attendance are useful for obtaining continuing education (CE) credits from various professional associations. Please note, each association’s guidelines for acceptance of conference credit hours may differ, and you should consult the appropriate association representative for information as to if, and how many, credits from PRIM&R’s 2015 AER Conference may be used for CE. Attendees of the conference can earn up to 20 hours of CE credit. Credit hours for the pre-conference programs vary.

CME Credit

Boston University School of Medicine designates this live activity for 20 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This program includes for 20 hours which meet the criteria of the Massachusetts Board of Registration in Medicine for risk management study. Upon conclusion of the conference, those seeking CME credits must complete an online survey (www.surveymonkey.com/r/PRIMR2015) distributed by Boston University School of Medicine, the CME provider for this event. Attendees must complete the online claim for credit and evaluation form within four weeks of the conference to receive a CME certificate. Once the survey is completed, Boston University will send you a CME certificate. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Sessions that meet CME credit requirements are designated with on the conference schedule. For questions about CME credit, please visit the Help Desk located in the Registration Area.

CIP® Recertification Credit

Credit hours from the 2015 AER Conference may be used by CIPs who are eligible to recertify by CE. Sessions that meet CIP® recertification requirements are designated with on the conference schedule. The conference is eligible for up to 20 credits that are accredited or have received advance recognition from the Council for Certification of IRB Professionals. Additional information on qualifying CE activities for CIP® recertification purposes can be found at www.primr.org/certification.

PRIM&R members enjoy a discount on all job postings.

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In pursuit of its mission to advance high ethical standard in the conduct of research with human subjects, PRIM&R offers scholarships to offset the cost of attending the AER Conference. These scholarships are available to those interested in the ethical conduct of research who may not otherwise be able to attend the conference. Scholarship awards vary and may include all or some of the following: registration fees, airfare, hotel accommodations, and a per diem stipend.

Scholarships are offered in three categories: Global Research Program

PRIM&R is dedicated to improving communication among research ethics committees (RECs), researchers, and other professionals involved in international research. This is especially important today as more and more research is being conducted outside of the United States. Many RECs in low- and middle-income countries lack adequate funding to develop their research programs, and thus may not be able to build strong research ethics oversight into these programs. Therefore, there is an urgent need to increase awareness and facilitate networking and collaboration among those involved in research globally.

Institutional Capacity Building Program

Many small, underfunded institutions of higher education in the United States need—and lack—fully functioning IRBs or HRPPs. Of these, many institutions support primarily minority populations with educational disparities, such as Historically Black Colleges and Universities, Hispanic-Serving Institutions, and Tribal Colleges and Universities. Others include health institutions serving minority populations with significant health disparities, such as community clinics, regional or area Indian Health

Boards, and tribal governments. In addition, many of these institutions are being asked to take on greater roles in research by participating in studies or initiating their own research activities. Warren Ashe, a former PRIM&R Board member and integral part of the development of this program, passed away in 2015. Read his obituary on page 104.

Community (Unaffiliated/Non-Scientific) IRB Member Program

Developed in response to feedback from advocates and IRB community members, the goal of this program is to ensure that unaffiliated and non-scientific IRB members receive equal educational opportunities to other IRB members, so as to develop and progress in their IRB service. This program extends educational and development opportunities to community members who are committed to advancing ethical research practices and to provide a networking base among collegial practitioners and peers. If you’re interested in supporting PRIM&R’s Scholarship Program with a donation, please visit the Help Desk in the Registration Area on Level Two. Information regarding next year’s scholarship opportunities will be available by April 2016.

Pillars of PRIM&R Award The Pillars of PRIM&R Memorial Fund underwrites the Pillars of PRIM&R Award, which recognizes early-career professionals whose scholarship and potential for leadership in the field of research ethics reflects PRIM&R’s mission and core values. In recognition of these accomplishments, awardees receive small grants to further their professional development. The 2015 Pillars of PRIM&R Award Recipient is Francis Kazungu Kombe, MPH. Mr. Kombe is a senior community facilitator in charge of training at the Kenya Medical Research Institute/Wellcome Trust Research Programme, and will use his grant to conduct an innovative project aimed at strengthening fieldworkers’ capacity to address practical and ethical challenges in their roles as frontline staff who maintain a strong link between research institutions and the communities in which they serve. In the long term, Mr. Kombe hopes that the outcomes of his project will contribute to a curriculum for fieldworker capacity building.

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conference conference information information

Scholarships

conference information

2015 ARENA Legacy Award The ARENA Legacy Award recognizes PRIM&R members who have made exemplary contributions to the mission and goals of PRIM&R by actively promoting the ethical conduct of research through mentoring, teaching, and leadership. This award was developed to honor not only those chosen, but also the living legacy created by the ARENA, the membership division of PRIM&R from 1986 to 2006.

PRIM&R is proud to announce that Karen N. Hale, RPh, MPH, CIP, has been selected as the 2015 recipient of the ARENA Legacy Award. Ms. Hale serves as the director of the Office of Responsible Research Practices and clinical assistant professor at The Ohio State University. Ms. Hale is responsible for overseeing administrative support services for the Ohio State research community and university review boards for research involving human subjects, animals, and biohazards. She also provides leadership for educational and quality improvement activities supporting accreditation of the university’s human and animal research programs. As noted by the PRIM&R member who nominated Ms. Hale: “ Karen Hale’s name is synonymous with education in human subjects research protections. She humbly and willingly shares her vast knowledge not only with those who are new to the field, but those with whom she teaches. Her unassuming demeanor and constant smile and laughter put others at ease, allowing them to soak up the information she shares.” These attributes have made Ms. Hale a go-to faculty member over the years and, as a result, PRIM&R has been the beneficiary of her many talents. Ms. Hale has led both preconference programs and breakout sessions at nine PRIM&R conferences, including this year’s 2015 AER Conference, where she is teaching session C8: A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for Studies Involving Drugs or Biologics. Ms. Hale has served in numerous conference planning roles for PRIM&R as well, including co-chair of the Core

Conference Planning Committee for the 2008 AER Conference, and as a member in 2006 and 2009. She also served as co-chair of the Workshop Didactic Subcommittee in 2007, and as a member in 2010 and 2011. In addition, Ms. Hale was the co-chair of the Breakouts-Advanced and Hot Topics Subcommittee in 2005. Since 2012, Ms. Hale has served on the Poster Abstract Subcommittee, where her review of submitted posters has shaped the content you see in the poster gallery at the AER Conference. In addition to contributing to our annual conferences, Ms. Hale has been a PRIM&R member since 2006, and has mentored hundreds of research professionals at her institution and beyond. In addition to the time she dedicates to PRIM&R, Ms. Hale is a member of SACHRP Subcommittee on Harmonization for the US DHHS, and serves as a consultant for the OHRP. She is a site visitor and former council member for the Association for the Accreditation of Human Research Protection Programs, Inc. Previously, Ms. Hale worked in The Ohio State University Wexner Medical Center Investigational Drug Service and served as vice chair of the university’s Biomedical Sciences IRB. Ms. Hale received her pharmacy degree and Master of Public Health from The Ohio State University and is a CIP®. She received a Distinguished Alumni Award from The Ohio State University College of Pharmacy in 2007. Ms. Hale’s commitment to PRIM&R and the field at large is undeniable, and our community of individuals working to advance ethical research is better for it. It is truly an honor to bestow this award upon her.

The 2015 ARENA Legacy Award will be presented to Ms. Hale on November 14 at 8:00 AM in the Veterans Auditorium at the Hynes Convention Center.

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November 13-16, 2016 Anaheim, CA

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Your Guide to the Pre-Conference Program

schedule

PRIM&R’s 2015 AER Pre-Conference Programs will be held on Thursday, November 12. Only those attendees who pre-registered are able to participate in these courses. Onsite Information

Attendees are encouraged to get breakfast on their own before the pre-conference programs begin. Coffee and tea will be served in the Boylston Hallway on the Level Two from 7:00 to 8:30 AM. A boxed lunch will be provided for all programs in Exhibit Hall D on the Level Two. Please review your course’s agenda, as lunch times differ for each course. All those registered for these courses are welcome to attend the Pre-Conference Programs Networking Reception from 4:30 to 6:00 PM in the Boylston Hallway on Level Two. Light refreshments will be served.

7:00 AM

Session Materials

We’ve Gone Paperless! PRIM&R is pleased to announce that the pre-conference educational handouts will be available online. An email from registration@primr.org with a link to access your materials and a password was sent to registrants before the conference. If you did not receive this email, please visit the PRIM&R Help Desk in the Registration Area, and we will provide you with your link and password. Pre-conference materials will be accessible online for up to one year after the conference.

Certificates of Attendance

Certificates of attendance for pre-conference programs will be provided to attendees upon completion of the online evaluation. A link to the evaluation will be sent to attendees via email on November 12. The number of continuing education credits differs for each course, and will be listed on the certificate of attendance.

Pre-Function Hall C

Registration Opens

Breakfast on your own. Coffee and tea only will be available in the Boylston Hallway on the second level.

8:30 AM-4:30 PM Room 203

Contemporary Issues in Biobanking: Forum on Research Involving Tissue and Biobanking – Domestic and International Considerations

Faculty: Mark Barnes, JD, LLM; Marianna J. Bledsoe, MA; Linda A. Ehler, RN, MN; William E. Grizzle, MD, PhD; Alberto (Betto) Antonio Ortiz-Osorno, MS, PMP, CIPM; Michele Russell-Einhorn, JD; Amelia Wall Warner, PharmD, RPh; and Aminu Adamu Yakubu, MPH.

8:30 AM-4:30 PM Room 210

IRB 101sm

Faculty: Susan S. Fish, PharmD, MPH; and Susie R. Hoffman, RN, BSN, CIP

8:30 AM-5:00 PM Room 204

QA/QI in Human Subjects Research

Faculty: Stanley Estime, CIP, CIP; Lisa Gabel, BA, CIP; Jennifer K.Graf; Nareg Grigorian; Leslie M. Howes, MPH, CIP; Kathleen Lawry, CIP; Eunice Yim Newbert, MPH; Jessica Randall, MA, CIP; Alyssa Knotts Speier, MS, CIP; Terry VandenBosch, PhD, RN, CIP, CCRP; Sarah H. White, MPH, CIP; and Delia Y. Wolf, MD, JD, MSCI, CIP

8:30 AM-4:30 PM Room 202

4:30-6:00 PM

Single IRBs Are Here: Are you Ready? Faculty: Jamin Alexander, BA; David G. Forster, JD, MA, CIP; Susan Z. Kornetsky, MPH; Pearl O’Rourke, MD Boylston Hallway, second level

Pre-Conference Programs Networking Reception

All those registered to attend a pre-conference program on November 12 are welcome to attend a networking reception immediately following the conclusion of their program. Light refreshments will be served.

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Your Guide to the Conference Schedule

Since there are so many choices, we advise you to use the descriptors to identify the breakout sessions that are most relevant to your needs and interests. As you consult these descriptions, please also note the following: 1. Double sessions are held over lunch and include a boxed meal. Attendees should pick this up at The Conference Connection located in Exhibit Hall D before arriving at the session. Please note that preregistration was required for these sessions to help ensure adequate seating. If you did not pre-register, but would like to attend, please go to the session room and wait until the session starts to see if seats are available. 2. The tracks are not meant to be exclusionary; everyone is welcome to attend any session. For example, feel free to attend a session in the Legal Track even if you’re not an attorney, or a session in the Small Research Programs Track even if you’re not affiliated with a small research program. 3. Sessions marked basic provide an introduction to the topic for those who have little or no prior knowledge of it. Teaching styles will be largely didactic. Focus will be on introducing, explaining, and illustrating basic concepts, principles, regulations, policies, or best practices relevant to the topic. Sessions in this track are designed for attendees new to the particular topic being discussed or individuals looking for a refresher on the fundamentals. 4. Sessions marked advanced assume mastery of central ethical concepts and principles, of the regulations, and of the processes of applying them to the day-to-day work of protocol review or other research oversight activities, and aim to provide attendees with the in-depth knowledge of an area and robust set of skills required for addressing difficult problems and navigating “grey

areas” in that area, improving their HRPPs, shaping their institutional cultures, or advancing their careers. Sessions will often make heavy use of active learning techniques, such as case studies and question-based lectures. Attendees are expected to have sufficient experience and understanding in order to actively contribute to discussion and the solution of difficult problems discussed. These sessions will not review basic concepts. 5. Sessions that do not have a learning level listed are intended for all audiences.

Icon Key Indicates a didactic session (lecture-based) Indicates a workshop (interactive) Indicates a double session (hybrid workshop/ didactic sessions; see note #1 about double sessions) Indicates session will be recorded for Conference Proceedings Qualifies for CME credit Qualifies for CIP® recertification credit Pre-registration required. Please visit the Help Desk to inquire about availability. Indicates a session chosen from our Call for Session Proposals

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schedule

The 2015 AER Conference features a wide variety of breakout sessions. To help you gain the most from your conference experience, and to make the breakout sessions easier to navigate, they are organized into 25 thematic “tracks” (see page 16 of this guide for more information on the tracks). Within the tracks, we offer three types of breakout sessions: workshops (interactive), didactic sessions (lecture-based), and double sessions (hybrid workshops/didactic sessions that are twice as long as the regular breakout sessions).

schedule

Your Guide to the Conference Tracks Recognition Conference Information TRACKS

DESCRIPTORS

1&2

A Dialogue with the Feds I and II

These tracks will provide attendees with an opportunity to hear from and ask questions of federal agency representatives.

Advanced Forum for IRB Professionals

This track will provide experienced IRB professionals with a series of sessions covering “hot button” issues and everyday aspects of their jobs.

Boundaries and Balance

This track will explore potential models for streamlining IRB processes through an examination of existing regulatory flexibility and best practices, and will explore health-related activities that are often said to occur along the imprecisely drawn borders of human subjects research.

Educating and Training

This track will help attendees develop effective educational programs for the assorted stakeholders involved in human subjects protections. In addition, the faculty members in each session will describe, and then discuss with the attendees, the various resources available for education and training.

Empirical Research Ethics Developed

This track will help attendees learn how to read and interpret empirical research ethics literature and make assessments on what counts as good research.

Ethical Issues

This track will explore the underlying ethical principles of human subjects research and issues for HRPPs/IRBs as they are translated from the theoretical to the human research setting.

FDA Regulations

This track will provide attendees with an opportunity to talk with representatives from the FDA and experts in the field about regulations and guidance pertaining to FDA-regulated clinical investigations.

Global Research Track

This track is designed for non-US-based research professionals and US-based professionals working outside North America. Sessions will examine issues relating to the conduct of ethical research across geographic and cultural borders.

Hot Topics

This track includes a variety of sessions that are current, complex, and/or late breaking.

Institutional Officials and HRPP Leadership

This track will provide institutional officials, IRB chairs, HRPP directors, and others with oversight responsibilities with an opportunity to discuss shared concerns, problems, strategies, best practices, and other useful innovations.

IRB Boot Camp

This track is designed for those new to the field of human subjects protections and IRB review and administration, or those in need of a refresher. IRB Boot Camp will provide a rigorous training in the elements of IRB operations that are key to successful HRPPs/IRBs and subject protections.

IRB Chairs

This track will provide IRB chairs an opportunity to gain new insight, exchange ideas, share best practices, and discuss strategies for becoming a successful IRB chair. The track will review the skills, additional education, and resources that can help IRB chairs excel in their role as chair while managing an efficient and effective IRB.

IRB Operations and Toolkit

This track is designed to provide IRB administrators, coordinators, and other professionals with practical tools and strategies to achieve administrative efficiency and effectiveness.

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Your Guide to the Conference Tracks DESCRIPTORS

Issues for Pharma/ Biotech

This track will provide representatives from HRPPs and drug, device, and biotechnology industries with an opportunity to discuss topics of mutual interest, including investigator-initiated research; clinical trials websites and social media; phase I/first-in-human pediatric studies; TransCelerate’s Risk-Based Monitoring initiative; and protocol deviations and violations.

Legal Track

This track will cover legal, legislative, and compliance issues. Participants will gain greater understanding of the role legal counsel can play within an HRPP, and how understanding and managing legal risks contributes to human subjects protections.

Non-Scientist IRB Members

This track will introduce non-scientist IRB members to basic scientific topics and foundational strategies for IRB review.

Out-of-Body Experiences: Research Involving Tissue and Data

This track will explore the complex and evolving ethical and regulatory issues for the collection and banking of biological specimens for both clinical and genetic research.

Populations Requiring Additional Protections

This track will explore issues related to vulnerable populations, including regulations, guidance, best practices, ethical principles, and community engagement. In addition, this track will redefine vulnerability by looking beyond populations recognized in the federal regulations.

Potpourri Track

This track consists of sessions addressing a variety of issues that may be novel and/or complex.

QA/QI and PostApproval Monitoring

This track will address current topics and issues faced by QA/QI programs, postIRB approval monitoring programs, or other institutional entities including how to set-up a QA/QI program, investigator site audits, assessing IRB compliance, novel methods, approaches, and tools, lean thinking.

Research Involving the Internet and Social Networking

This track will explore the risks, benefits, and challenges of using the internet and social media as research tools.

Small Research Programs

This track will address the special challenges faced by small research programs at entities such as community hospitals, colleges, and research institutions. The sessions in this track recognize that the designation “small” is typically self-imposed, and may be given on one or more of the following bases: protocol workload, number of FTE IRB staff, research budget, number of IRB members, and the character of the institution/researcher community. As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.

SBER I – Basic

This track will cover basic issues related to assessing risks and benefits, data streams and public health, exempt and expedited, research in the schools, and more.

SBER II – Advanced

This track will cover advanced issues related to the conduct and review of SBER, including scientific merit in qualitative research, student research, research investigating illegal behaviors, anonymity, confidentiality, and privacy, deception, and more.

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schedule

TRACKS

Schedule Recognition Conference Friday, November 13 schedule

7:00 AM

Pre-Function Hall C

Registration Opens

Breakfast on your own. Coffee and tea only will be available in The Conference Connection in Exhibit Hall C compliments of IRBNet. Grab-n-go breakfast items will be available for purchase at a food kiosk located near the Registration Area on Level Two. The kiosk will be open 7:00-10:00 AM.

7:00-8:00 AM

Room 302

Continental Breakfast to Welcome First-Time Attendees

Looking to connect and network with other first-time attendees before the conference starts? If so, please join us at this breakfast where you’ll have an opportunity to meet with colleagues, as well as hear answers to the top 10 most frequently asked questions about the conference from the PRIM&R staff.

7:00-8:00 AM

Ballroom A

Affinity Group (AG) Peer-to-Peer Networking Continental Breakfast

Join your AG facilitators and fellow members before the conference starts to connect and network! All attendees registered for an AG are welcome, and discussion questions for each group will be available to kick-start conversation.

8:00-8:15 AM

Veterans Memorial Auditorium

8:15-8:30 AM

Veterans Memorial Auditorium

8:30-9:15 AM

Veterans Memorial Auditorium

Welcome from the Conference Co-Chairs P. Pearl O’Rourke, MD; Laura Odwazny, JD, MA Welcome from PRIM&R’s Executive Director Elisa A. Hurley, PhD

eynote Address: Myth and Reality - An Insider’s Perspective on the Ethics of Healthcare K Research in Developing Countries.

Boghuma Kabisen Titanji, MD, MSc, PhD, Physician and Clinical Researcher, Ministry of Public Health, Cameroon 9:15-9:30 AM

Break

9:30-10:45 AM

Concurrent Plenary Sessions

Ballroom C

Panel I: From Ideal to Real: Post-Trial Access, Expanded Access, and Use of Ancillary Treatments Global Studies in Moderator: Robert J. Levine Panelists: Mark Barnes, Jerome Amir Singh, Michael A. Turik Global clinical trials are studies conducted in two or more countries around the globe, one of which may be the US and, usually, multiple countries are involved across two or more continents. Global research of this type must deal with a number of ethical challenges, three of which this session will explore: expanded access (sometimes referred to as compassionate use), post-trial access, and access to ancillary care. These topics will be discussed by three panelists representing varying perspectives: a physician from the pharmaceutical industry, an expert on multi-regional clinical trials, and an international bioethicist with experience in the developing world.

Ballroom B

Panel II: The Challenge of Research on Campus Sexual Violence: Ethical, Scientific, and Political Dimensions

Moderator: Claude Ann Mellins Panelists: Elizabeth A. Armstrong, Shamus Khan, Sharyn J. Potter Efforts to understand and address the troubling prevalence of sexual assault on college campuses have brought together college students, administrators, and scientists with varied agendas and diverse methodological backgrounds. This panel will offer data and perspectives on current research on campus sexual violence with reference to the challenges and barriers presented by this ethically complex and politically charged area of inquiry.

p rim&r’ s 20 1 5 2 adv i ns tianci tuting o nal e ti thh ani i cal m al re se c aarrc e a hncdon u sfee rceom n cm e i t t e e c on f e r e n c e

Friday, November 13

Veterans Memorial Auditorium

Panel III: Moving Targets: The Challenges of Responsible mHealth Research

Moderator: Camille Nebeker Panelists: Dror Ben-Zeev, Jeremy N. Block, Stanley Y. Shaw Over the past 10 years, mHealth technologies have increased dramatically with the proliferation of the smartphone, numerous apps, and other wearable data devices. The recent introduction of Apple’s “ResearchKit” and similar interfaces have made the rapid, widespread collection of personal health data possible on a scale and range unthinkable only a few years ago. This panel will discuss recent developments in mHealth research, highlight challenges for IRBs and researchers, including privacy and regulatory concerns, data reliability, subject perceptions of participation, and risks to subjects, and consider possible approaches to addressing these concerns.

10:45-11:15 AM Exhibit Hall C

Break

Join us for coffee in The Conference Connection compliments of iMedRIS.

11:15 AM– Innovations in… Series 12:30 PM Drawn from a rich pool of poster abstract submissions, the Innovations in… panel series features poster authors whose cutting-edge research and practices are advancing the field of human subjects protections. These sessions are loosely grouped around a specific theme, and each session features three posters selected from this year’s Poster Presentation Program.

Ballroom C

Innovations A: Innovations in Global Settings

Moderator: Nancy E. Kass Regardless of where research is conducted, issues may arise that require careful assessment and critical thinking in order to improve research operations and enhance subject protections. This panel will feature speakers from diverse global settings who will discuss their recent work navigating difficult issues and challenges related to the conduct of research, including, specifically, their work on research misconduct, student research, and informed consent in crisis situations. While the work being presented is specific to these countries and projects, the issues studied, data collected, innovations implemented, and lessons learned transcend their settings and will offer something to all those working within the research enterprise. The following posters will be presented during this session: •P OSTER #18: Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt Marwan T. Felaefel, American University in Cairo •P OSTER #47: Challenges Faced by the National Ethics Committee in the Review of Student Proposals: A Case of the Medical Research Council of Zimbabwe Muchineripi Richard Kanengoni, Medical Research Council of Zimbabwe •P OSTER #21: Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia Jerome F. Pierson, Office of Clinical Research Policy and Regulatory Operations, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, NIH •P OSTER #27: Establishing a Cancer Research Ethics Committee in Resource Limited Setting: Procedures, Challenges, and Lessons Learned Annet Nakaganda, Uganda Cancer Institute Veterans Memorial Auditorium

Innovations B: Innovations in IRB Operations

Moderator: Elyse I. Summers As research programs expand, collaborations become more frequent, and committee workloads increase, IRB offices are looking for new ways to facilitate the research review process. In light of this, efforts to streamline processes and procedures in order to create more effective operations, while still maintaining the highest standard for subject protections, are becoming increasingly common. This panel will highlight three initiatives carried out in the US aimed at improving research operations, including an evaluation of single patient exceptions to clinical trials, the creation of a Reliance Services Program to expedite industry-sponsored clinical trials, and the adoption of a flexible IRB model. The following posters will be presented during this session: •P OSTER #46: An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Exceptions to Clinical Trials in the Committee on Human Research Charles J. Ryan, University of California, San Francisco • POSTER #44: Innovation in IRB Reliance: A New Model Advances Multi-Site Research Rachael Sak, University of California Biomedical Research Acceleration, Integration, and Development •P OSTER #45: Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience Jon Newlin, North Shore-Long Island Jewish Health System n ove m b e r 12- 15 , b os t on , m a

schedules

Schedule Recognition Conference Information

schedules

Ballroom B

12:45-1:45 PM

Innovations C: Innovations in Subject Perspectives: Risks, Benefits, and Incidental Findings

Moderator: Steven Joffe The perspectives of research subjects can help to enhance our understanding of human subjects protections. Yet, many questions remain about what subjects think about certain aspects of research, as well as how their views on these topics inform their decision to participate in research. In this panel, three speakers will discuss their work to assess subject perspectives in relation to research protections, incidental findings in neuroimaging research, and the risks and benefits associated with a mHealth study, respectively.The following posters will be presented during this session: •P OSTER #58: “A Real Super Ethical Super Moral Perspective”: The Research Ethics of Research Participants Justin Snyder, Pennsylvania State University •P OSTER #12: “Ethical Responsibility” or a “Whole Can of Worms”: Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research from Focus Group Discussions With Participants, Parents, IRB Members, Investigators, Physicians, and Community Members Jody M. Shoemaker Roberts, University of New Mexico Health Sciences Center •P OSTER #13: Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a mHealth Study of Polydrug Use Alexis M. Roth, Drexel University School of Public Health Exhibit Hall D

Common Ground Networking Lunch

Time to connect… over lunch! Meet peers for conversation and networking. The tables will be divided by institution type: University/College (Medical), University/College (Non-Medical), Hospital/Medical Center, Government Agency, Pharma/Biotech Company, and, Small Research Programs. We will also have tables available for those wishing to “just lunch.” All are welcome.

12:45-1:45 PM

Ballroom A

Research Ethics Book Group Lunch and Book Signing: The Malaria Project: The US Government’s Secret Mission to Find a Miracle Cure

Participate in a vibrant discussion of The Malaria Project: The US Government’s Secret Mission to Find a Miracle Cure by Karen M. Masterson, a former political reporter for the Washington Bureau of the Houston Chronicle who left newspapers to pursue her interest in microbiology. In 2005, she won a Knight Journalism Fellowship to study malaria at the US CDC in Atlanta and in rural Tanzania. Attendees will have the opportunity to hear from and participate in a discussion with Ms. Masterson about her book and her work, and she will be available to sign books during this time. Ms. Masteron’s book is available in print and for the Kindle through Amazon.com, and copies will be available for purchase onsite at the conference Bookstore.

1:15-1:35 PM

Demonstration of PRIM&R’s E-ROC

Join us in the PRIM&R Pavilion for a demonstration of our interactive online course, E-ROC. During this brief overview, you will be introduced to this tool and how it can strengthen your understanding of the core regulations and underlying ethical principles of human subjects protections. If you are unable to join us for this presentation, but would like to learn more about E-ROC while onsite at the conference, please stop by the PRIM&R Pavilion or email Maeve Luthin, professional development manager, at mluthin@primr.org to set-up a one-on-one demonstration of this resource.

1:40-2:00 PM

Exhibit Hall C

Demonstration of PRIM&R’s Knowledge Center

Join us in the PRIM&R Pavilion for a demonstration of our online resource for members, the Knowledge Center, and its new annotated regulations feature. During this brief overview, you will see how you can use resources found in the Knowledge Center as continuing education tools at your institution. If you are unable to join us for this presentation, but would like to learn more about the Knowledge Center while onsite at the conference, please stop by the PRIM&R Pavilion or email Maeve Luthin, professional development manager, at mluthin@primr.org to setup a one-on-one demonstration of this resource.

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Friday, November 13 1:45-2:15 PM

Exhibit Hall C

Meet the 2015 AER Conference Poster Authors

1:45-2:15 PM

Exhibit Hall C

Meet the 2015 AER Supporters and Exhibitors

Network with this year’s conference Supporters and Exhibitors and learn about their important services.

1:45-2:15 PM

Exhibit Hall C

Do you have a specific question for FDA representatives? Do you have a follow-up question after attending a session with a FDA representation or on a FDA-related topic? If so, we encourage you to stop by the FDA Office Hours during this time, and representatives from the FDA will be available to help answer your questions.

2:05-2:20 PM

FDA Office Hours

Exhibit Hall C

Overview of PRIM&R’s Member Benefits

Join us in the PRIM&R Pavilion for a discussion of the many benefits that come with your PRIM&R membership. During this brief overview, you’ll learn about the ways membership pays for itself during the course of the year. If you are unable to join us, but would like to learn more about your member benefits (or becoming a member) while onsite at the conference, please stop by the PRIM&R Pavilion or email Megan Frame, membership manager, at mframe@primr.org to set-up a one-on-one discussion.

2:30-3:45 PM

Didactic Sessions and Workshops Series A

Room 107

A Dialogue with the NIH (A Dialogue with the Feds I Track)

Carrie D. Wolinetz This session will be led by representatives from the NIH. Attendees are encouraged to come with questions of interest to all. During this workshop, attendees will: • Hear from representatives of the NIH Office of Science Policy about activities that are pertinent to clinical research policy and the protection of human subjects in research • Participate in an open discussion about topics relevant to NIH stakeholders • Ask questions about new and ongoing initiatives at the NIH A2

Room 301

A Dialogue with the DOE (A Dialogue with the Feds II Track)

John Ordaz, Elizabeth P. White This session will be led by representatives from the DOE. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Participate in an open discussion of issues relevant to DOE stakeholders • Ask questions about new and ongoing initiatives at the DOE A3

Room 302

Advanced

Return of Results to Participants: Logistical, Ethical, and Regulatory Considerations (Advanced Forum for IRB Professionals Track)

Zachary Hallinan, Rebecca Li, Laurie Myers During this session, faculty will: • Review the current mandate for and operational issues attending to return of results to participants with an emphasis on patient centricity • Outline the principles of health literate communications and numeracy • Address the ethical challenges of return of results in the national and global context

n ove m b e r 12- 15 , b os t on , m a

schedules

Visit with the authors of the posters featured in the 2015 AER Conference Poster Presentation Program and learn about their innovative and important work on new program initiatives, empirical research, and conceptual analysis. The development and presentation of scientific and programmatic posters promotes interdisciplinary sharing and collaboration, and facilitates the exchange of ideas, information, and practical strategies for managing the many challenges faced by research professionals.

Schedule Recognition Conference Information A4

Room 304

You’ll Know it When You See it: Defining “Human Subjects Research” Under the DHHS

Regulations

(Boundaries and Balance Track)

schedules

Basic

Elizabeth Bankert, Julie Kaneshiro, Ada Sue Selwitz Evaluating whether an investigator is conducting research involving human subjects has many important ramifications for both the institution and the investigator in terms of cost, time, and requirements for the activity. Since interpretation of key definitions in the regulations – including “systematic,” “generalizable,” and “human subjects” can be tricky, thorough consideration is needed to ensure appropriate application of the regulations. During this session, faculty and attendees will : •D efine a process and a set of criteria for determining whether an activity is research according to the current federal regulations •E xplore key decision points for determining whether or not a research study involves human subjects according to the current federal regulations • Discuss proposed changes to the Common Rule’s definitions for “research” and “human subjects.” A5

Room 101

Recruitment Strategies: Sharing Our Secrets for Success (Educating and Training Track)

Albert J. Allen, Karen Christianson, Stavroula Osganian Recruitment for research is often difficult and poses many ethical and concrete challenges. In this session, faculty will share tips for successful subject recruitment, offer case examples of ethically complex recruitment situations, and discuss potential outcomes. Faculty will also discuss recruitment of populations that may require special considerations, such as non-English speaking subjects, prisoners, and high-risk populations. During this session, faculty and attendees will: • Share tips on successful recruitment strategies • Discuss if and when consent/assent is required during the recruitment process • Work through cases where recruitment is challenging and ethically complex A6

Room 111

How to Read the Empirical Ethics Literature (Empirical Research Ethics Track)

Robert M. “Skip” Nelson During this session, faculty will: • Discuss key aspects of research methods relevant to assessing empirical studies of ethical issues • Consider common logical fallacies in drawing conclusions from empirical data • Review and discuss an empirical study with a critical eye A7

Open – no session is scheduled for this slot.

Room 312

Special Topics for IRBs that Review FDA-Regulated Medical Device Investigations (FDA Regulations Track)

Dominic Chiarelli, Fabienne Santel There are some specific determinations that must be made by an IRB when they review a clinical investigation involving an FDA-regulated medical device. This session will cover special topics and situations encountered by IRBs when reviewing medical device studies and how best to address them to ensure subject safety, data quality, and regulatory compliance. During this session, faculty will: •E xplore FDA expectations of IRBs for certain device-specific situations, including IDE exempt, significant risk/ non-significant risk determinations, Expanded Access, and HUDs. •R eview examples of IRB 483 citations and warning letters where IRBs were not able to successfully address these situations. • Discuss IRB best practices in meeting FDA’s expectations for review of medical device studies.

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Friday, November 13 A9

Room 104

Different Models of Review: A Global Comparison (Global Research Track)

A10

Room 312

Proposed Changes: An In-Depth Discussion on the NPRM’s Section on Proposed Changes to

Informed Consent

(Hot Topics Track)

Heather H. Pierce, David H. Strauss A NPRM has been released, and it is important for those involved in research to have an awareness of the proposed changes and their potential implications for the field. This session will focus on the sections of the NPRM related to obtaining, waiving, and documenting informed consent, including provisions designed to ensure that only the most pertinent information is included in consent forms, the use of broad consent for research with biospecimens, additional elements of consent for some types of research, and new criteria for waivers of consent and its documentation. During this session, faculty and attendees will: • Review, briefly, the current rules on consent • Discuss what is being proposed in the NPRM and potential implications • Provide information on how to submit public comments on the NPRM A11

Advanced

A12

Basic

Room 203

Managing Intellectual Property Interests of Researchers and Institutions (Institutional Officials and HRPP Leadership Track)

Rupinder Grewal, Ross E. McKinney, Jr During this session, faculty will: • Discuss the potential challenges that arise for research designed to evaluate an invention/technology for which an investigator and/or the institution have intellectual property interests • Review when intellectual property interests may represent significant financial interests • Outline management strategies that may be employed to address and potentially mitigate conflicts of interest in these circumstances Room 306

Unanticipated Problems and Adverse Events: A Practical Approach for IRBs (IRB Boot Camp Track)

Kristina C. Borror, Jeffrey A. Cooper During this session, faculty and attendees will: • Define what is an unanticipated problem involving risk to subjects or others, and the overlap between unanticipated problems and adverse events • Use case examples to determine whether certain events should be considered unanticipated problems or an adverse events • Review the practical mechanisms for IRB receipt and review of reports of unanticipated problems and adverse events • Discuss strategies for managing and reporting adverse events, unanticipated problems involving risks to subjects or others, and other deviations from the original protocol • Share strategies for managing and dealing with adverse events, noncompliance, and expiring/expired protocols

n ove m b e r 12- 15 , b os t on , m a

schedules

Lama Jamhawi, Annet Nakaganda, Delia Y. Wolf, Rachel Zand Different countries have adopted different types of ethics review systems for health research. Such systems might include various combinations of structures that comprise local, regional, and national committees, and may involve different processes. For example: What is the relationship between national and regional committees? Does the national committee perform reviews and, if so, are the reviews restricted to certain types of research? What are the implications of different structures on issues such as the quality of such reviews, the turnaround time for reviews when multiple committee review the same protocols, and the implication for human resources? During this session, faculty and attendees will: • Review the different models of national ethics review systems • Discuss how context and concepts drive the structure and processes of different review structures • Consider how the structure of ethics review systems can affect functionality

Schedule Recognition Conference Information A13

Room 200

IRB Chairs and Members: Recruiting, Developing, Training, and Managing Board Members (IRB Chairs Track)

Advanced

schedules

Charlotte H. Coley, Sarah H. Kiskaddon, Eric C. Mah IRBs consistently struggle with identifying and retaining quality, committed IRB members, and are often in need of creative mechanisms for attracting new members or ensuring valued members will continue their service. During this session, faculty will: • Discuss best practices in identifying, recruiting, developing, and training IRB members and chairs • Describe succession planning strategies for leadership development of IRB chairs • Demonstrate how to work with institutional leadership to support IRB membership • Review various strategies to retain IRB members including member incentive programs

A14

Room 206

Considerations in the Selection of an Electronic Submission System

(IRB Operations and Toolkit Track)

Patricia A. MacCubbin, Nancy A. Olson Have you decided to move towards an electronic submission system, but are not sure where to start? This session will provide a detailed look at the various steps involved with an electronic system selection process and will provide guidance on what needs to be considered at each stage of the process. During this session, faculty will: •D iscuss methods for strategic planning to ensure the needs of various stakeholders are considered •R eview the logistics of electronic system selection including development of a formal request for proposals from external vendors and mechanisms for product evaluation • Provide insights on what must be considered when pursuing a packaged product versus a home grown approach

A15

Room 102

Investigator-Initiated Research: An Overview of Sponsor-Investigator Responsibilities and Tips

for Success at Your Institution

(Issues Pharma/Biotech Track)

George Gasparis, Cynthia M. Kern A sponsor-investigator is an individual who both initiates and conducts, alone or with others, an investigation that is under whose immediate direction the test article is administered, dispensed, or used. Investigators who become a sponsor-investigator, and institutions where investigator-initiated studies are conducted, must understand the regulatory responsibilities a sponsor-investigator assumes in such research. During this session, faculty will: •D iscuss the specific regulatory responsibilities a sponsor-investigator assumes when conducting investigatorinitiated research • Examine some of the challenges in meeting the regulatory requirements • Provide tips on processes the investigator and institution can implement to assist in meeting the regulatory requirements A16

Advanced

Room 309

State Law Issues in Online Research (Legal Track)

Elizabeth A. Buchanan, Julie M. Rusczek Research conducted through the internet and social media presents a number of unique challenges and questions for institutions, IRBs, researchers, and their legal counsel. Among the challenges is that participants may reside in any jurisdiction within the US, which raises questions about which state laws apply and when, and how to identify and comply with them. This session will focus on the issues in internet research most commonly posed or affected by state laws and variances in state laws. (Although internet research may also involve participants in countries outside the US, and consequently may raise issues under those countries’ laws as well, international law issues are not the focus of this session.) During this session, faculty will: • I dentify the most common state law issues that arise in internet research, including: definition of who is a “child” for consent/assent purposes; determination of when electronic signatures may be used in the consent process; assessment of what researcher-participant interactions constitute the “practice of medicine” and in what jurisdiction; and compliance with professional “duty to warn” obligations (such as of harm to self or others) and various obligations under state mandatory reporting rules (such as child and elder abuse reporting) •P rovide a framework for determining which state laws apply to a project and strategies for assuring compliance

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Friday, November 13 A17

Room 108

The Inside Scoop: What Every Non-Scientist Should Know (Non-Scientist IRB Members Track)

A18

Basic

Room 310

The ABCs of Genetics, DNA, and Related Research Issues (Out-of-Body Experiences: Research Involving Tissue and Data Track)

Stacey Donnelly, Laura Lyman Rodriguez, Susan Brown Trinidad, Melissa P. Wasserstein IRBs are reviewing an increasing number of research proposals involving genetic and genomic research. If genetic concepts and terminology are unfamiliar to you, or you’d like a primer on the state of the science and HRPP in genome-scale research, please consider attending. During this session, faculty will: • Review the basics of genetics, different types of genetic research, and how genetic research can contribute to improved health and healthcare • Identify the risks associated with genetic information and ways to protect subjects who participate in genetic research • Provide an overview of empirical research on patient and public perspectives on genetic research, including views about risk and informed consent

A19

Basic

Room 204

Defining Vulnerability: Regulations and Beyond (Populations Requiring Additional Protections Track)

Jeremy N. Block, Michelle Feige, Bruce G. Gordon, Irene E. Stith-Coleman In this session, faculty will give a basic overview of the regulations that cover vulnerable populations, and then discuss an expanded view of vulnerability beyond that outlined in the regulations, reframing vulnerability in the context of laws, policies, and processes in other fields. During this session, faculty will: • Review the basic regulations when doing research with vulnerable populations • Share examples of different types of vulnerabilities and explore how to think about these examples in the context of clinical research • Discuss the threshold questions an IRB should address before permitting research with these subjects • Go over examples of risks to subjects that may be different in nature or frequency for these subjects • Provide examples of how to incorporate additional protections into informed consent

A20

Room 110

The Intersection of Research Subjects Protections and Grants Management (Potpourri Track)

Debra Schaller-Demers Why do grants managers need to understand IRB policies and procedures? Why do IRB administrators need to understand grant submission and award acceptance policies and procedures? Often, the IRB and the Sponsored Program Office work in silos and neither may truly appreciate the processes, deadlines, and responsibilities of the other. In order to ensure timely communication with sponsors, compliant grant applications and progress reports, and audit-ready grants management records, it is best when both sides are in sync and can ensure grant congruency. During this session, faculty and attendees will: • Explore best practices for maintaining QA in grants management with regard to research subjects protections information • Share strategies for communicating more effectively with colleagues in order to achieve grant congruency and accurate records for both offices

n ove m b e r 12- 15 , b os t on , m a

schedules

Greg E. Manship, Veronica Todaro In this session, IRB members considered to be “non-scientists” will share their perspective about the who, what, where, why, and how of IRB membership. During this session, faculty and attendees will: • Outline the role of the non-scientist on the IRB and the importance of this role to the review process • Discuss first-hand knowledge and perspective of how the non-scientist can best contribute to the IRB • Share tips and tricks for being a non-scientist on the IRB

Schedule Recognition Conference Information A21

Nuts and Bolts of Investigator Site Audits (QA/QI and Post-Approval Monitoring Track)

Kelly Dornin-Koss, Jennifer A. Graf, Sarah A. White Investigator site audits are a hallmark of post-approval monitoring and are integrated into many IRB QA/QI programs. This session will introduce participants to the key concepts and practical strategies for developing investigator onsite audit activities. During this session, faculty will: • Provide an overview of the investigator site review/audit process • Address specific considerations of the investigator audit activity including, but not limited to: triggers for audits, sampling plans, grading/scaling onsite reviews, and who receives the report (the considerations will be compared/contrasted between multiple QA/QI programs) • Address how audits can be an opportunity for investigator education • Review practical and useful tools that sites can modify for their own use

schedules

Basic

Room 308

A22

Room 210

Ethical Issues in Research with Big Data

(Research Involving the Internet and Social Networking Track)

Liza Dawson, Miguel Hernan, Rachel Sachs Increasing amounts and types of data are collected on individuals through electronic means such as commercial databases, social media, GPS, and other sources of data. These large datasets have great potential for healthrelated research, but questions of public trust, privacy, identifiability of individuals or groups, and protection of public interest have yet to be fully explored. This session will summarize some key ethical issues and areas for further empirical and philosophical work related to big data. During this session, faculty will: •R eview the kinds of data sources that can be used in big data research and what questions about identifiability might emerge in using, combining, and analyzing datasets • Discuss current legal frameworks for privacy in data collection and use •D escribe the key ethical challenges for researchers, policy makers, and IRBs in establishing standards and guidelines for big data research • Highlight proposed solutions for participant protections, governance, and oversight

A23

Basic

Room 109

uilding and Maintaining an HRPP Within a Primarily SBER Institution With a Small B Research Portfolio (Small Research Programs Track)

Eric Allen, Shannon L. Harr This session will focus on the challenges of developing and maintaining an effective HRPP at an institution doing limited and primarily SBER. Topics will include: managing individualized and web-based training for IRB members and investigators, student-led research, informed consent waivers and alterations, research involving college students who are legal minors, and data security without encryption, and more. During this session, faculty and attendees will: •E xplore and outline how to establish and maintain an effective HRPP in an institution with a small SBER program • Identify proven strategies for engaging senior leadership, investigators, IRB members, and HRPP staff A24

Basic

Room 103

Best Practices for Assessing Risks and Benefits in SBER (SBER I – Basic Track)

Moira A. Keane, Yvonne Lau, Katherine Lerner This session will explore the unique characteristics of SBER and best practices for evaluating the types of risks and benefits that most commonly arise. During this session, faculty will: •D efine the criteria for evaluating risk (both magnitude and probability of harm – assessing the level of risk involves taking both into account), and address whether a study is “minimal risk” •O utline the types of risks that arise in SBER (including physical, psychological, social, and economic harms), and how risks in SBER differ from the risks typically encountered in biomedical research (e.g., social and psychological risks are time and situation-specific and very subjective) •D iscuss when a SBER IRB may need to obtain outside expertise to properly evaluate risk (e.g., input on appropriate data security procedures and SBER studies that involve the use of MRIs and other techniques more commonly associated with biomedical research) • Review methods IRBs can recommend to minimize risk to participants • Provide insight on how risk should be explained to potential participants in the informed consent process

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Friday, November 13 A25

Room 202

Advanced

Scientific Merit, Generalizability, and Risks in Qualitative Research: A Case Study Approach (SBER II – Advanced Track)

3:45-4:00 PM

Exhibit Hall C

Break

Join us for coffee, tea, and cold drinks in The Conference Connection.

4:00-5:15 PM

Didactic Sessions and Workshops Series B

Room 200

A Dialogue with the FDA (A Dialogue with the Feds I Track)

Richard Klein, Joanne R. Less, Diane M. Maloney, Catherine Parker, Kevin A. Prohaska, James F. Saviola This session will be led by representatives from the FDA. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from representatives of the FDA about new and evolving issues, initiatives, regulations, and guidance • Participate in an open discussion about topics relevant to FDA stakeholders • Ask questions about evolving issues and initiatives at the FDA B2

Room 104

A Dialogue with SACHRP (A Dialogue with the Feds II)

Jeffrey R. Botkin, David G. Forster, Julia Gayle Gorey, Michele Russell-Einhorn This session will be led by representatives from SACHRP. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from SACHRP representatives about evolving initiatives, issues, and guidance • Participate in an open discussion about topics relevant to SACHRP stakeholders • Discuss best practices currently under consideration by SACHRP • Ask questions of SACHRP representatives B3

Room 310

Reliance Agreements (Advanced Forum for IRB Professionals Track)

Jeremy J. Corsmo, Susan Z. Kornetsky During this session, faculty will: • Review different types of reliance agreements, including what to consider when drafting an agreement • Discuss the responsibilities of review when relying on different sites • Provide insight on how to educate investigators about their responsibilities when reliance agreements are used • Address considerations of IRB infrastructure in accommodating agreements B4

Room 311

Electronic Consent: A Discussion of the eConsent Experience, Ethical and Regulatory

Considerations, and IRB Review

(Boundaries and Balance Track)

J. Andrew Bertolatus, Donna A. Messner During this session, faculty will: • Review the use of electronic consent using computer-based, interactive approaches, including examples of eConsent processes • Discuss the use of “remote” consent • Outline the regulatory requirements of IRB review and consent documentation in the context of an electronic informed consent process and the regulatory acceptability of eConsent • Explore the potential ethical challenges of using electronic technology in streamlining the informed consent process

n ove m b e r 12- 15 , b os t on , m a

schedules

Julie Simpson, Matthew D. Stafford Using case studies, this session will provide strategies IRBs can use in assessing scientific merit, generalizability, and risk in SBER. During this session, faculty and attendees will: • Review a quick study guide with regard to the types of qualitative research methods • Discuss strategies for assessing scientific merit and generalizability in qualitative research • Identify risks to subjects and affected populations in qualitative research • Share IRB training resources

Schedule Recognition Conference Information B5

schedules

Room 110

Advanced

Emily E. Anderson, Joan E. Sieber In this session, strategies will be presented for developing and delivering IRB member education that highlights empirical research on key research ethics topics and that encourages incorporation of evidence into IRB decisionmaking. Participants will be introduced to “research on research ethics,” and shown how to find articles that relate to issues commonly debated by IRBs that can be informed by empirical data (e.g., the potential for participants to experience emotional distress from participating in research on traumatic experiences). Resources available to PRIM&R members via the PRIM&R website and through a partnership with the Journal of Empirical Research on Human Research Ethics will be highlighted, and sample articles will be provided along with talking points and potential discussion questions. During this session, faculty and attendees will: • Identify research articles relevant to issues commonly debated by IRBs that can be informed by empirical data • Develop summaries of empirical research articles for IRB member educational purposes • Develop discussion questions about empirical research articles for IRB member educational purposes

Strategies for Using Empirical Research Articles for IRB Member Education (Educating and Training Track)

Room 204

Enhancing the Responsible Conduct of Adolescent and Young Adult Health Research Through

Empirical Studies on Research Ethics

(Empirical Research Ethics Track)

Erin E. Bonar, Celia B. Fisher, Faith E. Fletcher This session will feature presentations describing empirical studies on research ethics issues that can help IRBs evaluate human subjects protections for health research involving adolescents and young adults. The research described draws on the perspectives of adolescents and parents to illuminate opportunities and barriers to the responsible conduct of HIV, drug use, and mental health research. During this session, faculty will: •R eview how mixed-method research (surveys and interviews) can illuminate best practices for assessing risks and benefits and protecting confidentiality in mHealth-based research on drug use and sexual risk among emerging adults •D escribe how empirical data on African American mothers’ and daughters’ attitudes toward adolescent participation in HIV biomedical prevention trials can inform IRB evaluations of research vulnerability. •O utline how to evaluate ethical justifications for requests to waive guardian permission using data from an innovative, web-based, asynchronous focus group methodology that examined ethical barriers and facilitators to lesbian, gay, bisexual, and transgender youth participation in HIV prevention medication adherence trials B7

Room 301

Ethical and Regulatory Issues in Controlled Exposure Studies

(Ethical Issues Track)

Daniel K. Nelson, Toby L. Schonfeld Controlled exposure studies, in which human volunteers are intentionally exposed to pollutants under controlled condition, are critically important for protecting public health, but present unique challenges for ethical review and oversight. The goal of these studies is to establish air quality standards, rather than clinical interventions, when there is no prospect of benefit to study participants. During this session, faculty will: • Describe issues related to risk-benefit analysis of controlled exposure studies •D etail a variety of related ethical issues, including informed consent, regulatory oversight, and compensation

Room 202

What Are Combination Products and How Are they Regulated by the FDA? (FDA Regulations Track)

Thinh X. Nguyen Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. During this session, faculty will: • Provide a general overview of how combination products are defined and regulated by the FDA • Present examples of combination products and test the knowledge of what attendees learned • Share resources for IRBs that oversee studies involving combination products

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Friday, November 13 B9

Room 313

(Global Research Track)

Latifa Adarmouch, A. Cornelius Baker, Henry Silverman, Jerome Amir Singh To ensure that marginalized, vulnerable populations have equitable access to health services, they need to be included in important health services research. Such groups include refugees, internally displaced persons, orphans, lesbians, gays, bisexuals, transgender people, sex workers, individuals with drug addiction, and others who suffer from social exclusion. Key questions include: What are the ethics of doing research with these populations when identifying them could lead to stigma or legal and political repercussions, but not doing the research can leave such populations at greater risk of health disparities? What are the risks to these populations and to investigators when a country has a poor record involving human rights? During this session, faculty and attendees will: • Discuss the ethical issues when performing research on marginalized, vulnerable populations • Describe how risks can be minimized • Review the process of obtaining ethics approval B10

Room 309

Clinical Research During the Ebola Epidemic: Recommendations from the Presidential

Commission for the Study of Bioethical Issues (Bioethics Commission)

(Hot Topics Track)

Kata L. Chillag, Elizabeth Fenton, Christine Grady The suffering and mortality brought about by the recent Ebola epidemic in western Africa created a demand for accelerated clinical research to test experimental preventative, diagnostic, and therapeutic interventions. Conducting clinical research in the midst of an ongoing public health emergency, and in a context of poverty and limited health infrastructure, raises numerous ethical challenges. This session will present the Bioethics Commission’s findings and recommendations on these complex ethical challenges from its brief, Ethics and Ebola: Public Health Planning and Response, focusing on the use of placebo controls in clinical trials for experimental Ebola vaccines and treatments, and the collection, storage, and international sharing of biospecimens for future research. During this session, faculty will: • Describe the ethical complexities of conducting research during a public health emergency • Discuss the Bioethics Commission’s recommendations on clinical research during the recent Ebola epidemic and their broader relevance for those involved in conducting or reviewing clinical research in advance of or during a public health emergency • Address the importance of ethics preparedness for public health emergency response, including conducting clinical research B11

Room 101

Ethical and Operational Issues Related to Clinical Trial Billing: What Do HRPPs and IRBs Need to Consider Basic (Institutional Officials and HRPP Leadership Track) Keren R. Dunn, Scott J. Lipkin, Sujatha Sridhar During this session, faculty will: • Review the Centers for Medicare and Medicaid Services (CMS) Clinical Trial Billing requirements • Examine the implications of the CMS requirements as they apply to the ethical review of research • Illustrate best practices to integrate Medicare Coverage Analysis with IRB review of research

B12

Basic

Room 210

Tools, Templates, and Checklists: Resources to Improve IRB Operations (IRB Boot Camp Track)

Lois Brako, Sharon Freitag, Megan Kasimatis Singleton Institutions and IRBs are often in need of new resources to help streamline the IRB application and review process and ensure all requirements for human subjects protections are appropriately addressed. During this session, faculty and attendees will: • Go over the resources compiled in PRIM&R’s Knowledge Center • Review various types of checklists and how they can be used in the IRB review process and by investigators • Discuss the use of templates for IRB applications, consent, and other processes • Describe other tools including: guidance, policy documents, and standard operating procedures • Share how IRB personnel can identify, access, and customize existing resources for use by their own IRB • Address the shortcomings of these resources and mechanisms for avoiding over-reliance on them during implementation

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Advanced

Recruiting Marginalized, Vulnerable Populations into Health Research: Issues in

International Research

Schedule Recognition Conference Information B13

schedules

Room 306

Advanced

B14

Basic

B15

Evaluating Members, Chairs, and Staff: What Works, What Doesn’t? (IRB Chairs Track)

Robert W. Frenck, Yvonne K. Higgins One critical aspect of managing IRB membership is the IRB member performance review process. Continuous QI is the hallmark of a model IRB, but how does an institution evaluate its IRB members? What are the political/ environmental considerations and change management strategies to consider when evaluating IRB members and chairs? During this session, faculty will: • Identify methods for evaluating members, chairs, and staff • Review different types of evaluation processes in IRBs •P rovide insight on feedback systems that work and ones that don’t, including strategies for using the IRB member performance appraisal process as a method for identifying member needs and increasing retention Room 109

Managing Subject Complaints (IRB Operations and Toolkit Track)

Stephanie Collins Reed, Ilene Frances Wilets During this session, faculty and attendees will: • Review a step-by-step process for addressing subject complaints, allegations, or questions •E xplore how to apply and adapt a standard operating procedure for managing subject complaints using case studies from biomedical and behavioral research • Share guidance for determining the legitimacy of a complaint or allegation • Discuss the special considerations for complaints from at-risk and marginalized study subjects Room 111

Is Facebook Hurting Your Study? Ethical and Study Integrity Concerns When Participants Use

Social Media

(Issues Pharma/Biotech Track)

Elizabeth A. Buchanan, Lindsay McNair With the ever-increasing use of social media, study participants are just one of many groups becoming increasingly connected online. The proliferation of interactions and opportunities for inter-subject discussions have raised concerns with researchers and research sponsors that discussion about adverse events and the perceived efficacy of investigational drugs could introduce bias in the conduct of clinical studies. Comparison of trial experiences and personal information can even lead to inadvertent or intentional unblinding during studies. During this session, faculty will: • Discuss the benefits and challenges of study participant communication through social media platforms • Explore implications to the study conduct and data validity when participants share study experiences •R eview specific tools and techniques for participant education, including the Center For Information and Study on Clinical Research Participation’s “Speak Out, but Speak Smart” website and videos B16

Basic

Room 103

Certificates of Confidentiality (CoCs): When, Why, and So What?

(Legal Track)

Ann Hardy, Julia Hesse, Leslie E. Wolf CoCs are often an area of confusion and consternation for investigators and IRBs. Determining when a study warrants one and what the process is for obtaining one are only the first steps. Confusion and misinformation also exist as to the scope of protection offered by this document. During this session, faculty will: •D efine the scope of legal protection and privilege afforded to researchers under a CoC, including a review of the applicable regulations and federal guidance • Review when it would be prudent to obtain a CoC and how to avoid potential pitfalls when implementing one • Outline how a CoC interfaces with state requirements • Share strategies for defending a CoC if challenged •D iscuss the implications for informed consent and how a CoC interfaces with other protective laws and possible disclosures • Address issues and differences specific to CoCs and Privacy Certificates issued by FDA and the Department of Justice (from CoCs issued by NIH)

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Friday, November 13 B17

Room 203

Basic

Michelle Feige, Nancy A. Olson, Veronica Todaro When it all sounds like Greek, how does the non-scientist IRB member know when to be concerned? This session will address the potential red flags to be aware of when reviewing a study protocol. During this session, faculty will: • Identify problematic areas of protocols • Define specific issues for methodological consideration in IRB review • Provide suggestions for the non-scientist IRB member when reviewing challenging protocols

B18

Room 302

Tissue Research Now and in a Potential Post-NPRM World (Out-of-Body Experiences: Research Involving Tissue and Data Track)

Stacey A. Donnelly, Julie Kaneshiro, P. Pearl O’Rourke The ability to de-identify tissue (and to some degree data) is being challenged; contributors include the explosion of genetic data, as well as the increased use of big data and the power of data aggregation. The NPRM, in fact, proposes that all biospecimens should be treated as human subjects research. What are the implications of the proposed changes for consent and waivers of consent? During this session, faculty will: • Address the difficulty of defining identifiability • Review the implications of considering all tissue identifiable • Outline the various options for consent/permission • Explore possible conditions for waiving consent • Discuss the proposed changes in the NPRM on biospecimens in research and consent, and implications for the field B19

Room 206

Research With and About Gender and Sexual Diversity (GSD) (Populations Requiring Additional Protections Track)

Sean Cahill, John A. Guidry This session will explore a variety of considerations and challenges when conducting research with and/or about GSD. During this session, faculty will: • Examine the special considerations study teams should address when designing a study involving individuals across the spectrum of GSD • Discuss complex issues such as how to assure confidentiality, balancing concerns about stigma, and avoiding pathologizing • Outline additional risks such as violence, discrimination, depression, and suicide • Explore unique considerations particular to recruiting and maintaining contact with subjects from these populations B20

Room 312

It’s Here! A Review of the NPRM (Hot Topics Track)

John R. Baumann, Katherine Gallin Heffernan, Andrew Rusczek A NPRM has been released, and it is important for researchers, institutions, IRBs, and other stakeholders involved in research to have an awareness of the proposed changes and their potential implications for the field. During this session, faculty will: • Review the history of human subjects protections regulations in the US leading up to the NPRM • Outline key proposals from the NPRM • Provide commentary on the implications of those proposals if adopted • Address how to review and submit comments on the NPRM

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Identifying Red Flags: Research Review for the Non-Scientist IRB Member (Non-Scientist IRB Members Track)

Schedule Recognition Conference Information B21

Room 308

Nuts and Bolts of Assessing IRB Compliance (QA/QI and Post-Approval Monitoring Track)

schedules

Basic

Lisa Buchanan, Susan A. Corl, Lisa Denney This session will introduce attendees to the various activities QA/QI programs can implement to assess IRB compliance with federal, state, and local requirements for research. During this session, faculty will: •P rovide considerations and mechanics for QA/QI review of IRB files, meeting minutes, and membership composition • Identify triggers that may prompt QA of the IRB • Discuss approaches to self-auditing HRPP offices, including techniques and timing • Review training approaches for QA/QI staff conducting QA of the IRB • Outline corrective and preventive actions that can be used to address IRB noncompliance

B22

Room 304

The Internet and the IRB: A Review of Human Subjects Issues in Technology-Based Research

(Research Involving the Internet and Social Networking Track)

Advanced

Brenda Curtis, Abby E. Rudolph Human subjects research that uses technology-based interventions (TBIs) have been increasing steadily. TBIs constitute research delivered via computer, internet, or mobile devices, and many of these interventions involve social networking sites either at the recruitment or intervention delivery phase of research. In addition, researchers are developing their own smartphone apps that include location-based technologies. This session will update participants on recent forms of TBI research and the attitudes and perspectives of research participants with regard to technology. Discussion will focus on IRB review of three major areas of ethics concern: privacy and confidentiality, informed consent, and validity of data collected in general and in research on socially and legally sensitive areas. Participants will discuss specific case examples of TBIs. During this session, faculty and attendees will: •R eview human subjects research that uses TBIs and the specific challenges this presents for privacy and confidentiality, informed consent, and validity of data collected •S hare guidelines and strategies for protecting privacy and confidentiality, providing adequate consent information, and validating the nature of data collected • Explore how to develop IRB decisional strategies for reviewing research utilizing TBIs

B23

Room 107

Tactical and Strategic Planning for Small IRBs (Small Research Programs Track)

Parker Nolen, Dale E. Theobald Using concepts grounded in strategic management theory and real-life examples of IRB transformations, this session will provide small IRBs with tips and tools on how to make the local IRB a legitimate option to sponsors. This topic is intended not only for hospital- or clinic-based IRBs, but also academic centers who still struggle with meeting or exceeding performance metrics of commercial IRBs. During this session, faculty and attendees will: • Identify key elements that impact IRB efficiency •R eview cost and revenue curves and ways to maximize revenue while minimizing cost (i.e., measure the economic cost/benefit of the IRB to the organization) •S hare potential strategic opportunities for positioning your local IRB as economically viable and competitively advantageous B24

Basic

Room 108

Data Streams, Behavioral Research, and Public Health (SBER I – Basic Track)

Camille Nebeker, Matthew D. Stafford This session will provide an overview of emerging public health research and the ways in which social media, mobile applications, and big data technologies are being employed. During this session, faculty will: •D iscuss the different types social media, mobile applications, surveillance tools, and big data technologies, how they’re being used in public health research, and the challenges they pose to the IRB • Describe different approaches to intervention research via ambulatory assessment methodologies •R eview the ethical concerns around privacy and risks as it relates to public health research and the use of new technologies

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Friday, November 13 B25

Room 102

IRB Revolt: Navigating and Negotiating Undergraduate Human Subjects Research Projects

B26

Basic

Room 305

5:15-6:30 PM

7:00-9:00 PM

Rebecca D. Armstrong, Leah A. Carroll At many institutions, undergraduate students learn how to conduct research and their first forays into the field often involve going back to their home communities and experiences in life. In areas where students come from underrepresented or marginalized groups, some very risky research projects are proposed. During this session, faculty will: • Describe the process in terms of players involved – individuals and their offices – in negotiating a resolution to the IRB/undergraduate researcher crisis • Identify and share strategies developed by an IRB, IRB staff, and an undergraduate research office (URO) to facilitate undergraduate human subjects research projects to better ensure the protection of research subjects • Share lessons learned by an IRB and an URO • Review a university’s continuous improvement of interaction in support of undergraduate investigators conducting human subjects research

A Dialogue with the DOC Human Subjects Protection Office: NIST Is Leading the Effort (A Dialogue with the Feds II Track)

Anne M. Andrews , Laura A. Baxter, Linda Beth Schilling NIST is the primary agency within the DOC conducting human subjects research. NIST continues to develop intramural, extramural, and collaborative research efforts in the area of human subjects research. During this session, attendees will: • Learn about evolving initiatives, issues, and guidance from NIST regarding their new Human Subjects Protection Office • Review specific requirements involved in conducting DOC/NIST sponsored research • Discuss best practices for collaborating with DOC/NIST Exhibit Hall C

2015 AER Welcome Reception with the Supporters and Exhibitors

Join us in The Conference Connection to celebrate the opening of the 2015 AER Conference. During this time, you’ll be able to meet our conference Supporters and Exhibitors, view the Poster Presentations, and receive a complimentary mini-massage. The Diversity Advisory Group will be available during the reception to network, answer questions, and provide guidance. Look for the Diversity Advisory Group Meet Up sign. Light refreshments will be served. PRIM&R would like to thank Schulman IRB for their support of the drink tickets at the Welcome Reception. Back Bay Social Club

Young Professionals Networking Reception

Connect with other young professionals interested in research ethics and relax after a busy day in Boston at the Back Bay Social Club, located on Boylston Street across the street from The Hynes Convention Center. Don’t forget to bring the drink ticket you received with your registration materials! While all attendees are welcome, complimentary drink tickets are reserved for young professional registrants.

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Advanced

(SBER II – Advanced Track)

Schedule Recognition Conference Information Saturday, November 14 schedules

7:00 AM

Pre-Function Hall C

Registration Opens

Breakfast on your own. Coffee and tea will be served in The Conference Connection in Exhibit Hall C, compliments of IRBNet. Grab-n-go breakfast items will be available for purchase at a food kiosk located near the Registration Area on Level Two. The kiosk will be open 7:00-10:00 AM.

7:00-8:00 AM

Ballroom A

CIP® Continental Breakfast

Interested in earning your CIP credential? Want to connect with other CIPs? Attend this continental breakfast to learn more about the credential, meet representatives of the Council for Certification of IRB Professionals, network with fellow CIPs, and ask questions of those already certified.

8:00-8:15 AM

Veterans Memorial Auditorium

Welcome from the Conference Co-Chairs P. Pearl O’Rourke, MD; Laura Odwazny, JD, MA

8:15-8:30 AM

Veterans Memorial Auditorium

Presentation of PRIM&R’s ARENA Legacy Award to Karen N. Hale, RPh, MPH, CIP, Director, Office of Responsible Resesarch Practices, The Ohio State Univesity Presented by Elisa A. Hurley, PhD, Executive Director, PRIM&R

Presentation of Pillars of PRIM&R Award to Francis Kombe, MPH, Senior Community Facilitator, Kenya Medical Research Institute Presented by Elisa A. Hurley, PhD, Executive Director, PRIM&R

8:30-9:15 AM

Veterans Memorial Auditorium

Keynote Address: Big Data and Human Subject Sendhil Mullainathan, PhD, Professor of Economics, Harvard University

9:15-9:30 AM

Break

9:30-10:45 AM

Concurrent Plenary Sessions

Veterans Memorial Auditorium

Panel IV: Picked Out of a Crowd: Privacy and Re-Identification Research

Moderator: Laura Odwazny Panelists: Jim Adler, Madeleine Price Ball, Michelle N. Meyer Some research protocols are designed to explore the limits of existing privacy and confidentiality protections; in particular, research attempting to re-identify supposedly de-identified data sets. These “proof of concept” projects involve re-identification risks to living individuals. What kinds of research are being conducted, and what are the ethical and regulatory issues presented by such research proposals? How should the IRB consider the risk-benefit calculus for research designed to identify an individual who may have no reason to believe that such re-identification is possible? Should subjects’ expectations of privacy be managed to acknowledge this possibility? If significant vulnerabilities that might be very difficult to correct are discovered, how should they be publicized, if at all? What obligations should be placed on the researchers conducting such research, and who should be responsible for any resulting harms to subjects? The panelists will examine the ethical tensions raised by re-identification research and share their perspectives as to how researchers and IRBs should address the relevant concerns.

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Saturday, November 14

Ballroom C

Panel V: Editing the Human Germline: The Promise and the Peril

Moderator: Carol Juliet Weil

Ballroom B

Panel VI: Presenting Risks and Potential Benefits to Prospective Human Subjects

Moderator: Ivor A. Pritchard Panelists: Lynn A. Jansen, Scott Y. H. Kim, Alan R. Tait Enormous attention is paid to what will be disclosed to prospective subjects as the risks of participating in research studies, while what is disclosed as the potential benefits of research generally receives less attention. The concern is about how these disclosures may influence prospective subjects’ decisions about whether to participate in research. At the same time, some researchers and others in the field worry these disclosures may serve to exaggerate the risks of research and impede enrollment. This session will consider how the risks and potential benefits of research are identified (e.g., What counts as risks or potential benefits of research? How should we decide, for example, whether compensation or feelings of altruism due to participation should be included?), and explore how people understand information about risks and potential benefits of research.

10:45-11:15 AM Exhibit Hall C

Break

Join us for coffee and tea in The Conference Connection in Exhibit Hall C, compliments of Tech Software/ IRB Manager.

10:45-11:15 AM Pre-Function Hall C

Book Signing with Authors and Panel II Speakers Elizabeth A. Armstrong and Shamus Khan

11:15 AM- 12:30 PM

Didactic Sessions and Workshops Series C

Room 200

Join us at the onsite Bookstore in Pre-Function Hall C for a book signing with authors and Panel II speakers Elizabeth A. Armstrong and Shamus Khan. Copies of Drs. Armstrong and Khan’s books are available online, as well as at the onsite Bookstore.

A Dialogue with Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)

(A Dialogue with the Feds I Track)

Elizabeth Fenton, Nicolle Strand This session will be led by representatives from the Bioethics Commission. Attendees are encouraged to come with questions of interest to all. In this session, attendees will: • Hear about the Bioethics Commission’s latest work • Review topics relevant to Bioethics Commission stakeholders, including: the Bioethics Commission’s recent recommendations concerning (i) ethical challenges of the public health response to the Ebola epidemic (including research ethics challenges) and ethics preparedness for future public health emergencies, and (ii) topics at the intersection of neuroscience, ethics, and society, including research with participants with diminished consent capacity; the Bioethics Commission’s current project on deliberation and bioethics education; and new Bioethics Commission educational materials • Participate in a question and answer session with Bioethics Commission staff

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Panelists: Misha Angrist, Joanna Smolenski The human genome harbors the building blocks for all human inherited traits, as well as the formulas for creating life. However, what if something goes wrong? Can it be fixed? Scientists have developed gene editing technology with the goal of changing mutated genetic segments to prevent or treat disease. A remarkable new technology for gene editing, called CRISPR/Cas9, is so simple and cost-effective that researchers say human trials to fix genetic conditions could be just a few years away. However, editing the genome, particularly germline editing, would have profound implications for the future of humanity and the planet. Given the ethical concerns gene editing techniques raise, in March 2015, scientists called for a moratorium on germline editing in Nature saying, “scientists should agree not to modify the DNA of human reproductive cells” because it “could have unpredictable effects on future generations.” This session will explore the ethical challenges associated with research involving germline editing, including public engagement versus self-regulation in setting scientific priorities, and distributive justice between generations (benefits to current persons versus unknown risks to future populations). This session will also consider the relative risks and benefits of proceeding with research involving modification of the human germline, including clinical and therapeutic applications of gene editing technologies.

Schedule Recognition Conference Information C2

Room 107

A Dialogue with the ORI (A Dialogue with the Feds II Track)

schedules

Kristen Grace, Loc Nguyen-Khoa This session will be led by representatives from ORI. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Participate in an open discussion of issues relevant to ORI stakeholders • Ask questions about new and ongoing initiatives at the ORI Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D before the session. C3

Room 104

Conflicted About Conflicts of Interest (COIs): When IRBs Don’t Know About or Disagree with Investigator COI Management Plans Advanced (Advanced Forum for IRB Professionals Track)

Raed A. Dweik, Katherine Gallin Heffernan, Lynn E. Smith During this session, faculty will: •R eview several models of communication channels between the IRB and the COI committee from academic institutions • Discuss the timing of COI determinations and IRB reviews • Address what an institution can do when the committee actions are not timed or structured to facilitate timely communication •U sing case studies, explore methods of resolving disagreements between determinations of the COI office and concerns about potential conflicts raised by IRBs

Room 312

The Flexible IRB: Finding and Applying Flexibility in the Federal Regulations and Beyond (Boundaries and Balance Track)

Rebecca Dahl, Martha F. Jones, Irene E. Stith-Coleman This session will explore various procedures that incorporate flexibilities within the regulations while providing equivalent protections to research subjects in both biomedical and behavior/social science research. During this session, faculty and attendees will: • Review the flexibilities in the regulations related to exemptions and expedited review •E xamine the issues related to consent, as well as issues around assent, parental permission, and documentation of assent/permission • Describe what a flexible IRB model is • List the pros and cons of the flexible IRB model compared to the more traditional IRB models • Provide implementation considerations for the flex IRB model Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session. C5

Room 308

Evidence-Based Ethical Problem Solving

(Educating and Training Track)

Emily E. Anderson, Amy Corneli, Toby L. Schonfeld, Joan E. Sieber Evidence-based ethical problem solving is increasingly recognized as a means for enhancing the ethical design of human research. However, determining whether the answer to a research question would be helpful to a broader audience can be difficult. What conversations should you have to identify the usefulness of answering a research question? Who should you talk to? During the first part of this session, associate editors of the Journal of Empirical Research on Human Research Ethics, will use case examples to provide an overview of empirical ethics research methods and approaches. During the second part of the session, attendees will have an opportunity to share their own ideas for research questions or projects in various stages of implementation. During this session, faculty and attendees will: • Outline a process for identifying and developing an empirical research study on research ethics • Identify methods and designs for conducting empirical research on research ethics •D escribe how findings from such studies can be used to inform evidenced-based decisions on ethical issues • Discuss ideas for research questions and projects and ways to move these projects forward Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

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Saturday, November 14 C6

Room 110

How to Be an Informed Consumer of Data on Research Subjects’ Understanding (Empirical Research Ethics Track)

Room 110

Pulling the Plug on Psych Student Pools: Should They Be Abolished? (Ethical Issues Track)

Advanced

Andrew Hedrick, Ivor A. Pritchard Many colleges and universities have established research pools of introductory-level psychology students to participate in research studies. This session will consider the pros and cons of such pools, and ask the question of whether such pools should be abolished. During this session, faculty and attendees will: • Briefly review the regulatory requirements that must be met by student research pools • Discuss what features make some research pools better than others • Debate whether research pools should be abolished in favor of alternative recruitment strategies

Room 302

Basic

A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for

Studies Involving Drugs or Biologics

(FDA Regulations Track)

Karen N. Hale, Patrick J. McNeilly Sponsors and sponsor-investigators are responsible for determining whether an IND is required for a particular study. In general, the IND regulations require that human research studies involving drugs or biologics be conducted under an IND if the study is a clinical investigation as defined in the IND regulations, and if the clinical investigation is not otherwise exempt from the IND requirements. IRBs should have an understanding of the regulatory platform for review of drug and biologic studies and ask questions about whether or not an IND is needed for a particular study when needed. During this session, faculty will: • Provide a basic overview of the applicability of the IND regulations that address when an IND is required • Discuss how to apply these regulations to studies involving investigational and marketed drug and biologic products • Share resources and guidance to assist IRBs who struggle with understanding when an IND might be needed C9

Room 301

Determining the Effectiveness of Community Engagement in Global Health Research (Global Research Track)

Edward E. Bartlett, David A. Borasky, Regina Kamene Owino, Steven Wakefield Community engagement has been recognized as an important ethical requirement for global health research. Various models have been used by researchers to engage with communities. However, challenges remain with determining the effectiveness of various models/strategies for engaging communities. During this session, faculty and attendees will: • Examine the value and science of community engagement in global health research • Share practical examples of community engagement models based on experience, including what works, best practices, and challenges • Elicit information about models and best practices in community engagement in research sites from session participants • Review the various ways of evaluating the effectiveness of community engagement including, what works and the way forward Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

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schedules

Scott Y. H. Kim, Rebecca D. Pentz, Kevin P. Weinfurt Data from interviews and surveys are often cited as evidence of the ubiquity of the therapeutic misconception and, therefore, of the poor quality of informed consent. However, there are several conceptual and methodological complexities that make it difficult to conclude that a research participant labors under a therapeutic misconception. This session will provide attendees with important tools for dissecting the empirical literature (or designing studies) on how well research participants understand the various elements of informed consent. During this session, faculty will: • Discuss main points from the literature on how well research participants understand elements of informed consent • Address the strengths and limitations of research on “therapeutic misconception” • Review the main validity issues to consider when reading research (or designing studies) on research subjects’ understanding

Schedule Recognition Conference Information C10

Room 109

The CIP® Credential: What’s it About? (Potpourri Track)

schedules

Gregorio Lim, Kelley O’Donoghue, Lori Roesch During this session, faculty and attendees will: •R eview the CIP council’s role in the development of exam content, as well as oversight and management of the certification program • Discuss the CIP credential and the steps involved in pursuing it • Go over the CIP Handbook eligibility and recertification requirements • Explore the Body of Knowledge and outline the types of questions on the CIP exam • Share general tips and resources for study preparation Please note this session will not review specific exam questions or provide exam preparation. C11

Room 210

Understanding the Elements of a Strong Compliance Program (Institutional Officials and HRPP Leadership Track)

Wesley G. Byerly, F. Lisa Murtha During this session, faculty will: • Identify the key components and characteristics of a strong compliance program • Discuss the challenges of day-to-day operations of such a compliance program • Outline compliance program performance metrics C12

Basic

Room 306

Let’s Review a Protocol: Regulatory Considerations in the IRB Review Process (IRB Boot Camp Track)

Yvonne Lau, Judy Matuk, Cheryl A. Savini This interactive session aims to assist IRB members, chairs, and staff with the initial review of projects submitted for review, including the determination as to whether IRB review is required, whether a protocol may qualify for exemption and, if expedited or convened IRB review is required, what specific considerations must be addressed during the review process. During this session, faculty and attendees will: •R eview the definitions of human subjects research found in the DHHS and FDA regulations to determine if IRB review is required • Discuss the federally mandated exemption categories and understand how to apply them •U se case examples to walk through the regulatory considerations required for protocols reviewed using the expedited mechanism or via convened IRB review

C13

Room 304

Advanced

IRB Chairs Forum: A Structured Discussion for Experienced IRB Chairs (IRB Chairs Track)

Robert W. Frenck, Elizabeth L. Hohmann, R. Peter Iafrate, C. Egla Rabinovich Given that it can be difficult to find venues where experienced IRB chairs can convene to discuss and wrestle with tough questions, this session will provide IRB chairs a forum to share ideas and best practices. In advance of the conference, attendees will be surveyed on topics of interest to them. The final list of topics will be sent to attendees before the meeting, and faculty members will provide a summary of each issue during the session. The discussions on each topic will be facilitated by the faculty ensuring no one dominates the conversation. Any off-topic issues that arise during discussion will be placed in a “parking lot” for later discussion if time permits. Participants are encouraged to bring relevant policies, forms, etc., with them to share with the group. During this session, faculty and attendees will: •R eview and discuss contemporary issues related to human subjects protections that are commonly faced by IRB chairs, and that may not have clear guidance in the federal regulations •S hare best practices, policies and procedures, forms, and methods that aid in resolving difficult issues presented by investigators and research study staff •D evelop a list of contacts so attendees can share ideas or benchmark issues that arise once they return to their institutions • Participate in topic development for future IRB chairs offerings Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

Icon Key p rim&r’ s 20 1 5 2 adv anci ng e ti thhi cal re se a rc h c on f e r e n c e

Saturday, November 14 C14

Room 313

Operationalizing Collaborative IRB Review (IRB Operations and Toolkit Track)

Jeanette Bailey, Paula Bistak, Tracy A. Ziolek In light of the recent draft NIH policy, which would require use of a single IRB of record for multi-site NIH funded research, many institutions are proactively engaging in reliance agreements. However, little guidance exists to help institutions consider the resources required to operationalize these agreements, either as an IRB of record or relying IRB. During this session, faculty will: • Discuss strategies for operationalizing various types of collaborative IRB agreements within an existing review structure, including document sharing and protocol tracking • Share work-aids and tools for successfully and efficiently serving as the reviewing IRB for a multi-site study or choosing to serve as a relying IRB • Review challenging issues that may arise in the context of reliance agreements, such as investigator noncompliance and strategies for managing these issues across IRBs

C15

Advanced

Room 103

Hal Landy, Michelle Roth-Cline, David A. Williams Pediatric studies must be approved under the Additional Safeguards for Children, 45 CFR 46 and 21 CFR 50 Subpart D of the DHHS/FDA regulations. According to these regulations, interventions presenting more than minimal risk must hold out a prospect of direct benefit to pediatric subjects. This session will discuss approaches to IRB review of early phase I/first-in-human pediatric research. During this session, faculty and attendees will: • Examine the issue of assessing prospect of direct benefit if adult human studies are absent or limited • Discuss the circumstances under which data from animal models may contribute to determinations regarding prospect of direct benefit and risk assessment • Outline frequently encountered concerns in first-in-pediatric study design, including dose selection, endpoint development, and nontherapeutic interventions and procedures Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

C16

Basic

Assessing Phase I/First-in-Human Pediatric Studies Under Subpart D (Issues Pharma/Biotech Track)

Room 102

When it Happens to You: Identifying and Managing Privacy Breaches in Research (Legal Track)

Lisa A. Griffin, Christina Heide, Susie R. Hoffman, Susan Stayn When a privacy or data security incident occurs in research, it may trigger reporting obligations under the Health Insurance Portability and Accountability Act (HIPAA) regulations, as well as under federal human subjects regulations and specific state laws. Each of these laws/regulations has a different definition of a reportable incident and different requirements for who must receive notification. In addition, within an institution, different offices or groups, including the Privacy Office and the IRB, are responsible for analyzing and reporting incidents and determining appropriate corrective actions in response. The existence of different reporting standards and requirements, and of multiple institutional “owners,” can cause confusion and create risks and challenges for institutions and investigators in identifying, reporting, and managing these incidents. During this session, faculty and attendees will: • Review how HIPAA applies in the conduct of research • Discuss the various legal and regulatory requirements applicable to privacy/security incidents • Work through case examples of breach analyses and possible resolutions • Share practical strategies for improved coordination of multiple processes, communication among institutional stakeholders, and investigator compliance with reporting requirements • Explore data security risks and best practices Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

n ove m b e r 12- 15 , b os t on , m a

schedules

Advanced

Schedule Recognition Conference Information C17

Room 202

Statistics Without Tears (Non-Scientist IRB Members Track)

schedules

Susan S. Fish, Janice Weinberg This session will explain the intimidating statistical terms that make your eyes glaze over! Attendees will start by reviewing the statistical basics and then, half-way through the session, the group will divide so those who need more study of the basics can obtain that information, while others ready for the next level can move on to more advanced topics. During this session, faculty and attendees will: • Review the basic concepts of testing • Discuss different ways to be right and wrong (e.g., type 1 and type 2 errors) • Review the concept of “power,” the types of statistical tests, and when to bring in a statistician • Explore the relationship between statistics and ethics • Learn how to apply statistical vocabulary Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session. C18

Room 203

Ethical, Regulatory, and Practical Challenges in the Use of Legacy Collections

(Out-of-Body Experiences: Research Involving Tissue and Data Track)

William E. Grizzle, Ty Hoover, Megan C. Morash, Carol Juliet Weil Specimens that have been collected for specific research projects or clinical trials in the past may be useful for additional research projects not originally envisioned at the time the specimens were collected. When is it acceptable to permit the use of specimens that were originally not described in the initial informed consent? How does one decide when the initial consent is adequate or when a new consent is required? During this session, faculty and will: • Explore the ethical, regulatory, and practical challenges in the use of legacy collections for additional research purposes • Discuss strategies for addressing these challenges • Share examples of how researchers and institutions are addressing these challenges Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

C19

Room 204

Advanced

C20

Basic

Resilience and Reciprocity: What Mindful Research Looks Like (Populations Requiring Additional Protections Track)

John A. Guidry, Cynthia R. Pearson, Amy Terpstra The intent of research is to help, not harm; yet, research has the ability to covertly harm already stigmatized groups or groups with low social standing. IRBs are trained to minimize the physical, emotional, and social risks to individual subjects involved in research studies and so, IRBs, in reviewing research, must also weigh studies’ potential pathologizing effects for entire social groups. During this session, faculty and attendees will: • Identify examples of bodies of research that have served to pathologize specific groups of people • Review the ethical principles that guide concern for how research shapes or reinforces stereotypes •E xplore how researchers and IRBs can be mindful of how each phase of a study, from question formulation to dissemination of findings, represents an opportunity to ensure that consideration is also given to the resiliency and strengths of stigmatized groups Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session. Room 108

The Uncomfortable Conversation: Talking About Diversity (Potpourri Track)

Eric Allen, Donna H. Eaton, Dorotha Love Hall The issue of diversity is not directly addressed in the federal regulations governing human subjects research, although it is referenced in the Belmont Report. Nevertheless, IRB professionals have opportunities to consider issues of diversity during the protocol review process, development of policies and procedures, investigator training, and the like. During this session, faculty and attendees will: • Discuss how IRB professionals can ensure the issue of diversity is adequately addressed during protocol review •R eview how to develop policies and procedures that support diversity when there are no clearly defined federal regulations • Share strategies on how to encourage investigators to recruit diverse subject populations when resources are short Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Levle Two before the session.

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Saturday, November 14 C21

Room 309

Novel Methods, Approaches, and Tools for QA/QI, Including Electronic Systems and Technology (QA/QI and Post-Approval Monitoring Track)

C22

Room 310

Basic

Jeremy N. Block, Linda Rogers In the past year, an uptick in mHealth applications are in use throughout the US, with many more to come. This session will discuss the challenges these applications pose IRBs who review them, as well as best practices that will allow IRBs to be forward-leaning to meet these new challenges. During this session, faculty will: • Describe problems that can now be solved through emergent properties of mobile technology used in research • Review some of the unique issues surrounding security, confidentiality, and privacy, and the risks central to research tasks using a mobile device • Identify best practices for IRB review of mHealth applications submitted to the IRB, including what to ask for and what to tell researchers to provide

C23

mHealth Applications: Best Practices for IRBs (Research Involving the Internet and Social Networking Track)

Room 111

Flying Solo: A Moderated Discussion on Challenges Encountered by Single Staff IRB Offices (Small Research Programs Track)

Ann Morrison, Amy Nolan This interactive session will explore the organizational, professional, and procedural circumstances that challenge HRPPs with only one staff person. Participants will create networks for ongoing professional development and support. During this session, faculty and attendees will: • Discuss implementation of solutions for recognized challenges unique to single staff offices • Learn specific strategies and resources to support staff in single staff offices • Network with others from similar program Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

n ove m b e r 12- 15 , b os t on , m a

schedules

Jeffrey A. Cooper, Michele Gomez, Elizabeth Tioupine Despite improved technology, to err is still human. IRB offices, whether fundamentally paper-based or using electronic systems, may not be fully realizing the tools and techniques available to identify errors, improve compliance, and support QA/QI activities. QA/QI programs conducting investigator site onsite reviews collect a tremendous amount of data that is critical to driving QI across the HRPP. This session will address novel methods and approaches to ensuring QI across HRPP operations and regulatory compliance. During this session, faculty and attendees will: • Learn how to create reports and perform analyses (even simply using Excel) to better target concerning areas, identify data entry errors or omissions, and implement process improvement strategies • Explore how to use reports for QA IRB submission processing, for identifying staff errors, and as a guide for additional office-wide training needs • Address techniques to identify outliers as possible noncompliance concerns or process-improvement opportunities, including Process Control for IRB QI Review, and demonstrate what programs can do with aggregate information • Review the advantages of a QA/QI database • Discuss considerations for developing a QA/QI database, including selecting a model and translating user needs into design • Share novel and innovative ways that QI programs can store, track, and analyze investigator and IRB compliance using technology tools Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D on Level Two before the session.

Schedule Recognition Conference Information C24

Room 206

Speed it Up: Exempt, Expedite, Relax! (SBER I – Basic Track)

schedules

Kristina C. Borror, Jeffrey M. Cohen, Dean R. Gallant During this session, faculty and attendees will: • Discuss the procedural sequence process for review of SBER • Use case vignettes to test the review process and classification system • Identify flexibility in the regulations consistent with ethical research • Share strategies for how to make the decision between exempt and expedited Please note this is a double session and will end at 1:45 PM. Please use the ticket included with your name badge to get your boxed lunch in Exhibit Hall D before the session. C25

Room 311

Is That Illegal? Developing Best Practices for IRB Review of Research Investigating

Illegal Behaviors

Advanced

(SBER II – Advanced Track)

Celia B. Fisher, Leonard Glantz Insofar as human subjects research involves the study of human behaviors, social values, and public policy, such research studies may involve the investigation of illegal/illicit behaviors. Collecting data about illegal/illicit behaviors exposes all stakeholders—individual participants, investigators, institutions—to risks and harms to personal well-being, social standing, and legal culpability. Inasmuch as human research protections professionals have the obligation to ensure minimization of risks in human subjects research, such professionals should develop and implement best practices for reviewing scientifically valid research involving illegal/illicit behaviors. During this session, faculty will: •R eview the definitions of “illegal” and “illicit” as they apply to human research protections within particular jurisdictions • Identify the nature, severity, and probability of risks inherent to research of illegal/illicit behaviors • Share best practices for meliorating risks in study design and conducting IRB review of study protocols C26

Room 305

A Dialogue with the OIG (A Dialogue with the Feds II Track)

Chris Galvin, Elizabeth M. Havener, Kimberly A. Ruppert This session will be led by representatives from OIG. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Receive an overview of OIG’s structure and initiatives • Learn about OIG’s evaluation work related to oversight of human subjects protections • Ask questions of OIG representatives 12:45-1:45 PM

Exhibit Hall D

2:00-3:15 PM

Didactic Sessions and Workshops Series D

Room 313

Lunch

A Dialogue with OHRP (A Dialogue with the Feds I Track)

Lisa Buchanan, Julie Kaneshiro, Yvonne Lau, Jerry Menikoff, Irene E. Stith-Coleman This session will be led by representatives from OHRP. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from OHRP representatives about evolving initiatives, issues, and guidance • Ask questions of OHRP representatives • Participate in an open discussion on topics raised at the session

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Saturday, November 14 D2

Room 109

A Dialogue with the NSF (A Dialogue with the Feds II Track)

Room 308

Advanced

Research With the Seriously Mentally Ill: Optimizing Benefit and Minimizing Risk (Advanced Forum for IRB Professionals Track)

David H. Strauss The review of research with psychiatric patients with serious mental illness, those with and without impaired consent capacity, requires an IRB to identify risks and susceptibilities to risk uniquely associated with these disorders and the settings in which these subjects are recruited. As some populations may demonstrate multiple vulnerabilities (socio-economic, cognitive, etc.), careful review of recruitment strategies, research design, inclusion and inclusion criteria, monitoring plans, exit criteria, etc., is necessary to safeguard subject rights and welfare. This case-based workshop will describe conceptual strategies and practical tools for IRB review of research with serious mentally ill. During this session, faculty and attendees will: • Review the characteristics of psychiatric disorders that confer susceptibility to risk in the research setting • Identify opportunities to minimize risk during protocol review, using monitoring and by enhancing consent • Consider the broader justification for protectionism in IRB review Room 312

IRB Oversight and the Boundaries Between Evidence-Based Practice (EBP), Performance

Advanced

Improvement, and Research

(Boundaries and Balance Track)

Judy E. Davidson, Hugh H. Tilson Clinical practice may be advanced through EBP change, performance improvement, or novel research. IRB review is indicated for novel research, but, at times, project leaders seek IRB approval solely for the purpose of potential publication, and this increases the workload of IRB staff and members. During this session, faculty and attendees will: • Identify the boundaries between performance improvement, EBP change, and research • Define a process for ensuring appropriate oversight of low risk performance improvement and EBP change projects while maintaining the QA standards required for publication • Analyze three project plans to determine whether IRB oversight is required according to regulatory standards D5

Room 306

Training for Success: Tools and Educational Methods for IRB Staff (Educating and Training Track)

Sarah Fowler-Dixon, Martha F. Jones, Jeanne Velders Regardless of the size and complexity of your office, IRB intensive staff training using formal training manuals can improve the functionality and morale of the work environment by empowering staff to become experts in the field of human subjects protections. These training manuals are important in that they: train IRB professional staff in a standardized and documented manner; establish staff expectations early on with a structured plan that contains incremental attainable goals over a period of time; are flexible and individualized based on staff learning styles, experience at entry, and progress through training; establish the level of knowledge needed to work with the IRB; help to professionalize the field of human subjects protections and prepare for the CIP® exam; can be used as part of continuous quality improvement; and demonstrate to senior leadership the complexity and breadth of IRB related functions to help provide justification for staff, salaries, space, resources, etc. During this session, faculty will: • Provide an efficient and effective training tool for IRB professionals at all levels of experience • Describe a training method that is proven successful in support of adult learners who have a need for jobbased, continuing education in a highly regulated environment • Discuss the use of orientation and training manuals as companion tools for an effective QA/QI program for IRB staff

n ove m b e r 12- 15 , b os t on , m a

schedules

Jeffrey W. Mantz This session will be led by a representative from NSF. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from a NSF representative about evolving issues, initiatives, and guidance • Participate in an open discussion of topics relevant to NSF stakeholders • Ask questions of a NSF representative

Schedule Recognition Conference Information D6

Room 200

Using Empirical Evidence to Reduce Consent Form Length

(Empirical Research Ethics Track)

schedules

Amy Corneli Research has repeatedly demonstrated that study participants often do not fully understand the research in which they are enrolled. The length of informed consent forms is a contributing factor. Long consent forms remain commonplace in clinical research, yet they can negatively affect potential participant’s understanding of research, as well as contribute to a time-consuming enrollment process. The Effective Delivery of Informed Consent study is partnering with the HIV Prevention Trials Network to conduct multi-phased, consensus-building research with key stakeholders to identify barriers to and strategies for reducing the length of informed consent forms. At the 2014 AER Conference, preliminary data from the initial key stakeholder interviews on the barriers to reducing the length of consent forms was presented. Data from the follow-up interviews with key stakeholders on the strategies for reducing consent form length will now be provided. During this session, faculty will: • Describe specific strategies for reducing consent form length that were identified by key stakeholders in the initial interviews •R eview strategies that were supported and non-supported by key stakeholders through the consensus-building follow-up interviews • Examine shortened consent form language

Room 107

Ethical Issues in CBPR (Ethical Issues Track)

Regina Kamene Owino, Terry J.M. Powell, Susan Brown Trinidad, Steven Wakefield CBPR proposes an engaged, respectful approach to research that envisions study participants as co-researchers, rather than subjects. This session will explore the ethical issues that arise in the design and conduct of CBPR in a variety of settings. During this session, faculty will: • Present an overview of the ethical principles and practices on which CBPR is based • Highlight real-life ethical conflicts and their resolution in the context of CBPR D8

Room 301

FDA Inspections of Radioactive Drug Research Committees (RDRCs) (FDA Regulations Track)

Catherine Parker, Kevin A. Prohaska The FDA has regulations explaining when radioactive drugs for basic science and medical research in humans is generally recognized as safe and effective, and is therefore not subject to the same requirements for investigational use as other new drugs. Under these regulations, human research using a radioactive drug or biologic product may be conducted without an Investigational New Drug application under an FDA approved RDRC, but only when that research is basic science research and not research that is intended for immediate therapeutic, diagnostic, or similar purposes, or to determine the safety and effectiveness of the radioactive product for such purposes. FDA conducts periodic reviews of approved RDRCs by looking at committees’ annual reports, minutes, and full protocols for certain studies, and through onsite inspections. During this session, faculty will: • Present a general overview of RDRC responsibilities • Review the FDA Bioresearch Monitoring RDRC onsite inspection program, including information about what to expect during an inspection • Share information about where you can find FDA resources on RDRCs • Provide general tips to help promote a smooth RDRC-IRB working relationship D9

Room 310

Advanced

The Ethics of Genomic Research in International Settings (Global Research Track)

Marianna J. Bledsoe, Mark A. Rothstein, Aminu A.Yakubu Genomic research presents a range of ethical issues related to the collection, export, storage, and reuse of human biological samples, the establishment of biorepositories, and the consent requirements for each of these. This session will focus on the ethical issues arising in the conduct of genomic research in an international research setting, using the Human Heredity and Health in Africa initiative (H3Africa) as a case study. During this session, faculty will: •D iscuss key ethical issues arising in the conduct of international genomic research, sharing experiences from the H3Africa project, including broad consent and re-consent for future uses of samples and feedback of findings (including what to do with incidental findings) •E xamine the rationale and guidelines for storage of biospecimens and data gathering/sharing practices; how access is controlled among multiple sites spread internationally; policies for the sharing of specimens across institutions and countries; and guidelines for biobanks in different countries •O utline examples/models of data and sample access committees, including the committee’s roles and responsibilities and who is able to analyze the data •R eview the role of IRBs and research ethics committees in international collaborative genomic research

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Saturday, November 14 D10

Room 110

Addressing Ethical Challenges for Enrolling At-Risk Adolescents in Research (Hot Topics Track)

D11

Room 304

Institutional Considerations When Accepting IRB Review from an Independent IRB or Academic Partner (Institutional Officials and HRPP Leadership Track)

Robin C. Ginn, Eric C. Mah Is the use of a central IRB or an external IRB right for your organization and, if so, what must be considered as part of the implementation process? Increasingly institutions are relying on other IRBs or entering into collaborative review agreements for multicenter clinical trial research and cooperative group studies. In light of the recent NIH draft guidance, which proposes mandating use of a single IRB of record for NIH-funded multicenter research, all HRPP leaders need to consider the implications of such reliance agreements. During this session, faculty will: • Describe institutional responsibilities when outsourcing or ceding IRB review responsibility for multicenter trials • Discuss implementation of business and operational strategies

D12

Basic

D13

Advanced

Room 102

Essential Documentation: IRB Membership, Recordkeeping, Meeting Minutes, and More (IRB Boot Camp Track)

Janet C. Donnelly, Michelle Feige, Julia Gayle Gorey, Ada Sue Selwitz The federal regulations define the requirements for IRB membership and for documenting IRB discussions, decisions, findings, and communication of IRB decisions. This session will focus on the basic regulatory requirements for documenting IRB activities. During this session, faculty will: • Outline the basic federal requirements for IRB documentation • Discuss the federal requirements for maintenance of accurate, complete, and timely IRB records • Identify the components of a complete record of IRB meeting activities as reported in IRB meeting minutes • Hear how the proposed changes in the NPRM could possibly affect IRB membership, recordkeeping, and documentation requirements Room 202

Meeting Management for IRB Chairs (IRB Chairs Track)

Jeremy N. Block, Bruce G. Gordon, C. Egla Rabinovich This session will cover key topics in the management of an IRB meeting from the IRB chairs’ perspective. During this session, faculty will: • Discuss the fundamentals of meeting management and member interactions from a leadership style perspective • Review how to increase engagement of members and how to interact with staff/consultants • Share tips, strategies, and approaches to becoming an IRB chair or how to build on current skills and training

n ove m b e r 12- 15 , b os t on , m a

schedules

Tamara E. Baer, Leslie Meltzer Henry, Frances E. Jensen, Seema Shah In research involving adolescents engaged in risky behaviors, such as HIV prevention research and research on drug addiction, obtaining consent/permission for research participation is challenging for at least two reasons: (1) adolescents may not be developmentally capable of making sound decisions regarding research participation, and (2) whether existing regulations permit adolescents to consent for themselves is unclear. DHHS regulations governing research allow for waiver of parental permission in some cases (though FDA regulations do not), and both sets of regulations do defer to state laws to determine when an individual can consent on her own behalf. Although the standard age of majority is 18, some states have mature minor laws that permit adolescents to consent to treatment when parental permission might serve as a deterrent to seeking treatment (such as abortion, drug abuse treatment, and treatment for sexually transmitted infections). This session will explore whether and how existing laws permit adolescents to participate in research without parental permission, as well as when it would be ethically appropriate for IRBs and investigators to use this legal flexibility given the latest science about the capabilities of the adolescent brain. During this session, faculty will: • Review the capacity of adolescents to provide consent for their own participation in research based on current developments in neuroscience • Discuss what existing regulations require for consent to pediatric research • Provide insight on how IRBs apply mature minor and related laws to consent to pediatric research

Schedule Recognition Conference Information D14

schedules

Basic

D15

Room 311

IRB Performance: Tools to Evaluate and Improve IRB Operations (IRB Operations and Toolkit Track)

Nichelle Cobb, Elizabeth Tioupine This session is designed to provide IRB administrators with tools and practical tips in assessing the performance of IRB operations. During this session, faculty will: • Present ideas and techniques that can be used to streamline IRB processes and optimize IRB operations •D iscuss key indicators and performance benchmarks that can be used to assess efficiencies/bottlenecks in the IRB process •P resent ideas for maximizing staff and IRB member efficiency Room 111

TransCelerate’s Risk-Based Monitoring Initiative

(Issues Pharma/Biotech Track)

Brett Wilson, Kathryn Owen The Risk-Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the research and development industry. By developing a model approach for risk-based monitoring of clinical trials, TransCelerate’s objective is to both enhance patient safety and ensure the quality of clinical data. During this session, faculty will: • Provide an overview of the Risk-Based Monitoring Initiative • Discuss risk-based monitoring/remote monitoring processes •S hare project milestones, resource solutions, and the latest information on the status of this and similar initiatives

D16

Room 302

Compassionate Access or Risky Hope? The Legal and Ethical Complexities of “Right to Try” Laws

(Legal Track)

Katherine Gallin Heffernan, Richard Klein, Greg E. Manship, Beth E. Roxland, Walter L. Straus Recently enacted and proposed Right to Try legislation in various states has grabbed national public and media attention. This legislation, which gives certain terminally ill patients possible access to experimental medicines for use in last resort treatment, raises important legal, ethical, medical, and financial implications for all stakeholders in medicine and clinical research. During this session, faculty will: •E xplain the legal frameworks applicable to expanded access, including FDA’s existing regulatory structure and the shift sought through recent Right to Try bills •R eview the potential ethical risks raised by access to investigational drugs outside of controlled clinical trials, including therapeutic misconception, distribution of unsafe drugs, and the potential harm from unknown side effects • Address where the line between autonomy and beneficence should be drawn for terminal patients seeking access to investigational products (i.e., do we, as a society, have an obligation to allow people this choice or an obligation to help patients accept futility and death?) •D iscuss, via a representative from industry, the perspective of drug manufacturers and the efforts they are making to respond to these issues •P rovide an overview of the potential economic issues related to who pays for the drugs and the cost of treating any harms, in addition to the possible impact Right to Try laws may have on coverage determinations for new drug therapies

D17

Basic

Room 204

Scientific Aspects of Study Design: A Primer for Non-Scientists (Non-Scientist IRB Members Track)

Susan S. Fish, Lindsay McNair This session will serve as a primer on clinical study designs and the important scientific considerations in clinical protocol development, designed to be understandable for the non-scientist IRB member. During this session, faculty and attendees will: • Discuss the essential components of a study question and how the question can be addressed in a clinical study •R eview the basics of both observational and interventional clinical study designs, and the strengths, weaknesses, and application of each design •E xplain the essential considerations (e.g., bias, confounding) that can impact the validity of a clinical study and the analysis of study data

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Saturday, November 14 D18

Room 309

Overview of the New Law on Newborn Blood Spots and Implications for Future Research (Out-of-Body Experiences: Research Involving Tissue and Data Track)

D19

Room 203

Populations on the Edge: The Homeless, Substance Abusers, and More

(Populations Requiring Additional Protections Track)

Teresa Doksum, Cynthia A. Gómez, Amy Terpstra There are many populations that have vulnerabilities related to their marginalized status. Thus, it is important for IRBs to understand the expertise needed to review studies with these populations and some of the special or heightened concerns related to these groups. During this session, faculty will: • Identify vulnerable populations beyond those addressed by the federal regulations who are nonetheless vulnerable because of homelessness, substance abuse, undocumented residency, or other issues •E xamine the special considerations study teams should address when designing a study involving these populations and that IRBs should be aware of when reviewing these studies (e.g., payment and undue influence) • Review the threshold questions an IRB should address before permitting research with these subjects • Discuss complex issues such as how to assure confidentiality, balancing concerns about criminal liability with the need to protect subjects and conduct valuable research, the need for assistance to avoid individual harm, and whether Certificates of Confidentiality should be a prerequisite for these studies • Explore how to recruit and maintain contact with subjects from these populations

D20

Room 101

When Noncompliance Processes Collide: How to Manage Multiple Different Internal Investigations of an Event Advanced (Potpourri Track)

Kristina C. Borror, Ernest D. Prentice, Andrew Rusczek, Megan Kasimatis Singleton One allegation or problem in a clinical study, such as a concern that a researcher has falsified research data, can spiral or uncover additional noncompliance and thereby trigger multiple requirements and policies for investigation and resolution. This session will present a root cause analysis of noncompliance issues, and offer strategies and training models for dealing with these events. During this session, faculty will: • Briefly review (using a case example) the various legal issues and institutional policies and processes that may be triggered by a noncompliance event, including IRB serious/continuing noncompliance investigations, research misconduct proceedings, and medical staff/peer review processes • Learn how to identify regulatory disconnects and knowledge gaps that lead to noncompliance issues in research, and recognize the ways in which the substantive and procedural requirements and standards applicable to different processes may overlap or be in tension • Share practical strategies for coordinating and conducting multiple investigations and stakeholders in a way that maximizes efficiency, but also maintains the integrity of the various processes

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schedules

Mark Barnes, Jeffrey R. Botkin All states collect newborn dried blood spots in order to conduct mandatory screening for serious medical conditions. Many state newborn screening programs retain residual blood spots after the completion of screening. In recent years, legitimate legal and ethical concerns have been raised about the practice of states to retain residual dried blood spots and use them for purposes unrelated to newborn screening programs. On December 18, 2014, the Newborn Screening Saves Lives Reauthorization Act of 2014 (Public Law No: 113-240) was signed into law. The law requires that all research funded pursuant to the Public Health Service Act using newborn dried blood spots be considered human subjects research regardless of whether the specimens are identifiable, and eliminates the ability of the IRB to approve alterations or waivers of informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots. During this session, faculty will: • Review newborn blood spot screening and research on blood spots • Discuss the Newborn Screening Saves Lives Reauthorization Act of 2014, which dictates that all research involving newborn blood spots must be considered human subjects research and must require informed consent • Examine the implications for research and IRB review of research involving newborn blood spots • Describe possible consent content for such research use

Schedule Recognition Conference Information D21

Room 103

Development of an Effective QA/QI Program at Your Institution (QA/QI and Post-Approval Monitoring Track)

schedules

Leslie M. Howes, Eunice Yim Newbert, Jessica A. Randall This session will provide strategies and tools for developing an effective QA/QI program within an organization, regardless of whether it conducts social and behavioral research or biomedical/clinical research. This session will provide an opportunity for faculty and attendees to share techniques and ideas that can help improve QA/QI programs. During this session, faculty and attendees will: •R eview different models of QA/QI (e.g., stand-alone department versus integrated into IRB), and their advantages and disadvantages • Explore the various activities a program can take on and how to prioritize activities • Discuss how to identify, establish, and evaluate benchmarks to assess the quality of a HRPP • Outline QA/QI Specialist qualifications • Share strategies for developing effective education and training opportunities for investigators D22

Room 206

Basic

Recruitment and Consent Challenges and Opportunities in Internet Research (Research Involving the Internet and Social Networking Track)

Brenda Curtis, Laura Odwazny This session will address ethical, regulatory, and methodological issues associated with recruitment and consent in online research. A basic understanding of internet venues and tools is assumed. During this session, faculty will: • Outline current guidelines and strategies for protecting privacy and confidentiality • Discuss what constitutes adequate consent with regard to the type of data collected •P rovide IRB decisional strategies for reviewing legally and socially sensitive research that utilizes social media for recruitment using case studies

D23

Room 108

Building and Maintaining an HRPP in a Large Health System with a Small Research Portfolio (Small Research Programs Track)

Advanced

Scott J. Lipkin, Tina Noonan, Lori Roesch This session will focus on the challenges of developing and maintaining an effective HRPP in a large health system with a small biomedical research program. Topics will include: noncompliance and conflict of interest management, effective interactions with organizational leadership, adherence to FDA requirements when overseeing drug and device research, emergency use of test articles, and more. During this session, faculty and attendees will: • Review how to support an effective HRPP in a large health system with a small research portfolio • Discuss challenging structural and operational aspects common in small HRPPs and identify effective solutions •S hare strategies for engaging senior leadership, investigators, IRB members, and those who work in other components of the HRPP •O utline how to create action priority lists and timelines • Identify effective institutional change agents, offices, mechanisms, etc.

D24

Room 104

Basic

School Rules! Conducting Research in Elementary and Secondary Public Schools (SBER I – Basic Track)

Eric Allen, Fanny K. Ennever, Jeffery Rodamar, Shannon Sewards This session will cover the regulatory requirements relevant to obtaining parental permission and protecting confidentiality of students’ academic records and will identify areas of flexibility to enable research on students and records, especially in challenging populations, venues, and districts with historically low parental involvement. During this session, faculty and attendees will: •R eview the Family Educational Rights and Privacy Act and the Protection of Pupil Rights Amendment, including what is required, permitted, prohibited, and waivable • Learn about who has “school authority” to release information •O utline consideration as to when an education project qualifies either as not human subjects research (quality improvement), as exempt human subjects research, or as non-exempt human subjects research •E xplore requirements for parental permission and identify “opt-out” or “passive” parental permission as an alteration of the consent process in non-exempt research • Analyze how opt out parental permission may or may not meet the four criteria for waiver/alteration of the consent process • Share strategies for developing relationships with local school districts

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Saturday, November 14 D25

Room 210

3:30-4:45 PM

5:00-6:00 PM

Scott Bradner, Dean R. Gallant Can we still promise our research participants anonymity? What are the limits of confidentiality? Is privacy still a fundamental concept for human subjects research? Do individuals have an accurate perception of where their privacy rights end and begin, and does the public have an accurate perception of what privacy is for them? This session will explore the rapidly evolving landscape around these concepts. During this session, faculty and attendees will: • Discuss the definitions of anonymity, confidentiality, and privacy from the regulatory, philosophical, and research perspectives • Share examples of de- and re-identification • Clarify the distinct and overlapping roles that Information Technology, the IRB, and the researchers share in the common enterprise of data security • Review strategies for SBE researchers and IRBs Veterans Memorial Auditorium

Town Hall Meeting: The NPRM and the Future of Human Subjects Protections

Moderator: David H. Strauss Panelists: Mark Barnes, Diana T. Chingos, Jerry Menikoff, Kathy L. Hudson Join PRIM&R for this town hall meeting during which representatives of PRIM&R’s Public Policy Committee and other stakeholders will share their perspectives on areas of the NPRM that merit attention, as well as invite audience members to participate in a wide-ranging discussion about the proposed revisions and the ethical considerations underlying the stated goals of the NPRM. This session aims to foster collective critical thinking about the implications for human subjects protections of the proposed changes to the Common Rule and help all stakeholders formulate their comments on the NPRM. Exhibit Hall C

Networking Reception with the Supporters, Exhibitors, and Poster Presentations

Join us in The Conference Connection to meet and greet the Supporters and Exhibitors and view this year’s Poster Presentations. Light refreshments will be served.

5:00-6:00 PM

Exhibit Hall D

AER Conference Group Mentoring

Gather with your colleagues for a new group mentoring activity where you can connect with your peers to get answers, solve problems, and improve practices. Tables will be divided by general topics and led by an expert facilitator. Groups will include: Career/Leadership/Management, Compliance/Federal/Legal/Regulatory, Diversity, Global Research, IRB Chairs, IRB Administrators/Coordinators, Non-Scientist IRB Members, QA/QI/ Post IRB Approval Monitoring, Small Research Programs, and SBER (five seats per table, a maximum of 10 seats per topic). During this activity, participants can present an issue or question they have to the group, and members of the group will respond to the problem or issue presented. The facilitator will manage the time so that all who want to share have time to do so. Participants can also just come for the discussion. Pre-registration was required for this event, but attendees may also come onsite to fill any open seats that might be available.

5:00-6:00 PM

5:00-5:15 PM

Changing Concepts of Anonymity, Confidentiality, and Privacy in SBER (SBER II – Advanced Track)

Exhibit Hall C

FDA Office Hours

Demonstration of PRIM&R’s E-ROC

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schedules

Advanced

schedules

Schedule Recognition Conference Information 5:15-5:30 PM

Exhibit Hall C

Demonstration of PRIM&R’s Knowledge Center

5:30-5:45 PM

Exhibit Hall C

Overview of PRIM&R’s Member Benefits

5:45-6:05 PM

Exhibit Hall C

Demonstration of PRIM&R’s E-ROC

6:05-6:25 PM

Exhibit Hall C

Demonstration of PRIM&R’s Knowledge Center

6:00-7:00 PM

Ballroom B

DNA in Play: The ABC’s of Assent, Blurred Boundaries, Capacity, Disclosure, Ethics, Families...

Moderators: Lynn W. Bush, Karen H. Rothenberg Actors: Mark Barnes, Jeffrey R. Botkin, Christine Grady, Susan Z. Kornetsky, Robert “Skip” Nelson, P. Pearl O’Rourke This interactive new play by Lynn W. Bush and Karen H. Rothenberg, and performed by distinguished colleagues, will bring to life the complexity of bioethical challenges in the context of the informed consent and decision-making processes surrounding genome sequencing in pediatric clinical research and medicine. Familial and professional relationships influencing, and influenced by, the ethical landscape of genomics will provide the drama with a way to critically explore and debate thorny issues, including the power of information generated and developmental factors. What, when, how, to whom, and whether findings should be discovered and disclosed is controversial, particularly in determining whose voice matters if children are involved or capacity is diminished. The audience will have the opportunity to weigh in as the mock ethics committee after each act, and a lively discussion between the actor-panelists and audience will follow the play.

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Sunday, November 15 Sunday, November 15 Pre-Function Hall C

Registration Opens

Breakfast on your own. Coffee only will be served in The Conference Connection. Grab-n-go breakfast items will be available for purchase at a food kiosk located near the Registration Area on Level Two. The kiosk will be open 7:00-10:00 AM.

8:00-8:15 AM

Veterans Memorial Auditorium

Welcome from the Conference Co-Chairs

P. Pearl O’Rourke, MD; Laura Odwazny, JD, MA

8:15-8:30 AM

Veterans Memorial Auditorium

PRIM&R Membership Update

8:30-9:30 AM

Veterans Memorial Auditorium

Presented by Susan S. Fish, PharmD, MPH, Professor, Biostatistics and Epidemiology, Boston University School of Public Health; Co-Chair, PRIM&R Membership Committee

Keynote Address: A Song in the Night: Lessons from a Life of Resilience Robert K. Massie, IV, MDiv, DBA, Author, A Song in the Night: A Memoir of Resilience

9:30-9:45 AM

Pre-Function Hall C

Join us at the onsite Bookstore in Pre-Function Hall C for a book signing with author and keynote speaker Robert K. Massie, IV, MDiv, DBA. Copies of Dr. Massie’s books are available at the onsite Bookstore.

Book Signing with Author and Keynote Speaker Robert K. Massie, IV, MDiv, DBA

9:30-9:45 AM

Break

9:45-11:00 AM

Concurrent Plenary Sessions

Veterans Memorial Auditorium

Panel VII: The Precision Medicine Initiative: What Is it and What Issues Does it Raise?

Moderator: P. Pearl O’Rourke Panelists: Sandro Galea, Gary H. Gibbons Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person involved. The NIH’s Precision Medicine Initiative plans to create a one million person cohort to support precision medicine research and, ultimately, to improve treatment of cancer for the present time and other diseases in the future. This session will provide a description of the Precision Medicine Initiative, including the challenges of logistically coordinating and overseeing huge genomic and clinical databases, will review the ethical issues associated with such an initiative, and will address whether such an individualistic, and expensive, approach will enhance or distract from other methods currently available to enhance the health of the population. Ballroom B

Panel VIII: When the Lines are Blurred Between SBER and Biomedical Research: Challenges for SBER IRBs

Moderator: Celia B. Fisher Panelists: Melissa E. Abraham, Elena Leonidovna Grigorenko, William E. Grizzle, Michele Kuchera This session will examine the wide array of medical devices, such as fMRIs and genetic technologies, that are being employed with greater frequency in social science research and the impact this has on the IRB’s review process. Issues to be discussed include: How can social science IRBs determine the investigator expertise necessary to evaluate medical risk and identify and provide appropriate participant referrals for incidental findings for this array of new devices and technologies? Given the increasing incorporation of genetic susceptibility models in social, behavioral, educational, and mental health research, as well as the probabilistic nature of geneenvironment influences, what competencies should social scientists have in order to make decisions regarding disclosure to participants of their research-derived, personal genetic information, to ensure adequate privacy protections during analysis and storage, and to provide appropriate informed consent?

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schedules

7:00 AM

Schedule Recognition Conference Information

Ballroom C

schedules

Panel IX: Patients With Lethal Diseases: Experiments in Research Design

Moderator: Alexander M. Capron Panelists: Jeffrey W. Clark, Richard T. Penson Recruiting patients with lethal conditions into studies of novel medical interventions raises difficult questions about how to assess the ratio of potential benefits to risks. Moreover, the lack of attractive therapeutic alternatives, which can lead patients to overcome their reluctance to enter a randomized control trial where they may be assigned a relatively ineffective treatment, creates concerns for IRBs about subjects’ voluntariness. Recently, FDA officials have indicated possible receptivity to allowing data from “basket trials,” a novel study design in which, regardless of the histology of their tumor, patients with particular mutations affecting tumor development are matched to a drug expected to work on that mutation. By essentially eliminating the control arm in the usual trial, this would represent a major change in what counts as supporting evidence for approving new drugs. Is such a change dependent on the lethal nature of some cancers, or could it signal a broader change in methodology, with implications for the current “gold standard” that IRBs usually expect? How would basket trials impact the recruitment of patients with lethal conditions into trials?

11:00-11:15 AM Exhibit Hall C

Break

Join us for coffee and tea in The Conference Connection.

11:15 AM- 12:30 PM

Didactic Sessions and Workshops Series E

Room 210

A Dialogue with the DOD: Updates for DOD-Funded Researchers (A Dialogue with the Feds I Track)

Lt. Col. Imelda Catalasan, Terrence Clemmons, Cmdr. Joseph V. Cohn, Capt. William Deniston, Col. Molly Klote, Lisa Mattocks, Patrice Robinson-Haley, Leah Watson This session will be led by representatives from the DOD, and is for researchers who have or are seeking extramural DOD funding. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from DOD staff about policies affecting the conduct of DOD-funded research • Ask questions about current issues and initiatives • Participate in an open discussion about DOD-related topics relevant to the research community E2

Room 308

A Dialogue with the Environmental Protection Agency (EPA) (A Dialogue with the Feds II Track)

Daniel K. Nelson, Toby L. Schonfeld While the US EPA has adopted the Common Rule, EPA-supported research presents special challenges, and there are some unique regulatory restrictions and requirements. This session will feature two representatives who will give an update on EPA structure and initiatives. During this session, faculty and attendees will: • Review the regulatory restrictions and requirements that are unique to EPA-sponsored research • Address some of the special challenges with the types of research conducted or supported by EPA • Discuss initiatives and organizational developments within the EPA E3

Room 302

Advanced

Inching Towards Harmonization: Electronic Consent and the FDA/OHRP Guidance (Advanced Forum for IRB Professionals Track)

Mark Barnes, Heather H. Pierce On May 7, 2015, comments were due to FDA and OHRP on two simultaneous requests published in the federal register: one on a draft FDA guidance document on electronic consent, and another from OHRP asking whether the FDA guidance would equally apply to other DHHS funded research and whether it should be issued as a draft guidance from both FDA and OHRP. In addition to providing new guidance, this approach signals a relatively novel approach to harmonization and could lead to similar FDA/OHRP alignment efforts. During this session, faculty will: •R eview the proposed FDA guidance, the practical implications for implementing the draft as is, and the nature of the public comments received (if available) •D iscuss how the draft guidance should or should not apply to research under the Common Rule and what challenges IRBs might face if this were finalized from FDA and OHRP without change • I dentify remaining (or next) areas to harmonize FDA and OHRP guidance, using facilitated discussion and the work the SACHRP Subcommittee on Harmonization has been doing over the past several years

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Sunday, November 15 E4

Room 312

QA/QI/Program Evaluation: Is it or Is it Not “Research”? (Boundaries and Balance Track)

George Gasparis, Sean Philpott-Jones This session will use case studies to highlight distinctions between QA/QI, program evaluation, and research. During this session, faculty and attendees will: • Use case studies to highlight distinctions between QA/QI, program evaluation, and research • Address how to determine whether an activity is human subjects research, and discuss generalizability • Discuss the issues raised by an investigator’s involvement in another institution’s QA/QI research, including whether, in such cases, the home institution is engaged in research Room 304

Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff and IRB Members (Educating and Training Track)

Hila F. Berger, Charlotte H. Coley, Karen M. Hansen For human subjects protections staff and IRB members, keeping up with the evolving field can be a challenge. Faculty will discuss current options and new trends in professional development, training, and education, and will provide tips on networking. During this session, faculty will: • Review methods, techniques, and credentialing programs available for staff development, including CIP®, Certified Clinical Research Associate, Certified IRB Manager, etc. • Provide information on available opportunities for training and education • Discuss the importance of networking as it relates to professional development in the field

Room 103

Questions about Central IRBs: How Can We Use Empirical Research to Find Answers? (Empirical Research Ethics Track)

Ann-Margret Ervin, Holly A.Taylor OHRP, NIH, and the House of Representatives recently issued draft guidance on mandatory use of a single IRB of record (central IRB) for multicenter research. This session will highlight the findings of an NIH-funded project to collect empirical data on the practices of central IRBs in the US to inform future guidance on implementation in the academic setting. This session will present the results of a systematic review and preliminary results from stakeholder focus groups to identify priorities for the formation and conduct of central IRBs. During this session, faculty and attendees will: • Review how empirical research can inform contemporary policy debates in the conduct of human subjects research • Solicit feedback from the audience on the faculty’s initial and future empirical efforts E7

Room 204

Assessing the Prospect of Direct Benefit in Pediatric Studies (Ethical Issues Track)

Susan Z. Kornetsky, Robert M. “Skip” Nelson Under Section 405, Subpart D of the DHHS regulations, pediatric research that presents more than minimal risk, but holds out the prospect of direct benefit for the individual participant may be approvable. This session will discuss approaches to IRB review of such studies. During this session, faculty will: • Examine the process for reviewing research interventions that offer the prospect of direct benefit to a pediatric population • Discuss the application of component analysis in the IRB’s review of pediatric studies • Outline the expectations for documenting the prospect of direct benefit and use of component analysis during the review of pediatric studies

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schedules

Advanced

Schedule Recognition Conference Information schedules

Room 203

Humanitarian Use Device (HUD) Designation and Humanitarian Device Exemptions (HDEs):

The Role of the IRB

(FDA Regulations Track)

David G. Forster, Nicole L. Wolanski As defined by the regulations, a HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the US per year. IRBs should be able to distinguish between the “use” of a HUD (i.e., in accordance with its approved labeling and indication) versus the “investigational use”/“clinical investigation” of a HUD (i.e., collection of safety and effectiveness data), whether for its HDE-approved indication or for a different indication. During this session, faculty will: • Present a general overview of the HUD designation and HDE application process •D iscuss the difference between the use of a HUD in accordance with its approved labeling and indication versus the investigational use of a HUD in a clinical investigation • Describe the role of the IRB in the review of these various uses of an HUD E9

Room 109

QA/QI Activities to Ensure Research Compliance of Multicenter and International Research (Global Research Track)

Leslie M. Howes, Lama Jamhawi, Walter L. Straus During this session, faculty and attendees will: •S hare strategies for building and operationalizing effective QA/QI programs for multicenter and international studies •D iscuss how QA/QI programs can utilize remote monitoring to achieve QA/QI reviews for multicenter and international studies •R eview commonly recognized compliance risks identified while monitoring international and multicenter studies E10

Room 310

Proposed Changes: An In-Depth Discussion on the NPRM’s Sections on Exclusions and Exemptions (Hot Topics Track)

Dean R. Gallant, Ada Sue Selwitz A NPRM has been released, and it is important for those involved in research to have an awareness of the proposed changes and their potential implications for the field. This session will focus on the sections of the NPRM related to the new category of activities called “exclusions” and on the proposed revisions to the exemption categories. During this session, faculty and attendees will: • Review, briefly, the current scope of the Common Rule and exemptions •E xamine what is being proposed in the NPRM and potential implications for IRBs and for human subject protections • Provide information on how to submit public comments on the NPRM E11

Room 102

Advanced

Litigation and Enforcement Actions in Clinical Research: Implications for IRB Members and Institutions (Institutional Officials and HRPP Leadership Track) Lisa Rooney, Robyn S. Shapiro During this session, faculty will: •R eview and analyze recent claims and enforcement actions brought against IRB members and institutions supporting IRBs related to human subjects protections • Discuss approaches for minimizing risk of litigation • Utilize hypothetical cases to illustrate institutional risk minimization

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Sunday, November 15 E12

Room 305

Basic

Elizabeth Bankert, Michelle Feige During this session, faculty will: • Discuss the components of comprehensive and effective HRPP/IRB SOPs • Review the resources, input, and/or approvals needed to develop specific SOPs

E13

Room 200

The Work of the IRB Chair: Beyond the IRB Meeting (IRB Chairs Track)

J. Andrew Bertolatus, Bruce G. Gordon, Patience B. Stevens The IRB chair’s work is primarily conducted outside of IRB meetings. This session will cover the broad spectrum of other duties that come with being an IRB chair. During this session, faculty and attendees will: • Discuss how chairs have added responsibilities and challenges often without (or regardless of) significant administrative support • Best practices for pre-review and preparation for an IRB meeting • Explore techniques for resolving disputed issues between IRB and researchers • Learn about the regulatory and other expertise required of the chair or designee • Share strategies for communicating with Research Integrity Officer, legal counsel, risk management, sponsored programs, and other Committees necessary for appropriate review and follow-up • Review how to do a 360 evaluation of the HRPP process and IRB chair leadership E14

Room 206

Enhancing Effective Communications Between IRBs and Investigators (IRB Operations and Toolkit Track)

John R. Baumann, Moira A. Keane This interactive session will use case studies and concrete examples to enhance communication between IRBs and investigators. During this session, faculty and attendees will: • Review techniques for delivering information (good or bad) to investigators in clear, concise, and tactful ways • Share feedback and strategies for helpful, respectful interactions with the research community • Discuss strategies for using email more effectively to transmit IRB findings and stipulations • Explore the skills needed to diffuse frustration and resolve conflicts in a professional manner E15

Room 202

Considerations for Effective IRB Review and Management of Protocol Deviations and Violations (Issues Pharma/Biotech Track)

Albert J. Allen, Michele Russell-Einhorn, Megan Kasimatis Singleton FDA regulations (and the Common Rule) require prospective IRB approval of modifications to the research unless such changes must be implemented immediately by the investigator to remove/minimize potential imminent harm to subjects. Obtaining prospective sponsor and IRB approval for individual subjects poses potential compliance challenges for investigators. This session will discuss effective policy and processing considerations to enhance compliance of protocol deviations. During this session, faculty will: • Define what types of deviations need prompt reporting and prospective IRB approval • Categorize the types of deviations/violations that should be submitted promptly versus those that should be submitted for continuing review • Explore the types of deviations that raise serious noncompliance concerns • Discuss effective processing by the IRB for prompt review

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schedules

Writing Stellar Standard Operating Procedures (SOPs) (IRB Boot Camp Track)

Schedule Recognition Conference Information schedules

E16

Room 101

The Error of Our Ways: IRB and Legal Considerations in Research on Medical Errors and

Clinician Behavior

(Legal Track)

Melissa E. Abraham, Emily Chi Fogler, Elizabeth L. Hohmann Proposals for research on medical errors and clinician behaviors are increasingly common and complex, and present unique challenges for IRBs and institutions. Investigators may submit such proposals with the assumption or hope that their analyses will benefit from peer review protection and may not appreciate the potential risks to individual clinicians or to their institution from this work. However, most peer review laws will not likely provide protection for such research analyses and indeed are inconsistent with the concept of research and publication. Depending on the circumstances, some of this work may be best conducted as QA/QI under the purview of institutional peer review committees, rather than as research. When it is conducted as research, questions regarding the status of the clinicians as human subjects and the protection of their confidentiality must be considered. This session will explore the risks, as well as the IRB/human subject and legal issues and considerations involved with undertaking these important projects. During this session, faculty and attendees will: • Review research in medical errors, clinician behavior, and related areas • Analyze case examples and provide suggestions for structuring these projects, as well as possible strategies for addressing some of the issues • Identify legal issues that require consideration in medical errors/clinician behavior research •C larify risk determinations, identify when consent is required, and share best practices for recruitment and consent methods and minimizing risk for survey, intervention, and record review studies in this area E17

Room 108

It Takes a Village: Community Members as Research Partners in CBPR (Non-Scientist IRB Members Track)

Cynthia R. Pearson, Amy Terpstra With its unique orientation to research that involves all stakeholders in the entire research process from conceptualization to dissemination, CBPR blurs the line between researcher and subject. How can IRBs understand and assess risk and weigh human “subject” considerations in these types of studies? During this session, faculty will: • Review the core concepts of CBPR with a special emphasis on the multiple roles of the subjects • Identify common risks for stakeholders inherent in this research approach •D iscuss potential tensions between CBPR principles and human subjects protections principles, and explore ways for how to minimize them E18

Room 309

Informed Consent for Genome-Scale Sequencing

(Out-of-Body Experiences: Research Involving Tissue and Data Track)

Sandra Soo-Jin Lee, Laura Lyman Rodriguez, Amelia Wall Warner As the research use of comprehensive (e.g., whole-exome and whole-genome) sequencing approaches continues to grow, new questions arise with respect to informed consent. This session will explore pragmatic and ethical issues from the perspectives of ethics experts, study participants, and pharmaceutical industry researchers. During this session, faculty will: •H ighlight key issues in informed consent for genome-scale sequencing, including data-sharing, future undefined uses, and re-consent • Offer recommendations on best practices for informed consent

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Sunday, November 15 E19

Room 313

Representing Prisoners: Insights from an IRB Member Who Has Been Incarcerated

(Populations Requiring Additional Protections Track)

Fanny K. Ennever, Shannon Sewards, David Neil Tavares In 2013, the Committee on the Use of Human Subjects (the IRB) for Harvard University-Area research recruited David Neil Tavares, a former prisoner, as a member. During this session, faculty will use the seven additional approval criteria from Subpart C of 45 CFR 46 as a framework to present important insights provided by a member who has “been there, done that,” as well as discuss the experience of recruiting a former prisoner and integrating him into the IRB. Case studies will be used to illustrate how Mr. Tavares provided a perspective not available from someone who has only worked with prisoners, and how he has improved the ability of the IRB to protect prisoners as research subjects. During this session, faculty will: • Interpret the federal requirements for membership in IRBs that review research on prisoners • Analyze the criteria for approval for prisoner research incorporating the perspective of an IRB member who was a prisoner • Review how an academic IRB was able to incorporate a former prisoner as a valued member

E20

Room 111

Ask the Experts! Everything You Wanted to Know, but Were Afraid to Ask (Potpourri Track)

Rebecca D. Armstrong, Edward E. Bartlett, Lisa Buchanan, Jeffrey M. Cohen, Sharon Freitag, Susie R. Hoffman, Kevin A. Prohaska, Elyse I. Summers Are you new to the field of research ethics? Do you still have nagging questions regarding HRPPs and IRBs? Join us for this session where experts in the field will be available to answer all the questions you’ve been afraid to ask. Come with your questions and concerns, and be prepared to participate in an open, interactive, and lively discussion with experienced faculty and peers. During this session, faculty and attendees will: • Participate in an open and interactive discussion about a broad range of issues in human research protections • Share ideas and strategies for addressing issues about protocol review, HRPP/IRB operations, and the regulations • Have a final opportunity to have questions addressed by the experts E21

Room 311

Advanced

E22

“Lean” Thinking for IRB Process Improvement (QA/QI and Post-Approval Monitoring Track)

Ross A. Hickey, Elizabeth Tioupine This session will emphasize hands-on application of commonly used Lean tools and techniques, and attendees will learn how Lean concepts can enhance their continuous improvement efforts. During this session, faculty will: • Review basic techniques • Discuss approaches to simplifying the IRB review process within the HRPP office • Provide tips and techniques to reduce inefficiencies and minimize hand-offs • Explore metrics for evaluating efficiency Room 107

Innovative Approaches to Assent

(Research Involving the Internet and Social Networking Track)

Rebecca Dahl, Moore Rhys This session will focus on the development and use of “Consent Quest,” a game app developed to educate children ages eight through 12 about participating in a research study by: (1) Giving them examples of what they might be asked to do in a study, and (2) Asking questions throughout the game and providing educational information along with the answers. By thinking about the game cards and giving thoughtful answers to the questions asked, players can eventually gain skills and decide whether or not to participate in a research study. During this session, faculty and attendees will: • Learn how this application was developed and how it has been used with children • Demonstrate how “Consent Quest” is used and review the possible outcomes of using an electronic game • Review the education and learning results from the use of “Consent Quest”

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Schedule Recognition Conference Information schedules

E23

Room 110

Outsourcing IRB Review While Maintaining a Robust HRPP at an Institution with a Small Research Program Basic (Small Research Programs Track)

Shannon L. Harr, Scott J. Lipkin This session will describe how an institution with a self-described small research program maintains an effective HRPP while outsourcing some or all of its IRB review. During this session, faculty will: • Explore the ethical tensions involved in outsourcing IRB review • I dentify shared and single-sourced responsibilities, accountabilities, and liabilities between the home institution and the outsourced IRB • Discuss how to measure and maintain an effective HRPP when some or all protocol review is outsourced

E24

Room 104

Basic

Julie Kaneshiro, Ivor A. Pritchard This session will use dramatic presentations of case studies of social and behavioral research studies to raise questions about IRB review and approval. The ethical principles of the Belmont Report (respect for persons, beneficence, and justice), as well as the regulatory provisions which apply those principles, will be called into play. A discussion on the application of the principles of the Belmont Report, and tensions between those principles, will be included. During this session, faculty and attendees will: • Discuss at least two ethical challenges in SBER • Discuss at least two issues involving the application of the regulations in SBER

E25

Ethical and Regulatory Issues in SBER (SBER I – Basic Track)

Room 306

The Use of Deception in SBER (SBER II – Advanced Track)

Advanced

Andrew Hedrick, Alison Orkin The use of deception in research is not uncommon, including in psychology, and marketing studies. While most of this research poses few risks to participants and is justifiable for methodological reasons (e.g., avoiding recruitment and response bias), informed consent is the touchstone of the ethical conduct of human subjects research. However, critics argue that any level of deception violates The Belmont Report’s principle of respect for persons. This session will explore the ethics of different types and degrees of deception and an IRB’s role and responsibility in reviewing such research. During this session, faculty and attendees will: • Use case studies to discuss IRB considerations and responsibilities when reviewing research involving deception

12:45-1:45 PM Exhibit Hall D

Lunch

2:00-3:15 PM

Veterans Memorial Auditorium

Closing General Session: Could this Happen to You? Lessons Learned from the University of Minnesota Reports

Moderator: Elisa A. Hurley Panelists: Brian Herman, Steven Joffe, Martha F. Jones Recent reports from the University of Minnesota, as well as past situations at other institutions, force HRPPs to carefully review their own research systems and structures. After all, we learn not only from our own mistakes, but also from the mistakes of others. This panel will feature individuals representing various roles in the research enterprise who will discuss their thoughts on how to handle difficult situations that arise within institutions, and the lessons learned for moving forward to ensure effective operations and adequate protections of those involved in research.

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CME Accreditation Statement

Boston University School of Medicine designates this live activity for 20 AMA PRA Category 1 Credits . Physicians should claim only the credit commensurate with the extent of their participation in the activity. This program includes for 20 hours, which meet the criteria of the Massachusetts Board of Registration in Medicine for risk management study. Course director: Susan S. Fish, PharmD, MPH, Professor, Biostatistics and Epidemiology, Boston University School of Public Health. Target audience: The target audience of this activity includes Human Research Protection Program/ Institutional Review Board (HRPP/IRB) chairs, members, and administrators; researchers and research staff; institutional officials; regulatory officials; compliance officers; those charged with overseeing responsible conduct of research programs; hospital/university attorneys; patient advocates; representatives of voluntary health organizations; industry and biotechnology representatives; and those involved with science policy. Educational objectives: Upon completion of this activity, participants should be able to: (1) Explain the principles listed in the various research ethics reports (Belmont Report, Nuremberg Report, Declaration of Helsinki) and apply them in their day to day work; (2) Identify the core federal regulations governing human subjects research and recognize which aspects of their work put those regulations into practice; (3) Develop strategies for managing successful HRPPs/IRBs; (4) Assess how their HRPP/IRB policies and procedures compare with the best practices in the field; (5) Communicate effectively with those involved in various aspects of the research enterprise to ensure adherence to federal regulations and that human subjects are properly protected before, during, and after a research study; and (6) Define a vulnerable population and demonstrate how ethical principles and federal regulations apply to these groups during research. Needs addressed statement: In order to successfully implement HRPPs, professionals involved with IRBs need access to current and accurate information on the laws, regulations, policies, and guidance documents governing human subject research ethics and compliance. How this information and policies are implemented varies. Past participants have rated highly the opportunity to discuss these principles with experts in the field and their peers. This conference enables participants to exchange best practices and other creative strategies that institutions around the country are employing to maximize protection of research participants, while at the same time streamlining administrative procedures that influence the implementation of policies. Faculty disclosure statement: Boston University School of Medicine asks all individuals involved in the development and presentation of CME activities to disclose all relationships with commercial interests. This information is disclosed to CME activity participants. Boston University School of Medicine has procedures to resolve any apparent conflicts of interest. In addition, faculty members are asked to disclose when any unapproved use of pharmaceuticals and devices is being discussed. Disclaimer: THESE MATERIALS AND ALL OTHER MATERIALS PROVIDED IN CONJUNCTION WITH CONTINUING MEDICAL EDUCATION ACTIVITIES ARE INTENDED SOLELY FOR PURPOSES OF SUPPLEMENTING CONTINUING MEDICAL EDUCATION PROGRAMS FOR QUALIFIED HEALTH CARE PROFESSIONALS. ANYONE USING THE MATERIALS ASSUMES FULL RESPONSIBILITY AND ALL RISK FOR THEIR APPROPRIATE USE. TRUSTEES OF BOSTON UNIVERSITY MAKES NO WARRANTIES OR REPRESENTATIONS WHATSOEVER REGARDING THE ACCURACY, COMPLETENESS, CURRENTNESS, NONINFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE MATERIALS. IN NO EVENT WILL TRUSTEES OF BOSTON UNIVERSITY BE LIABLE TO ANYONE FOR ANY DECISION MADE OR ACTION TAKEN IN RELIANCE ON THE MATERIALS. IN NO EVENT SHOULD THE INFORMATION IN THE MATERIALS BE USED AS A SUBSTITUTE FOR PROFESSIONAL CARE. Americans with Disabilities Act (ADA) statement: The Hynes Convention Center is a handicap accessible facility. To request reasonable accommodations for a disability, please visit the Help Desk located in the Registration Area at the Hynes Convention Center.

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schedules

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Boston University School of Medicine and PRIM&R.

Faculty List Recognition Conference Information

faculty

Melissa E. Abraham, PhD, MSc Chair, Human Research Committee, Partners HealthCare; Assistant Professor, Harvard Medical School; Assistant Psychologist, Massachusetts General Hospital; Faculty Associate, Center for Bioethics, Harvard Medical School. Panel VIII, E16. Latifa Adarmouch, MD, MPH Assistant Professor, Caid Ayyad University. B9 Jim Adler, MS Vice President, Products and Marketing; Chief Privacy Officer, Metanautix. Panel IV. Jamin Alexander, BA Manager, Division of Medicine Critical Care, Boston Children’s Hospital. Single IRBs Pre-Con. Albert J. Allen, MD, PhD Senior Medical Fellow Bioethics and Pediatric Capabilities, Eli Lilly and Company. A5, E15. Eric Allen, MA, CIP, CPIA Associate Director of Consulting Services, The HRP Consulting Group, Inc. A23, C20, D24. Emily E. Anderson, PhD, MPH Assistant Professor of Bioethics, Loyola University Chicago. B5, C5. Anne M. Andrews, PhD Director, Human Subjects Protection Office, NIST. B26. Misha Angrist, PhD, MFA Associate Professor of the Practice, Social Science Research Institute; Senior Fellow, Science and Society, Duke University; Visiting Associate Professor of the Practice, Sanford School of Public Policy. Panel V. Elizabeth A. Armstrong, PhD Professor of Sociology and Organizational Studies, University of Michigan. Panel II. Rebecca D. Armstrong, DVM, PhD Director, Research Subject Protection, University of California, Berkeley. B25, E20.

Tamara E. Baer, MD, MPH Adolescent Medicine Attending; Lecturer in Pediatrics, Boston Children’s Hospital. D10. Jeanette Bailey, BS, MT(ASCP), CIP IRB Consultant, Cincinnati Children’s Hospital Medical Center. C14. A. Cornelius Baker Deputy Coordinator for Affected Populations and Civil Society Leadership, US Department of State’s Office of the US Global AIDS Coordinator. B9. Madeleine Price Ball, PhD Director of Research, PersonalGenomes.org. Panel IV. Elizabeth Bankert, MA IRB Director, Dartmouth College. A4, E12. Mark Barnes, JD, LLM Partner, Ropes & Gray Law Firm; Faculty and Co-Director, Multi-Regional Clinical Trial Center, Harvard University and Brigham and Women’s Hospital. Biobanking Pre-Con, Panel I, D18, Town Hall Meeting, DNA in Play , E3. Edward E. Bartlett, PhD International Human Research Liaison, OHRP. C9, E20. John R. Baumann, PhD Assistant Vice President Research Compliance, Indiana University. B20, E14. Laura A. Baxter Attorney, Office of the Chief Counsel, NIST. B26. Dror Ben-Zeev, PhD Associate Professor of Psychiatry, Dartmouth College. Panel III. Hila F. Berger, MPH, CIP Compliance Officer, Montclair State University. E5. J. Andrew Bertolatus, MD IRB Co-Chair, Research Services Administration; Associate Professor, Internal Medicine, University of Iowa. B4, E13. Paula Bistak, DMH, CIP, MS, RN, CHRC Executive Director, Human Subjects Protection Program, Rutgers University. C14. Marianna J. Bledsoe, MA Independent Research Professional/Consultant, Marianna J. Bledsoe Consulting, LLC. Biobanking Pre-Con, D9. Jeremy Block, PhD, MPP IRB Chair; Assistant Professor, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai. Panel III, A19, C22, D13. Erin E. Bonar, PhD Assistant Professor, Psychiatry, University of Michigan. B6. David A. Borasky, MPH, CIP Vice President, Quality Management, Copernicus Group IRB. C9. Kristina C. Borror, PhD Director, Division of Compliance Oversight, OHRP. A12, C24, D20. Jeffrey R. Botkin, MD, MPH Associate Vice President for Research Integrity; Professor of Pediatrics, University of Utah. B2, D18, DNA in Play. Scott Bradner Senior Technical Consultant, Office of the Chief Technology Officer, Harvard University. D25. Lois Brako, PhD Assistant Vice President for Research, University of Michigan. B12. Elizabeth A. Buchanan, PhD Endowed Chair in Ethics; Director, Center for Applied Ethics, University of Wisconsin Stout. A16, B15. Lisa Buchanan, MAOM, CIP Compliance Officer, Compliance Oversight, OHRP. B21, D1, E20. Lynn W. Bush, PhD, MS, MA Faculty, Pediatric Clinical Genetics; Faculty Associate, Center for Bioethics, Columbia University. DNA in Play. Wesley G. Byerly, PharmD, CIP Associate Vice President for Research, Research Compliance, University of Connecticut Storrs. C11.

Sean Cahill, PhD Director of Health Policy Research; Director of Curriculum and Policy, The Fenway Institute. B19. Alexander M. Capron, LLB University Professor; Scott H. Bice Chair in Healthcare Law, Policy and Ethics, University of Southern California. Panel IX. Leah A. Carroll, PhD Haas Scholars Program Manager and Advisor, Office of Undergraduate Research and Scholarships, University of California, Berkeley. B25. Imelda Catalasan, LtCol. Director, AF Research Oversight & Compliance Division, Air Force Medical Support Agency. E1 Dominic Chiarelli, JD, CIP Senior Regulatory Attorney, Quorum Review IRB. A8 Kata L. Chillag, PhD Associate Director, Presidential Commission for the Study of Bioethical Issues. B10 p rim&r’ s 20 1 5 2 adv anci ng e ti thhi cal re se a rc h c on f e r e n c e

Rebecca Dahl, PhD, CIP Director, Human Subjects Protection Program, Children’s Hospital Los Angeles. C4, E22. Judy E. Davidson, DNP, RN, FCCM Evidence-Based Practice and Research Nurse Liason, University of California, San Diego Health System. D4. Liza Dawson, PhD Team Leader, National Institute of Allergy and Infectious Diseases. A22. William Deniston, CAPT. USN, MSC, PhD Director, Department of Navy Human Research Protections Program, US Navy. E1 Lisa Denney, MPH Associate Director for Program Development, Research Compliance Office, Stanford University. B21. Teresa Doksum, MPH, PhD Director of Research Ethics, Abt Associates, Inc. D19. Janet C. Donnelly, RAC, CIP Policy Analyst, Office of Good Clinical Practice, FDA. D12. Stacey A. Donnelly, MPA Senior Director, Strategic Operations and Chief Compliance Officer, Broad Institute. B18. Kelly Dornin-Koss, MPPM, RN, CIP Director, Education and Compliance, Office for Human Subject Research, University of Pittsburgh. A21. Keren R. Dunn, BS, CIP Manager, Research Compliance and QI, Cedars-Sinai Medical Center. B11. Raed A. Dweik, MD Professor of Medicine; Director, Innovation Management and Conflict of Interest Program; Chair, Innovation Management and Conflict of Interest Committee, Cleveland Clinic Ohio. C3.

Donna H. Eaton, RN, MSN, MHA Director, Research Compliance and Ethics; Research Integrity Officer, North Carolina A&T State University. C20. Linda A. Ehler RN, MN Senior Nurse Consultant, National Institute of Allergy and Infectious Diseases, Biobanking Pre-Con. Fanny K. Ennever, PhD Senior IRB Administrator, Committee on the Use of Human Subjects, Harvard University. D24, E19. Ann-Margret Ervin, PhD, MPH Assistant Scientist, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health. E6. Stanley Estime, CIP QA/QI Specialist, Harvard School of Public Health. QA/QI Pre-Con.

Michelle Feige, MSW, LCSW-C Executive Vice President, AAHRPP, Inc. A19, B17, D12, E12. Marwan T. Felaefel Senior Clinical Research Associate, American University in Cairo, MCT-CRO. Innovation A. Elizabeth Fenton, PhD, MPH Research Analyst, Presidential Commission for the Study of Bioethical Issues. B10, C1. Susan S. Fish, PharmD, MPH Professor, Biostatistics and Epidemiology, Boston University School of Public Health. IRB 101 PreCon, C17, D17. Celia B. Fisher, PhD Director, Center for Ethics Education, Fordham University. B6, C25, Panel VIII. Faith E. Fletcher, PhD Assistant Professor, Division of Community Health Sciences, University of Illinois at Chicago. B6. Emily Chi Fogler, JD Counsel, Verrill Dana LLP. E16. David G. Forster, JD, MA, CIP Chief Compliance Officer, WIRB-Copernicus Group. Single IRBs Pre-Con, B2, E8. Sarah Fowler-Dixon, PhD, CIP Education Specialist, Clinical Research Management and Research Ethics; Instructor, Washington University in St. Louis. D5. Sharon Freitag Director, Research Ethics Office, St. Michael’s Hospital. B12, E20. Robert W. Frenck, MD Professor of Pediatrics; Interim Director, Division of Infectious Diseases, Cincinnati Children’s Hospital Medical Center. B13, C13. n ove m b e r 12- 15 , b os t on , m a

faculty

Diana T. Chingos, MS, MFA Community Member, University of Southern California. Town Hall Meeting Karen Christianson, RN, BSN, CCRP Consultant, The HRP Consulting Group, Inc. A5. Jeffrey W. Clark, MD Associate Professor, Medicine, Harvard Medical School; Director, Clinical Trials Core, Dana-Farber/Partners Cancer Care, Massachusetts General Hospital. Panel IX. Terrence Clemmons Acting Director, Research Protection Division, Office of Naval Research. E1 Nichelle Cobb, PhD Director, Health Sciences IRBs, University of Wisconsin—Madison. D14. Jeffrey M. Cohen, PhD Chief Executive Officer, HRP Consulting Group, Inc. C24, E20. Joseph V. Cohn, PhD, CDR Deputy Director, Human Performance, Training, and BioSystems Directorate; Associate Director, Human Research Protections, US Naval Research Laboratory. E1. Charlotte H. Coley, MACT, CIP Training Coordinator, Office of Human Research Ethics, University of North Carolina at Chapel Hill. A13, E5. Stephanie Collins Reed, PhD IRB Analyst, New York State Psychiatric Institute; Assistant Professor of Clinical Neurobiology (in Psychiatry), Columbia University Medical Center. B14. Jeffrey A. Cooper, MD, MMM Vice President Process and Strategic Improvement, WIRB-Copernicus Group. A12, C21. Susie A. Corl, MSW, MPH, CIP, CCRP Education and Quality Improvement Specialist, Boston Children’s Hospital. B21. Amy Corneli PhD, MPH Faculty, Duke Clinical Research Institute, Duke University. C5, D6. Jeremy J. Corsmo, MPH, CIP, CHRC Senior Director, Cincinnati Children’s Hospital Medical Center. B3. Brenda Curtis, PhD, MSPH Research Associate, Department of Psychiatry - Addictions, University of Pennsylvania School of Medicine. B22, D22.

Faculty List Recognition Conference Information

faculty

Lisa Gabel, BA, CIP QA/QI Specialist, Harvard Medical School. QA/QI Pre-Con. Sandro Galea, MD, DrPH Dean; Professor, Boston University School of Public Health. Panel VII. Dean R. Gallant, AB Consultant, HRP Consulting Group, Inc. C24, D25, E10. Chris Galvin, MBA Program Analyst, OIG, DHHS. C26. George Gasparis, CIP President, The PEER Consulting Group. A15, E4. Gary H. Gibbons, MD Director, National Heart, Lung, and Blood Institute, NIH. Panel VII. Robin C. Ginn, MBA, BSN, CHC, CHRC, CIP Executive Director, Office for Clinical Research, Emory University. D11. Leonard Glantz, JD Professor Emeritus of Health Law, Bioethics, and Human Rights, Boston University School of Public Health. C25, Town Hall Meeting. Michele Gomez, BA, CIP Senior QA/QI Analyst, Partners HealthCare System, Inc. C21. Cynthia A. Gómez, PhD Director, Health Equity Institute for Research, Practice, & Policy, San Francisco State University. D19. Bruce G. Gordon, MD Professor and Division Chief, Pediatric Hematology/Oncology, University of Nebraska Medical Center. A19, D13, E13 Julia Gayle Gorey, JD Public Health Analyst, OHRP. B2, D12. Kristen Grace, MD, PhD Senior Scientist-Investigator, ORI. C2. Christine Grady, RN, PhD Chief, Department of Bioethics, NIH. B10, DNA in Play. Jennifer A. Graf Manager, Human Research Protection Program and Research Integrity, Cambridge Health Alliance. QA/QI Pre-Con, A21. Rupinder Grewal Conflict of Interest Officer, Massachusetts Institute of Technology. A11. Lisa A. Griffin, JD, MPH Director, Sponsored Programs and Compliance, Brigham and Women’s Hospital. C16. Elena Leonidovna Grigorenko, PhD Emily Fraser Beede Professor in the Child Study Center, Professor of Epidemiology (Chronic Diseases) and of Psychology, Yale School of Medicine. Panel VIII. Nareg Grigorian Data and Safety Monitoring Manager, Dana-Farber Cancer Institute. QA/QI Pre-Con. William Grizzle, MD, PhD Professor of Pathology, University of Alabama. Biobanking Pre-Con, C18. John A. Guidry, PhD Consultant, Icahn School of Medicine at Mount Sinai; IRB Chair, Gay Men’s Health Crisis. B19, C19.

Karen N. Hale, RPh, MPH, CIP Director, Office of Responsible Resesarch Practices; Clinical Assistant Professor, College of Pharmacy, The Ohio State University. C8. Dorotha Love Hall, PhD, MPA, CIP Senior Public Health Advisor, CDC. C20. Zachary Hallinan Director, Patient Communication and Engagement Programs, The Center for Study on Clinical Research Participation. A3. Zoë H. Hammatt, JD, MPhil Director, Division of Education and Integrity, ORI. C2. Karen M. Hansen Director, Institutional Review Office, Fred Hutchinson Cancer Research Center. E5. Ann Hardy, DrPH Extramural Human Research Protection Officer, NIH. B16. Shannon L. Harr, CIM, EdD Director, Research Integrity and Compliance, Morehead State University. A23, E23. Elizabeth M. Havener, MPH Program Analyst, Office of Evaluation and Inspections, OIG, DHHS. C26. Andrew Hedrick, MPA Social/Behavioral/Educational IRB Coordinator, University of Kentucky. C7, E25. Katherine Gallin Heffernan, JD Counsel, Verrill Dana LLP. B20, C3, D16. Christina Heide, JD Senior Health Information Privacy Policy Specialist, DHHS. C16. Brian A. Herman, PhD Vice President for Research, University of Minnesota. Closing General Session. Miguel Hernan, MD, MPH, ScM, DrPH Professor of Epidemiology, Harvard School of Public Health. A22. Julia Hesse, JD, M. Bioethics Partner, Choate, Hall & Stewart LLP. B16. Ross A. Hickey, JD, CIP, CPIA Assistant Provost for Research Integrity, University of Southern Maine. E21. Yvonne K. Higgins, CIP Vice President, Quality Management, Copernicus Group IRB. B13. Susie R. Hoffman, RN, BSN, CIP Director, IRB for Health Sciences Research, University of Virginia. IRB 101 Pre-Con, C16, E20. Elizabeth L. Hohmann, MD Chair and Physician Director, Partners HealthCare, Inc., Massachusetts General Hospital, Brigham and Women’s Hospital. C13, E16. Ty Hoover, MD, JD Director, Biorepository Regulatory Support, University of Texas MD Anderson Cancer Center. C18. Leslie M. Howes, MPH, CIP Director, Office of Human Research Administration, Harvard School of Public Health. QA/QI Pre-Con, D21, E9. Kathy L. Hudson, PhD Deputy Director, Science, Outreach, and Policy, NIH.Town Hall Meeting. Elisa A. Hurley, PhD Executive Director, PRIM&R. Closing General Session.

R. Peter Iafrate, PharmD Chairman, Health Center IRB, University of Florida. C13.

p rim&r’ s 20 1 5 2 adv anci ng e ti thhi cal re se a rc h c on f e r e n c e

Lynn A. Jansen, PhD Madeline Brill Nelson Chair in Ethics Education; Associate Director, The Center for Ethics in Health Care, Oregon Health & Science University. Panel VI. Lama Jamhawi, MSc, CIP IRB Member, Nova Scotia Health Authority Research Ethics Board. A9, E9. Frances E. Jensen, MD, FACP Professor and Chair, Department of Neurology, University of Pennsylvania School of Medicine D10. Steven Joffe, MD, MPH Emanuel and Robert Hart Associate Professor of Medicine Ethics and Health Policy, Associate Professor of Pediactrics, University of Pennsylvania School of Medicine. Innovations C, Closing General Session. Martha F. Jones, MA, CIP Executive Director of the Human Research Protection Office, Washington University in St. Louis. C4, D5, Closing General Session.

Julie Kaneshiro, MA Deputy Director, OHRP. A4, B18, D1, E24. Megan Kasimatis Singleton, JD, MBE, CIP Associate Director, Human Research Protections, University of Pennsylvania. B12, D20, E15. Nancy E. Kass, ScD Phoebe R. Berman Professor of Bioethics and Public Health, Berman Institute of Bioethics, Johns Hopkins University. Innovations A. Moira A. Keane, MA, CIP Human Research Protections Professional; Retired-Executive Director, HRPP, University of Minnesota. A24, E14. Cynthia M. Kern, RN, CCRC, CIP Director, Office for Investigator-Sponsored Investigational New Drug/Investigational Device Exemption Support, University of Pittsburgh. A15. Shamus Khan, PhD Associate Professor, Sociology, Columbia University. Panel II. Scott Y. H. Kim, MD, PhD Senior Investigator, Department of Bioethics, NIH; Adjunct Professor of Psychiatry, University of Michigan. Panel VI, C6. Sarah H. Kiskaddon, JD Director of Global Development and Public Affairs, AAHRPP, Inc. A13. Richard Klein Patient Liaison Program Director, FDA. B1, D16. Molly Klote, COL Director, Army Human Research Protections Office, Department of the Army. E1 Susan Z. Kornetsky, MPH Director, Clinical Research Compliance, Boston Childrenâ&#x20AC;&#x2122;s Hospital. Single IRBs Pre-Con, B3, E7, DNA in Play. Michele Kuchera, CIP IRB Manager, Fordham University. Panel VIII

Hal Landy, MD Medical Consultant, Valerion Therapeutics, LLC. C15. Yvonne Lau, MBBS, MBHL, PhD Director, Division of Education and Development, OHRP. A24, C12, D1. Kathleen Lawry, CIP Assistant Director, Research Administration and Compliance, MetroHealth System. QA/QI Pre-Con. Sandra Soo-Jin Lee, PhD Senior Research Scholar, Center for Biomedical Ethics, Stanford University Medical School. E18. Katherine Lerner, JD, CIP Associate Director, Social and Behavioral Sciences IRB, University of Chicago. A24. Joanne R. Less, PhD Director, Office of Good Clinical Practice, FDA. B1. Robert J. Levine, MD Professor of Internal Medicine; Chair, Executive Committee of the Center for Bioethics, Yale University. Panel I. Rebecca Li, PhD Executive Director, Multi-Regional Clinical Trials Center, Harvard University. A3. Gregorio Lim, CIP Human Subjects Protection Program Administrator, The Boeing Company. C10. Scott J. Lipkin, DPM, CIP Managing Director, Health Solutions, FTI Consulting. B11, D23, E23. Laura Lyman Rodriguez, PhD Director, Division of Policy, Communications, and Education, National Human Genome Research Institute. A18, E18.

Patricia A. MacCubbin, MS President and CEO, Research Ethics Group. A14. Eric C. Mah, MHS, CIP Executive Director, Clinical Research Operations, University of California, San Diego. A13, D11. Diane M. Maloney, JD Associate Director for Policy, FDA. B1. Greg E. Manship, D.Bioethics, MDIV, CIP, CIM IRB Director, University of Indianapolis. A17, D16. Jeffrey W. Mantz Human Subjects Research Officer, NSF. D2. Robert K. Massie, IV, MDiv, DBA Author. Keynote (November 15). Karen M. Masterson Author. Research Ethics Book Group Lunch. Lisa Mattocks Assistant Director, Program Management, Defense Advance Research Projects Agency. E1 Judy Matuk, MS Assistant Vice President, Research Compliance; Institutional Official, State University of New York - Stony Brook University. C12. Ross E. McKinney Jr, MD Director, Trent Center for Bioethics, Humanities, and Medical History; Professor, Pediatrics, Duke University Medical Center. A11. Lindsay McNair, MD, MPH, MSB Chief Medical Officer, WIRB-Copernicus Group. B15, D17.

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faculty

Faculty List Recognition Conference Information Patrick J. McNeilly, PhD, CIP Senior Health Policy Analyst, FDA. C8. Claude Ann Mellins, PhD Co-Director, HIV Center for Clinical and Behavioral Studies; Co-Director, Office of Clinical Psychology, Professor of Medical Psychology in Psychiatry and Sociomedical Sciences; Columbia University Medical Center, NewYork State Pyschiatric Institute. Panel II. Leslie Meltzer Henry, JD, MSc Professor of Law, University of Maryland School of Law; Core Faculty, Johns Hopkins Berman Institute of Bioethics. D10. Jerry Menikoff, MD, JD Director, OHRP. D1,Town Hall Meeting. Donna A. Messner, PhD Research Director, Center for Medical Technology Policy. B4. Michelle N. Meyer, PhD, JD Assistant Professor and Director of Bioethics Policy, Union Graduate College-Icahn School of Medicine at Mt. Sinai Bioethics Program. Panel IV. Megan C. Morash RN, MEd IRB Chair, Partners HealthCare System, Inc. C18. Ann Morrison, PhD Assistant Professor of Teacher Education; Human Subjects Protection Program Education and Outreach Liaison, Metropolitan State University of Denver. C23. Sendhil Mullainathan, PhD Professor of Economics, Harvard University. Keynote (November 14). F. Lisa Murtha, Esq, CHC, CHRC Senior Managing Director, FTI Consulting. C11. Laurie Myers, MBA Global Health Literacy Director, Merck & Co., Inc.; Co-Chair, Multi-Regional Clinical Trials Return of Results Working Group, Harvard University. A3.

Annet Nakaganda, Dip. Medicne, BSC, MPH IRB Operations Manager and Research Administrator, Uganda Cancer Institute. A9. Camille Nebeker, EdD, MS Assistant Professor (Behavioral Medicine and Global Health), Department of Family Medicine and Public Health; Director, Collaborative to Advance Professional and Research Integrity, University of California, San Diego. Panel III, B24. Daniel K. Nelson, MSc, CIP Director, Human Research Protocol Office, EPA; Professor of Social Medicine and Pediatrics, University of North Carolina at Chapel Hill. B7, E2. Robert M. “Skip” Nelson, MD, PhD Deputy Director and Senior Pediatric Ethicist, Office of Pediatric Therapeutics, FDA. A6, DNA in Play, E7. Eunice Yim Newbert, MPH Manager, Education and QI Program, Boston Children’s Hospital. QA/QI Pre-Con, D21. Jon Newlin, CIP Assistant Director, Office of the Human Research Protection Program, Feinstein Institute for Medical Research/North Shore Long Island Jewish Health System. Innovations B. Thinh X. Nguyen, PhD Director, Office of Combination Products, FDA. B8. Loc Nguyen-Khoa Director, Communications, ORI. C2. Amy Nolan, CIP IRB Manager, Cooper University Hospital. C23. Parker Nolen, MBA, CCRC, CIP Network Manager, IRB, Community Health Network. B23. Tina Noonan, MBA, CHRC, CIP Executive Director of Research, St. Vincent Indianapolis Hospital. D23.

Kelley O’Donoghue, MPH, CIP Associate Vice President for Human Subject Protection, University of Rochester. C10. P. Pearl O’Rourke, MD Director, Human Research Affairs, Partners HealthCare System, Inc.; Associate Professor of Pediatrics, Harvard Medical School. Single IRBs Pre-Con, B18, Panel VI, DNA in Play. Laura Odwazny, JD, MA Senior Attorney, Office of the General Counsel, DHHS. D22, Panel IV. Nancy A. Olson, JD Director, Human Research Office, University of Mississippi Medical Center. A14, B17. John Ordaz National Nuclear Security Administration Human Subjects Protection Program Manager, DOE. A2. Alison S. Orkin, CIP Associate Director, Office of the Human Research Protection Program, University of California, Los Angeles. E25. Alberto “Betto” Antonio Ortiz-Osorno, MS, PMP, CIPM Clinical Research Implementation Subject Matter Expert, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH. Biobanking Pre-Con. Stavroula Osganian, MD, ScD Co-Chief, Clinical Research Center, Boston Children’s Hospital. A5. Kathryn Owen Vice President – Clinical Trial Management, Novo Nordisk Inc. D15 Regina Kamene Owino, BA, RN Deputy Manager, QI, Academic Model Providing Access to Healthcare Plus. C9, D7.

Catherine Parker, RN, BSN Team Lead, Human Subject Protection Branch, Division of Safety Compliance, FDA. B1, D8. Cynthia R. Pearson, PhD Associate Professor; Interim Director of Research, Indigenous Wellness Research Institute, National Center of Excellence, University of Washington. C19, E17. Richard T. Penson, MD, MRCP Associate Professor, Harvard Medical School; Clinical Director, Medical Gynecologic Oncology; Clinical Director, Cancer Services on Martha’s Vineyard and Nantucket, Massachusetts General Hospital; IRB Chair, Dana-Farber/ Partners CancerCare. Panel IX. Rebecca D. Pentz, PhD Professor of Research Ethics, Emory School of Medicine. C6. Sean Philpott-Jones, PhD, MSBioethics Director, Center for Bioethics and Clinical Leadership; Associate Professor, Union Graduate College. E4. Heather H. Pierce, JD, MPH Senior Director, Science Policy and Regulatory Counsel, Association of American Medical Colleges. A10, E3. p rim&r’ s 20 1 5 2 adv anci ng e ti thhi cal re se a rc h c on f e r e n c e

Jerome F. Pierson, RPh, PhD Director, Office of Clinical Research Policy and Regulatory Operations, National Institute of Allergy and Infectious Diseases, NIH. Innovations A Sharyn J. Potter, PhD, MPH Co-Director, Prevention Innovations Research Center; Associate Professor of Sociology, University of New Hampshire. Panel II. Terry J.M. Powell IRB Administrator, Alaska Area IRB, Alaska Native Medical Center. D7. Ernest D. Prentice, PhD Associate Vice Chancellor, Academic Affairs, Regulatory Compliance, University of Nebraska Medical Center. D20. Ivor A. Pritchard, PhD Senior Advisor To the Director, OHRP. Panel VI, C7, E24. Kevin A. Prohaska, DO, MPH Senior Medical Policy Analyst, Office of Good Clinical Practice, FDA; Captain, US Public Health Corps. B1, D8, E20.

Rachel Sachs, JD Academic Fellow, The Petrie-Flom Center, Harvard Law School. A22. Rachael Sak, MPH Director, University of California Biomedical Research Acceleration, Integration, and Development, University of California San Francisco Medical Center Hospital. Innovations B. Fabienne Santel, MD Medical Officer, Office of Compliance, Division of Bioresearch Monitoring, Center for Devices and Radiological Health, FDA. A8. Cheryl A. Savini, CIP Principal, Chief Operating Officer, HRP Consulting Group, Inc. C12. James F. Saviola, OD, CAPT, USPHS Director, Division of Bioresearch Monitoring, FDA. B1. Debra Schaller-Demers, MSOM Director, Research Outreach and Compliance, Memorial Sloan-Kettering Cancer Center. A20. Linda Beth Schilling, CIP Senior Analyst, Human Subjects Protections Office, NIST. B26. Toby L. Schonfeld, PhD Director, Program in Human Research Ethics and Oversight, EPA. B7, C5, E2. Ada Sue Selwitz, MA Director, Office of Research Integrity; Adjunct Associate Professor, College of Medicine, Behavioral Sciences; Co-Director, Center for Clinical and Translational Science Regulatory Support, University of Kentucky. A4, D12, E10. Shannon Sewards, MA, CIP Director of IRB Administration, Committee on the Use of Human Subjects, Harvard University. D24, E19. Seema Shah, JD Research Fellow, NIH. D10. Robyn S. Shapiro, JD Partner, Health Law, Drinker Biddle & Reath LLP. E11. Stanley Y. Shaw, MD, PhD Co-director, Center for Assessment Technology and Continuous Health; Cardiologist, Corrigan Minehan Heart Center, Massachusetts General Hospital; Assistant Professor of Medicine, Harvard Medical School. Panel III. Jody M. Shoemaker Roberts, MS, CCRP, CIP Chief Operating Officer, Director of Research, The Mind Research Network. Innovations C. Joan E. Sieber, PhD Editor, Journal of Empirical Research on Human Research Ethics. B5, C5. Henry Silverman, MD, MA Professor of Medicine, University of Maryland School of Medicine. B9.

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C. Egla Rabinovich, MD, MPH Chair, Duke IRB; Associate Professor of Pediatrics, Duke University Medical Center. C13, D13. Jessica A. Randall, MA, CIP Manager, HRPP Research QA and Compliance, Yale University. QA/QI Pre-Con, D21. Moore Rhys, CIP Supervisor, Human Subjects Protection Program, Childrenâ&#x20AC;&#x2122;s Hospital Los Angeles. E22. Patrice Robinson-Haley Director, Research Regulatory Oversight Office, Office of the Under Secretary of Defense (Personnel and Readiness) E1. Jeffery W. Rodamar Protection of Human Subjects Coordinator, US Department of Education. D24. Lori Roesch, CIM, CIP Senior IRB Administrator, Milwaukee VA Medical Center. C10, D23. Linda Rogers, MD Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai; Clinical Director, Adult Asthma Program, Mount Sinai National Jewish Health Respiratory Institute. C22. Lisa Rooney, JD Senior Director, FTI Consulting. E11. Alexis M. Roth, PhD, MPH Assistant Professor, Drexel University School of Public Health. Innovations C. Michelle Roth-Cline, MD, PhD Pediatric Ethicist and Health Scientist, Office of Pediatric Therapeutics, Office of the Commissioner, FDA. C15. Karen H. Rothenberg, JD, MPA Marjorie Cook Professor of Law, University of Maryland, Baltimore. DNA at Play. Mark A. Rothstein, JD Herbert F. Boehl Chair of Law and Medicine; Director, Institute for Bioethics, Health Policy, and Law, University of Louisville School of Medicine. D9. Beth E. Roxland, JD, M.Bioethics Bioethics and Strategy Leader, Office of the Chief Medical Officer, Johnson & Johnson; Associate, Division of Medical Ethics, New York University Langone Medical Center. D16. Abby E. Rudolph Research Scientist, The Calverton Center, Pacific Institute for Research and Evaluation. B22. Kimberly A. Ruppert, MPH Program Analyst, OIG, DHHS. C26. Andrew Rusczek, JD, M.Bioethics Counsel, Verrill Dana LLP. B20, D20. Julie M. Rusczek, JD Senior Attorney, Drinker Biddle & Reath LLP. A16. Michele Russell-Einhorn, JD Senior Director, Office for Human Research Studies, Dana-Farber Cancer Institute. Biobanking Pre-Con, B2, E15. Charles J. Ryan, MD Professor of Medicine and Urology, University of California, San Francisco. Innovations B.

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Faculty List Recognition Conference Information Julie F. Simpson, PhD Director, Research Integrity Services, University of New Hampshire. A25. Jerome Amir Singh, BA, LLB, LLM, MHSc, PhD Head of Ethics and Law, Centre for the AIDS Program of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal; Adjunct Professor, Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto. Panel I, B9. Lynn E. Smith, JD Director, Huron Consulting Group. C3. Joanna Smolenski PhD Student, Philosophy, Graduate Center, The City University of New York. Panel V. Justin Snyder, PhD Quality Management Coordinator, Office for Research Protections, Pennsylvania State University. Innovations C. Alyssa Ashley Knotts Speier, MS, CIP QA/QI Specialist, Harvard School of Public Health. QA/QI Pre-Con. Sujatha Sridhar, MBBS, MCE Executive Director, Research Compliance, Education and Support Services, University of Texas Health Science Center at Houston Medical School. B11. Matthew D. Stafford, MPH Assistant Director, Clinical Research Compliance, Boston Children’s Hospital, Co-Chair, Harvard Catalyst Regulatory Working Group SBER Sub-Committee. A25, B24. Susan Stayn, JD Senior University Counsel, Stanford University. C16. Patience B. Stevens, MD, MPH, CIP IRB Vice Chairperson, Copernicus Group IRB. E13. Irene E. Stith-Coleman, PhD Director, Division of Policy and Assurances, OHRP. A19, C4, D1. Nicolle Strand, JD, M.Bioethics Research Analyst, Presidential Commission for the Study of Bioethical Issues. C1. Walter L. Straus, MD, MPH Associate Vice President, Clinical Safety and Risk Management 2, Merck & Co., Inc. D16, E9. David H. Strauss, MD Director of Psychiatric Research, New York State Psychiatric Institute; Vice Chair for Research Administration, Ethics, and Policy, Columbia University Department of Psychiatry. A10, D3, Town Hall Meeting. Elyse I. Summers, JD President and CEO, AAHRPP, Inc. Innovations B, E20.

Alan R. Tait, PhD Endowed Professor and Director of Clinical Research, Department of Anesthesiology, University of Michigan Medical School. Panel VI. David Neil Tavares Associate Director of Housing, YMCA For A Greater Boston. E19. Holly A. Taylor, PhD, MPH Associate Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health; Core Faculty, Johns Hopkins Berman Institute of Bioethics. E6. Amy Terpstra, MSW Director of Research, Heartland Alliance. C19, D19, E17. Dale E. Theobald, MD, PhD IRB Chairman, Community Health Network. B23. Hugh H. Tilson, MD, MPH, DrPH Adjunct Professor and Senior Advisor, University of North Carolina at Chapel Hill. D4. Elizabeth Tioupine, CIP Senior Systems and Process Analyst, Office of Research Administration, University of California, San Francisco. C21, D14, E21. Boghuma Kabisen Titanji, MD, MSc, PhD Physician and Clinical Researcher, Ministry of Public Health, Cameroon. Keynote (November 13). Veronica Todaro, MPH Vice President, National Programs, Parkinson’s Disease Foundation. A17, B17. Susan Brown Trinidad, MA Research Scientist, Department of Bioethics and Humanities, University of Washington. A18, D7. Michael A. Turik, MD Senior Medical Director, Clinical Pharmacology; Chair, Lilly Bioethics Advisory Committee, Eli Lilly and Company. Panel I.

Terry VandenBosch, PhD, RN, CIP, CCRP Senior Research Compliance Associate, University of Michigan. QA/QI Pre-Con. Jeanne Velders, JD, CIP Associate Director, Human Research Protection Office, Washington University in St. Louis. D5.

Steven Wakefield Director, External Relations, HIV Vaccine Trials Network, Fred Hutchinson Cancer Research Center. C9. Amelia Wall Warner, PharmD, RPh Founder and CEO, Global Specimen Solutions, Inc. Biobanking Pre-Con, E18. Melissa P. Wasserstein, MD Director, Program for Inherited Metabolic Diseases, Icahn School of Medicine at Mount Sinai. A18. Leah Watson IRB Chair, HRPO and HRPP Program Manager, United States Marine Corps Under the Cognizance of the Deputy Commandant, Combat Development and Integration. E1 Carol Juliet Weil, JD Program Director for Ethical and Regulatory Affairs, Office of Biorepositories and Biospecimen Research, National Cancer Institute. Panel V, C18. Janice Weinberg, ScD Professor, Department of Biostatistics; Director, Master of Science in Clinical Investigation, Boston University School of Public Health. C17. Kevin P. Weinfurt, PhD Professor, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center. C6. Elizabeth P. White, MBA, MPH, CIP Human Subjects Protection Program Manager, DOE. A2.

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Sarah A. White, MPH, CIP Director, Human Research QI Program, Partners HealthCare System, Inc. QA/QI Pre-Con, A21. Ilene Frances Wilets, PhD, CIP Executive Director, IRB, New York State Psychiatric Institute. B14. David A. Williams, MD Chief, Division of Hematology/Oncology; Director, Clinical and Translational Research; Associate Chair, Pediatric Oncology, Boston Children’s Hospital. C15. Brett Wilson, BSP RBM Business Partner, Bristol Myers-Squibb Company. D15. Nicole L. Wolanski Senior Health Policy Analyst, Office of Good Clinical Practice, FDA. E8. Delia Y. Wolf, MD, JD, MSCI, CIP Associate Dean for Regulatory Affairs and Research Compliance, Harvard School of Public Health. QA/QI Pre-Con, A9. Leslie E. Wolf, JD, MPH Professor of Law; Director Center for Law, Health & Society, Georgia State University College of Law. B16. Carrie D. Wolinetz, PhD Associate Director for Science Policy. NIH. A1

Aminu A. Yakubu, MPH Principal Health Research Officer, Federal Ministry of Health, Nigeria. Biobanking Pre-Con, D9.

Rachel Zand, PhD Director, Human Research Ethics, University of Toronto. A9. Tracy A. Ziolek, MS, CIP Director, Human Research Protections, University of Pennsylvania. C14.

Our webinars provide on-demand learning at your desk or on the go, viewable from your desk, a tablet or smart phone. Watched live or downloaded for later, you’ll ﬁnd our webinars always include must-have information that you can use right away, whether the topic is universally applicable or one that’s more narrowly focused. membe can access recordings of PRIM&R members webinars that occurred more than one year ago for free via the Knowledge Center. Non-members can purchase the recordings on demand at www.primr.org/webinars.

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Plenary and Keynote Biographies Recognition Conference Information Melissa E. Abraham, PhD, MSc, is a chair of the Partners Human Research Committee (PHRC), an assistant professor in psychiatry at Harvard Medical School, an associate psychologist at Massachusetts General Hospital, and is a faculty associate at the Center for Bioethics at Harvard Medical School where she teaches a course to students in the Masters in Bioethics Program. Dr. Abraham obtained her doctorate in clinical psychology from Northwestern University Medical School in Chicago, IL, and a master’s degree in epidemiology from the Harvard School of Public Health. Dr. Abraham completed the Fellowship in Medical Ethics at Harvard Medical School and went on to become a chair at the PHRC in 2004. Dr. Abraham reviews minimal risk biomedical and social-behavioral research conducted at Massachusetts General and Brigham and Women’s Hospitals. She is interested in issues related to social and behavioral research in the biomedical setting, and has developed guidance on topics related to the use of deception, social media and the internet, and emerging digital technologies in research for the IRB and investigator community at Partners HealthCare. Dr. Abraham has a psychotherapy practice in Boston, MA. Jim Adler, MS, is the vice president of products and marketing and the chief privacy officer at Metanautix. He is a business executive, entrepreneur, and thought leader on big data, privacy, security, and voting systems. Mr. Adler also serves on the Department of Homeland Security (DHS) Data Privacy and Integrity Advisory Committee providing advice at the request of the Secretary of Homeland Security and the DHS chief privacy officer. Most recently, Mr. Adler was vice president of data systems at inome and the first chief privacy officer at Intelius. Mr. Adler led the big data team that powers the company’s products, as well as serves as its chief consumer advocate. Prior to inome and Intelius, Mr. Adler served as president and chief technology officer at Identity.net, an internet company giving consumers control of their online identity and reputation. He was the founder and CEO of VoteHere, a pioneer in the development of private and secure electronic voting. He is a co-inventor of patents related to cryptographic voting and digital signatures. He has also served on the advisory boards of the Future of Privacy Forum and Helios Voting. He received his BS with high honors in electrical engineering from the University of Florida and his MS in electrical and computer engineering from the University of California, San Diego. Misha Angrist, PhD, MFA, is associate professor of the practice at the Duke Social Science Research Institute, a senior fellow in Duke’s Initiative for Science & Society, and a visiting associate professor of the practice in the Sanford School of Public Policy. He is interested in the intersection of biology and society, especially as it relates to the governance of human participation in research and medicine. As the fourth participant in the Personal Genome Project, he was among the first to have his entire genome sequenced and made public. He chronicled this experience in his book, Here is a Human Being: At the Dawn of Personal Genomics. Professor Angrist has an MFA from the Bennington Writing Seminars, an MS in genetic counseling from the University of Cincinnati, and a PhD in genetics from Case Western Reserve University. Elizabeth A. Armstrong, PhD, is a professor of sociology and organizational studies at the University of Michigan. She is a sociologist with research interests in the areas of sexuality, gender, culture, organizations, social movements,

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and higher education. Professor Armstrong joined the department of sociology and the Organizational Studies Program at the University of Michigan in 2009. Before that, she held a faculty appointment in the department of sociology at Indiana University. She was a fellow at the Radcliffe Institute for Advanced Study at Harvard University and a recipient of a National Academy of Education/Spencer Postdoctoral Fellowship. She earned her MA and PhD degrees in sociology at the University of California, Berkeley, and a BA in sociology and computer science from the University of Michigan. Madeleine Price Ball, PhD, is the director of research at PersonalGenomes.org and co-founder of the Open Humans Network. Dr. Ball has also been the director of research at the Harvard Personal Genome Project (PGP) – a position she still holds today. At the Harvard PGP, she’s contributed to various aspects, including research collaborations, genome interpretation, and participant communications. These projects enroll participants willing to publicly share their genome, health data, and other potentially identifiable data. They feature highly informed consent processes and ongoing relationships with participants, and explore an alternative approach for broadly sharing data for when anonymity cannot be guaranteed. Communicating the identifiability of data to participants is a key component of consent in these studies, and public data from the Harvard PGP has been used in re-identification research. Mark Barnes, JD, LLM, is a partner at Ropes & Gray Law Firm and his law practice focuses on human and animal research, stem cell and genetic research, research grants and contracts, research misconduct, and international research. Mr. Barnes is also faculty and the co-director of the Multi-Regional Clinical Trial Center of Harvard University and Brigham and Women’s Hospital. Mr. Barnes formerly served at Harvard University as the senior associate provost and the University senior research officer and, in 2004, he started and directed Harvard’s HIV/AIDS treatment programs in Nigeria, Tanzania, and Botswana for several years. Mr. Barnes served as chief administrative officer at St. Jude Children’s Research Hospital, and he has held senior appointed positions in the New York City and State Departments of Health. Mr. Barnes is co-chair of the Subcommittee on Harmonization of DHHS SACHRP, and he is a member of the Ethics Working Group of the National Institutes of Health HIV Prevention Clinical Trials Network. Dror Ben-Zeev, PhD, is an associate professor at the Dartmouth Psychiatric Research Center and a licensed clinical psychologist. He leads a research group focused on the development and deployment of mobile technologies in the study, assessment, and treatment of mental health conditions (www.mh4mh.org). Dr. Ben-Zeev has completed seminal studies in this area, including development and evaluation of the first smartphone intervention for schizophrenia, the largest evaluation of the penetration of mobile technologies among people with severe mental illness, the largest deployment of a mHealth intervention for psychiatric illness, co-design and development of the first automated text messaging intervention for schizophrenia, and implementation of multi-modal behavioral sensing technologies in outpatients and inpatients with psychosis. He has conducted technology-based intervention research in a variety of settings (i.e., community mental health, psychiatric inpatient units, academic outpatient clinics), and with diverse clinical populations (i.e., schizophrenia, bipolar disorder,

major depressive disorder, dual diagnosis). His research has been supported by National Institute of Mental Health, Patient Centered Outcomes Research Institute, National Institute of Drug Abuse, NSF, the Center for Medicare and Medicaid Innovation, and Dartmouth Institute for Clinical and Translational Science. In 2013, he received a EUREKA award from NIH designed to support innovative high-risk/high-reward research, and was invited to speak at the White House Conference on Technology Innovations for Substance use and Mental Health.

Lynn W. Bush, PhD, MS, MA, is on the faculty of Pediatric Clinical Genetics at Columbia University Medical Center, is a faculty associate at their Center for Bioethics, and she consults as the bioethicist on both the weekly Personalized Genomic Medicine clinical genomic sign-outs and clinical Pediatric/ Maternal Fetal Medicine/Neurogenomic case conference. Dr. Bush serves as an ethicist and liaison on pediatric and genomic advisory committees for numerous academic medical centers and professional organizations, including the American College of Medical Genetics, Newborn Screening Translational Research Network, and the American Public Health Association. Dr. Bush has an interdisciplinary graduate background in clinical and developmental psychology, bioethics, genomics, public health, and neuroscience that informs her research, writing, and teaching on the ethical, psychological, and policy challenges of genomic diagnosis, screening, clinical care, and research involving fetuses, newborns, infants, and children. Her focus is on ethical dilemmas posed during the prenatal-neonatal period and with pediatric chronic and acute conditions, including unknown or rare diseases and neurodevelopmental disorders. She developed narrative genomics with Karen H. Rothenberg, JD, MPA, as a creative pedagogical approach to bring to life these complex issues, enhance ethical reflection, and foster interdisciplinary discourse. The plays are frequently used at the NIH, medical schools, and professional conferences. Alexander M. Capron, LLB, holds the rank of university professor at the University of Southern California, where he occupies the Scott H. Bice Chair in Healthcare Law, Policy, and Ethics at the Gould School of Law. He is also a professor of medicine and law

Diana T. Chingos, MS, MFA whose first breast cancer diagnosis came 20 years ago, is an independent patient advocate in Los Angeles, CA. Engaged in research at the University of Southern California (USC), the City of Hope National Medical Center, Kaiser, and University of California, San Diego, she advises on clinical trials, and epidemiologic, basic science, and survivorship studies. She navigates newly diagnosed individuals with cancer and assists with treatment and clinical trial decision-making. Ms. Chingos serves as the patient representative on SACHRP and on the National Institute of Cancer (NCI) Steering Committees for Investigational Drugs, Correlative Sciences, and Patient Advocacy. She performs Data Safety Monitoring for the California Cancer Consortium and is a member of the USC IRB. Formerly, Ms. Chingos served as the executive director of the Noreen Fraser Foundation, a nonprofit that funds women’s cancer research. She contributed to the Young Survival Coalition’s White Paper on Breast Cancer in Young Women, and provided oversight to the NCI/National Institute of Environmental Health Sciences Breast Cancer Environmental Research Centers for over 10 years on its External Advisory Board/ Working Group. She mentors stakeholder reviewers new to peer review at the Patient-Centered Outcomes Research Institute. Ms. Chingos is a graduate of Bennington College and USC. Jeffery W. Clark, MD, is an associate professor of medicine at Harvard Medical School, director of the Clinical Trials Core at Dana-Farber/Partners Cancer Care and Massachusetts General Hospital, and the medical director of the Cancer Center Protocol Office at Massachusetts General Hospital. Dr. Clark received his medical degree from Tufts University School of Medicine. Over the last 30 years, Dr. Clark has been extensively involved in research efforts evaluating new agents or combinations of agents for malignancies, especially hepatocellular, biliary, gallbladder, pancreatic, and other gastrointestinal cancers. This has included studies evaluating the best approaches for imaging malignant disease in the liver and using changes to evaluate both tumor response and the effects of targeted agents (such as inhibitors of the Vascular Endothelial Growth Factors and their receptors) on the changes in tumor characteristics as measured by imaging studies. Dr. Clark also continues to see a large number of patients with these malignancies and who might be considered for potential participation in trials evaluating innovative approaches to imaging of malignant diseases in the liver.

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Jeremy Block, PhD, MPP, is an assistant professor of population health science and policy at the Icahn School of Medicine at Mount Sinai where he is also a chair/vice-chair of IRBs at hospitals within the Mount Sinai Health System. Jeremy is primarily interested in the intersection of science and technology with society and public policy. His background includes advising at the federal, state, and local level on a variety of science and technology relevant fields including: green procurement, human research subject protections, chemical and biological weapons, emerging properties and markets with science and technology components, and research systems at public and private universities. In addition, Dr. Block has been involved in technology development in the areas of virtual reality and mHealth applications. He has a background in teaching ethics in public policy, bioethics, and science and technology policy at both the undergraduate and graduate level. Dr. Block holds a Bachelors in chemistry and biology, a Masters in public policy, and a PhD in biochemistry from Duke University.

at the Keck School of Medicine, and is co-director of the Pacific Center for Health Policy and Ethics. An honors graduate of Swarthmore College and Yale Law School, he previously taught at Georgetown, Pennsylvania, and Yale. He was the executive director of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, a congressionally chartered body that recommended creation of the Common Rule, and he served for four years as the first director of ethics, trade, human rights, and health law at the World Health Organization in Geneva. An elected member of the National Academy of Medicine and of the American Law Institute, and a founding fellow of The Hastings Center, Professor Capron has served as president of the International Association of Bioethics, president of the American Society of Law, Medicine, and Ethics, and currently as PRIM&R’s Board Chair and a member of the 2015 AER Conference CCPC.

Plenary and Keynote Biographies Recognition Conference Information

faculty

Marwan T. Felaefel is a senior clinical research associate and leads a team of clinical research associations in Egypt and Saudi Arabia at MCT-CRO. Mr. Felaefel has four years of experience in clinical research, including laboratory research in academia, clinical trials in different phases and therapeutic areas in a multinational pharmaceutical company, and contract research organizations. Mr. Felaefel studied pharmacy as an undergraduate student, received a Master of Science degree in biotechnology, and is currently pursuing a post-graduate certificate in research ethics from the University of Maryland, Baltimore. Celia B. Fisher, PhD, is the Marie Ward Doty Endowed University Chair and professor of psychology and the founding director of the Fordham University Center for Ethics Education and the HIV and Drug Abuse Prevention Research Ethics Training Institute, which is funded by the National Institute on Drug Abuse. She chaired the EPA’s Human Studies Review Board and the American Psychological Association’s Ethics Code Task Force, and was a member of SACHRP, the NAS’ Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, the National Institute of Mental Health Data Safety and Monitoring Board, and the IOM’s Committee on Clinical Research Involving Children. Dr. Fisher was awarded the Lifetime Achievement Award for Excellence in Human Research Protection in 2010, and was named a 2012 Fellow of the American Association for the Advancement of Science. She is the author of Decoding the Ethics Code: A Practical Guide for Psychologists (3rd edition, 2013); co-editor of eight books, including The Handbook of Ethical Research with Ethnocultural Populations and Communities (2006, Sage Publications) and Research with HighRisk Populations: Balancing Science, Ethics, and Law (2009, APA Publications); and over 150 theoretical and empirical publications. Professor Fisher is a member of the 2015 AER Conference CCPC.

Medical School. He completed his residency and cardiology fellowship at Brigham and Women’s Hospital in Boston, MA. He was a member of the faculty at Stanford University from 1990 until 1996, and Harvard Medical School from 1996 until 1999. He joined Morehouse School of Medicine in 1999 where he served as the founding director of the Cardiovascular Research Institute, chairperson of the department of physiology, and professor of physiology and medicine until 2012 when he was appointed director of NHLBI. Dr. Gibbons has received numerous honors, including election to the IOM of NAS, and selection as a Robert Wood Johnson Foundation Minority Faculty Development Fellowship awardee. Leonard Glantz, JD, is a professor emeritus of health law, bioethics, and human rights at the Boston University School of Public Health. Professor Glantz has spent much of his career examining issues related to the protection of human subjects. He is the author of numerous books, articles, reports, and appellate briefs on medico-legal issues. He is the author or editor of two books, Informed Consent to Human Experimentation: The Subject’s Dilemma, with George Annas and Barbara Katz (1977), and Children as Research Subjects: Science, Ethics and Law, coedited with Michael Grodin (1994). He has been an IRB member for more than 30 years. His current research interests include reproductive rights, rights of the terminally ill, regulation of research with human subjects, children’s rights, and the constitutional limits of public health regulation. Mr. Glantz is a former member of PRIM&R’s Board of Directors, previously serving as chair. He is also a member of the 2015 AER Conference CCPC.

Sandro Galea, MD, DrPH, is dean and professor at the Boston University School of Public Health, and he is a physician and an epidemiologist. Dr. Galea is centrally interested in the social production of health of urban populations, with a focus on the causes of brain disorders, particularly common mood-anxiety disorders and substance abuse. Dr. Galea has a medical degree from the University of Toronto, graduate degrees from Harvard University and Columbia University, and an honorary doctorate from the University of Glasgow. He was named one of TIME magazine’s epidemiology innovators in 2006. He is past-president of the Society for Epidemiologic Research and an elected member of the American Epidemiological Society and of the IOM of NAS. Dr. Galea serves frequently on advisory groups to national and international organizations. He formerly served as chair of the New York City Department of Health and Mental Hygiene’s Community Services Board and as a member of its Health Board.

Elena Leonidovna Grigorenko, PhD, is the Emily Fraser Beede Professor in the Child Study Center and a professor of epidemiology (Chronic Diseases) and psychology at Yale School of Medicine. She received her PhD in general psychology from Moscow State University, Russia, in 1990, and her PhD in developmental psychology and genetics from Yale University in 1996. Dr. Grigorenko has published more than 350 peer-reviewed articles, book chapters, and books. She has received awards for her work from five different divisions of the American Psychological Association (APA) (Divisions 1, 7, 10, 15, and 24). She also won the APA Distinguished Award for Early Career Contribution to Developmental Psychology and the American Educational Research Association Sylvia Scribner Award for research representing significant advancement in the understanding of learning and instruction. Dr. Grigorenko has worked with children and their families in the United States as well as in Africa (Kenya, Tanzania and Zanzibar, the Gambia, and Zambia), India, Saudi Arabia, and Russia. Her research has been funded by the NIH, NSF, National Institute of Justice, DOE, and other federal and private sponsoring organizations.

Gary H. Gibbons, MD, is director of the National Heart, Lung, and Blood Institute (NHLBI), NIH, where he oversees the third largest Institute at the NIH, with an annual budget of over $3 billion and a staff of 917 employees. Dr. Gibbons’ research program is recognized for its discovery science related to cardiovascular health of minority populations. His laboratory is currently focused on discovering novel, ancestry-specific mediators of vascular disease. Originally from Philadelphia, PA, Dr. Gibbons earned his undergraduate degree from Princeton University and graduated magna cum laude from Harvard

Brian A. Herman, PhD, is the vice president for research at the University of Minnesota and has been so since January 1, 2013. In this role, he is responsible for the oversight and administration of an externally funded research program of more than $800 million, which encompasses all five campuses in the University of Minnesota system. Dr. Herman has primary responsibility for the overall vitality of the university-wide research environment, including supporting evolution of new research, maintaining a competitive research infrastructure, developing and managing campus-wide research policies,

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Kathy L. Hudson, PhD, is the deputy director for science, outreach, and policy at the NIH. Dr. Hudson leads the science policy, legislation, communication, and outreach efforts of the NIH, and serves as a senior advisor to the NIH director. She is responsible for creating major new strategic and scientific initiatives for NIH and is currently leading the planning and creation of the President’s Precision Medicine Initiative Cohort Program. Dr. Hudson was a key architect of the National Center for Advancing Translational Sciences (NCATS) and the NIH Brain Research through Advancing Innovative Neurotechnologies Initiative. She directs the agency’s efforts to advance biomedical research through policy development, public and stakeholder communication and education, and innovative projects and partnerships. Dr. Hudson’s professional experience includes serving as the NIH chief of staff; acting deputy director of NCATS, NIH; assistant director of the National Human Genome Research Institute, NIH; and the founder and director of the Genetics and Public Policy Center at John Hopkins University. Dr. Hudson was also an associate professor in the Berman Institute of Bioethics, Institute of Genetic Medicine, and department of pediatrics at John Hopkins University. Dr. Hudson holds a PhD in molecular biology from the University of California, Berkeley, a MS in microbiology from the University of Chicago, and a BA in biology from Carleton College. Elisa A. Hurley, PhD, is the executive director of PRIM&R. In that capacity, she has overall strategic and operational responsibility for PRIM&R’s staff, programs, and organizational relationships, and leads the organization in the execution of its mission. Dr. Hurley also teaches webinars and short courses for PRIM&R; serves as a blog contributor for both PRIM&R and other research-focused organizations; and represents PRIM&R and its mission at meetings in the US and abroad. Prior to taking on the role of executive director in April 2014, Dr. Hurley served for three years as PRIM&R’s education director. She oversaw curriculum development and faculty cultivation for the organization’s suite of in-person and virtual educational programs; managed PRIM&R’s public policy activities; and served as a member of the senior management team. Dr. Huley is a moral philosopher by training. Prior to arriving at PRIM&R in December 2010, she was an assistant professor of philosophy at The University of Western Ontario, where her research and teaching focused on biomedical ethics, metaethics, and moral psychology. Dr. Hurley received a BA in philosophy from Brown University in 1996, a PhD in philosophy from Georgetown University in 2006, and held a Greenwall Fellowship in Bioethics and Health Policy at the Johns Hopkins Berman Institute of

Bioethics and Georgetown University’s Kennedy Institute of Ethics from 2006 to 2007. She is most recently co-author of a chapter on the past and present of human subject protections in Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014) and a commentary in Hastings Center Special Report: The Intersection of Research Fraud and Human Subjects Research: A Regulatory Review (2014). She also currently serves as a nonaffiliated member on both an IRB and an institutional animal care of use committee. Lynn A. Jansen, PhD, is the holder of the Madeline Brill Nelson Chair in Ethics Education and is the associate director of the Center for Ethics in Health Care at Oregon Health & Science University. Dr. Jansen has published widely on topics in both medical ethics and research ethics. Her work has appeared in the leading journals in the field including The Hastings Center Report, The Kennedy Institute of Ethics Journal, Bioethics, and The Journal of Medicine and Philosophy. She served as a co-editor of Theoretical Medicine and Bioethics from 2002 to 2009, where she is now an associate editor. Dr. Jansen has served on a number of national advisory boards including the ethics council for the American Academy of Pain Medicine and the ethics council for the National Ovarian Cancer Coalition. She also served as an advisory panel member for the Fred Friendly Seminar on Science and the Ethics of Enhancement for the National Public Broadcasting Service. Dr. Jansen is the principal investigator on a five year RO1 Grant funded by the National Cancer Institute designed to study the impact of the optimistic bias on risk/benefit assessments by patient-subjects who enroll in early phase cancer trials. Steven Joffe, MD, MPH, is the Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy, and associate professor of pediatrics, at the University of Pennsylvania Perelman School of Medicine. He is also vice-chair of the department of medical ethics and health policy. He is a pediatric oncologist and bioethicist whose research focuses on ethical and policy issues in science, biomedical research, and genomics. Martha F. Jones, MA, CIP is the executive director of Human Research Protection Office at the Washington University in St. Louis. Ms. Jones serves as a member of the OnCore Steering Committee, CTSA Clinical Trials Task Force, and Barnes Jewish Hospital/Washington University School of Medicine Clinical Trials Steering Committee. Ms Jones leads the ongoing development of the institution’s IRB and Project Management data systems. She is a member of AAHRPP Council and serves as an AAHRPP Team Leader and site visitor. She has experience with a wide variety of biomedical, behavioral/social science research and expertise in database design for multi-center clinical research studies and human subjects protection programs. Ms. Jones was previously an IRB Chair and Director at the University of Iowa and served on the Conflict of Interest committee, the Internal Advisory Committee for the Iowa Clinical and Translational Science Award (CTSA), the Clinical Trials Billing Task Force, and co-directed a course in Clinical Research Ethics. Ms. Jones has also served as a Deputy Director of the Center for Public Health Statistics and as Center Coordinator for the Clinical Trials Statistical and Data Management Center.

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and overseeing administrative management of all sponsored research activity. He is also responsible for technology commercialization activities and for the administration of regulatory offices. Dr. Herman received his undergraduate degree in biology from Adelphi University, his doctorate from the University of Connecticut Health Science Center, and undertook postgraduate training at Harvard Medical School. He then joined the faculty at the University of North Carolina at Chapel Hill School of Medicine. In June 1998, he assumed the position of professor and chair of the department of cellular and structural biology at the University of Texas Health Science Center at San Antonio, and he served in this capacity until October 2004, when he assumed the position of vice president for research at the institution.

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Plenary and Keynote Biographies Recognition Conference Information Nancy E. Kass, ScD, is the Phoebe R. Berman Professor of Bioethics and Public Health in the Berman Institute of Bioethics at The Johns Hopkins University, and is a professor in the department of health policy and management at the Johns Hopkins Bloomberg School of Public Health. She is also a fellow of The Hastings Center. She received her bachelor’s degree from Stanford University, doctoral training from the Bloomberg School of Public Health, and was awarded a National Research Service Award to complete a postdoctoral fellowship at the Kennedy Institute of Ethics at Georgetown University. Dr. Kass conducts empirical work in bioethics and health policy. She served as a member of the IOM’s Committee on Perinatal Transmission of HIV, and as a consultant to the National Bioethics Advisory Commission to examine American investigators’ experiences working in developing countries. Her current research projects examine ethics and learning healthcare systems, informed consent, obesity and public health ethics, and ethics issues in international health research. Dr. Kass has taught courses on HIV/AIDS policy, research ethics, and international research ethics. She also directs the Johns Hopkins PhD program in Bioethics and Health Policy and the Johns Hopkins-Fogarty African Bioethics Training Program.

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Shamus Khan, PhD, is an associate professor of sociology and the director of the graduate program at Columbia University. He writes on culture, inequality, and elites. He is the author of Privilege: The Making of an Adolescent Elite at St. Paul’s School (Princeton), The Practice of Research (Oxford, with Dana Fisher), and the forthcoming books, Exceptional: The Astors, the New York Elite, and the Story of American Inequality (Princeton) and Approaches to Ethnography: Modes of Representation and Analysis in Participant Observation (Oxford). He directs the working group on the political influence of economic elites at the Russell Sage Foundation, is the series editor of The Middle Range at Columbia University Press, and the editor of the journal, Public Culture. Scott Y. H. Kim, MD, PhD, senior investigator in the Department of Bioethics, NIH, and an adjunct professor of psychiatry, University of Michigan. Previously, he was professor of psychiatry and codirector of the Center for Bioethics and Behavioral Sciences in Medicine at the University of Michigan. Dr. Kim received his MD from Harvard and PhD in moral philosophy (on Kantian ethics) from the University of Chicago, and trained in adult psychiatry at the Massachusetts General Hospital. Dr. Kim combines philosophical, clinical, and empirical research approaches to his scholarly work, using a variety of methods (both empirical and normative) to address several bioethical topics, including: assessment of decision-making capacity, surrogate consent for incapacitated patients, theory of informed consent, end of life dilemmas, and research ethics. Dr. Kim’s work has been supported by the National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Human Genome Research Institute, Michael J. Fox Foundation, American Association for Geriatric Psychiatry, and the Greenwall Foundation. His book, Evaluation of Capacity to Consent to Treatment and Research (Oxford, 2010), was recently translated into Japanese. Michele Kuchera, MBA, CIP, is currently the IRB manager at Fordham University. She has over 15 years of experience overseeing the protection of human subjects in research. In her current position, Ms. Kuchera is responsible for managing all IRB procedures, drafting and implementing IRB policy, providing

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guidance to the Fordham University community, and advising institutional officials on regulatory matters. She began her career in research ethics as the assistant director of sponsored research and IRB administrator at Long Island University. Ms. Kuchera received her MBA from Long Island University and is a CIP. Robert J. Levine, MD, is professor of internal medicine and chair of the executive committee of the Center for Bioethics at Yale University. He is a fellow of The Hastings Center and the American College of Physicians, past president of the American Society of Law, Medicine, and Ethics, and a member of PRIM&R’s Board of Directors. Dr. Levine was chair of the IRB at Yale-New Haven Medical Center (1969-2000) and founding editor of IRB: Ethics and Human Research. He has served several agencies involved in policy development for human subjects protections, including the Council for International Organizations of Medical Sciences Steering Committee for the 1993 and 2002 revisions of International Ethical Guidelines for Biomedical Research Involving Human Subjects (chairperson); the World Medical Association Working Group to Propose a Revision to the Declaration of Helsinki (chairperson); and the National Research Council Committee on Proposed Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. He was co-author of The Belmont Report. Dr. Levine received PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics in 2005. Dr. Levine is a member of PRIM&R’s Board of Directors. He is also a member of the 2015 AER Conference CCPC. Robert K. Massie, IV, MDiv, DBA, is an ordained Episcopal minister, and received a doctorate from Harvard Business School in 1989 where he specialized in corporate strategy and social responsibility. After teaching at Harvard Divinity School for seven years, he became the president of Ceres, the largest coalition of environmental groups and institutional investors in the United States. During his tenure at Ceres (1996-2003), he launched the Global Reporting Initiative, a set of guidelines for corporate disclosure on sustainability that is now in use among 11,000 multinational companies. He also created the Investor Network on Climate Risk, with more than 100 institutional investors with $11 trillion in assets focused on the financial challenges of climate change. In 1998, Dr. Massie published Loosing the Bonds: The United States and South Africa in the Apartheid Years, which won the prestigious Lionel Gelber prize for the best book on international relations. In the midst of all these activities, Dr. Massie faced difficult medical challenges, beginning with his life-long battle with severe Factor VIII hemophilia exacerbated by becoming infected with HIV and hepatitis C later in life as result of transfusions for the hemophilia. His autobiography, A Song in the Night: A Memoir of Resilience (Doubleday, 2012) recounts how his childhood illness laid the foundation for a life filled with compassion and activism. Karen M. Masterson is the author of The Malaria Project: The U.S. Government’s Secret Mission to Find a Miracle Cure (NAL, Penguin, 2014), a historical narrative about the US government’s hunt for a malaria cure during World War II. Ms. Masterson is a former political reporter for the Washington Bureau of the Houston Chronicle, and she left newspapers to pursue her interest in microbiology. In the midst of all these activities, Dr. Massie faced difficult medical challenges, beginning with his life-long battle with severe Factor VIII hemophilia exacerbated by becoming infected

with HIV and hepatitis C later in life as result of transfusions for the hemophilia. His autobiography, A Song in the Night: A Memoir of Resilience (Doubleday, 2012) recounts how his childhood illness laid the foundation for a life filled with compassion and activism.

Jerry Menikoff, MD, JD, is the director of OHRP. Prior to this, he was in charge of the internal human subject protections program at the NIH. He is the author of Law and Bioethics: An Introduction (Georgetown University Press) and What the Doctor Didn’t Say: The Hidden Truth about Medical Research (Oxford University Press). Michelle N. Meyer, PhD, JD, is an assistant professor and director of bioethics policy in the Union Graduate College Icahn School of Medicine at Mount Sinai Bioethics Program, where she teaches, writes, and speaks on topics arising at the intersection of law, ethics, science and technology, especially research ethics and regulation. In addition to serving on the advisory boards of other academic research collaboratives, she is a member of the Board of Directors (unpaid) of PersonalGenomes.org, a nonprofit that develops novel ways of managing the ethical, legal, and technical aspects of open access repositories of highly identifiable human genomic data, and she is also a research participant in its Personal Genome Project. She holds a JD from Harvard Law School and a PhD from the University of Virginia in religious studies with a focus on applied ethics. Her scholarly work has appeared in leading journals of law, ethics, and science. She is also a Forbes contributor, and her writing for a popular audience has additionally appeared in the New York Times, the LA Times, Wired, and Slate. Sendhil Mullainathan, PhD, is a professor of economics at Harvard University and a Cornell Tech Fellow. His real passion is behavioral economics, and his work runs a wide gamut: the impact of poverty on mental bandwidth; whether CEO pay is excessive; using fictitious resumes to measure discrimination; showing that higher cigarette taxes makes smokers happier; modeling how competition affects media bias; and a model of coarse thinking. His latest research focuses on using machine learning and data mining techniques to better understand human behavior. He

Camille Nebeker, EdD, MS, is an assistant professor of behavioral medicine in family medicine and public health at the University of California, San Diego (UCSD), and is the founder/ director of the Collaborative for Advancing Professional and Research Integrity. Prior to her UCSD appointment, she led the research ethics and regulatory compliance programs at San Diego State University. Her research program is developing educational interventions that incorporate the research on human learning to the design of research/bioethics education. Project Building Research Integrity and Capacity or BRIC, for example, is a research ethics training designed for community members (e.g., community research facilitators or promoters) who assist academic researchers to carry out community- and clinic-based health research. Dr. Nebeker is also exploring the ethical dimensions (i.e., informed consent, risk assessment, data management) of socio/biomedical research that utilize emerging technologies. Dr. Nebeker refers to this project as Mobile Imaging, pervasive Sensing, Social media, and Tracking - Ethics or MISST-E. Dr. Nebeker is leading a study to explore research risks (e.g., privacy, confidentiality, bystander rights), risk management strategies (e.g., data management/security), and informed consent from several stakeholder perspectives (e.g., participants, researchers, ethics board members) with a goal of developing accessible best practices. Since 2002, her research has received continuous support from the NIH, NSF and ORI. Jon Newlin, CIP, is the assistant director of the HRPP at the North Shore-Long Island Jewish Health System (soon to be Northwell Health) in New York. He is responsible for supporting the operations of the health system’s flexible IRB system, and providing regulatory guidance to the research community. He began his career as a regulatory coordinator in oncology research at Hartford Hospital, and then moved into IRB management within the Feinstein Institute for Medical Research, the research arm of the North Shore-Long Island Jewish Health System. Mr. Newlin’s efforts have been directed towards consolidating smaller hospital IRBs into a broader flex model that serves the needs of an expanding health system, with hospitals across New York State. His research interests are IRB operational QI, measuring turnaround times, and finding flexibility within current regulations to maximize productivity without diminishing participant protections. P. Pearl O’Rourke, MD, is the director of Human Research Affairs at Partners HealthCare Systems in Boston, MA, and an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and

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Claude Ann Mellins, PhD, is a clinical psychologist with expertise in the psychosocial aspects of HIV disease, substance use, and stress and trauma in children, adolescents, and young adults. She is a professor of medical psychology (in psychiatry and sociomedical Sciences) at Columbia University, as well as a research scientist and co-director of the HIV Center for Clinical and Behavioral Studies in the Division of Gender, Sexuality, and Health. She is also co-director of the Office of Clinical Psychology for clinical psychologists at Columbia University Medical Center. For 25 years, Dr. Mellins has been the principal- or co-investigator of foundation and federally-funded research projects, based in the US and internationally, examining neurodevelopment, mental health, adherence, and sexual and drug risk behavior in vulnerable populations of youth affected by HIV, poverty, and substance abuse. She also co-founded the Special Needs Clinic at New York Presbyterian Hospital, one of the first and largest mental health clinics for women, children, and families affected by HIV. Most recently, Dr. Mellins is co-leading the Sexual Health Initiative to Foster Transformation, a comprehensive research project examining the individual, interpersonal, and structural (cultural, community, and institutional) factors that shape sexual health and sexual misconduct for Columbia University undergraduates.

enjoys writing, having recently co-authored Scarcity: Why Having too Little Means so Much and writes regularly for the New York Times. He helped co-found a nonprofit organization to apply behavioral science (ideas42), co-founded a center to promote the use of randomized control trials in development (the Abdul Latif Jameel Poverty Action Lab), serves on the board of the MacArthur Foundation, and has worked in government in various roles, including most recently as assistant director of research at the Consumer Financial Protection Bureau. Professor Mullainathan is a recipient of the MacArthur Genius Award, was designated a Young Global Leader by the World Economic Forum, labeled a Top 100 Thinker by Foreign Policy Magazine, and named to the Smart List: 50 people who will change the world by Wired Magazine (UK).

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Plenary and Keynote Biographies Recognition Conference Information ethical oversight of human research and human embryonic stem cell research. Dr. O’Rourke’s career began as a pediatric critical care physician at Children’s Hospital, Boston, and then Children’s Hospital, University of Washington, Seattle, WA as director of the Pediatric Intensive Care Unit. She did clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. Following a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy from 1997 to 2000, she was the deputy director of the Office of Science Policy in the Office of the Director at the NIH, where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination. Dr. O’Rourke is the former chair and a current member of the PRIMR Board of Directors, and she is a co-chair of the 2015 AER Conference CCPC. Laura M. Odwazny, JD, MA, is a senior attorney with the Office of the General Counsel at the US DHHS. Ms. Odwazny’s primary client is OHRP, which interprets and enforces the HHS regulations that provide protections for human research subjects. Ms. Odwazny also currently advises the Presidential Commission for the Study of Bioethical Issues and the DHHS Office of Global Affairs. Throughout her 15 years with the Office of the General Counsel, Ms. Odwazny has provided legal advice to various other agencies within DHHS, including the Office of the Assistant Secretary for Health, the Program Support Center Division of Freedom of Information Act Services, the Health Resources and Services Administration, and the Substance Abuse and Mental Health Administration. Prior to her employment with DHHS, Ms. Odwazny served as a law clerk to the Superior Court of Pennsylvania and the Supreme Court of Pennsylvania. Ms. Odwazny is a graduate of the University of Chicago and the University of Pittsburgh School of Law, and received a MA in bioethics through the history and philosophy of science department at the University of Pittsburgh. Ms. Odwazny has served as an adjunct professor at American University Washington College of Law, teaching the course “The Law and Ethics of Human Subjects Research.” Ms. Odwazny has served on the PRIM&R AER Conference CCPC since 2013, and is currently the co-chair of the 2015 AER Conference CCPC. Richard T. Penson, MD, MRCP, is an associate professor at Harvard Medical School, clinical director of Medical Gynecologic Oncology at Massachusetts General Hospital (MGH), and clinical director for MGH Cancer Services on Martha’s Vineyard and Nantucket. Dr. Penson sits on the Ovarian Committee for the National Comprehensive Cancer Network and the Quality of Life Research Committee for the Gynecologic Oncology Group. He is the national principal investigator of the registration study for the PARP inhibitor, olaparib, SOLO-2, the international PI of SOLO-3, a faculty member teaching on Patient Doctor I for first year Harvard Medical Students, and one of the chairs of the IRB of Dana-Farber/Partners CancerCare. Jerome F. Pierson, RPh, PhD, is the director of the Office of Clinical Research Policy and Regulatory Operations in the Division of Clinical Research of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Pierson coordinates with the NIAID Intramural Research Program the support required for investigational drug management, clinical safety, IRB

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administration, clinical trial monitoring, and protocol development. Dr. Pierson also leads a team that oversees clinical research policy standardization throughout the NIAID intramural and extramural research divisions. Prior to joining NIAID, he served 27 years in the United States Army. His final army assignment from 2004 to 2007 was as commander of the US Army Medical Materiel Development Activity, the army’s project management arm for regulated medical product development. He also served as a regulatory affairs director in the army medical research community for several years and prior to that, as a pharmacist and a healthcare planner. In addition to BS and PhD degrees from The Ohio State University, Dr. Pierson received his MS at Wayne State and is a resident graduate of the Army’s Command and General Staff College. Sharyn J. Potter, PhD, MPH, is the co-director of Prevention Innovations Research Center: Ending Sexual and Relationship Violence and Stalking, and is a professor in the department of sociology at the University of New Hampshire. Dr. Potter’s research focuses on engaging community members to work collaboratively to reduce campus sexual assault. She has been a leader in the development, dissemination, and evaluation and of the theory- and research-based Know Your Power® Bystander Social Marketing Campaign that models pro-social bystander behaviors that have been shown to be effective for both campus and military audiences. She has been awarded research funding from competitive sources including the US Department of Justice, US CDC, DOD, the National Institute of Justice, and the Verizon Foundation. Dr. Potter is the lead researcher on a study identified in the White House Task Force to Protect Students from Sexual Assault examining the delivery methods of campus sexual misconduct policies. She is also the principal investigator on a National Institute of Justice Award to develop and evaluate a sexual violence bystander video game for college students. Dr. Potter has conducted research for the US Army in Europe and advised different US military branches on prevention strategies. Ivor A. Pritchard, PhD, is the senior advisor to the director of OHRP in DHHS. He came to OHRP in 2004 from the Institute for Education Sciences at the US Department of Education, where he was a senior research analyst. He joined the US Department of Education in 1986. Dr. Pritchard has a PhD in philosophy from Boston University. His authored or co-authored publications include “Students as Research Subjects” (with Koski, in The Encyclopedia of Bioethics, 2014); “How Do IRB Members Make Decisions? A Review and Research Agenda” (Journal of Empirical Research on Human Research Ethics, 2011); “Searching for ‘Research Involving Human Subjects’: What Is Examined? What Is Exempt? What Is Exasperating?” (IRB: Ethics & Human Research, 2001); “Travelers and Trolls: Practitioner Research and Institutional Review Boards” (Educational Researcher, 2002); Ethical Standards of the American Educational Research Association: Cases and Commentary (Strike et. al., 2002); and “Power, Truth and Justice in Youth Participatory Action Research: Ethical Questions” (Practicing Anthropology: A Career-Oriented Publication of the Society for Applied Anthropology, 2004). His research interests are in research ethics and federal policy, moral and civic education research and practice, and education policy. Dr. Pritchard is a member of the 2015 AER Conference CCPC.

Alexis M. Roth, PhD, MPH, is an assistant professor of community health and prevention at the Drexel University School of Public Health. She uses community-engaged research methods to address sexual health and substance abuse disparities. Dr. Roth is particularly interested in using technology to understand eventlevel factors associated with high-risk sexual behavior and drug abuse. Her current projects evaluate an intervention to increase sexual healthcare among persons who inject drugs in Camden, NJ, alcohol and drug abuse-related disparities among adolescents and young adults in Louisiana, and the ethics of conducting mHealth research with persons who inject drugs in Philadelphia, PA, and San Diego, CA. Dr. Roth obtained her MPH from Tulane University, her PhD from Indiana University, and completed a T32 post-doctoral fellowship in infectious disease and substance abuse at the University of California, San Diego. Karen H. Rothenberg, JD, MPA, is the Marjorie Cook Professor of Law and founding director at the Law & Health Care Program, University of Maryland Carey School of Law. She is a former dean of the University of Maryland Carey School of Law. Professor Rothenberg is a visiting professor at Johns Hopkins Berman Institute of Bioethics and a visiting scholar in the Department of Bioethics at the Clinical Center at NIH. She served for the last few years as senior advisor on genomics and society to the director of the National Human Genome Research Institute at the NIH. Over the last two decades, her research has focused on the ethical, legal, and social implications of genetic testing and research, including the legislative approaches to genetic information in the health insurance and employment context, the impact of genetic research on racial and ethnic populations, women’s health care, prenatal testing, and the use of genetic information in the courtroom. Professor Rothenberg’s current research includes the use of theatre as an innovative tool to identify and encourage discussion of the unique ethical, legal, and social issues posed by emerging technologies in healthcare. She co-authored, with Lynn W. Bush, the book, The Drama of DNA: Narrative Genomics (Oxford University Press 2014), as well as articles and plays exploring the intersection of drama, genetics, genomics and bioethics. Professor Rothenberg’s other numerous publications cover diverse research interests including the role of gender in health care, AIDS, research ethics, the right to forego treatment, emergency care, and new reproductive technologies.

Charles J. Ryan, MD, is currently a professor of medicine and urology at the University of California, San Francisco (UCSF) and is the program leader for Genitourinary Medical Oncology. Nationally, he serves as co-chair of the National Cancer Institute’s Prostate Cancer Task Force, and leads the Advanced Prostate Cancer Cadre in the Alliance for Clinical Trials in Oncology, a national clinical trial Cooperative Group. He serves on the editorial board of the Journal of Clinical Oncology and is a member of the American Society of Clinical Oncology Communications Committee. Dr. Ryan was educated at Marquette University were he graduated magna cum laude with a degree in philosophy and was elected to Phi Beta Kappa. He attended the University of Wisconsin Medical School and subsequently trained at the University of Wisconsin Hospital and Clinics and in Medical Oncology at Memorial Sloan Kettering Cancer Center. Dr. Ryan is internationally known for his clinical research in advanced resistant prostate cancer and has authored or co-authored over 100 peerreviewed publications. He has been the chair of the UCSF Cancer Center Committee on Human Research, one of four investigational review boards at UCSF, since 2013. In 2014, Dr. Ryan was named the Thomas Perkins Distinguished Professor in Cancer Research. Rachael Sak, MPH, is the director of the University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID), a consortium of the five University of California biomedical campuses, and is based in San Francisco, CA. She plays a leadership role in envisioning and implementing a network that leverages the campuses collective strengths to streamline processes and accelerate research. Ms. Sak is responsible for a team of professionals and oversees the launch of cross-campus initiatives and facilitates partnerships and collaborations with the goal to increase the competitive advantage of its member institutions. She received her MPH with a focus in health management and policy at the University of Michigan where she researched the use of health information technology in healthcare delivery and was the recipient of an Oak Ridge Institute for Science and Education scholarship from the US CDC. She has worked for 15 years in clinical research at Stanford University, UC San Francisco, and the University of North Carolina, and served as the associate director of the Pancreas Cancer Program at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. Prior to joining UC BRAID, she was the assistant director of the Strategic Initiatives of the Clinical & Translational Science Institute at UCSF. She received her undergraduate degree in nursing at Oakland University in Michigan. Stanley Y. Shaw, MD, PhD, is co-founder and co-director of the Center for Assessment Technology and Continuous Health (CATCH) at Massachusetts General Hospital (MGH). CATCH seeks to better assess human wellness and disease through new phenotypes (measurable traits), especially those related to environment and behavior. Dr. Shaw’s phenotyping research spans the range from patient-derived cells, electronic medical records, the gut microbiome in human disease, and digital health. Dr. Shaw recently led the development of GlucoSuccess, an iOS app for type 2 diabetes patients, in partnership with Apple. Dr. Shaw is a founding principal investigator in the MGH Center for Systems Biology, an assistant professor at Harvard Medical School, and an associate member of the Broad Institute. He received his AB in chemistry and physics from Harvard College, and his MD and PhD from Harvard University. He is a practicing cardiologist in the Corrigan Minehan Heart Center at MGH. n ove m b e r 12- 15 , b os t on , m a

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Jody M. Shoemaker Roberts, MS, CCRP, CIP, is the chief operating officer and director of research at the Mind Research Network (MRN) in Albuquerque, NM. She previously worked in the department of psychiatry at the University of California, San Diego with an emphasis on neuropsychopharmacology. She has a BS in health sciences, an MS in biology, and is the site principal investigator for an NIH research grant related to optimizing the disclosure of incidental findings. At MRN, she works with others to develop and streamline the process of returning MRI results to research participants and published the methods in a neurology article titled “A Practical Approach to Incidental Findings in Neuroimaging Research.” She is a participant and contributor to the NIH Working Group for Incidental Findings in Neuroimaging Research, as well as an author on the resulting guidance documents. In addition to her research, she serves as a nonaffiliated scientific reviewer for the University of New Mexico Health Sciences Center IRB.

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Plenary and Keynote Biographies Recognition Conference Information Jerome Amir Singh, BA, LLB, LLM, MHSc, PhD, is head of ethics and law at the Centre for the AIDS Program of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal. He is also an adjunct professor in the Dalla Lana School of Public Health and Joint Centre for Bioethics at the University of Toronto, Canada. He serves as a consultant to the World Health Organization, has served as a consultant to United Nations Programme on HIV/AIDS, Special Programme for Research and Training in Tropical Diseases, and United Nations Interregional Crime and Justice Research Institute. He is the co-chair of the US NIH’s HIV Prevention Trial Network’s Ethics Working Group, and is a member of the HIV Vaccine Trial Network’s Efficacy Trial Working Group. He has served as a senior consultant to the Ethical, Social, and Cultural Program on Global Health, which advised the Bill and Melinda Gates Foundation on ethical, social, and cultural issues, and the NIH’s African Data and Safety Monitoring Board. He currently serves on several oversight bodies, including the International Ethics Review Board of Médecins Sans Frontières. He is a two-term co-chair of the South African Young Academy of Science, and currently serves as an academic editor for PLOS One.

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Joanna Smolenski is currently a third-year PhD student and Graduate Center Fellow in Philosophy at the City University of New York (CUNY) Graduate Center, where she is studying moral psychology, ethics, applied ethics, and social and political philosophy. Prior to her work at CUNY, Ms. Smolenski pursued graduate studies in bioethics at New York University’s Center for Bioethics and was a John Jay Scholar in philosophy and political science at Columbia University, where she graduated magna cum laude with honors in philosophy. Her work on the ethics of editing the human germ line was recently featured in Nature. Justin Snyder, PhD, is currently the quality management coordinator in the Pennsylvania State University Office for Research Protections. He received his PhD in sociology from the University of Virginia. Previously, Dr. Snyder served as an assistant professor of sociology at Saint Francis University. In his current position, Dr. Snyder conducts post-IRB approval reviews, educational site visits, administrative activities supporting protections programs, and quality improvement and academic research. He is interested in evidence-based research protections, such as those that address the subjectivity of participants and the sociological nature of researcher-participant interaction. Dr. Snyder also has expertise in medical sociology and conducts qualitative research with combat veterans suffering from posttraumatic stress disorder. This research explores the subjective experience of combat trauma, the content of traumatic memories, and the moral underpinnings of both. David H. Strauss, MD, is deputy director for research at the New York State Psychiatric Institute (NYSPI) and vice chair for research administration, ethics, and policy in the Columbia University department of psychiatry. He oversees NYSPI’s 23 research divisions and 10 research centers, its core imaging facilities, animal care, and research oversight functions. From 2000 until 2010, Dr. Strauss chaired the NYSPI IRB and directed the Office of Human Subjects Research. He co-chairs Columbia University’s Standing Committee on the Conduct of Research, and previously served as co-director of the ethics,

public policy, and human rights core of the current HIV Center for Clinical and Behavioral Studies. Dr. Strauss is a past recipient of two NIH grants on research ethics training and the enhancement of human subjects oversight for psychiatric research. He is a former member of SACHRP and completed work as co-chair of its Subcommittee on the Inclusion of Individuals with Impaired Decision-Making in Research. He currently serves on a SACHRP subcommittee charged with developing recommendations to enhance Subpart A or The Common Rule. Dr. Strauss practices psychiatry, psychotherapy and psychopharmacology, and lectures and consults widely on research and professional ethics. Dr. Strauss is a member of the PRIM&R Board of Directors and serves as chair of PRMI&R’s Public Policy Committee. In addition, Dr. Strauss is a member of the 2015 AER Conference CCPC. Elyse I. Summers, JD, is the president and CEO of AAHRPP, Inc. She provides strategic and substantive leadership and oversight on all aspects of AAHRPP’s operations and is looking forward to leading AAHRPP well into the 21st century as the indispensable global organization for the accreditation of HRPPs. Prior to that, Ms. Summers was the director of the Division of Education and Development at OHRP. Prior to OHRP, Ms. Summers practiced food and drug law at the firm of Buc & Beardsley. While there, she offered guidance and counseling on Federal regulations and ethical issues related to the conduct of biomedical research. Before Buc & Beardsley, Ms. Summers spent five years in the Office of the Commissioner at FDA as special assistant to the Deputy Commissioner for External Affairs, and later as an original staff member of FDA’s Office of Women’s Health. Ms. Summers began her professional career representing research universities at the Association of American Universities. She earned a JD from the George Washington University National Law Center and a BA from the University of Michigan. She is a member of the Bar of the District of Columbia and of the Commonwealth of Pennsylvania. Alan R. Tait, PhD, is currently the endowed professor of clinical research in the department of anesthesiology at the University of Michigan and a former long-standing member of the Medical School’s IRB. Dr. Tait is originally from the United Kingdom where he obtained his undergraduate degree in zoology from London University and subsequently his graduate degree in epidemiology from the University of Michigan. His primary research interests focus on developing strategies to improve research subjects’ (adults and children) and patients’ understanding of research and medical information. His recent work has centered on the use of multimedia as a means to optimize the consent process. Dr. Tait’s other research interest’s center on the effects of anesthesia on children who present for surgery with a variety of risk factors including respiratory infections, obesity, attention deficit hyperactivity disorder, and sleep-disordered breathing. Boghuma Kabisen Titanji , MD, MSc, PhD, is a Cameroonian born physician and clinical researcher who recently completed her PhD at University College London (UCL) following an MSc in tropical medicine and international health from UCL. Her current research focuses on the mechanisms of HIV transmission and antiretroviral drug resistance. Dr. Titanji is passionate about health policy and the ethics of medical research in Africa. In 2012, as a TED speaker, she shed light on the ethics of scientific

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research in vulnerable communities. She continues to promote the improvement of research within the continent, recently addressing the centenary assembly of the association of commonwealth universities on creating an environment favoring the return of early career researchers to Africa. She also made the list of the British Broadcasting Company’s 100 Women Changing the World in 2014. Dr. Titanji continues to work towards combining medical research with clinical practice to influence health policy in Africa, through the advancement of ethically sound research.

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faculty

Michael A. Turik, MD, is currently senior medical director for clinical pharmacology at Lilly Research Laboratories, and he has been conducting clinical research developing new drugs in various roles at Eli Lilly and Company for the past 22 years. His group is responsible for delivering the late-stage, clinical pharmacology packages to support registration for all Lilly investigational drugs. He chairs both Lilly’s US early phase protocol review and Bioethics Advisory Committee. Dr. Turik is also the vice-chair of the Indiana University Ethical Review Board serving on this committee since 2009. Dr. Turik received his medical training at the Northeastern Ohio Universities’ College of Medicine in internal medicine, and later went to the Virginia Commonwealth University/Medical College of Virginia for sub-specialty training in infectious diseases. He joined Lilly in 1993 and has worked in all phases of clinical research. Prior to his current role, Dr. Turik was medical director for the Lilly Center for Medical Science, which conducted early exploratory method and biomarker validation studies to support early phase clinical work aimed at finding data to quickly determine a new medicine’s potential benefits and risks.

Carol Juliet Weil, JD, is a program director for ethical and regulatory affairs at the National Cancer Institute (NCI), and is an expert in research protections pertaining to the collection, storage, and downstream uses of biological samples and genomic and clinical data. Ms. Weil oversees the ethical, legal, and social implications of cancer research in NCI’s Cancer Diagnosis Program, including policies on consent, data sharing, biospecimen governance, community engagement, the formation of community advisory boards, and disclosure of research results and incidental findings. She facilitates the development of embedded bioethics protocols in NCI’s precision medicine oncology trials, including surveys about tissue donation and genetic counseling pilots for returning genomic findings. She has served, since 2012, as a non-scientist member of the NCI IRB. Her recent primary author publications include a book chapter titled “Mandating General Consent for Use of Biospecimens in Research: A Call for Enhanced Community Engagement” in The Future of Human Subjects Research Regulation, Perspectives on the Future edited by I. Glenn Cohen and Holly Fernandez Lynch (MIT Press 2014), and the journal article titled “NCI Think Tank Concerning the Identifiability of Biospecimens and ‘Omic Data” (Genetics in Medicine, 2013).

Posters Selected for Presentation Recognition Conference Information PRIM&R is pleased to present the 2015 AER Conference Poster Presentation Program. The posters listed in the pages that follow will be on display throughout the meeting in The Conference Connection located in Exhibit Hall C. Please see page 7 of this guide for information on The Conference Connection’s hours. In addition, don’t miss these dedicated times to hear from the poster authors: • “Innovations in…” panel series on November 13 from 11:15 AM to 12:30 PM: Nine exemplary posters were selected for presentation in this panel series (posters marked with the “star” icon). • Meet and greet with the poster authors: Visit the Conference Connection on November 13 from 1:45 to 2:15 PM to talk with the poster authors about their important work. Many thanks are owed to the Poster Abstract Subcommittee for coordinating this conference event (committee members are listed on the inside cover of this guide).

posters

The posters are grouped by theme, and a map of the posters can be found on page 109 of this guide. Authors are listed in the order that they appear on the abstract, and therefore, authors from the same organization may not be listed together.

Biobanking and Genomics Research 1. Genomic Advisory Panel: Human Subjects Protection in a Brave New World Roy Cambria, BS; Mark Robson; Roger S. Wilson, MD; Collette Houston, BA Memorial Sloan-Kettering Cancer Center

Community Engagement 2. Standardizing Implementation of the Good Participatory Practice Guidelines: A Distance Learning Approach Jessica Handibode, MBE AIDS Vaccine Advocacy Coalition Elizabeth Kroboth San Francisco Department of Public Health Anne Schley AIDS Vaccine Advocacy Coalition Johnathan Fuchs, MD, MPH San Francisco Department of Public Health Stacey Hannah, MHS AIDS Vaccine Advocacy Coalition

Education and Training 3. Transcending Turnover by Standardizing Staff Training Scott S. Katz, MS, CIP; Kevin Wack, MA, MTS, CIP; Michael Arenson, MA; Steven J. Anzalone, MS Emory University 4. R esearch Common Core: Revitalizing the Monthly Research Education Conference Janet Leary-Prowse, MSEd, CIP; Melanie Chichester, BSN, RNC-OB, CPLC Christiana Care Health System

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5. The Impact of Student-Specific Workshops on IRB Applications Kimberley Serpico, MEd, CIP; Grace Bullock, BA; Jada Dixon, MJ, MPH, CIP; Lisa Gabel, CIP; Paul Hryvniak, MS, CIP; Keren-Nicole Insalaco, MS, CIP, CIM; Keisha Turner, BA; Leslie Howes, MPH, CIP; Julie Kaberry, MPH, CIP; Delia Wolf, MD, JD, MSCI, CIP Harvard T.H. Chan School of Public Health 6. Implementation of an Educational Initiative for Addressing “Common Pitfalls” With IRB Submissions Pamela Johnson, MPH; Cherie Bilbie, MS; Corey Glider, BA; Sharice A. Brown, PhD. Hartford HealthCare 7. Teamwork Makes the Dream Work! The Implementation of an Immersion Based Group Training Program for New IRB Staff Members Alan Teller, CIP; Yaritza Collazo, CIP; Brenda Ruotolo, CIP; Rafael Santos, CIP Columbia University 9. Leave No Man Behind: A Novel Approach to Study Team Member Training Kelly Unsworth, MS, CCRC, CIP; Kelley O’Donoghue, MPH, CIP University of Rochester 63. IRB Grand Rounds: A Novel Educational Format for Human Subject Research Protection Programs Jose E. Casanova III, BBA, CIP; Amanda Coltes-Rojas, MPH, CIP; Kenia Viamonte, MA; Dushyantha Jayaweera, MD, FACP, CIP University of Miami

Ethics and Risk 10. Reducing Unnecessary IRB Oversight Judy E. Davidson, DNP, RN, FCCM University of California, San Diego

Global Research

11. The Role of Bioethics in the Pharmaceutical Industry: Informal Review of Five-Year Trends and One Company’s Systematic Approach Luann E. Van Campen, PhD, MA-Bioethics; Donald G. Therasse, MD Eli Lilly and Company

13. Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a mhealth Study of Polydrug Use Alexis M. Roth, PhD MPH; John Rossi; Quan Truong; Jesse L. Goldshear Drexel University School of Public Health Janie Simmons National Development and Research Institutes 14. Patient Lay Summaries: Meeting the Ethical Obligation to Share Trial Results With Study Volunteers Behtash Bahador; Julia Farides-Mitchell; Zachary Hallinan; Laurin Mancour Center for Information and Study on Clinical Research Participation 15. Conflict of Interest: A National Perspective Peter Lichtenthal, MD; Mariette Marsh, MPA, CIP; Adriana Encinas, CIP University of Arizona 16. Adherence to Integrity and Ethical Conduct in Publications by the Authors Barna Ganguly, MBBS, MD; Somashekhar Nimbalkar; Krunal Dalal Pramukhswami Medical College, Karamsad, Gujarat, India Parthasarathi Ganguly Indian Institute of Public Health

18. Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt Marwan Felaefel American University in Cairo; MCT-CRO Hillary Anne Edwards, BA University of Maryland, Baltimore Mohammed Salem, MD, MPH American University in Cairo Rola Jaafar, MSc Ain Wazein Medical Center Ghufran Jassim; Fiza Rashid Doubell; Khalifa Elmusharaf Royal College of Surgeons in Ireland Fouad Othman; Rehab Abdelhai Cairo University Henry Silverman, MD, MA University of Maryland, Baltimore

Informed Consent 19. Can Meaningful Use Improve Informed Consent Forms that Advance Health Literacy? Stephanie J. Zafonte, DNP, RN, CCRP Huron Consulting Group 20. Considerations for Informed Consent Process for a Rehabilitation Program for People Living with HIV/AIDS in a Lower Middle Income Country Nnenna Nina Chigbo, Humphrey Fellow, MPH, BMR (PT); Ezeome E.R., MA, MD, FWACS, FACS; Chris Amah, MBBS, FWACS, FICS; Chinwe Chukwuka, MBBS, FWACP; Christopher Onugha, BSc PT University of Nigeria Teaching Hospital, Enugu, Nigeria 21. Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia Jerome F. Pierson, RPh, PhD National Institute of Allergy and Infectious Diseases/NIH Stacy Kopka; Sara Albert; Tracey Miller RN, CCRP Leidos Biomedical Research, Inc., support to National Institute of Allergy and Infectious Diseases/NIH

selected for Innovations In... series

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posters

12. “Ethical Responsibility” or “A Whole Can of Worms”: Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research from Focus Group Discussions with Participants, Parents, IRB Members, Investigators, Physicians, and Community Members Caitlin E. Cole, BA; Linda E. Petree, CIP; John P. Phillips, MD; Jody M. Shoemaker Roberts, MS, CCRP, CIP; Mark T. Holdsworth, PharmD; Deborah L. Helitzer, ScD Mind Research Network, University of New Mexico

17. Child’s Objection to Non-Beneficial Research: An International Perspective Marcin Waligora, PhD Jagiellonian University, Madical College Joanna Rozynska, PhD, MAMS University of Warsaw Jan Piasecki, PhD, MA Jagiellonian University, Medical College

Posters Selected for Presentation Recognition Conference Information IRB Operations 22. Improved Data Security via Collaboration Between the Information Security Office and the IRB Brian Davis; Susie Hoffman, RN, BSN, CIP; Tim Tolson University of Virginia 23. How Instituting a Formalized Pre-IRB Review Process Improves IRB Review Outcomes Laura Kimberly, RHIT, CIM, CIP; Melissa Bryant, RN, MS, CIP; Patricia Sweet, RN, MSN, CCRP, CIP; Dandre Thornhill, RN, BSN, MBA, CCRP National Heart, Lung, and Blood Institute

posters

24. A Novel VBA-Based System Not Only Dramatically Facilitates IRB Protocol Pre-Review, but also Reveals Previously Unrecognized Frequent Findings Masayuki Yoshida, MD; Hitoshi Kuwana; Hiroko Kohbata; Yusuke Ebana; Yuka Ozasa, PhD, RN Tokyo Medical and Dental University 25. Using In-Person Express Reviews to Accelerate Exempt Determinations and Foster Collaboration with Researchers Amy Neuman, MPH; Jillian Coleman, CIP Oregon State University 26. Coordinating Multi-Site Input for Central IRBs Maria Sundquist, MPA; Rosalyn Gray, BS; Elizabeth L. Hohmann, MD; P. Pearl O’Rourke, MD Partners HealthCare Systems, Inc. 27. Establishing a Cancer Research Ethics Committee in Resource Limited Setting: Procedures, Challenges, and Lessons Learned Annet Nakaganda, BSc, MPH Uganda Cancer Institute Rachael McClennen, MS Fred Hutchinson Cancer Research Center Joyce Kambugu, MBChB, MMED; Rebecca Kampi, BSc, RN, MPH; Jackson Orem, MBChB, MMED, PhD Uganda Cancer Institute 28. Analysis of the Barriers in the IRB Pre-Review Process Marina Godina, RN, CIP; Dana Pogorelec-Khan, BA; Jasmine Liu, BS, CIP New York University, School of Medicine 29. Centralizing IRB Review Functions for a Growing, Urban HealthCare System Cherie Bilbie, MS; Sharice A. Brown, PhD; Brian Byrne, MD; Robert Dicks, MD; Corey Glider, BA; Susan Hughes, BS; David M. O’Sullivan, PhD; Janice Saucier; Carolyn Hoban Hartford HealthCare 30. Violations Submissions via Protocol Information Management System-Phase II Jenny Deighan; Marissa Kehoe; Jenny Anopa; Timothy Downey-Zayas; Dustin Rathbone; Margaret Isaacs; Sandy Iyer-Horan, MPH, CIP; Michael J. Trinos Memorial Sloan-Kettering Cancer Center

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31. IRB and Patient Safety Office Collaboration to Improve Participant Safety in Clinical Research: A Systems Approach eFeedback Model Jessica Huening, JD; Rosemay Vazeux, MD; Michelle Grienauer, JD, MPH; Tara Polek, PhD; Kelly Hebner, JD; Llilian Garcia, BS; Laurie Bolton, JD Seattle Children’s Research Institute 32. Throwing the Baby Out With the Bathwater and Other Changes Made to Improve Office Operations: Successes and Missteps Lori Jennex, MA, CIP; Liz Carroll, BA, CIP; Rebecca Banchik, BA, CIP Icahn School of Medicine at Mount Sinai 33. Innovative Tools and Approaches for Streamlining the Research Review Process for American Indian Tribal IRBs Temana Andalcio, BA Sanford Research Anita Fredrick, MA Tribal Nations Research Group Jyoti Angal, MPH, CIP Sanford Research 34. Improving the IRB Meeting Minutes Approval Process Michelle Grienauer, JD, MPH; Llilian Garcia, BS; Jessica Huening, JD; Tara Polek, PhD; Kelly Hebner, JD Seattle Children’s Research Institute 35. Managing Non-Compliance: Systematic Approach that Improves Human Subject Research Protections Ishita Modi, BS, MLT; Raffaella Hart, CIP; Michelle Rodriguez, CIP, CIM Biomedical Research Alliance of New York 36. The Long and Winding Road: Development of a Central IRB Reliance Program at an Academic Medical Center Diane Towle, RN, CIP, CCRP; Christina Tyler, MPH University of North Carolina at Chapel Hill 37. “Approval Parties!” Faculty Ad-Hoc Meetings for Exempt/Expedited Determinations Brandy M. Dionne, BS, CIP; Stephen Latham, JD, PhD; Carrie McDaniel, CIP; Cathleen Montano, JD, CIP Yale University 38. On-Target With On-Site IRB Reviews and Approvals Brandy Dionne, BS, CIP; Stephen Latham, JD, PhD; Carrie McDaniel, CIP; Cathleen Montano, JD, CIP Yale University 39. Developing a Practice and Guidance Committee to Document IRB Standard Procedures and Pilot Projects S. Joseph Austin, JD, LL.M; Judith Birk, JD; Diana Miller, MS University of Michigan Medical School

40. “But I WANT You to Review My Project!” An IRB’s Experience with Implementing Policy Change for Reviewing Undergraduate-Initiated Research Proposals Louise Tipton, EdM, CIP; Diana Holt, MS, CIP; Rebecca Armstrong, DVM, PhD University of California, Berkeley 41. IRB Staff Meetings: Not Your Average Meeting Judith Birk, JD; Diana Miller, MS; S. Joseph Austin, JD, LLM University of Michigan Medical School 42. Optimizing Pathways to Reliance on Academic Health Center Central IRB Review for Private Practice Group Research Sites Angela Braggs-Brown, MA, RAC, CIP; Michael Linke, PhD; Jane Strasser, PhD; Judith Spilker, RN, BSN; Deepak Krishnan, DDS; Kareemah Mills, CIP; Sarah Morabito, JD, MBA University of Cincinnati

44. Innovation in IRB Reliance: A New Model Advances Multi-Site Research Nate Buscher University of California Biomedical Research Acceleration, Integration, and Development Eric Mah, MHS, CIP University of California, San Diego Courtney McFall, MA; Rachael Sak, RN, MPH University of California Biomedical Research Acceleration, Integration, and Development 45. Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience Jon Newlin, CIP; Hallie Kassan, MS, CIP North Shore-Long Island Jewish Health System 46. An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Exceptions to Clinical Trials in the Committee on Human Research Sunhee S. Kim, BS; Michael J. Thomas, CIP, CCRP; Lisa V. Denny, MPH, CIP, CCRP; Liz Tioupine, CIP; Charles J. Ryan, MD University of California, San Francisco School of Medicine

49. Development of Automated Methods for Big Data to Achieve Compliance with IRB, Institutional, and Federal Requirements in the De-Identification of Narratives and Structured Data Focused on Safety Signals for Adverse Drug or Device Events from Electronic Medical Records Dennis P. West, PhD; William H. Temps; Debra G. Tice, MS; Michael S. Kelley, BS; Eileen M. Yates, MS; Tinatin Kiguradze, BS; Sara Majewski, BS; John P. Cashy, PhD; Beatrice Nardone, MD, PhD; Steven M. Belknap, MD Northwestern University Feinberg School of Medicine

QA/QI 50. Changing Culture: Introducing Post Approval Monitoring Through a ‘Soft-Rollout’ Pamela Johnson, MPH; David M. O’Sullivan, PhD; Cherie Bilbie, MS Hartford HealthCare 51. Raising the Bar: Improving Quality of Research Conduct Through a Study Initiation Program Michael Leary, MA CIP; Andrea Morris, BA CCRC; Mickey Clarke, BA; Martha Jones, MA CIP Washington University in St. Louis 52. Creating a New Pathway to Differentiate QI and Human Subjects’ Research David Prakash, MBBS, MS, CIP; Hoon Chung, MPH, CIP; Megan Singleton, JD, MBE, CIP; Tracy Ziolek, MS, CIP; Jennifer Myers, MD; Shivan Mehta, MD, MBA, MSHP University of Pennsylvania 53. Internal QA/QI Process for an University IRB Maria Davila, CCRC, CIP; Jessica Baker, BS; Shara Karlebach, WHNP-BC, CIP; Sean Kiskel, BA, CIP; Kevin Wack, MA, MTS, CIP Emory University 54. Facilitating the Ethical Conduct of Research Catherine Powers, CIP; Erin Lynch; Tricia Eifler, CIP; Eriika Etshokin; Joshua Fedewa, CIP; Jessica Macha, CIP; Kelly Verel Ann & Robert H. Lurie Children’s Hospital of Chicago

selected for Innovations In... series

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posters

43. Shifting Perspectives: Changing the Way the IRB is Perceived Through Education and Superior Customer Service Silvia Jimenez, AA; Royell Sullivan-Green, MA; Helen Panageas, CIP New York University, School of Medicine

48. Multicenter Protocol Management at a Large Comprehensive Cancer Center Stephanie Karpoff; Ann Jenckes, MPH; Jaclyn Nunner; Ann Rodavitch Malhotra, MA; Dion Harris; Andrew Zarski; Joseph Lengfellner; Collette Houston, BA; Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center

Posters Selected for Presentation Recognition Conference Information

posters

55. A Solution to Creating and Managing your Regulatory Binder Electronically Michele Gomez, CIP; Stephen Hayes; Charlene Malarick, RN; Emily Ouellette, JD; Angela Savlidis; Sarah White, MPH, CIP Partners HealthCare Systems, Inc. Dimitar Dimitrov, MSSE Partners HealthCare Information Systems, Enterprise Research Infrastructure & Services Lynn Simpson, MPH; Jeremy Alphonse Harvard Catalyst, The Clinical and Translational Science Center 56. Collaboratively Delivering QA/QI Support, Tools, and Resources by Leveraging Internal and External Expertise: A Harvard Catalyst Model Leslie Howes, MPH, CIP Harvard T.H. Chan School of Public Health Sarah White, MPH, CIP Partners HealthCare, Systems, Inc. Hila Bernstein, MS Harvard Catalyst, The Harvard Clinical and Translational Science Center Elizabeth Bowie, JD, MPH, MSc Mount Auburn Hospital Susan Corl, MSW, MPH Boston Children’s Hospital Maureen English Memorial Sloan-Kettering Cancer Center Michele Gomez, CIP Partners Healthcare, Systems, Inc. Jennifer A. Graf Cambridge Health Alliance Nareg Grigorian Dana-Farber/Harvard Cancer Center Jennifer Hutchinson, CIP, CPIA Beth Israel Deaconess Medical Center Fariba Houman, PhD,CIP Massachusetts Eye and Ear Grace Kennedy Joslin Diabetes Center Ellen Kornell New England Baptist Hospital Angela Lavoie, RN Beth Israel Deaconess Medical Center Eunice Newbert, MPH Boston Children’s Hospital Shannon Sewards Harvard Catalyst, The Harvard Clinical and Translational Science Center Catherine Sutherland, CIP Spaulding Rehabilitation Hospital Sabune Winkler, JD Harvard Catalyst, The Harvard Clinical and Translational Science Center Barbara E. Bierer, MD Brigham and Women’s Hospital; Harvard Medical School

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57. When Does QI Need IRB Review and Approval? Shelby Moench, BA, CIP; Anita Pascoe, MS, CIP Intermountain Healthcare 58. “A Real Super Ethical Super Moral Perspective”: The Research Ethics of Research Participants Justin Snyder, PhD; Joanna Lyons, DEd The Pennsylvania State University 64. Protocol Information Management System Regulator Binder: Streamlining Regulatory Binder Documentation Maintenance and Improving Compliance Abdul Abdullah; Michelle Thomas; Roy Cambria, BS; Bonnie Edelman, BS; Marcia Latif Memorial Sloan-Kettering Cancer Center

Regulations and Guidance 59. Decisions for Non-Significant Risk Device Studies: Laboratory-Developed Tests Allison Blodgett, PhD, CIP; Michelle Ferretti, CIP; Michael Centola, MHS, CIP University of Massachusetts Medical School 60. Expanding a Post-Approval Monitoring Program: Building on Success Erika Etshokin; Jessica Macha, CIP; Erin Lynch; Tricia Eifler, CIP; Joshua Fedewa, CIP; Catherine Powers, CIP Ann & Robert H. Lurie Children’s Hospital of Chicago 61. Qualitative Review of Ethical Guidelines for Epidemiological Studies Jan Piasecki, PhD, MA; Marcin Waligora, PhD; Vilius Dranseika, MPhil Jagiellonian University, Krakow

Special Populations 62. A Review of the New York State Psychiatric Institute’s IRB Serious Adverse Event Policy Andria L. Whited, LMSW, CIP New York State Psychiatric Institute

selected for Innovations In... series

Poster Gallery Key Biobanking & Genomics Research: 1 Community Engagement: 2 Education & Training: 3-7, 9, 63 Ethics & Risk: 10-16 Global Research: 17-18 Informed Consent: 19-21 IRB Operations: 22-49 QA/QI: 50-58, 64 Regulations & Guidance: 59-61 Special Populations: 62 14 13

41 38

15 12

42 37

16 11

43 36

17 10

44 35

18 63

45 34

19 9

46 33

20 7

47 32

21 6

48 31

22 5

49 30

23 4

50 29

24 3

51 28

25 2

52 27

26 1

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40 39

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Posters Selected for Recognition Conference Innovations in…Information Series This year, nine exemplary posters have been selected for presentation in our “Innovations in…” panel series on November 13 from 11:15 AM to 12:30 AM. The “Innovations in…” panel series is composed of three concurrent sessions that are grouped thematically and on cutting-edge topics. During these sessions, research professionals will present their work in the field of human subjects protections and provide audience members with concrete strategies designed to improve the effectiveness of their own HRPPs/IRBs. The posters that will be presented during each panel are listed below along with the full text of the abstract. These nine posters will also be on display in The Conference Connection (see page 85 for a map to the posters).

Innovations A: Innovations in Global Settings

posters

Ballroom C Moderator: Nancy E. Kass, ScD

POSTER 18 Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt Presenter: Marwan Felaefel, American University in Cairo Description of the Research: Recently, the Middle East has experienced an increase in research, but robust regulations, appropriate ethics review systems, and training in research ethics have not kept pace. A particular concern includes the extent of research misconduct. Objective: To assess investigators’ attitudes, as well as the prevalence of research misconduct in an Egyptian University, and identify possible factors that might account for our results. Methods: We performed a survey study at an Egyptian University that included undergraduates, post-graduates, and faculty. The survey tool included: a) demographics, b) attitudes regarding the acceptability of certain practices in research conduct, and c) frequency of observed and self-identified instances of scientific misconduct. Ethics: The study was approved by the university’s IRB and a US-based IRB. Data Analysis: We used descriptive analysis and a chi-square test for bivariate analysis. A p < 0.05 was considered significant. Results: We analyzed data from 191 respondents. Demographics included: Gender – Males: 31.9%, Females: 66.5%; Position – Undergraduate student: 18.8%, MSc student: 34.0%, PhD Student: 12.6%, Research Position: 8.4%, Academic position: 9.4%; Received Ethics Training? Yes: 52.4%, No: 43.5%; If yes, did training include research misconduct? Yes: 56.0%, No: 11.0%, Not sure: 33.0%; Regarding attitudes toward research misconduct: 77.3% expressed concern about the occurrence of research misconduct, 50.0% agreed that dishonesty and misrepresentation of data are common, 64.5% regard pressures to publish and gain promotion are a major reason for engaging in misconduct, and 71.8% of participants confirmed their awareness of regulations that govern research involving humans, animals, or laboratory practices. Incidence of research misconduct observed at least once by participants included: plagiarism: 43.8%, obtaining improper informed

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consents: 34.6%, and eliminating data that contradicts one’s hypothesis: 46.9%. Self-identified incidences for the same categories were: 9.1%, 10.4%, and 26% respectively. Conclusions: This study provides insights on the attitudes towards and prevalence of misconduct among researchers in the Middle East. Our results may be explained by lack of understanding or lack of awareness of the nature of research misconduct. Limitations: This study included self-reporting of self-identified practices, which could underestimate actual practices. Also, results from the one university in Egypt may not be generalizable to other universities in the region. Next steps: We recommend further training in the responsible conduct of research and qualitative research (e.g., interview studies) to explore reasons for our results. POSTER 21 Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia Presenter: Jerome Pierson, RPh, PhD,Office of Clinical Research Policy and Regulatory Operations, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, NIH Description: The need to rapidly plan and implement a vaccine clinical research response to the emerging threat of Ebola virus disease in West Africa provided the opportunity to develop a graphic aid to augment the informed consent process for the study “Partnership for Research on Ebola Vaccines In Liberia (PREVAIL).” As an economically challenged country with limited existing clinical research infrastructure and an illiteracy rate of 57.1%, Liberia presented substantial obstacles to the informed consent process. Of primary concern was the ability to meaningfully convey the most important points of the clinical research process in general, and of the PREVAIL study specifically, to ensure that potential subjects provided valid informed consent. Methods: Brainstorming alternatives to the long, text-heavy consent documents that serve as the standard for most clinical trials led our team to consider graphic presentation of relevant material. Cards produced by the CDC depicting Ebola control and prevention recommendations (e.g., safe burial practices, what to do when in contact with a sick person, etc.) were proposed as an example. The team initiated discussions with

Posters Selected for Innovations in… Series CDC National Center for Immunization and Respiratory Diseases staff to request guidance and initial assistance, based on CDC experience in Sierra Leone. CDC collaborators shared existing illustrations of study-specific draft pictorials. The team created an outline of main concepts to be captured in the guide, searched picture banks, and engaged an illustrator to develop country-appropriate illustrations of each idea to be conveyed. Simple, concise text was drafted to provide relevant study details related to each illustration. Drafts were refined through reviews by Liberian collaborators, CDC staff, and the study team members. Liberian collaborators provided invaluable guidance on verbiage and illustrations, which reflected Liberian cultural norms. For example, Liberian men do not wear white T-shirts that can be seen under their shirts, as they had been represented in an initial version of the illustrations. The illustrations were submitted for IRB approvals and posted in the “consent room.” Potential subjects reviewed flip book binders as part of the consent process. The consenting team member reviewed study information and requirements with the potential subject and obtained a signature or fingerprint on an abbreviated informed consent document.

Innovations B: Innovations in IRB Operations Veterans Memorial Auditorum Moderator: Elyse Summers, JD

Conclusions: Almost all SPEs at our institution are approved. The majority of SPEs from April 2014 to April 2015 occurred pretrial and originated from industry-sponsored cancer clinical trials. Review of the necessity, administrative burden, and effect on data integrity of this practice will motivate future studies.

POSTER 46 An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Exceptions (SPE) to Clinical Trials in the Committee on Human Research

POSTER 44 Innovation in IRB Reliance: A New Model Advances MultiSite Research

Presenter: Charles J. Ryan, MD, University of California, San Francisco

Presenter: Rachael Sak, MPH, University of California Biomedical Research Acceleration, Integration, and Development

Description of the Research: SPE is a mechanism that allows for a one-time, one-patient enrollment exception to an already approved study protocol. While SPE requests are intended to be rare, little is known about the number, frequency, and the specific rationale. To better define the nature of SPE requests, this study seeks to formally characterize our institutional experience with SPEs.

Description: With increasing national focus on IRB reliance to reduce duplicative reviews for multi-site studies, a regional consortium of five universities has developed an innovative Reliance Services program to expedite industry-sponsored clinical trials. In many current reliance models, a “lead principal investigator (PI)” oversees multi-site studies and takes on additional responsibilities as subsequent sites are added. The unique element of our approach is “PI Independence,” whereby each site has its own PI acting independently of one another while benefiting from central administrative support.

Methods: All SPE requests from April 2014 to April 2015 were generated through the Committee on Human Research’s (CHR’s) electronic database. Clinical trials associated with the SPEs were determined to be either oncologic or non-oncologic, and were categorized based on trial type and funding sources (i.e., investigator-initiated/industry unfunded, investigatorinitiated/industry funded, industry-sponsored, cooperative group, and departmental). Moreover, all SPEs were evaluated for sponsor approval letter submissions and subsequent protocol amendments. Based on the written rationale given on the proposed modifications, the SPEs were grouped by rationale type and classified as having occurred pre-trial, midtrial, or post-trial (i.e., before subject enrollment, after subject enrollment, or after treatment respectively).

In our model, any one of the five IRBs can serve as the Reviewing IRB, which is typically the institution that first approves a multi-site study. If no initial approval has taken place, member institutions choose the Reviewing IRB based on factors such as IRB expertise and capacity, and input from PIs and sponsors. The Reliance Services Program provides administrative support to the relying investigators throughout the life of a study and serves as a conduit to the Reviewing IRB, facilitating post-approval reporting, continuing reviews, and study closures. Ancillary reviews (e.g., biosafety, radiation) take place at the local level.

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Results: Liberian research staff and subjects responded well to the graphic aids, and they served as a useful tool in guiding the consent discussion.

Results: Of the 185 SPEs identified, 178 were approved (96.2%), six were withdrawn (3.3%), one was returned for correction (0.5%), and zero were not approved (0%). Only 53 sponsor approval letters were submitted (28.6%), and only 25 SPEs were followed by protocol amendments (13.5%). With respect to the clinical trial type and funding sources associated with the SPEs, 55 were investigator-initiated/ industry unfunded (29.7%), nine were investigator-initiated/ industry funded (4.9%), 104 industry-sponsored (56.2%), 15 cooperative group studies (8.1%), and two were departmental (1.1%). Ninety SPEs occurred pre-trial (48.7%), 87 mid-trial (47%), and eight post-trial (4.3%). Inclusion/exclusion criteria violations regarding disease status (n=40, 21.6%), changes in treatment monitoring (n=40, 21.6%), and treatment scheduling (n=30, 16.2%) were the three most common reasons for SPE requests. Interestingly, 38 unique studies (35.2%) accounted for 115 SPEs (62.2%), highlighting the frequent occurrence of multiple SPEs per study. Of the 106 cancer clinical trials (57.3%), any solid tumor (n=25, 23.6%), genitourinary oncology (n=16, 15.1%), melanoma (n=16, 15.1%), and gastrointestinal oncology (n=15, 14.1%) represented the majority of the cancer SPE distribution. In contrast, neurology (n=19, 24.1%), gastroenterology (n=13, 16.5%), psychiatry (n=10, 12.7%), and pulmonology (n=10, 12.7%) contributed to the majority of the non-cancer SPE distribution.

Posters Selected for Recognition Conference Innovations in…Information Series To enable identification of reliance opportunities, the consortium built a searchable database of approved clinical trials populated by IRB data. When investigators submit a new application to an IRB, intake analysts search the database to see if the trial is underway at one of the other institutions. If so, the IRB contacts Reliance Services to initiate a reliance. The Reliance Services team tracks actionable metrics throughout the studies. Average reliance approval time is 11.6 calendar days (n=13) versus weeks or months for a full IRB review, with some reliance approvals taking less than 24 hours. Approval times continue to improve as IRBs become more experienced with this reliance model and Reliance Services streamlines processes.

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Next Steps: Future development includes: expanding Reliance Services capacity sustainably, which includes billing industry sponsors for reliances; broadening Reliance Services eligibility beyond industry-sponsored trials; engaging researchers to use the clinical trials database, enabling them to pursue a reliance before assembling a full IRB application; and evaluating technology solutions supporting reliances, including tracking, workflow, notifications, and document management. Other consortia looking to implement this IRB Reliance model should: establish an advisory committee including members from all participating institutions; share IRB data on approved studies through a searchable database to identify reliance opportunities; and develop shared standard operating procedures to harmonize processes and ensure regulatory compliance. POSTER 45 Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience Presenter: Jon Newlin, CIP, North Shore-Long Island Jewish Health System Description: In December 2013, the Human Research Protections Program at our Health System evaluated its local IRB committee structure. While the structure had worked effectively for decades, an increasing research portfolio was pressing for change. At the time, the structure included large agendas and multiple IRBs at different physical locations (some generalist committees, others restricted to reviewing research at their site), each meeting monthly, in-person, with 20 plus members in attendance. This resulted in several disadvantages: long wait times before studies reached an agenda; agendas too long for members to reasonably review each item prior to a meeting; extended meeting length; exclusion of institutions from sending members to the IRB because of commute time; and slow turnaround times. Starting in July 2014, the decision was made to restructure the local IRB system. The new system consists of: “flexible” IRB model, with all members listed on one roster with Office for Human Research Protections; four small IRB committees, each meeting on a bi-weekly basis; each committee is a generalist committee, reviewing research from any Health System site; all meetings held via videoconference; committees include persons from any of the Health System’s institutions (not just those who live close to the IRB office); each IRB meeting is

attended by seven to 15 persons; no submission deadlines – submissions go to a meeting within 14 days of receipt; agendas limited to no more than five items; and an IRB meeting time that is limited to 60 minutes. Results: As a result, full board, new study turnaround times have been drastically reduced (halved from an average of 113.5 calendar days in 2013 to 48.9 days between September 1, 2014, and April 20, 2015); meeting length shortened; and regulatory compliance enhanced, as members can now be familiar with all items on the shorter agendas. The videoconference method is well tolerated, with members able to participate from anywhere. Ad hoc meetings are simple to arrange, providing flexibility to handle urgent issues (i.e., Ebola treatment protocol). In a survey of IRB members at 90 days post-transformation, 68% of members (n=24) found the new system more efficient than the old, in person meetings. Eighty-four percent of members (n=37) thought the new system offered the same level of protection of human subjects as the old system. Sixtyone percent of members (n=27) thought the system offered better or equivalent opportunity for discussion, compared to in-person meetings. When asked which system the members preferred overall, only 30% (n=14) preferred the old system. In regards to the use of videoconferencing, 95% of members (n=41) found it easy to use, 84% (n=37) found the video quality good, and 80% (n=35) felt the audio (sound) quality was good. At this point, the restructuring is considered a success, and is expected to be maintained into the foreseeable future. No member has yet asked the IRB staff to return to the old, inperson meeting structure. As health systems continue to add new institutions through mergers and acquisitions, the flexible videoconference IRB model easily adapts to new members or even to the creation of new committees. It is a strong viable alternative to physical location-based in-person meetings, and offers an effective solution for organizations with multiple facilities and IRB members whose schedules cannot allow for long commutes or extended meetings.

Innovations C: Innovations in Subject Perspectives: Risks, Benefits, and Incidental Findings Ballroom B Moderator: Steven Joffe MD, MPH

POSTER 58 “A Real Super Ethical Super Moral Perspective”: The Research Ethics of Research Participants Presenter: Justin Snyder, PhD, Pennsylvania State University Description of the Research: What are the research protection ethics of contemporary research participants? There are few answers to this question. However, to fully honor the principle of “respect for persons,” human research protections programs should engage community opinion. Some have called this an “evidence based and participant centered” approach to protections (McDonald, Cox, and Townsend, 2014). As part of

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Posters Selected for Innovations in… Series a quality improvement initiative and larger research project, focus groups were conducted to explore participants’ attitudes toward research participation. The present findings come from questions exploring participants’ knowledge of and opinion on research protections policies and programs. Methods: Five focus groups, including 24 adult participants total, were conducted. Selection criteria included having participated in only non-clinical (biomedical and/or social scientific) research at a single specified large university in the five years prior to the focus groups.

Limitations: Some limitations of this study regard its small sample size and its composition, such as only including experienced participants from a single university. Future studies should probe more deeply into how participants define and apply their principles for human protections, which may uncover differences among participants and between participants and HRPPs. POSTER 12 “Ethical Responsibility” or a “Whole Can of Worms”: Differences in Opinion on Incidental Finding (IF) Review and Disclosure in Neuroimaging Research from Focus Group Discussions With Participants, Parents, IRB Members, Investigators, Physicians, and Community Members Presenter: Jody M. Shoemaker Roberts, MS, CCRP, CIP, University of New Mexico Health Sciences Center Description of the Research: Background: As the detail and quality of neuroimaging scans improves, the issue IFs in neuroimaging research is increasingly recognized in ethics literature. IFs are defined as findings of potential medical significance discovered outside the purpose of a research scan. In order to create feasible and adoptable policies for managing IFs, institutions must gather more empirical stakeholder information to consider the needs of all those impacted by disclosure.

Methods: Six key stakeholder groups were identified to participate in focus group: participants, parents of child participants, investigators, IRB members, physicians, and community members. A total of 151 subjects attended these discussions. Transcripts were analyzed using principles of Grounded Theory and group consensus coding. Results: A series of similar and divergent themes were identified across our subject groups. Similarities included beliefs that it is ethical for researchers to disclose IFs as they grant certain health and emotional benefits to participants. All stakeholders also recognized the potential psychological and financial risks to disclosure. Divergent perspectives elucidated consistent differences between our “participant” subjects (participants, parents, community members) and our “professional” subjects (IRB members, investigators, and physicians). Key differences included: 1) what results should be reported; 2) participants’ autonomous right to research information; and 3) the perception of the risk-benefit ratio in managing results. Conclusions: Understanding the perceived impact on all stakeholders involved in the process of disclosing IFs is necessary to determine appropriate research management policy. Our data further demonstrate the challenge of this task as different stakeholders evaluate the balance between risk and benefit related to their unique positions in this process. These findings offer some of the first qualitative insight into the expectations of the diverse stakeholders affected by IF disclosure. Next Steps: Overall, this data supports the ethical demand for investigators to manage IFs, but the downstream impact on the research institution and the healthcare system remain unclear. Further empirical data is still needed on the actual impact of this full disclosure model, as well as greater investigation of all current models of IF management. POSTER 13 Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a Mobile Health (mHealth) Study of Polydrug Use Presenter: Alexis Roth, PhD, MPH, Drexel University School of Public Health Description of the Research: mHealth is an emerging field that harnesses the increasingly sophisticated capabilities of mobile communications technology for measurement and intervention in health research and care. As a new field of inquiry, researchers have yet to articulate best-practice guidelines for mHealth projects that enroll vulnerable populations, especially those who engage in stigmatizing and illegal behavior (e.g., persons who inject drugs (PWIDs)). The

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Results: Participants knew or assumed, as well as desired, there to be ethical oversight of human participant research, but they showed only a vague understanding of the protections actually afforded them. We found, nonetheless, that research participants and HRPPs share similar ethical principles. Both generally agree on what it means to have, adopting the words of one research participant, “a real super ethical super moral perspective.” We identify and exemplify four ethical principles or expectations for HRPPs commonly vocalized in the focus groups: Programs should assess risk and ensure participant safety, ensure participant confidentiality/privacy, ensure investigator compliance through post-approval activities, and ensure participants are treated with respect. The latter includes ensuring the autonomy of subjects and that the research has scientific merit so the participant’s time and altruism in volunteering is respected. Participants were often unclear as to the definitions and applications of their ethics, with the exception of scientific merit: HRPPs should only allow research to be conducted if the design is appropriate for the scientific question and, more importantly, if the question is one that serves a scientific and/or public good.

Research Question/Thesis: Identify the specific needs, preferences, and expectations of the stakeholders impacted by returning neuroimaging IFs to research participants, specifically within the context of an active imaging center that conducts a formal review of all research magnetic resonance imaging scans by a trained radiologist and where all findings, regardless of medical significance, are returned to participants.

Posters Selected for Recognition Conference Innovations in…Information Series goal of this study is to explore potential harms and benefits of mHealth to assess daily polydrug use among PWIDs. Methods: PWIDs ≥ 18 years old from Philadelphia and San Diego who reported weekly polydrug use. They (n=40) completed brief behavioral surveys on a cell phone and a semi-structured interview assessing their experience and principles of research ethics including beneficence and respect for persons. Interviews were transcribed verbatim and coded using thematic analysis.

Conclusion: Data suggest that few harms and many potential benefits may exist for PWIDs engaging in high-intensity behavioral studies using mHealth platforms. To confirm findings, larger, longitudinal studies are needed. However, researchers and ethics review boards should consider this kind of formative assessment as they develop and review protocols for mHealth studies with drug users. Potential implications for best-practice and protocol development will be discussed. Limitations: The study is limited by sample size and recruitment strategies (PWIDs from a longitudinal cohort study (California) or syringe access program (Pennsylvania)). Other populations of drug users (e.g., less frequent users) may have a higher sense of risk or benefit.

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Results: PWIDs identified few, if any, harms related to participation in a mHealth study and all reported potential benefits associated with participation. Many felt answering questions about their daily drug use and sexual activity would positively influence their abilities to reflect on and assess their risk behaviors. Some showed a propensity for altruism through contribution to research and most indicated that the questions were not harmful to their mental and behavioral states. In contrast, potential harms of participation, which included legal, social, behavioral, and psychological risks, were identified less than half as often as benefits. Participants also provided insights into making processes for participant selection more fair while maximizing data collection

for the study protocol, and on how to maximize the risk-benefit ratio (e.g., incorporate information about potential harms into the informed consent process and provide a report at the end of the study which quantifies their drug use and related spending during their participation in the study).

Colleagues couldn’t attend? Bring PRIM&R to them! A cost-effective way to bring PRIM&R education to your institution. You select the courses, dates, and location, and our faculty works with you to customize sessions that address topics relevant to your needs. Limit attendance to your institution or open it to others in your area and defray your costs.

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Supporters & Exhibitors Please visit our Supporters and Exhibitors in The Conference Connection, located in Exhibit Hall C on Level Two. And while you’re there, complete the Treasure Hunt to be entered to win! Your Treasure Hunt form is included in your conference bag. Visit the participating supporters and exhibitors, and answer the questions on the form. Return your completed form (don’t forget your name and cell number!) to the PRIM&R Pavilion by 6 PM on Saturday, November 14, to be entered to win the prizes on display. The drawing takes place on Sunday at 1 PM, and you must be onsite at that time to claim your prize. A map of The Conference Connection, which includes the locations of the individual Supporter and Exhibitor booths can be found on page 97 of this guide; the hours that The Conference Connection is open are listed on page 7.

Platinum Supporters

supporters & exhibitors

The Collaborative Institutional Training Initiative (CITI) Program at the University of Miami 305.243.9180 | www.citiprogram.org Booth: 212 The CITI Program provides web-based research ethics and compliance education. Our materials cover a number of key regulatory and ethical areas including: animal care and use, biosafety and biosecurity, clinical research coordinator, conflicts of interest, disaster planning for the research enterprise, export compliance, good clinical practice, good laboratory practice, human subjects research, IRB administration, information privacy and security, responsible conduct of research. For subscription information, please contact us by phone 305.243.9180, and by email at citisales@med.miami.edu, or visit www.citiprogram.org. PRIM&R would like to thank CITI Program for supporting the Conference Bookstore. See page 4 for bookstore hours of operation. Evisions 888.533.5993 | www.evisions.com/research Booth: 418 Evisions develops innovative, easy-to-use software that simplifies work for higher education institutions and research organizations. Evisions is transforming the face of electronic Research Administration by producing intuitive, cloud delivered products, and executing quick implementations. Evisions makes Research Administration easier by increasing office efficiency and rapidly responding to support needs. The Evisions Research Suite includes, Cayuse 424, Cayuse SP and Cayuse IRB. Please visit us at www.evisions.com/research, follow Evisions on Twitter (@EvisionsInc), and join the conversation on our Evisions blog at blog.evisions.com. PRIM&R would like to thank Evisions for supporting the charging lounge in The Conference Connection. Schulman IRB 513.761.4100 | www.schulmanirb.com Booth: 202 Schulman IRB provides high quality, rigorous IRB reviews for all phases of research in North America via streamlined processes, customized technology, and responsive customer service. We offer dedicated IRB services for research institutions and also offer Clinical Quality Assurance and Human Research Protections consulting via our partner Provision Research Compliance Services. PRIM&R would like to thank Schulman IRB for supporting the conference attendee water bottles. Visit booth 202 to fill your water bottle, compliments of Schulman IRB throughout the conference. PRIM&R would also like to thank Schulman IRB for their support of the drink tickets at the Welcome Reception. Western Institutional Review Board (WIRB) 609.945.0113 | www.wirb.com Booth: 218 Recognized as the gold standard of human subject protection, WIRB is the trusted partner to over 1,300 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. With seven individual AAHRPP-accredited panels, over 100 experienced board members, and over 40 years of experience in protocol and study-related review, only WIRB has the capacity and expertise to provide custom solutions to meet the unique and highly-specialized needs of its institutional partners. PRIM&R would like to thank WIRB for supporting this year’s conference attendee notebooks. p rim&r’ s 20 1 5 adv anci ng e th i cal re se a rc h c on f e r e n c e

Gold Supporters FTI Consulting 484.793.2854 | www.fticonsulting.com Booth: 322 FTI Consulting’s Clinical Research and Compliance Practice provides a comprehensive array of healthcare related research and compliance support services including, but not limited to: research billing, human subjects protection, AAHRPP accreditation assistance, conflicts of interest, research administration, scientific misconduct, grants management, and good clinical practices. PRIM&R would like to thank FTI Consulting for supporting the conference attendee pens. HRP Consulting Group, Inc. 347.862.9321 | www.thehrpconsultinggroup.com Booth: 219 HRP Consulting Group is a leading provider of human subject protection and research compliance consulting services to universities, hospitals, industry, IRBs, non-profit, private, government, and military organizations. We leverage our over 100 years of combined experience to develop commonsense solutions to the challenges our clients face. Services include: education and training, program evaluation, program development, QA monitoring, collaborative IRB development, IRB and ethics committee start-up, IRB management, accreditation assistance, assistance with federal agencies, and more. PRIM&R would like to thank HRP Consulting Group for supporting the Conference Internet Café located in The Conference Connection.

Silver Supporters

The PEER Consulting Group (PEER) 551.265.2040 | www.peercg.com Booth: 119 PEER helps institutions, researchers, and sponsors enhance Performance, Excellence, and Efficiency in Research. PEER consists of three divisions: Associates for IRB/HRPP Solutions (AIS), Associates for Clinical Trials (ACT) Management, and Associates for Research Compliance (ARC). The group is complemented with a team of over 70 consultants who have extensive expertise in all areas of research administration and clinical trial management. PRIM&R would like to thank the PEER Consulting Group for supporting lunch on November 15. Quorum Review IRB 877.472.9883 | www.quorumreview.com Booth: 318 Quorum Review IRB is a privately held, independent ethics review board fully accredited by AAHRPP. Our mission is to safeguard the rights and well-being of research participants. With 15 board meetings a week, we provide sponsors, Contract Research Organizations, institutions, and sites with reliable, responsive service to support efficient study start-up and management. PRIM&R would like to thank Quorum Review IRB for supporting lunch on November 14.

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supporters & exhibitors

Huron Consulting Group 866.229.8700 | www.huronconsultinggroup.com Booth: 103 At Huron, we help our clients create the best HRPPs. Huron is the only provider combining the industry’s leading HRPP regulatory and process experts with the #1 IRB enterprise software solution, Click® IRB. Working with Huron, your research organization will improve principal investigator satisfaction, strengthen compliance, and increase organizational efficiency. PRIM&R would like to thank Huron Consulting Group for supporting the Common Ground Networking Luncheon on November 13.

Supporters & Exhibitors Bronze Supporters iMedRIS 1888.519.7072 | www.imedris.com Booth: 319 iMedRIS provides state-of-the-art electronic research administration software in the form of an innovative research management system called iRIS™ (“integrated Research Information System”). iRIS™ is the most versatile and comprehensive research administration software suite available to the research community. iMedRIS offers a completely configurable software platform that empowers institutions with the tools they need to optimize research administration operations by eliminating inefficiencies and increasing productivity. iRIS™ modules: IRB Assistant™, IACUC Assistant™, COI Assistant™ eProposal Assistant (Pre-Award), Post-Award. PRIM&R would like to thank iMedRIS for supporting the coffee break at 10:45 AM on November 13 in The Conference Connection.

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IRBNet, A WIRB-Copernicus Group Company 877.261.6461 | www.irbnet.org Booth: 222 IRBNet is the leading compliance and research oversight solution for institutions. Developed in 2001 as part of an NIH Enhancement Grant, IRBNet supports over 2,500 research sites and review boards and over 125,000 research professionals in the successful and efficient management of research involving humans, animals, and recombinant DNA. PRIM&R would like to thank IRBNet for supporting the morning coffee break at 7:00 AM on November 13 in The Conference Connection. Key Solutions, Inc. 510.456.4505 | www.keyusa.com Booth: 109 Key Solutions, Inc. is the leader in providing integrated, comprehensive software products and services to universities, hospitals, pharmaceutical companies, biotech firms, government facilities, and independent institutes worldwide. Our software solutions streamline and automate Research Administration and Compliance processes, Grants Management, and Conflict of Interest Management for our customers. Founded and based in Silicon Valley, Key Solutions continuously strives to advance discovery as an effective partner to the Life Science and Research communities. PRIM&R would like to thank Key Solutions, Inc. for supporting the morning coffee break at 7:00 AM on November 14 in The Conference Connection. Tech Software/IRBManager 888.871.7575 | www.techsoftinc.com Booth: 329 With its award-winning IRBManager offering, Tech Software/BEC continues to deliver best of breed solutions for research oversight and compliance. A modern cloud solution, IRBManager supports all your compliance needs from IRB and COI to IACUC and Export Control including electronic submissions, online reviews, agendas and minutes, notifications and, of course, reporting. IRBManager builds on Tech Software’s 30 year history of providing solutions that meet and exceed industry norms while still delivering user-friendliness and configurability second to none. IRBManager is used to manage research occurring at over 10,000 locations around the globe, including research in universities, hospitals, and medical centers, independent oversight organizations, and federal, state, and local government institutions. For more information, visit www. techsoftinc.com or call 516.627.3800 today. PRIM&R would like to thank Tech Software/IRBManager for supporting the coffee break at 10:45 AM on November 14 in The Conference Connection.

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Exhibitors The Association of Clinical Research Professionals (ACRP) 703.254.8100 | www.acrpnet.org Booth: 326 ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote excellence in clinical research. Apex Ethical Services, LLC 517.290.3965 | www.apexethical.com Booth: 228 Apex Ethical Services offers state-of-the-art and cost-efficient consulting and products to help your HRPP and IRB become more knowledgeable, functional, and efficient. IRB EasyEdTM is our landmark educational product designed for brief educational sessions at IRB meetings. Our webinar series brings current thinking on basic, regulatory, and hot topics to your computer.

a-tune software Inc. 512.243.8539 | www.a-tune.com Booth: 426 a-tune software Inc. is a provider of medical research software. Our software suite, tick@lab, delivers compliance management for IACUC, IRB, and IBC. Other tick@lab applications are available for protocol management, transgenic breeding, capacity planning, task management, accounting, facility management, and vet records. User defined templates provide the ability to collect data specific for your institution. A data mart offers easy access to all data for reporting and integration. Professional service team assists in rapid implementation. Axiom Education 513.437.1289 | www.axiomeducation.com Booth: 325 Axiom Education provides Mentor IRB, a full featured paperless and web based IRB system. We also have modules for IACUC and IBC. Designed for both biomedical and social science IRBs, Mentor is highly customizable and loaded with the features you need to meet efficient and cost effective management of your research compliance committees. Mentor supports multiple committees, principal investigator certification, protocol messaging, research coordinators, student submission, protocol messaging, customizable notification templates and forms, meeting agendas, and a full reviewer system.

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AAHRPP, Inc. 202.783.1112 | www.aahrpp.org Booth: 327 AAHRPP works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

Supporters & Exhibitors The Bioethics Program of Union Graduate College and Icahn School of Medicine at Mount Sinai 518.631.9860 | www.bioethics.uniongraduatecollege.edu Booth: 223 Jointly offered by Union Graduate College and the Icahn School of Medicine at Mount Sinai, the Bioethics Program provides competency- and skills-based education in clinical ethics, research ethics, and bioethics policy. The program uses a hybrid approach to teach bioethics. Students take a mixture of online and onsite courses, which are taught by internationally recognized experts in the field, and include the use of case studies, supervised exercises, and innovative real-world simulations.

supporters & exhibitors

Chesapeake IRB 410.884.2900 | www.chesapeakeirb.com Booth: 113 Chesapeake IRB companies have been providing central independent IRB services, throughout the US and Canada, since 1993. Chesapeake IRB, AAHRPP accredited since 2004, has a history of creating innovative and adaptive solutions including our 21 CFR Part 11 compliant, electronic IRB management platform (CIRBI) that streamlines protocol submissions, decreases investigator review turnaround times, and results in faster subject enrollment. CIP® Program 617.423.4112 | www.primr.org/certification/cip Booth: 203 (in the PRIM&R Pavilion) The CIP Program, PRIM&R’s certification initiative, was developed for individuals participating in and overseeing the daily activities of IRBs. The credential establishes and promotes standards for professional knowledge, and supports adherence to regulatory requirements, best practices, and ethical standards. More than 2,500 individuals have become certified since the inception of the program in 1999. Columbia University School of Continuing Education 212.854.9666 | ce.columbia.edu Booth: 129 The School of Continuing Education at Columbia University offers master’s degrees in a dozen emerging and cross-disciplinary fields,16 certificates, and access to thousands of courses. Columbia’s programs in bioethics, which confront the 21st century’s broadest and deepest issues, include a master’s degree, an online certification, and individual online courses. Complion 703.254.8100 | www.complion.com Booth: 328

Complion, the leading eRegulatory provider for sites, was founded by certified clinical research professionals to empower sites. In collaboration with leading sites and based on best practices, Complion developed Acuvia, a common standard platform for sites to store FDAcompliant electronic regulatory binders and other standardized processes. Complion facilitates the sharing of best practices and educational resources on infoVera.org, a community-led collaborative education initiative, with user-led eRegulatory community work groups.

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Harvard Medical School Center for Bioethics 617.432.5617 | bioethics.hms.harvard.edu Booth: 229 The Harvard Medical School Center for Bioethics is founded on the principle that we have a responsibility to ensure values and ethics are always part of medical training, laboratory and clinical research, and ongoing professional education. Through our Master of Bioethics degree, Fellowship in Medical Ethics, Consortia, and Forums, we prepare professionals to address the profound moral questions raised by advances in the life sciences. The Health Care Compliance Association (HCCA) 888.277.4977 | www.hcca-info.org Booth: 210 HCCA is a member based organization for compliance professionals in the healthcare field. Our events, products, and resources offer education for those who are looking to be certified in healthcare compliance, or for those just looking to keep their compliance department updated with the latest news. HCCA currently has over 10,000 members and over 8,200 actively certified through its seven certification programs.

Infonetica Ltd. 44 (0) 208 334 6900 | www.infonetica.net Booth: 225 Infonetica is a world leader in web-based software for IRBs, Clinical Research Management, Tissue Tracking, and Online Training. We created the United Kingdom, Australia, and New Zealand national ethics application and approval systems. Infonetica’s Ethics Review Manager is used by health institutions and universities in the United Kingdom, United States, and Canada. “After an exhaustive search for IRB systems, EthicsRM was the clear winner. They exceeded all expectations with their commitment to our success.” – Fairfield University, CT National Cancer Institute Central IRB 888.657.3711 | www.ncicirb.org Booth: 125

The NCI’s Central IRB (CIRB) is designed to reduce administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. Using the CIRB enables principal investigators to open studies and enroll study participants into network group clinical trials significantly faster.

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supporters & exhibitors

InfoEd Global 518.713.4200 | www.infoedglobal.com Booth: 422 Research Administration without boundaries™ - Configurable yet turn-key software. - Complete S2S and Pre/Post Award support. - Comprehensive Compliance modules for ALL areas of Research Administration. We are the world’s most deployed eRA software that can accommodate institutions of all Research and Development volumes.

Supporters & Exhibitors

Novelution 212.864.1653 | www.novelution.com Booth: 107 Novelution provides tailor-made research management software, including Sponsored Research Pre and Post Award, IRB, IACUC, IBC, Conflict of Interest, Effort Reporting, Facilities Management, Content Management Systems, and other modules our partners need to support their research administration.Our software is custom-built rather than custom-configured; as such, we have unlimited flexibility to create an ideal system for each partner. OHRP 866.447.4777 | www.hhs.gov/ohrp Booth: 227 The DHHS OHRP oversees the protection of human subjects for HHS-conducted or supported research activities and accomplishes its mission through assurances, policy and guidance development, compliance oversight, and education programs. Staff will be available to discuss ethical principles, regulations, policy guidance, and educational resources.

supporters & exhibitors

Protocol Builder™ 646.791.6178 | www.protocolbuilderpro.com Booth 127 Protocol Builder™ is a first-of-its-kind cloud-based solution to assist researchers in the development of investigator-initiated research protocols. Protocol Builder makes writing investigator-initiated protocols faster and easier. Protocol Builder guides the experienced researcher to the nonexperienced researcher thru the protocol process. Protocol Builder creates a collaborative environment for the principal investigators and team members to work together. • Boost research knowledge with a guided and collaborative learning experience. • Save time and effort writing protocols with expert step-by-step guidance based on protocol type. • Improve quality and adherence to IRB and regulatory standards with resources, such as FDA information and forms.

RosterTech Integrated learning & data management solutions

™

RosterTech™ 801.213.3573 | www.rostertech.com Booth: 208 “Research Compliance & Training Software” RosterTech™ delivers cost-effective, customizable solutions for research compliance and training programs! “Built by trainers for trainers,” RosterTech™ provides efficient registration, tracking, certification, and reporting for your institution and federal funding agencies. RosterTech™ fully integrates with existing software platforms enabling live and online instructional content in one centralized and secure environment. RosterTech™ features include intuitive data management, individual notification, and targeted promotional capabilities. The RosterTech™ team of professionals offer high-quality client support services. Veterans Affairs Boston Healthcare System 857.364.5473 | www.boston.va.gov Booth: 123 Does your facility use SharePoint? If so did you ever think of extending it beyond content management to a workflow and webform-enabled, full-blown research administration management system? VA Boston and several other VA centers have collaborated to do just that. We want to share our experience in this development effort with other research management organizations. To learn more, visit us at booth 123, or email: david.rose@va.gov.

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Supporter & Exhibitor Map

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Huron Consulting Group Novelution Key Solutions, Inc. Chesapeake IRB The PEER Consulting Group VA Boston Healthcare System NCI CIRB Columbia University School of Continuing Education Schulman IRB RosterTechTM HCCA CITI Program at the University of Miami Western Institutional Review Board HRP Consulting Group IRBNet The Bioethics Program of Union Graduate College and Icahn School of Medicine at Mount Sinai Infonetica OHRP Apex Ethical Services Harvard Medical School Center for Bioethics Quorum Review IRB iMedRIS FTI Consulting Axiom Education, LLC ACRP AAHRPP, Inc. Complion Tech Software/IRBManager Evisions InfoEd Global a-tune software Inc.

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Booth

Board of Directors Conference Information Officers

Members

Alexander M. Capron Chair University of Southern California

A. Cornelius Baker Office of the US Global AIDS Coordinator

Barbara E. Bierer Brigham and Women’s Hospital; Harvard Medical School

David A. Borasky, Jr. Copernicus Group IRB

Cynthia A. Gómez San Francisco State University

Bruce G. Gordon University of Nebraska Medical Center

Christine Grady NIH Serves in Personal Capacity

Karen M. Hansen Fred Hutchinson Cancer Research Center

Tanise L. Jackson Florida Agricultural and Mechanical University

Moira A. Keane University of Minnesota Retired

Robert J. Levine Yale University

Christian E. Newcomer AAALAC International

P. Pearl O’Rourke Partners HealthCare

Heather H. Pierce Association of American Medical Colleges

David H. Strauss Columbia University

Jeremy M. Sugarman The Johns Hopkins University

about PRIM&R

Susan Z. Kornetsky Vice Chair Boston Children’s Hospital

Joseph J. Byrne Tufts University Emeritus

Susan S. Fish Secretary Boston University

Ada Sue Selwitz University of Kentucky

Walter L. Straus Treasurer Merck & Co., Inc.

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Elisa A. Hurley PRIM&R Ex officio

Barbara Stanley Columbia University

Staff

Noelani Alexis Operations Assistant

Joanna Cardinal Assistant Director for Membership and IT Operations

Megan Frame Membership Manager

Kimberly Hensle Lowrance Managing Director

Elisa A. Hurley Executive Director

Jen Levine-Fried Staff Accountant

Maeve Luthin Professional Development Manager

Mariellen Morris Associate Director for Conferences

Anne Meade Senior Manager for Website and Social Media

Nora Murphy Online Learning Coordinator

Caroline Slymon Executive Coordinator

Ashley Savannah Program Coordinator

Meredith Elkins Director of Marketing and Communications

about PRIM&R

Alysa Perry Meeting Planner

Elise Davis Membership Assistant

Kelly Whelan Marketing Coordinator

Not pictured: Darby Hull, Research and Policy Specialist

n ove m b e r 12- 15 , b os t on , m a

Thank You to Our Conference Information 2015 Committee Members We would like to thank our member volunteers who serve on our standing committees. In doing so, they generously share their time and energy with PRIM&R for the greater good of the research ethics community. Their contributions are critical to fulfilling our mission of advancing the highest ethical standards in the conduct of research through education, membership services, professional certification, public policy initiatives, and community building. Diversity Advisory Group

The Diversity Advisory Group’s goal is to examine the issue of diversity as it pertains to PRIM&R’s membership. Specifically, the Diversity Advisory Group makes recommendations to the staff and Board of Directors regarding strategies and/or activities designed to ensure we are maximizing our outreach to diverse populations (including diversity of gender, age, ethnicity, race, geography, professional position, and institutional affiliation), and that PRIM&R is generally fostering an environment where different communities, professions, and ideas can flourish. Eric C. Mah, MHS, CIP (Chair) Eric Allen, CIP, CPIA Donna H. Eaton, RN, MSN, MHA Melissa Epstein, PhD, CIP Susan S. Fish, PharmD, MPH William Freeman, MD, MPH, CIP Dorotha Love Hall, PhD, MPA, CIP Donna Matthews Jarrell, DVM, DACLAM Natalie L. Mays, BA, LATG, CPIA Roberto L. Veloso, JD

about PRIM&R

Knowledge Center Advisory Group

The Knowledge Center Advisory Group is charged with guiding the development of the Knowledge Center. This group contributes to goal setting and strategic planning for the site. Advisory group members also participate in the development of new resources. Through its work, the group is an integral part of PRIM&R’s continued efforts to provide human subjects protections and animal care and use professionals with the resources they need to do their jobs effectively and efficiently. Lois Brako, PhD (Chair) Hila F. Berger, MPH, CIP Melissa A. Epstein, PhD, CIP Amy Neuman, MPH Kaarkuzhali Babu Krishnamurthy, MD Michael Leary, MA, CIP Gina Prochilo-Cawston, MS, CPIA, PMP Lauren Solberg, JD, MTS Matt Zembrzuski, MEd

Education Committee

The Education Committee sets broad educational goals to further PRIM&R’s mission and uphold its core values by: (1) determining and prioritizing the educational needs of its membership, (2) monitoring trends in the field to recommend and develop appropriate educational opportunities, and (3) evaluating educational activities to determine whether the educational goals are being met. Ada Sue Selwitz, MA (Chair) Emily E. Anderson, PhD, MPH Rebecca D. Armstrong, DVM, PhD Jeremy J. Corsmo, MPH, CIP Jonathan M. Green, MD Karen M. Hansen Susan Z. Kornetsky, MPH Robert J. Levine, MD Christian E. Newcomer, VMD, DACLAM Rachel Zand, PhD

Membership Committee

PRIM&R’s Membership Committee works to strengthen the membership community by improving the reach of member benefits and volunteer opportunities. They review applications for PRIM&R’s Regional Connections Program, conduct outreach to welcome new members to PRIM&R’s community, and evaluate new membership initiatives. These efforts, as well as their thoughtful group discussions, allow the Membership Committee to reach broader audiences and cultivate new leadership from within the membership. Susan S. Fish, PharmD, MPH (Co-Chair) David G. Cannon, CPIA (Co-Chair) Carol Bienstock, CIP Karen M. Hansen Joy Jurnack, RN, CCRC, CIP Greg E. Manship, D.Bioethics, MDiv, CIP Maribel Martinez, MPH Kelly O’Keefe, MPH LaWanda Holland Thompson, PhD Steven Ziemba, PhD, FACHE, CIP, CCRC

p rim&r’ s 20 1 5 2 adv anci ng e ti thhi cal re se a rc h c on f e r e n c e

PRIM&R established the CIP® credential in 1999, and since then, more than 2,500 individuals have become certified. Certification improves human subjects protections and promotes ethical research practices and programs by recognizing that those charged with their administration have demonstrated an advanced level of knowledge, understanding, and experience.

CIP® at the 2015 AER Conference

The CIP® credential… • Promotes the ethical conduct of research by strengthening the professional administration of HRPPs • Validates an individual’s professional experience and mastery of the body of knowledge determined by national experts to be essential to competent HRPP and IRB administrative practices • Encourages personal growth and professional development • Strengthens the quality of HRPPs by certifying a cadre of committed and educated individuals As the CIP® credential has gained visibility, the number of employers seeking candidates with this certification continues to grow. Those who have obtained the credential report greater job satisfaction, workplace recognition, and personal pride. To support individuals who are considering obtaining the CIP® credential or those who are actively preparing for the exam, PRIM&R offers an overview session during the AER Conference, described at right. Facebook and LinkedIn groups of peers are also available for exam preparation assistance, support, and mentoring.

• CIP® Continental Breakfast Saturday, November 14, 7:00-8:00 AM, in Ballroom A This session is for anyone interested in becoming certified, or those already certified who would like to network with other CIPs. • C10: The CIP® Credential: What’s it About? Saturday, November 14, 11:15 AM-12:30 PM in Room 109 This session is for individuals interested in learning about earning the CIP® credential. CIP® Exams Examinations are conducted during two periods of two weeks each in the spring and fall. Upcoming exam dates can be found on the PRIM&R website at www.primr.org/certification. CIP® Recertification Participation in the 2015 AER Conference qualifies as continuing education for the purpose of CIP® recertification. A maximum of 20 credit hours issued by a recognized accrediting body are available for the 2015 AER Conference.

A special thank you to the Council for Certified IRB Professionals (CCIP)

Gregorio Lim Chair

Erica Heath Vice Chair

Barbara Bigby

Elizabeth Kipp Campbell

Jerry Castellano

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Gary Chadwick

about PRIM&R

PRIM&R would like to thank the current members of the CCIP for their dedication to the program:

Susan Delano

Scioneaux n ove m Lori b e r Roesch 12- 15 , b os t on , mCarla a

In Memoriam Conference

Information Remembering Warren K. Ashe: A sincere, generous mentor

Warren K. Ashe, PhD, retired associate dean for research at Howard University and former PRIM&R Board member, passed away on July 26, 2015. He was 85.

about PRIM&R

Dr. Ashe had a self-described love affair with Howard University from childhood, when he dreamed of being involved in the medical school. After receiving his bachelor’s degree in psychology from Howard, Dr. Ashe enlisted in the US Marines Corps. He remarked that the day he enlisted was both the best—and the worst—day of his life. “[The Marines] have a motto that I still remember. They say, ‘the difficult we do immediately; the impossible takes a little time.’…I live my life on that principle.” After an honorable discharge in 1953, Dr. Ashe was hired at the NIH. He worked at NIH for 20 years, and was the first African-American to become a senior scientific advisor at the National Institute for Dental Research. In 1961, after spending time studying the herpes simplex virus, he published his first paper in the journal, (Archives of Oral Biology). In 1962, he earned a master’s degree in microbiology from Howard. In 1971, Dr. Ashe was invited by the dean of Howard University College of Medicine to join the administration. Dr. Ashe began his work at Howard later that year, starting as an assistant dean and instructor of microbiology. In 1976, he enrolled as a PhD student in the department of microbiology, working during the day and taking classes at night. He completed his longed-for doctoral degree in 1984. When Dr. Ashe first arrived at Howard, there was no formal process for reviewing research. He formed the Human Research Review Committee, charged with reviewing all human research in the College of Medicine, which eventually transformed into the first IRB at the University. He served as executive secretary for the IRB from 1971 until 2006.

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While involved with the IRB, Dr. Ashe began attending PRIM&R conferences, and was invited by Dr. William Freeman, a PRIM&R Board member, to speak at the 1998 conference on a panel titled Can Tuskegee Happen Again? That same year, Dr. Ashe was elected to the PRIM&R Board of Directors and served until 2010. A testament to his tireless commitment to support others in the research community, Dr. Ashe worked with Dr. Freeman to create the organization’s Institutional Capacity Building Scholarship Program, which was established to help individuals from under-represented minority institutions participate in PRIM&R’s annual conferences. The program continues today, and has been instrumental in bringing professionals from Historically Black Colleges and Universities, tribal colleges, and Hispanic-serving institutions to PRIM&R events for more than a decade. Dr. Freeman noted Dr. Ashe’s passing: “I learned much from Warren. It was my pleasure to work closely with him on several PRIM&R Board issues, including the creation of our scholarship program. His memory is a blessing for me.” Dr. Ashe, along with fellow board member Charles McCarthy, was also instrumental in the development of the Pillars of PRIM&R Program, to recognize sustained contributions from members of the PRIM&R board to PRIM&R and to provide support for early career professionals. Dr. Ashe will be long remembered for his kindness and his eagerness to share his wealth of knowledge with others. As PRIM&R’s Managing Director, Kimberly Hensle Lowrance, attested: “I am very lucky to have known Warren. He was such a special man—so committed to research, to doing better, to supporting one another. He always provided great advice to our staff and was a warm, lovely human being.” He will be deeply missed.

In Memoriam

Remembering Alan P. Wertheimer: A respected leader and compassionate teacher

Alan P. Wertheimer, PhD, senior research scholar in the Department of Bioethics at the NIH Clinial Center and professor emeritus of political science at the University of Vermont (UVM), passed away on April 10, 2015.

Center exploring topics related to research ethics until he passed away. Dr. Wertheimer’s most recent work at the NIH focused on ethics of clinical research with particular emphasis on issues of coercion, exploitation, and consent.

He was was a respected leader and philosopher who made significant contributions to the field of research ethics. He was also a dedicated, passionate, and kind teacher who will long be remembered for the joy and patience he brought to teaching.

Christine Grady, PhD, MSN, chief of the NIH Clinical Center’s Department of Bioethics and PRIM&R Board member, was a colleague of Dr. Wertheimer’s. She shared: “Alan was a well-known and accomplished scholar in political philosophy before coming to bioethics. After he joined the NIH Clinical Center Department of Bioethics, he did some of the finest work the field has ever seen, challenging received wisdom on many important topics in research ethics. Alan was an incredible colleague, teacher, mentor, and friend. His humility, humor, generosity, and kindness touched so many people. We will miss him tremendously.”

Throughout his tenure at UVM, Dr. Wertheimer explored topics related to the political philosophy of law. Of particular interest were the topics of coercion, exploitation, and consent. He published numerous articles on these topics, as well as several books, including: Coercion (Princeton University Press, 1987) and Exploitation (Princeton University Press, 1996). Upon his retirement from teaching in 2005, Dr. Wertheimer was invited by Ezekiel Emanuel, MD, PhD, who served as chief of the Department of Bioethics at the NIH Clinical Center at the time, to become a visiting scholar in the department. Through this experience, Dr. Wertheimer discovered that coercion and exploitation— topics that he had previously studied in the political science realm—also had a place in research ethics. Though it was originally a year-long engagement, Dr. Wertheimer continued to work with the NIH Clinical

Dr. Wertheimer was an active participant in PRIM&R’s AER Conference for many years, serving as both a breakout session facilitator and panelist. He also served on the Core Conference Planning Committee from 2009 to 2014. Elisa A. Hurley, PRIM&R’s executive director, noted his impact this way: “Alan’s contributions to PRIM&R and to the research ethics community—as a scholar and truth-seeker, a teacher and mentor—cannot be overstated. To read Alan’s books and articles, or hear him teach a course or deliver a lecture, was to be challenged to think differently about some of the hardest questions in our field—What constitutes valid informed consent? When does research threaten to exploit its subjects? What should we really think about paying research subjects? I learned so much, personally, from Alan, and I was blessed to call him a friend.” Dr. Wertheimer’s vast contributions to research ethics scholarship have enriched the field and helped challenge conventional wisdom. His commitment to exploring challenging topics, his willingness to teach, and his always kind and generous nature made him a true leader. He will be deeply missed.

n ove m b e r 12- 15 , b os t on , m a

about PRIM&R

Dr. Wertheimer spent much of his career in the field of political science. As an undergraduate student at New York University (NYU), Dr. Wertheimer took his first course in political philosophy, an experience that served as inspiration for his career. He completed his bachelor’s degree at NYU in 1964, and went on to receive his PhD from Case Western Reserve University in 1968. From there, he took a position teaching political science at UVM, where he continued to teach until 2005. He also served as visiting professor of public policy at the John F. Kennedy School of Government at Harvard University and professor of law at the University of San Diego.

Maps

Lost and found

maps

To Hilton hotel

p rim&râ&#x20AC;&#x2122; s 20 1 5 adv anci ng e th i cal re se a rc h c on f e r e n c e

Escalators to up Level Three, down to Plaza and Street Levels

Unattended coat & bag storage

General Session Penary Sessions

maps

n ove m b e r 12- 15 , b os t on , m a

Bookstore

Help Desk

No sessions will be held in these rooms

Registration

The Conference Connection: - PRIM&R Pavilion & Demo Area - Internet CafĂŠ - Supporters & Exhibitors - Poster Gallery - Charging Lounge - FDA Office Hours - Breaks & Receptions

General Lunches Group Mentoring

Escalators to down to Level Two, Plaza, and Street Levels

p rim&r’ s 20 1 5 adv anci ng e th i cal re se a rc h c on f e r e n c e

Plenary Sessions Innovations A & C The Drama of DNA

Research Ethics Book Group Lunch, Affinity Group Breakfast, CIP® Breakfast

maps

Maps

You Ask. Prologue Answers. Find the regulatory references and compliance documents you need when you need them with Prologue.

Single search ensures you never miss a critical resource Fast relevant results for confident decision making Alerts notify you when new regulatory information is available Unrivaled content collected and cataloged by trusted research law experts

Research Compliance Services and Flexible Institutional Solutions from

Visit us at booth #202

or http://www2.sairb.com/prologue

The Custom Choice for Institutions Whether we’re supplementing the work of a local IRB or serving as the primary review board, we offer highly responsive service, competitive turnaround times, and intuitive, user-friendly technology solutions for maximum transparency and efficiency. Let us show you why we’ve been the IRB of choice for more than three decades. Central and Local IRB Services

Experienced, CIP-Certified Team

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Superior FDA Audit History

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Minimal Risk Review & Exemption Determinations

Best in Class Technology

Research in Canada and Latin America

www.wirb.com

Proven Expert. Global Leader. Trusted Opinion.

VISIT US AT BOOTH 218

WIRB is proud to support the members of Public Responsibility in Medicine and Research (PRIM&R) in their mission to continuously raise the bar of research administration and oversight. n ove m b e r 12- 15 , b os t on , m a

maps

The first independent review board, Western Institutional Review Board速 (WIRB) was founded in 1968 and remains the unrivaled leader in ethical review. Recognized as the gold standard of human subject protection, WIRB is the trusted partner to over 1,300 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. WIRB is also the largest global presence in the ethical review space, with a network of affiliates and fellows reviewing research around the world.

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1. INTRODUCTION & GLOSSARY Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual

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Come and See Us at Booth

Research Ethics and Compliance Solutions

#219

Working in research ethics is both challenging and constantly evolving, that’s why we’re here to help. HRP Consulting Group (HRP) has been in the business of research ethics and compliance for over 10 years. With over 100 combined years of hands-on experience as HRPP, IRB and Research Compliance professionals, federal regulators and AAHRPP representatives, we use our experience to provide expert support to research professionals throughout the world. In addition to our in-house expertise, HRP has developed a network of highly experienced associates who can be called upon when assisting clients. Relationships are the core of our business. We take a personalized hands-on approach to develop customized solutions to the challenges you face. HRP prides itself on being there for you as an ongoing source of support.

Services provided for IRB, IACUC and IBC include:

• HRPP and IRB Development • Training and Education • Program Evaluations • Temporary Staffing • Accreditation Assistance • Institutional “Rescues” • Responding to Regulatory Agencies • Non-Compliance and Misconduct Solutions • Monitoring and Auditing

HRP is committed to charity, fitness and the advancement of research; with you as our partner, we can make a difference. Due to last year’s tremendous success with the Take Steps for Research Challenge, join us once again for a chance to win prizes for yourself and a donation to a charity of your choice.

Make HRP Consulting Group (BOOTH #219) your first stop at the conference to sign up!

For additional information, visit our website or contact us at: +1 347 862 9321 ph | +1 347 862 9323 fax | info@thehrpconsultinggroup.com | thehrpconsultinggroup.com

Expert Consultation for: • Institutional Officials • Compliance Oversight • IRB Operations • Clinical Trials Offices • Clinical Trial Management or Monitoring

Visit us at Booth 119 Visit our website: http://www.peercg.com

VAHCS Boston has realized an interesting platform for electronic Research Administration management and wants to share this knowledge with industries managing research portfolios and clinical trials. The system has features needed to create, submit and manage research portfolios from concept to study closure. This includes integrated document management, electronic forms and automated workflows. It’s one we hadn’t realized we already owned. You may already own it too. In place we are able to leverage current IT investments, scale to the enterprise and absorb new technologies. Most importantly it allows us to more efficiently bring products of VA research from benchtop to bedside for the benefit of our veterans. A big differential is the ability to capture business information automatically as protocols are processed through their review lifecycle. This means no more manual data entry into spreadsheets, forms or desktop databases. If your organization hasn’t gone digital yet you’ll want to know about this breakthrough realization. - No more paper. - No more scanning or photocopying. - No more delivery charges. - No more data entry. And the platform can just as easily be expanded to digitize other business lines in your organization. That’s pretty good ROI. The system is self-service and capable of in-house customizations of all components so you can port your practices the way you want them into a well-supported and tested digital technology. Host the application or use it as software as a service in the cloud. VA will share this knowledge with industries managing research portfolios and clinical trials.

To learn more, visit us at booth 123, or email: david.rose@va.gov

Educating the Next Generation of Practitioners and Leaders in Bioethics

Master of Bioethics 1-year (full-time) or 2-year (part-time) course of study and capstone experience with Harvard-affiliated mentors Fellowship in Medical Ethics Certificate program in bioethics for active clinicians, researchers and academics. Lifelong Learning Activities Clinical, Research, and Organizational Ethics Consortia, Neuroethics Seminars, and Bioethics Forums.

/hmsbioethics @hmsbioethics

bioethics@hms.harvard.edu 617.432.2570

CENTER LEADERSHIP

Director Robert D. Truog, MD

Fellowship Program Director Mildred Z. Solomon, EdD

Associate Director Executive Director Edward M. Hundert, Christine Mitchell, MD RN, MS, MTS

bioethics.hms.harvard.edu

Master of Bioethics Director Rebecca Weintraub Brendel, MD, JD

How effective is your IRB approval system ? With EthicsRM you can :

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BOARD MEMBERS can comment directly onto a protocol...

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Work smarter, not harder. IRBNet can help you manage more information in less time.

See for Yourself. Join the network of over 2,500 research sites and review boards – and over 125,000 research professionals – that depend on IRBNet for the successful and efficient management of research involving humans, animals and recombinant DNA.

Learn more at www.irbnet.org Visit us at Booth 222

EXPERIENCE | REDEFINED

AT HURON, WE HELP OUR CLIENTS CREATE THE BEST HUMAN RESEARCH PROTECTION PROGRAMS. Huron is the only provider combining the industry’s leading HRPP regulatory and process experts with the #1 enterprise IRB software solution. Working with Huron, your research organization will improve PI satisfaction, strengthen compliance, and increase organizational efficiency.

See us at Booth 103 at PRIM&R’s AER Conference or visit www.huronconsultinggroup.com/IRBTransformation.

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Visit us in Booth 329

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To learn more about our solutions visit us www.techsoftinc.com or call 516-627-3800

Our webinars provide on-demand learning at your desk or on the go, viewable from your desk, a tablet or smart phone. Watched live or downloaded for later, you’ll ﬁnd our webinars always include must-have information that you can use right away, whether the topic is universally applicable or one that’s more narrowly focused. PRIM&R members membe can access recordings of webinars that occurred more than one year ago for free via the Knowledge Center. Non-members can purchase the recordings on demand at www.primr.org/webinars.

www.primr.org/webinars

Find the right sites for your studies with Site Match Get a customized list of sites using criteria tailored to the protocol

Our site directory includes thousands of clinical researchers willing to be contacted for potential studies. Reports can be customized by therapeutic area, disease area, geographic location, affiliations with research institutions, and more. Visit QuorumReview.com/SiteMatch for more information.

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SHARE WITH YOUR PEERS The IRB Forum is an active online community for anyone working with HRPPs and IRBs. Members can pose questions, exchange guidance, and share best practices with peers, generating candid and constructive discussions on the challenging issues in ethics, regulations, and policies related to human subjects research.

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THANK YOU . . . to our Conference Planning Committee members who made this conference possible. CORE CONFERENCE PLANNING COMMITTEE Co-Chairs

Members

Director Human Research Affairs Partners HealthCare System, Inc.; Associate Professor of Pediatrics, Harvard Medical School

Senior Medical Fellow, Bioethics and Pediatric Capabilities Eli Lilly and Company

P. Pearl O’Rourke, MD

Laura Odwazny, JD, MA

Senior Attorney Office of the General Counsel US DHHS

Albert J. Allen, MD, PhD

Dean R. Gallant, AB

Consultant HRP Consulting Group, Inc.

Leonard Glantz, JD David A. Borasky, Jr., MPH, CIP Professor Emeritus of Health Law, Vice President Quality Management Copernicus Group IRB

Bioethics, and Human Rights Boston University School of Public Health

Alexander M. Capron, LLB

Celia B. Fisher, PhD

University Professor; Scott H. Bice Chair in Healthcare Law, Policy, and Ethics; Co-Director, Pacific Center for Health Policy and Ethics University of Southern California

Susan Z. Kornetsky, MPH Director Clinical Research Compliance Boston Children’s Hospital

Robert J. Levine, MD

Professor of Internal Medicine; Chair, Executive Committee of the Center for Bioethics Yale University

David H. Strauss, MD

Director of Psychiatric Research, New York State Psychiatric Institute; Vice Chair for Research Administration, Ethics, and Policy Department of Psychiatry Columbia University

Elyse I. Summers, JD President and CEO AAHRPP, Inc.

Ivor A. Pritchard, PhD

Senior Advisor to the Director OHRP

WORKSHOP DIDACTIC SUBCOMMITTEE Co-Chairs

Members

Susie R. Hoffman, RN, BSN, CIP Jeremy N. Block, PhD, MPP

Janet C. Donnelly, RAC, CIP

Eric Mah, MHS, CIP

Scott J. Lipkin, DPM, CIP

Michelle Feige, MSW, LCSW-C

Greg E. Manship, D.Bioethics, MDiv, CIP, CIM

Sharon Freitag

Megan Kasimatis Singleton, JD, MBE

Director IRB for Health Sciences Research University of Virginia Managing Director Health Solutions FTI Consulting

IRB Chair Mount Sinai Health System; Assistant Professor Department of Population Health Science and Policy Icahn School of Medicine at Mount Sinai

Kristina C. Borror, PhD

Director Division of Compliance Oversight OHRP

Elizabeth A. Buchanan, PhD Endowed Chair and Director Center for Applied Ethics University of Wisconsin-Stout

Policy Analyst Office of Good Clinical Practice FDA Executive Vice President AAHRPP, Inc.

Director, Research Ethics Office St. Michael’s Hospital

George Gasparis, CIP

President The PEER Consulting Group

Shannon L. Harr, CIM, EdD

Director Research Integrity and Compliance Morehead State University

Susan Brown Trinidad, MA

Research Scientist Department of Bioethics and Humanities University of Washington

POSTER ABSTRACT SUBCOMMITTEE Co-Chairs

Members

Susan S. Fish, PharmD, MPH

Hila F. Berger, MPH, CIP

Professor Biostatistics and Epidemiology Boston University School of Public Health

Nancy A. Olson, JD

Director Human Research Office and IRBs University of Mississippi Medical Center

Research Compliance Administrator Montclair State University

Stacey A. Donnelly, MPA Director, Sponsored Research Broad Institute

Patricia A. MacCubbin, MS President and CEO Research Ethics Group

Okyere “Boat” Boateng, MSc, MHSc Samantha M. Ferrante, MS, CIP Cynthia R. Pearson, PhD IRB Chair Noguchi Memorial Institute for Medical Research

Warren Capell, MD

IRB Analyst II Children’s Hospital of Philadelphia

Karen N. Hale, RPh, MPH, CIP

Neha Kaul, MS, MA, MPH

Susan Corl, MSW, MPH, CIP, CCRP Director Education and QI Specialist Boston Children’s Hospital

Human Subjects Administration New York Medical College

Michele Kennett, JD, RN, CIP Assistant Vice Chancellor for Research University of Missouri Columbia

Director of Research Policy and Methods; Assistant Professor University of Washington

Lauren B. Solberg, JD, MTS Assistant Professor Program in Bioethics, Law, and Medical Professionalism University of Florida College of Medicine

Holly A. Taylor, PhD, MPH

Associate Professor Berman Institute of Bioethics Johns Hopkins Bloomberg School of Public Health

Cheryl A. Savini, CIP Principal, COO HRP Consulting Group, Inc. Alan Teller

Assistant Director of IRB Operations Columbia University

Ilene Frances Wilets, PhD, CIP Executive Director, IRB New York State Pyschiatric Institute

Rachel Zand, PhD

Director Office of Research Ethics University of Toronto

Pre-Function Hall C See schedule for room locations Boylston Hallway, Level Two

Saturday, November 14 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Boston, MA

November 12-15

Sunday, November 15 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

PRIM&R’s 2015 Advancing Ethical Research Conference

Friday, November 13 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •