CONFERENCE INFORMATION Welcome from PRIM&R’s Executive Director Welcome from the Conference Co-Chairs Announcements ARENA Legacy Award Continuing Education SCHEDULES Your Guide to the Tracks and Conference Schedule Schedule: November 12
22 24
FACULTY Faculty List Keynote and Plenary Biographies
25 27 28 29 30
ABOUT PRIM&R Board of Directors Staff Thanks to Committee Members CIP® In Memoriam
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MAPS
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NOTES
about PRIM&R
Common Abbreviations and Acronyms AAALAC Association for Assessment and Accreditation of Laboratory Animal Care International AER Advancing Ethical Research Conference
CIP® Certified IRB Professional DHHS Department of Health and Human Services FDA US Food and Drug Administration
NPRM Notice of Proposed Rulemaking OHRP Office for Human Research Protections ORI Office of Research Integrity PRIM&R Public Responsibility in Medicine and Research QA Quality Assurance
maps
ARENA Applied Research Ethics National Association, PRIM&R’s Former Membership Division
faculty
10 11
schedule
2 3 4 7 8
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Contents
QI Quality Improvement
IRB Institutional Review Board
SACHRP Secretary’s Advisory Committee on Human Research Protections
NIH National Institutes of Health
SBER Social, Behavioral, and Educational Research
NSF National Science Foundation
notes
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conference information
Welcome from PRIM&R’s Executive Director Dear Friends, Thank you for joining us at PRIM&R’s 2015 SBER Conference. My colleagues and I are pleased to welcome you to our hometown of Boston for this opportunity to learn, share, and connect around our common goal of advancing the highest ethical standards in social and behavioral science research with human subjects. This is a special meeting for us, since it only happens once every four years. And this year’s meeting comes at an especially interesting and exciting time for the social and behavioral sciences. The release this fall of the longawaited NPRM represents the first possible changes to the Common Rule since it was published in 1991. As you know, many of the changes are intended to respond to concerns that the protections provided by the current regulations are not appropriately tailored to social science and behavioral research methodologies and technologies.
Jeffery Rodamar, Julie Simpson, and Matthew D. Stafford. We couldn’t have asked for more thoughtful and dedicated stewards of the planning process.
You also know that those methodologies and technologies are themselves changing rapidly—the internet, mobile devices, social media, and now smartphone apps and wearable devices are increasingly the tools of choice for much research on individual and social behavior, raising new and complicated questions about privacy and anonymity, risk, and consent. Disciplinary boundaries are also stretching and blurring: the expanding use of field studies in political science and economics raises difficult questions about deception and consent. And social and behavioral IRBs are increasingly required to be familiar with traditionally biomedical research tools, such as functional MRIs, EKGs, and biospecimens.
Finally, thank you for being here and demonstrating your commitment to advancing ethical research. Over the next few hours (or days, if you’ll be staying on for our 2015 Advancing Ethical Research Conference, beginning tomorrow), you’ll have the opportunity to attend thoughtprovoking and hands-on sessions, 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 the conference evaluation.
So this is the perfect time for us to gather and begin to make sense of it all. As you will see in the pages that follow, this year’s conference examines all of these emerging topics, as well as ethical issues and best practices around research in schools and universities, qualitative research, IRB operations and documentation, exempt and expedited categories of review, international research, and much more. Such content diversity wouldn’t be possible without the partners, volunteers, and professionals who contributed to this endeavor. I want to thank our planning committee who worked to craft this exceptional program, under the capable leadership of co-chairs Elizabeth A. Buchanan, and Jeffrey M. Cohen. They were joined by Katherine Lerner, Sangeeta Panicker,
Thanks, too, to our 50 faculty, who will provide you with the most current information, the newest and best practices, and their professional expertise and wisdom, so 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.
Before I close, I want to mention a second reason this year’s meeting is special, one that’s much more personal. This is my first SBER Conference as PRIM&R’s executive director. I was honored to take the helm in April, 2014, and embraced the opportunity to serve PRIM&R’s extraordinary and diverse community. I’ve spent a lot of my time since then listening to members of our community. This will be my first occasion to hear from many of you, so I look forward to meeting you, and to learning about how PRIM&R can continue to support the social and behavioral science community. 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 SBER Conference and to Boston – PRIM&R’s hometown. As your conference co-chairs, we are pleased you’re here to take part in an exciting conference schedule—at an exciting time in our field—developed by this year’s Planning Committee with your input.
Held once every four years since 2007, PRIM&R is proud to host this meeting, which focuses solely on the ethical and regulatory aspects of behavioral and social science research. We are confident this one-day conference will provide you many opportunities to examine the ongoing challenges inherent in reviewing and conducting socially sensitive research, as it will afford our community the chance to explore the critical ethical issues raised by SBER in a focused and intimate environment. Developing the schedule for this conference involved the time and expertise of the Planning Committee, seven volunteers (see the list on the inside front cover of this guide) who worked to develop a roster of relevant topics and accompanying speakers. The Planning Committee looked at where the field has been and where it’s going to create a schedule we believe is both informative and engaging. Highlights of this year’s meeting include: our keynote speaker, Ivor A. Pritchard, PhD, senior advisor to the director, OHRP, who will discuss how behavioral research has and has not changed over the last 40 years, what the ethical implications are, how the NPRM could alter requirements for behavioral research compared to the existing rule, and what requirements would stay the same. In addition, we will host a high-level plenary session devoted to emerging areas of SBER. This panel will begin with a conceptual discussion of privacy in research, then the audience will hear from speakers working in the fields of social media and mobile health. Given the increase in public awareness, the challenges and opportunities within SBER, and the myriad ethical issues that accompany certain types of research (such as social media, mHealth, big data, and
ubiquitous computing), academic and research institutions, IRBs, and investigators are changing the ways they think about research in general and their roles in the research enterprise. We feel this session will assist with that effort. Finally, there are 24 breakout sessions on a broad variety of topics related to human subjects protections and best practices in SBER. The sessions are divided into four thematic tracks that will help you navigate the session topics: Advanced (for those who have been in the field for some time and are looking for their next level of learning), Basic (for those new to the field or in need of a refresher), Innovations (sessions on new and emerging techniques and trends in SBER), and Potpourri (sessions that are on novel, complex, or timely topics). Many thanks are owed to all those who contributed topics, time, and talent to this year’s meeting. It is a more robust schedule because of your generosity. Welcome, again, to the 2015 SBER Conference. We are confident that 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, Elizabeth A. Buchanan, PhD Endowed Chair in Ethics; Director, Center for Applied Ethics, University of Wisconsin Stout Jeffrey M. Cohen, PhD Chief Executive Officer, HRP Consulting Group, Inc.
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Welcome from the Co-Chairs
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Announcements Certificate of Attendance
A certificate of attendance for the 2015 SBER Conference will be provided to attendees who complete the online conference evaluation sent on November 12. 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.
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.
Courtesy Reminder
As a courtesy to speakers and other attendees, please turn off or silence all cell phones and electronic devices during sessions.
Lost and Found
To inquire about a lost item or report a found item, please call the Hynes Public Safety Command Center at 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 in the Registration Area.
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).
Networking Ribbons
First-Time Attendees
Please help us welcome first-time attendees! You can recognize them by the rainbow-colored ribbons attached to their name badges.
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.
Guest Services Associates (Red Coats)
Nursing Mothers
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 can be easily distinguished by their red blazers and are stationed throughout the facility.
Help Us Improve
Our goal is to make each SBER 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 evaluation, which will be emailed to you at the end of the day. Thank you in advance for your feedback.
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.
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 in the Registration Area to obtain access to this room.
Onsite Photography
A professional photographer will be onsite to capture images from this event as part of PRIM&R’s efforts to create an enduring photo archive. We hope you are willing to be a part of it. 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.
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. p rim&r’ s 20 1 5 s o ci al, b e h av i o ral, an d e d u c at i ona l r e s e a rc h c on f e r e n c e
We’re doing our best to make the 2015 SBER 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, 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 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
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 booth where you can get a copy of your personalized conference schedule (i.e., the list of sessions you registered for) if you didn’t bring that information with you. Please note that if you’re staying on for the 2015 Advancing Ethical Research Conference (AER15) on November 13-15, you do not need to register again. You will be given everything for both conferences when you check in. 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 a room for your convenience. Please visit the Help Desk in the Registration Area to obtain access to this room.
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.
In the interest of promoting learning for all participants when asking questions or 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.
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PRIM&R’s “Green” Initiatives
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Announcements Session Materials To access session materials using the interactive schedule: 1. Visit bit.ly/sber15schedule. 2. Locate 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, 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). Please check the interactive schedule onsite and after the meeting, 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. (See schedule for which sessions will be recorded).
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 from 9:00 AM to 5:00 PM on November 12-15.
Special Meal Tickets
If you indicated a specific dietary request as part of your registration, you should have received a special meal ticket 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 a special meal ticket, or you forgot to include a dietary request during registration, please visit the PRIM&R Help Desk in the Registration Area.
Wireless Internet
Want to check email or review the conference handouts electronically? Connect wirelessly to the Hynes Center Wi-Fi: simply open your wireless network connection on any device and click on “Hynes Wireless Network.” No password is required.
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
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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 during the AER Conference on November 14 at 8:00 AM in the Veterans Auditorium at the Hynes Convention Center.
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2015 ARENA Legacy Award
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Continuing Education Certificate of Attendance
A certificate of attendance for the 2015 SBER Conference will be distributed upon completion of the online conference evaluation, which will be sent electronically on November 12. The certificate of attendance is useful for obtaining continuing education (CE) credits from various professional associations.
CE Credits
Attendees of the conference can earn up to 8.75 hours of CE credit. 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 the 2015 SBER Conference may be used for CE.
CIP® Recertification
Credit hours from the 2015 SBER Conference may be used by CIPs who are eligible to recertify by CE. Sessions that meet CIP® recertification requirements are designated with a on the conference schedule. The conference is eligible for up to 8.75 credits that are accredited or have received advance recognition from the Council for Certification of IRB Professionals.
PRIM&R members enjoy a discount on all job postings.
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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.
Follow us on Twitter
@primrconnect twitter.com/primrconnect
facebook.com/primrconnect
Use hashtag
#SBER15
linkedin.com/company/prim&r
#SBER15 primr.org/blog
irbforum.org
Share your thoughts, comments, opinions, questions, n ove m b e r 12, b os t on , m a and pictures.
Your Guide to the Conference Schedule and Tracks
schedule
The 2015 SBER 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 four thematic “tracks” (see below). 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). We advise you to use the track descriptors below and the session descriptors in the conference schedule to identify the sessions that are most relevant to you.
SBER Conference tracks: TRACKS
DESCRIPTORS
Advanced Track
This track will cover advanced issues related SBER. Advanced sessions a) 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 b) 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.
2
Basic Track
This track will cover basic issues related to SBER. Basic sessions provide an introduction to the topic for those who have little or no prior knowledge of it. Teaching styles will be largely didactic, and the 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.
3
Innovations Track
This track consists of sessions addressing a variety of issues related to SBER that are emerging or that feature programs and processes that are innovative in their approach to addressing SBER related issues.
4
Potpourri Track
This track includes a variety of sessions that are current, complex, and/or late breaking.
1
ICON KEY Indicates a didactic session (lecture-based)
Indicates session will be recorded for Conference Proceedings
Indicates a workshop (interactive)
Qualifies for CIP® recertification credit
Indicates a double session (hybrid workshop/ didactic sessions)
Pre-registration required. Please visit the Help Desk to inquire about availability.
ouble sessions are held over lunch and include a boxed D meal. Attendees should pick this up at the session room before the session starts. Please note pre-registration 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/meals are available.
Indicates a session chosen from our Call for Session Proposals
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Thursday, November 12 Thursday, November 12
7:00 AM
Pre-Function Hall C on Level Two
Registration Opens
8:00-8:15 AM
Ballroom B
Welcome from the 2015 SBER Conference Co-Chairs Elizabeth A. Buchanan, PhD, Jeffrey M. Cohen, PhD
8:15-9:00 AM
Ballroom B
Keynote Address: Regulating Behavioral Research Behavior: Back to the Future? Ivor A. Pritchard, PhD, Senior Advisor to the Director, OHRP
9:00-9:15 AM
Break
9:15-10:30 AM
Didactic Sessions and Workshops Series A
A1
Room 304
schedule
Breakfast on your own.
Strategies to Assess and Mitigate SBER Risk: Collaborative Learning Through Case Studies (Advanced Track)
Jennifer H. Campbell, Cynthia J. Monahan Through a collection of SBER case studies, attendees will identify, examine, and explore IRB strategies to address and mitigate SBER risk based on IRB review criteria such as: study procedures, population, risk/benefit, harm, confidentiality, etc. The cases raise important and difficult ethical issues connected with planning, reviewing, or conducting SBER. During this session, faculty and attendees will: • Review how research that does not necessarily pose risk of physical harm can pose other harms (e.g., psychosocial, legal, psychological, data protection) and how this can challenge researchers and IRBs with respect to how they identify and assess risk • Identify and examine the ethical and practical issues surrounding risk to subjects when designing and implementing SBER protocols • Explore IRB and researcher strategies to identify, assess, mitigate, and manage SBER risks
A2
Room 312
Changing Concepts of Anonymity, Confidentiality, and Privacy in SBER (Advanced Track)
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 in SBER • Clarify the distinct and overlapping roles that Information Technology, the IRB, and researchers share in the common enterprise of data security • Review research and IRB best practices for ensuring anonymity, confidentiality, and privacy in SBER
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Schedule Recognition Conference Information A3
Room 302
You’ll Know It When You See It: Defining “Human Subjects Research” Under the DHHS Regulations (Basic Track)
schedule
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: • Define a process and a set of criteria for determining whether an activity is research according to the federal regulations • Explore key decision points for determining whether or not a research study involves human subjects according to the federal regulations • Discuss proposed changes to the Common Rule’s definitions for “research” and “human subjects”
A4
Room 313
What You Need to Know About Privacy and Confidentiality (Basic Track)
Brenda Curtis, Andrew Hedrick During this session, faculty and attendees will: • Explore the question of public vs. private behavior, including what counts as a reasonable expectation of privacy • Outline identifiable vs. anonymous participation and data • Discuss the tension between public recognition of research participation and de-identification of results to ensure participants are not individually identifiable • Examine the adequacy of confidentiality protections and procedures designed to avoid or minimize privacy invasion • Review how to create and implement a data security plan
A5
Room 306
What Did We Learn from the Facebook Emotional Contagion Study? (Innovations Track)
Elizabeth A. Buchanan, Jeffrey T. Hancock This session will provide an in-depth discussion of the Facebook Emotional Contagion study, including study design, methodological and ethical considerations, and the role of the IRB. The complexities of the case and a discussion of the backlash will be shared. During this session, faculty will: • Describe the methods and procedures used in the Facebook Emotional Contagion study • Explore the complexities of academic-industry research from the IRB perspective • Offer strategies for innovative IRB review of social media research
A6
Room 311
Flexibility and Innovations in SBER IRB Review Procedures (Innovations Track)
Jeffrey M. Cohen, Susan L. Rose This session will describe the ways in which “unchecking the box” provides optimal flexibilities for researchers while still protecting research participants. It will explore such issues as multi-year approvals and expanded exemption categories for non-federally funded, minimal risk research. During this session, faculty will: • Define what it means to “uncheck the box” • Review how to implement flexibilities once the box is “unchecked” • Offer guidance for SBER researchers and IRBs on using the flexibilities
A7
Room 310
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Thursday, November 12
“Innocents Abroad?”: SBER in International Settings (Potpourri Track)
A8
Room 309
Action/Practitioner/Teacher Research: Issues for IRBs (Potpourri Track)
Matthew J. Welch What is action/practitioner/teacher research and why does it present issues for some IRBs? In this session, participants will learn about the factors that create misunderstandings and challenges for IRBs and action researchers during the review process of such studies. These include, but are not limited to: deciding whether the activity is research, the vagaries of conducting research in natural settings, the potential for role conflict presented to practitioners, informed consent, and assessing risk. During this session, faculty and attendees will: • Review the fundamentals of action/practitioner/teacher research • Explore whether the proposed action/practitioner/teacher research requires IRB review • Discuss the ethical challenges action/practitioner/teacher research projects present for IRBs and practitioners
10:30-11:00 AM Boylston Hallway, Level Three
Break
Join us for coffee. 11:00 AM-12:15 PM Didactic B1
Sessions and Workshops Series B
Room 302
SBER and Vulnerable Populations (Advanced Track)
Ashley D. Hicks, Lara N. Sloboda This session will explore the concept of “vulnerability” in research. The regulations (subparts) identify three specific populations as “vulnerable,” and call for additional protections (e.g., full review, prohibition of waivers of informed consent) for research with these populations. The IRB Guidebook refers to other “special classes of subjects” – commonly translated as other “vulnerable” populations, including the cognitively impaired, students, employees, pregnant women, traumatized and comatose patients, terminally ill patients, and minorities, with no guidance on how and when the term applies to these populations. The characterization of certain populations as potentially “vulnerable” has a significant impact on research. Thus, this session will focus on those populations that are considered “special” or “vulnerable,” but are not covered by the present subparts including: (1) the way it is used within the current regulatory framework; (2) the ethical implications of its usage; and (3) its impact on SBER. During this session, faculty will: • Review what it means to label a person or group vulnerable • Discuss the issues that arise when using the same manipulations or interventions with “vulnerable” and “non-vulnerable” populations • Address how vulnerability and level of risk intersect • Outline what vulnerability means when the research involves only minimal risk
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schedule
David A. Borasky, Matthew D. Stafford Conducting research outside the borders of the US can present a variety of issues for researchers. This session will address what IRBs should consider with respect to some of these issues, including differing cultural norms, community authorizations to conduct research, community consultation, contextual risks, and creating an IRB where there isn’t one. During this session, faculty will: • Compare regulations and cultural norms in different countries, and identify general and local resources on regulations and cultural considerations in research • Outline US regulations for waivers of consent and assent and documentation thereof • Discuss the cultural need for non-participant authorization to conduct research • Review culturally sensitive/specific risk assessments, including dangerous situations (e.g., drug lords, blood diamonds) • Share about the challenges of students conducting research abroad
Schedule Recognition Conference Information B2
Room 304
Speed it Up: Exempt, Expedite, Relax! (Basic Track)
schedule
Kristina 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 this decision Please note this is a double session and will end at 1:45 PM. Please get your lunch outside the session room before the session begins.
B3
Room 306
Essential Documentation for SBER IRBs: IRB Membership, Recordkeeping, Meeting Minutes, and More (Basic 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 and attendees 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
B4
Room 313
Certificates of Confidentiality (CoCs) (Basic Track)
Ann Hardy, Julia Hesse, Leslie Wolf A CoC is 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 this document offers. During this session, faculty and attendees will: • Review the scope of legal protection and privilege afforded to researchers under a CoC, including a review of the applicable regulations and federal guidance • Discuss the considerations around when it would be prudent to obtain a CoC and how to avoid potential pitfalls when applying for and implementing one • Address the implications for informed consent and how a CoC interfaces with other protective laws and possible disclosures • Outline how a CoC interfaces with state mandatory reporting laws • Discuss National Institute of Justice Privacy Certificates and how they differ from CoCs, especially with regard to reporting of abuse • Share strategies for defending a CoC if challenged and alternatives to CoCs Please note this is a double session and will end at 1:45 PM. Please get your lunch outside the session room before the session begins.
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Thursday, November 12 B5
Room 310
Informed Consent in Field Studies (Innovations Track)
B6
Room 312 onducting Research on Campus C
(Innovations Track)
Andrea Rossing McDowell, Jeffery W. Rodamar, Julie F. Simpson There is a lot of research that takes place on university/college campuses where students are the subjects. Further, many institutions have established research pools of introductory-level students to participate in research studies and other projects for credit. This session will review applicable regulatory and ethical standards, as well as the specific issues that are raised when reviewing research in which college students on campuses are the subjects, and where they may serve as investigators or study staff. During this session, faculty and attendees will: • Distinguish research from common non-research projects that take place on university/college campuses • Review and discuss the operation and use of subject pools in research, especially data security and selection bias • Identify and discuss ethical issues that such studies raise, including mandatory reporting, instructors conducting research using students enrolled in their classes, and use of extra credit as an incentive • Discuss ethical and regulatory justifications for waiver of parental permission for minor-aged college students, including jurisdictions where majority age is not 18 • Outline the roles and accountability of students as principal investigators (especially undergraduates) and as research personnel B7
Room 309
SBER IRBs at Biomedical Institutions (Potpourri Track)
Scott B. Cantor, Sara L. Harnish, Mary A. O’Connor This session will address the issues and challenges of working on an SBER IRB at a biomedical institution. During this session, faculty will: • Outline the issues and challenges that IRBs at biomedical institutions face when reviewing SBER studies • Provide insight on the knowledge and expertise needed to handle issues and challenges posed by SBER research • Share strategies for addressing ethical and regulatory issues specific to various kinds of SBER projects and suggestions for managing them
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schedule
Rebecca D. Armstrong, Jeremy Johnson, Cynthia S. Shindledecker The use of field experiments in social science has rapidly expanded in fields that traditionally were not heavily involved in human subjects research on a large scale, including political science and economics. Difficult issues related to consent and deception often arises in carrying out these field experiments. Field experiment sample sizes can be in the thousands of people, sometimes in the millions. Is consent feasible in field experiments and, if deception is used, when is debriefing feasible? What types of research interventions are appropriate in sensitive situations such as election campaigns or situations where individuals are making decisions about how to invest money? During this session, faculty will: • Share strategies for obtaining consent in field experiments, including potentially involving entire communities in consideration of research before it is undertaken • Discuss when a waiver of consent and the use of deception are appropriate for field experiments, and when is debriefing feasible • Explore appropriate types of research interventions that can be used in particularly sensitive settings, such as elections or studies of investment decisions
Schedule Recognition Conference Information B8
Room 311
schedule
A Dialogue with OHRP on SBER Issues (Potpourri Track)
Julie Kaneshiro, Ivor A. Pritchard This session will be led by representatives from OHRP. Attendees are encouraged to come with questions of interest related to SBER IRB work. During this session, attendees will: •H ear from OHRP representatives about the NPRM, evolving initiatives, issues, and guidance on SBER issues • Participate in an open discussion about topics relevant to OHRP stakeholders, including the NPRM • Ask questions of OHRP representatives
12:30-1:45 PM
Ballroom A
12:30-1:45 PM
Room 312
Networking Lunch
Lunch Session: It’s Here! A Review of the NPRM (Basic Track)
John R. Baumann, PhD, Kate Gallin Heffernan, JD, Andrew Rusczek, JD 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
2:00-3:30 PM
Ballroom B
Plenary Session: Emerging Areas in SBER Moderator: Camille Nebeker
Panelists: Solon Barocas, Jeffrey T. Hancock, Stephen S. Intille It’s been a remarkable year for SBER – from the Facebook Emotional Contagion study to the Montana Voter study and fabricated gay marriage opinion study, there is no shortage of research ethics issues on the front pages. There’s an increase in public awareness and concern around SBER and the issues that accompany these forms of research. Social media, mobile health (mHealth), big data, and ubiquitous computing are changing the ways in which the public, academic and research institutions, IRBs, and researchers think about research in general and their roles in research. SBER is also flourishing from the blurring of disciplinary boundaries and methodologies. With this, we see changes to privacy, consent, jurisdiction, and other critical areas of the research domain. This session will begin with a conceptual discussion on privacy in research and the audience will then hear from those working within the fields of social media and mHealth. In these discussions, panelists will explore how SBER IRBs are dealing with these new domains and methods of research, while exploring the mashing of ethical issues that were typical of one area (e.g., deception in social psychology) with emerging areas (e.g., potential physical risks in using what was/is considered biomedical procedures).
3:30-3:45 PM
Boylston Hallway, Level Three
Break
Join us for coffee and cold beverages.
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Thursday, November 12 3:45-5:00 PM
Didactic Sessions and Workshops Series C
C1
Room 302
To Exempt or Not to Exempt (Advanced Track)
C2
Room 306
C3
Mandatory Reporting (Advanced Track)
Katie M. Edwards, Sharyn J. Potter, Andrew P. Rusczek Mandatory reporting requirements (federal, state, local/institutional) may present methodological and ethical issues for IRBs and researchers. During this session, faculty will: • Identify the legal aspects of mandatory reporting, such as who is and is not required to report, implications of not reporting (e.g., duty of a citizen), and the legal definitions of “reporter” (e.g., all psychologists or only clinicians) • Review common federal mandatory reporting requirements that researchers face, as well as survey state requirements • Discuss the intersection of mandatory reporting laws with Certificates of Confidentiality and National Institute of Justice Privacy Certificates • Discuss how mandatory reporting applies to research done outside the state/country of the researcher’s institution • Explore how mandatory reporting may impact study design • Outline mandatory reporting considerations for informed consent Room 309
The What, Why, When, and How of Informed Consent (Basic Track)
Elizabeth A. Buchanan, Irene E. Stith-Coleman In this session, faculty will: • Explore the regulatory requirements for obtaining informed consent • Review the various waivers and alterations of consent available under the regulations • Discuss challenging issues related to use of “opt-out” procedure, minor assent, and short forms • Address challenges related to consent with various vulnerable populations, including situations where individuals may lack the capacity to consent
C4
Room 311
Fundamental Issues in Qualitative Research (Basic Track)
Julie F. Simpson, Matthew D. Stafford During this session, faculty will: • Review the types of research methods used in qualitative research • Discuss strategies for assessing scientific merit and generalizability in qualitative research • Outline challenges to obtaining informed consent in qualitative research • Identify risks to subjects and affected populations in qualitative research
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schedule
Jeffrey M. Cohen, Cheryl A. Savini The regulations regarding the exemptions only state that research in the attached list of categories is exempt. They do not provide guidance on how to do that determination. OHRP has provided some guidance on making exemption determinations, but institutions still face many decisions when developing policies and procedures for exemption determinations. This session will focus on the issues involved in making exemption determinations rather than on the exempt categories of research. During this session, faculty will: • Define who should make exemption determinations • Review how to document exemption determinations • Provide a discussion on continuing review of exemption determinations • Outline other ethical issues to be considered in making exemption determinations
Schedule Recognition Conference Information C5
Room 310
School Rules! Conducting Research in Elementary and Secondary Public Schools (Basic Track)
schedule
Eric Allen, Fanny K. Ennever, Jeffery W. Rodamar, Shannon Sewards This session will cover the regulatory requirements for protecting confidentiality of students’ academic records and 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: • Review 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 • Discuss waivers and alterations of assent/consent/permission standards as they apply in schools with low parent involvement • Explore opt out parental permission as an alteration of the consent process in non-exempt research, and analyze how opt out research methodology may or may not meet the four criteria for waiver/alteration of the consent process • Share strategies for developing relationships with local school districts for ongoing research activity presence • Outline considerations for regulatory oversight of distance learning beyond exemption category 1
C6
Room 304
Panel Follow-Up: What Do We Need to Do With This? Reviewing SBER Studies that Involve Emerging Methods and Technologies (Innovations Track)
Solon Barocas, Stephen S. Intille, Katherine Lerner, Camille Nebeker This session will explore SBER review of studies involving emerging methods and technologies, and the ethical issues that emerge in such multidisciplinary research. For example, psychology studies are increasingly using fMRIs, EKGs, EEGs, eye tracking technology, biospecimens, smart phones, etc. These innovations pose challenges for SBER IRBs that may not be accustomed to evaluating these methods and technologies, including dealing with sensitive data, incidental findings, and timely review and reporting. During this session, faculty and attendees will: • Understand the challenges that use of traditional and emerging technologies in research studies present for SBER IRBs • Review FDA regulations with which SBER IRBs may need to become familiar with in reviewing these studies • Discuss guidelines and considerations for studies that include a genetics component • Identify best practices for SBER IRBs when reviewing such studies
C7
Room 312
The Internet and the IRB: A Review of Human Subjects Issues in Technology-Based Research (Innovations Track)
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 (e.g., GPS). 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: • Review human subjects research that uses TBIs and the specific challenges this presents for privacy and confidentiality, informed consent, and validity of data collected • Share 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
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C8
Room 313
5:30-6:00 PM
Kip M. Kantelo, Alison S. Orkin Imagine your IRB is presented a study that involves risky, sensitive, controversial, politically-unpopular, and/or confrontational research. Even if the proposed study has the potential to generate valuable new knowledge, the resultant public relations could be harmful to the institution. This session will look at the issues IRBs must consider when reviewing an application for the use of human subjects, as well as other considerations or institutional pressures that research “on the edge” may present. During this session, faculty and attendees will: • Review the criteria for approving research projects involving human subjects • Identify issues that could potentially present concerns when reviewing studies, and evaluate them vis-a-vis the regulatory framework • Explore ways to address the issues these types of studies raise • Discuss how the IRB fits into the institutional context of “research on the edge” Boylston Hallway, Level Three
2015 SBER Conference Networking Reception
Join us to celebrate the 2015 SBER Conference and your involvement in this event and to network with your colleagues. Light refreshments will be served. Room 305
Demonstration of PRIM&R’s Knowledge Center
Join us 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, email Maeve Luthin, professional development manager, at mluthin@primr.org to set-up a one-on-one demonstration of this resource.
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schedule
5:00-6:00 PM
Research on the Edge (Potpourri Track)
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.
Write. Comment. Share. Research ethics commentary and news Event recaps
www.primr.org/blog
Helpful tips Interviews with the PRIM&R community
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.
Faculty List Recognition Conference Information A
Eric Allen, MLS, CIP, CPIA Associate Director for Consulting Services, HRP Consulting Group, Inc. C5. Rebecca D. Armstrong, DVM, PhD Director, Research Subject Protection, University of California, Berkeley. B5.
B
Solon Barocas, PhD, MSc Postdoctoral Research Associate, Center for Information Technology Policy, Princeton University Panel. C6. John R. Baumann PhD Assistant Vice President Research Compliance, Indiana University. NPRM Lunch. David A. Borasky, MPH, CIP Vice President, Quality Management, Copernicus Group IRB. A7. Kristina C. Borror, PhD Director, Division of Compliance Oversight, OHRP. B2. Scott Bradner Senior Technical Consultant, Office of the Chief Technology Officer, Harvard University. A2. Elizabeth A. Buchanan, PhD Endowed Chair of Ethics; Director, Center for Applied Ethics, University of Wisconsin Stout. A5, C3.
C faculty
Jennifer H. Campbell, PhD Manager of Research Integrity and Compliance, The Fenway Institute at Fenway Community Health. A1. Scott B. Cantor, PhD Professor, Department of Health Services Research, The University of Texas MD Anderson Cancer Center. B7. Jeffrey M. Cohen, PhD Chief Executive Officer, HRP Consulting Group, Inc. A6, B2, C1. Brenda Curtis, PhD, MSPH Research Associate, Department of Psychiatry - Addictions, University of Pennsylvania School of Medicine. A4, C7.
D
Janet C. Donnelly, RAC, CIP Policy Analyst, Office of Good Clinical Practice, FDA. B3.
E
Katie M. Edwards, PhD Assistant Professor, University of New Hampshire. C2. Fanny K. Ennever, PhD Senior IRB Administrator, Committee on the Use of Human Subjects, Harvard University. C5
F
Michelle Feige, MSW, LCSW-C Executive Vice President, Association for the Accreditation of Human Research Protection Programs, Inc. B3.
G
Dean R. Gallant, AB Consultant, HRP Consulting Group, Inc. A2, B2. Julia Gayle Gorey, JD Public Health Analyst, OHRP. B3.
H
Jeffrey T. Hancock, PhD Professor, Department of Communication, Stanford University. A5, Panel. Ann Hardy, DrPH Extramural Human Research Protection Officer, NIH. B4. Sara L. Harnish, JD Associate Director for Non-Clinical Research, Office for Human Research Studies, Dana-Farber Cancer Institute. B7. Andrew Hedrick, MPA Social/Behavioral/Educational IRB Coordinator, University of Kentucky. A4. Katherine Gallin Heffernan, JD Counsel, Verrill Dana LLP. NPRM Lunch Julia Hesse, JD, M. Bioethics Partner, Choate, Hall & Stewart LLP. B4. Ashley D. Hicks, CIP IRB Analyst, Tufts University. B1.
I
Stephen S. Intille, PhD Associate Professor, College of Computer and Information Science and Bouvé College of Health Sciences, Northeastern University. Panel, C6.
J
Jeremy Johnson, PhD Associate Professor of Political Science, Carroll College. B5.
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K
Julie Kaneshiro, MA Deputy Director, OHRP. A3, B8 Kip M. Kantelo, CIP Director, Office of the Human Research Protection Program, University of California, Los Angeles. C8.
L
Katherine Lerner, JD, CIP Associate Director, Ethics, Education, Policy, and Compliance, Social and Behavioral Sciences IRB, University of Chicago. C6.
M
Andrea Rossing McDowell, PhD IRB Administrator; Visiting Assistant Professor of Russian/Soviet Literature, Seattle University. B6. Cynthia J. Monahan, MBA, CIP IRB Director, Boston University. A1.
N
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, C6.
O P
Sharyn J. Potter, PhD, MPH Co-Director, Prevention Innovations Research Center; Associate Professor of Sociology, University of New Hampshire. C2 Ivor A. Pritchard, PhD Senior Advisor to the Director, OHRP. Keynote, B8.
R
Jeffery W. Rodamar Institute for Social Research (former); US Congress (former); US Department of Education (current). B6, C5. Susan L. Rose, PhD Executive Director, Office for Protection of Research Subjects, University of Southern California. A6. Abby E. Rudolph Research Scientist, The Calverton Center, Pacific Institute for Research and Evaluation. C7. Andrew P. Rusczek, JD, M. Bioethics Counsel, Verrill Dana LLP. C2, NPRM Lunch.
S
Cheryl A. Savini, CIP Principal, Chief Operating Officer, HRP Consulting Group, Inc. C1 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. A3, B3. Shannon Sewards, MA, CIP Director of IRB Administration, Committee on the Use of Human Subjects, Harvard University. C5. Cynthia S. Shindledecker, CIP Director, Health Sciences and Behavioral Sciences IRB, University of Michigan. B5. Julie F. Simpson, PhD Director, Research Integrity Services, University of New Hampshire. B6, C4. Lara N. Sloboda, PhD IRB Operations Manager, Tufts University. B1. Matthew D. Stafford, MPH Assistant Director, Clinical Research Compliance, Boston Children’s Hospital; Co-Chair, Harvard Catalyst Regulatory Working Group SBER Sub-Committee. A7, C4. Irene E. Stith-Coleman, PhD Director, Division of Policy and Assurances, OHRP. C3
W
Matthew J. Welch, PhD Researcher, American Institute for Research. A8. Leslie E. Wolf, JD, MPH Professor of Law; Director, Center for Law, Health, & Society, Georgia State University College of Law. B4.
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faculty
Mary A. O’Connor, BSN, MS, PhD, RN Assistant Clinical Professor Nursing (Retired), University of Missouri at Kansas City. B7. Alison S. Orkin, CIP Associate Director, Office of the Human Research Protection Program, University of California, Los Angeles. C8.
Plenary and Keynote Biographies Recognition Conference Information
faculty
faculty
Solon Barocas, PhD, MSc, BA, is a postdoctoral research associate at the Center for Information Technology Policy at Princeton University. His research focuses on emerging applications of machine learning and the ethical and epistemological issues they raise. He completed his doctorate in the department of media, culture, and communication at New York University, where he remains an affiliate of the Information Law Institute. Dr. Barocas also works with the Data & Society Research Institute and serves on its NSF-funded Council for Big Data, Ethics, and Society. Jeff T. Hancock, PhD, is a professor in the department of communication at Stanford University. Professor Hancock works on understanding psychological and interpersonal processes in social media. He specializes in using computational linguistics and experiments to understand how the words we use can reveal psychological and social dynamics, such as deception and trust, emotional dynamics, intimacy and relationships, and social support. Recently, Professor Hancock began work on understanding the mental models people have about algorithms in social media, as well as on the ethical issues associated with computational social science. Professor Hancock is well-known for his research on how people use deception with technology, from sending texts and emails to writing fake reviews. His TED Talk on deception has been seen over one million times and he’s been featured as a guest on CBS This Morning for his expertise on social media. His research has been published in over 80 journal articles and conference proceedings, and his lab has been supported by funding from NSF. His work on lying and technology has been frequently featured in the popular press, including in the New York Times, and on CNN, NPR, CBS, and the BBC. Professor Hancock was a customs officer in Canada before earning his PhD in psychology at Dalhousie University. He was a professor of information science and communication at Cornell University prior to joining Stanford University in 2015. Stephen S. Intille, PhD, SM, BSE, is an associate professor in the College of Computer and Information Science and Bouvé College of Health Sciences at Northeastern University. His research focuses on the development of novel healthcare technologies that incorporate ideas from ubiquitous computing, user-interface design, pattern recognition, behavioral science, and preventive medicine. His areas of special interest include technologies for measuring and motivating health-related behaviors, technologies that support healthy aging and wellbeing in the home setting, and mobile technologies that permit longitudinal measurement of health behaviors for research, especially the type, duration, intensity, and location of physical activity. Professor Intille received his PhD from the Massachusetts Institute of Technology (MIT) in 1999, working on computational vision at the MIT Media Laboratory, a master’s degree from MIT in 1994, and a BSE degree in computer science and engineering from the University of Pennsylvania in 1992. He has published research on computational stereo depth recovery, real-time and multi-agent tracking, activity recognition, perceptually based interactive environments, and technology for healthcare. In 2012, after 10 years as technology director of the House_n Research Consortium at MIT, he joined Northeastern University to help establish a new transdisciplinary PhD program in personal health informatics.
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. 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.
p rim&r’ s 20 1 5 2 adv s o cianci al, bng e h av e tii h o cal ral, re ansedaerc d uhc cat on i ona f e r le nrcees e a rc h c on f e r e n c e
faculty
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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
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
Alysa Perry Meeting Planner
Caroline Slymon Executive Coordinator
Elise Davis Membership Assistant
Ashley Savannah Program Coordinator
Meredith Elkins Director of Marketing and Communications
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about PRIM&R
Noelani Alexis Operations Assistant
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
about PRIM&R
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
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
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PRIM&R established the CIP® credential in 1999, and since then, more than 2,600 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. 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 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® at the 2015 AER Conference • 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® Recertification Participation in the 2015 SBER Conference qualifies as continuing education for the purpose of CIP® recertification. A maximum of 8.75 credit hours issued by a recognized accrediting body are available for the 2015 AER Conference.
about PRIM&R
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 here. Facebook and LinkedIn groups of peers are also available for exam preparation assistance, support, and mentoring.
A special thank you to the Council for Certified IRB Professionals (CCIP) PRIM&R would like to thank the current members of the CCIP for their dedication to the program:
Greg Lim Chair
Erica Heath Vice Chair
David Forster
Bambi Grilley
Barbara Bigby
Elizabeth Kipp Campbell
Ross Hickey
Jerry Castellano
Barbara LoDico
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Gary Chadwick
Lori Roesch
Susan Delano
Carla Scioneaux
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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.
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.
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In Memoriam
Remembering Alan P. Wertheimer: A respected leader and compassionate teacher
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.”
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. 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.
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about PRIM&R
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.
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Escalators to up Level Three, down to Plaza and Street Levels
Unattended coat & bag storage
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Registration
Help Desk
Keynote & Plenary Sessions
SBER Networking Lunch
SBER Breakout Sessions, Rooms 302 -312 (see schedule for session room assignments)
Prayer & Mother’s Room: Room 307 (Visit the Help Desk on Level Two for access)
SBER Networking Reception
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NPRM Lunch
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