About PRIM&R by Anne Meade

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PRIM&R creates a synergy much larger than our jobs or even our research institutions. The outcome is priceless.

public responsibility in medicine and research

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40 Years of Connecting and Protecting 20 Park Plaza, Suite 720, Boston, MA 02116 T: 617.423.4112 F: 617.423.1185 www.primr.org

TABLE OF CONTENTS History of PRIM&R

Mission

About PRIM&R

Education

Membership

Professional Development

Public Policy

Additional Initiatives

Contact Information

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The support I have received from PRIM&R over the years has enabled me to handle the challenges I face in my job. I can’t imagine that I’d have made it even half as far without the support network and immense resources provided.

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History of PRIM&R The story of PRIM&R’s (Public Responsibility in Medicine and Research’s) founding starts with a small group of committed and principled individuals who, in 1973, gathered to discuss the future of medical research in Massachusetts. Among the issues that most concerned them was the indictment of four doctors who were conducting fetal research at the Boston City Hospital. A second rallying point was the Controlled Substances Act, a new law that restricted research on psychoactive drugs with persons institutionalized in state hospitals.

promoting ethical behavior. PRIM&R’s first conference on human subjects protections was held in 1977, and the organization was quickly embraced as a place where both the research community and federal regulatory agencies could discuss the evolving research rules. The conferences steadily grew in both size and reputation, and, buoyed by this early success, the Board expanded PRIM&R’s programming to other areas, including institutional animal care and use committees (IACUCs), the ethics of HIV/AIDS research, research with special populations, and the responsible conduct of research.

Not only were local problems on the minds of PRIM&R’s founders, but there was also a keen awareness of new national laws regulating research that had been passed in the wake of the exposé of the United States Public Health Service Syphilis Study at Tuskegee. That abuse, as well as revelations of other ethical violations, led to the passage of the National Research Act in 1974, the same year in which PRIM&R was incorporated. Regulations (45 CFR part 46) governing the protection of human subjects and mandating institutional review boards (IRBs) followed, also in 1974, and the Belmont Report in 1979. Both a field and an organization were born, and the synergies between them have remained strong and constructive.

During these 40 years of protecting and connecting, PRIM&R has become a strong and vibrant learning community that serves the needs of research professionals worldwide. A membership division, the Applied Research Ethics National Association (ARENA), was created in 1985, and provided a professional home for those working with IRBs and IACUCs for the next 25 years, until ARENA membership was fully integrated into PRIM&R as a whole. The 61 individuals who joined in 1985 have given rise to the more than 4,000 members of today, and they are PRIM&R’s lifeblood.

Those working with, or affected by, IRBs were struggling to interpret and apply these new regulatory structures, and PRIM&R’s Board of Directors understood that education was the most effective means of reducing such struggles and of

Some of those who have brought us to this milestone anniversary are pictured in the foldout to the left. To learn more about these individuals, visit www.primr.org/40. We thank them, and each one of you, for supporting PRIM&R’s mission to advance ethical research.

Mission

About PRIM&R

PRIM&R advances the highest

Since its founding in 1974, PRIM&R’s highest priority has been providing those charged with ensuring research protections, as well as those involved in the design and implementation of research protocols, with education, practical tools, and cutting-edge strategies for their careers. Hosting highly acclaimed conferences and short courses on the ethics, regulation, and administration of research are some of the ways PRIM&R achieves this goal.

ethical standards in the conduct of biomedical, behavioral, and social science research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.

PRIM&R’s educational and professional development programs provide balanced, thorough, and accurate information on the full range of issues surrounding research involving human subjects and animals. Those who take advantage of these offerings also benefit from valuable and enduring connections with colleagues who share similar professional pursuits and challenges. www.primr.org

PRIM&R has an active and diverse membership community of more than 4,000 members from more than 30 countries. Members represent a number of professions, including:

›› Human research protection program (HRPP) staff

›› Institutional review board (IRB) members, administrators, chairs, and staff

›› Institutional animal care and use committee (IACUC) members, administrators, chairs, and staff

›› Researchers and research staff ›› Institutional officials ›› Government representatives ›› Research subjects and their advocates ›› Ethicists ›› Policy makers ›› Pharmaceutical, device, biotechnology, and other industry personnel

›› Attorneys ›› Members of the media

Education PRIM&R is widely acknowledged to be the premier educator in the research ethics and oversight field. Whether at in-person meetings or through online learning, PRIM&R’s consistently high-quality programming features respected and experienced teachers who provide participants with the most relevant and reliable information available. PRIM&R events are known to be gatherings in which information and strategies are shared everywhere one looks. Everyone is both a teacher and a learner at PRIM&R, and the organization fosters collaborative relationships between and among those it serves.

Conferences PRIM&R’s annual conferences are the cornerstones of its commitment to advancing the ethical conduct of research, and the PRIM&R community is the cornerstone of these conferences. Attendees from around the globe come together and immerse themselves in lively discussions and debates about everything from best oversight practices to key ethical concepts. As a result of this intensive immersion in learning and networking, participants leave newly energized and better equipped to help their research programs become stronger and more effective. PRIM&R’s conference content reflects and addresses ongoing changes in research and their implications for regulatory and ethical oversight. Those attending PRIM&R meetings have unparalleled access to:

›› Inspiring keynote addresses, thoughtprovoking panels, and hands-on breakout sessions

›› Practical information on the content, interpretation, and implementation of the regulations

›› Solutions for many of the challenges that arise when dealing with highly sensitive research and emerging methodologies, as well as with longstanding ethical, administrative, and compliance issues

›› Abundant networking opportunities with a large and vibrant community known for its supportiveness and professional generosity

›› Conference proceedings consisting of audio and video archives of plenary and keynote presentations www.primr.org/conferences

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When my institution told me that I had to choose just one conference to attend for the year, my choice was easy: I’m going to PRIM&R !

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Regional Meetings

In order to make its educational programming as accessible as possible, PRIM&R regularly hosts Regional Meetings around the United States and beyond its borders. In addition to easing the financial burden of long-distance travel, these gatherings enable attendees to meet with similarly situated professionals in their geographic area.

Courses offered at Regional Meetings may include:

Regional Meetings make experts, ideas, information, and networking readily available, and allow attendees’ concerns—some of which are regionally or institutionally based—to be addressed in a collegial and collaborative environment.

›› IRB Administrator 101: An introduction, or

›› IRB 101sm: A crucial “nuts-and-bolts” program for HRPP/IRB members and staff

›› IRB 201: An In-Depth Analysis of the Criteria for Review: “Next-level” training for HRPP/ IRB members and staff refresher, for IRB administrators that covers the key responsibilities and strategies for navigating the regulatory framework

›› Essentials of IACUC Administration: An examination of the constellation of practices and procedures necessary for the development and maintenance of an effective animal care and use program

›› Collaborating for Compliance: The Role of the Research Team, the IRB, & the Institution: A course that provides tools to help ensure an effective and comprehensive protections process, highlights common compliance pitfalls, and suggests best practices for avoiding them www.primr.org/regionals

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It is difficult to express how much it means to me to attend PRIM&R’s educational events. I always come away feeling like the regulatory requirements have been demystified.

At Your Doorstep For more than 15 years, institutions around the globe have relied on PRIM&R’s At Your Doorstep program to help educate members of their staff and the wider community. At Your Doorstep provides an easy and practical way to ensure that HRPP/IRB staff, chairs, and members, as well as compliance personnel, institutional officials, and researchers, understand and can apply the latest regulations and ethical principles governing research.

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At Your Doorstep courses include:

›› IRB 101sm : A crucial “nuts-and-bolts”

Webinars

program for HRPP/IRB members and staff

PRIM&R’s webinars are a convenient and affordable way for busy professionals to keep up with new developments or brush up on existing regulations and policies.

›› IRB 250 : A course designed for those seeking to deepen their understanding of, and insight into, core topics, and to learn practical strategies for enhancing their institution’s HRPP/IRB operations Offering one or both of these At Your Doorstep courses is an effective way for an institution to deliver continuing education in an economical manner. www.primr.org/AYD

How At Your Doorstep works: ›› The institution chooses IRB 101sm and/or IRB 250. ›› The institution chooses the date and location that is most convenient for hosting the course(s).

Watched from offices, conference rooms, and homes, these 60- or 90-minute sessions are known and valued for delivering clear and comprehensive information on thorny issues, as well as for analyzing late-breaking changes in the field. Respected and dynamic presenters provide participants with the knowledge and skills necessary to strengthen their understanding of key and emerging issues, remain abreast of regulatory updates, and more generally expand their expertise in their respective fields. www.primr.org/webinars

›› Based on the educational goals and learning needs of the audience, PRIM&R selects seasoned faculty members who then work with the institutional liaisons to create a customized offering that addresses topics relevant to the research reviewed and conducted locally. 7

Ethical Research Oversight Course PRIM&R’s Ethical Research Oversight Course (E-ROC) is a thorough, authoritative, and user-friendly way to learn the human subjects protections landscape. E-ROC is geared toward new IRB members and staff, as well as those seeking a refresher on the core principles of research regulations and underlying ethical principles. Simulated IRB meetings and discussions provide a practical and interactive introduction to all aspects of research oversight. www.primr.org/EROC

IRB members who complete E-ROC will be able to:

›› Define the function and purpose of an IRB ›› Apply the ethical principles and regulations that govern human subjects research

›› Utilize these principles and rules when reviewing biomedical, behavioral, and social science protocols

›› Effectively express and explain one’s opinions during an IRB meeting HRPP/IRB staff members who complete E-ROC will be able to:

›› Utilize the tools and strategies described to build and strengthen an effective IRB

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Most regulatory information that surrounds the IRB process clouds the ethical concerns behind the rules. This course removed those clouds. I feel that I am prepared to take on the role of an IRB member after taking the course.

›› Communicate more clearly with investigators and other institutional staff members

›› Find and utilize the resources necessary to stay abreast of regulatory changes The result? Improved knowledge of what is required, why it is required, and what constitutes a best practice.

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Membership Join the thousands of research professionals who, through their membership in PRIM&R, receive invaluable educational, networking, certification, and professional development opportunities. PRIM&R’s diverse and supportive community numbers more than 4,000 members, and brings together individuals from more than 1,000 institutions located in more than 30 countries. Members include those involved in every aspect of biomedical, behavioral, and social science research, and from every setting in which research is conducted. www.primr.org/membership

PRIM&R Membership

Member Benefits

Stay Informed

Members have access to the definitive sources for current information on regulations, ethical principles, and administrative best practices in research via our monthly Newsletter, bi-monthly issues of Research Ethics Digest, and an online Knowledge Center that is continuously updated and augmented.

knowledge center

Connect With Colleagues PRIM&R’s Membership Directory, Mentoring Program, and Regional Connections offer members a variety of ways to engage with, and get help from, a large and talented network of those working in the field.

Enhance Your Career Members can take advantage of a number of benefits designed to help strengthen their skills and thus their workplaces, including comprehensive workload and salary information and an array of volunteer opportunities. Additionally, members receive discounts on all of PRIM&R’s conferences, educational programs, and other initiatives, allowing them to receive essential professional development and workplace resources at an affordable cost. www.primr.org/benefits

The Knowledge Center (KC) is a resource-rich members-only section of PRIM&R’s website. The KC is updated regularly to ensure that members have access to the most current and relevant tools, information, policies, articles, and other wide-ranging materials relating to the ethics, regulation, and administration of both human subjects protections and animal care and use programs. Highlights include: PRIM&R Program Archives: This easily navigable collection of presentations on critical topics from past conferences and webinars, as well as poster abstracts and PRIM&R’s Workload and Salary Surveys, offers an excellent way to gain in-depth knowledge of and perspective on the field. Workplace Tools: For members looking to update and improve their workplace practices, this section of the KC features a searchable database of sample forms, policies, standard operating procedures, templates, and checklists from a variety of institutions and organizations. Historical Cases and Documents: The history of research ethics is still relevant to the field today. This collection of foundational documents and regulations enables users to gain a deeper understanding of the underpinnings of research and research oversight, so as to better comprehend the reasons for the current regulatory structure.

Research Ethics Publications: This repository includes the latest news and articles related to research regulation, administration, and ethics. www.primr.org/knowledgecenter

newsletter PRIM&R’s monthly Newsletter serves as the information hub for for the organization’s members, and offers them an easy way to keep current. This electronic publication includes reliable information about the ever-changing field via regulatory updates, new resources, upcoming events at PRIM&R and elsewhere, and more.

research ethics digest PRIM&R’s Research Ethics Digest (RED), an electronic publication, delivers timely and relevant abstracts and full-text articles from a wide array of scholarly journals to the inboxes of PRIM&R members every two months. Articles featured in RED highlight new research and scholarship related to ethics and regulation that affect—and potentially enhance—daily work.

Selected Regulations and Guidance: The KC’s summary of the core regulations governing the conduct of research with human subjects and animals is an essential guide for members, whether they are new to their work or are seasoned professionals. 11

Connect With Colleagues

Enhance Your Career

membership directory

workload and salary survey

PRIM&R’s online Membership Directory helps members from around the world find one another for consultation, advice, guidance, and any other type of professional support. Members can make productive connections by searching this large, user-friendly database using criteria such as name, region, institution, shared areas of interest, and keywords.

The data collected from PRIM&R’s annual Workload and Salary Survey is compiled into a report that gives members valuable information on workload, staffing patterns, and compensation in the field. The report also includes crucial data for resource management and professional advancement. Two surveys are administered each year, one for professionals working primarily with HRPPs/IRBs, and another for those working primarily with IACUCs.

www.primr.org/memberdirectory

mentoring program Whether members are new to the research oversight world or have experience and advice to share, they have a place in PRIM&R’s Mentoring Program. This service matches those in the early stages of their careers, or those facing work-related challenges, with seasoned professionals who have volunteered to provide ongoing or occasional guidance, depending on the mentee’s needs. www.primr.org/mentor

regional connections Via its Regional Connections program, PRIM&R facilitates the creation of mutually helpful relationships among members in a given geographic area. Many professionals would like to talk, network, and swap ideas and strategies with those who work or live nearby, but don’t have the resources to do so. By making both small grants and a how-to toolkit available, PRIM&R helps those wishing to host a Regional Connections event with planning and funding. Regional Connections programs are customized to include panels, speakers, book groups, or other substantive content.

www.primr.org/WLSS

volunteer opportunities

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PRIM&R has always played an integral role in my career and has given me more than I could ever hope to return in kind. Over the years

PRIM&R members are encouraged to share their knowledge, skills, and experience with others in the community. From contributing to the PRIM&R blog to mentoring a colleague, volunteering gives members the opportunity to make valuable connections, become more involved with the organization, and showcase their talents. www.primr.org/volunteer

PRIM&R has become my professional family and a place where I have been able to develop and maintain life-long friendships. Thank you PRIM&R !

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www.primr.org/regionalconnections

Professional Development

Public Policy

Certification

PRIM&R’s public policy efforts support its mission by tracking and responding to relevant initiatives and regulatory proposals issued by government agencies or national advisory committees. Where appropriate, PRIM&R develops and issues public policy statements and produces white papers on questions relating to research policy and practice.

PRIM&R’s certification credentials strengthen the profession by establishing an accepted body of knowledge and national standards. They also recognize the knowledge and achievement of those working in the fields of IRB and/or IACUC administration. By becoming a Certified IRB Professional (CIP®) or Certified Professional IACUC Administrator (CPIA®), those working in the respective fields will:

PRIM&R also periodically engages in other activities intended to have a potential impact on public policy, such as the convening of highly specialized forums on emerging challenges. Past forums have examined the boundaries between research and practice, regulatory burden, and central IRBs.

›› Increase and validate their expertise ›› Demonstrate their understanding of the relevant regulations, ethical principles, and administrative best practices

›› Have access to potential career advance-

www.primr.org/publicpolicy

ment opportunities As the CIP and CPIA credentials gain visibility, the number of employers seeking candidates with these certifications continues to grow. Those who have obtained the credential report greater job satisfaction, workplace recognition, and personal pride. www.primr.org/certification

Career Center

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Becoming certified represents a commitment to what we do in this field and the level of excellence with which we strive to do it.

PRIM&R’s Career Center includes listings applicable to those in the research ethics and administration fields from the job boards of more than 250 organizations, as well as résumés from over 120,000 qualified applicants. Those seeking a new position, or looking to fill an open one, will find this easily navigable resource an invaluable asset to any search. careers.primr.org

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Additional Initiatives

contact information

Affinity Groups

People & Perspectives

address 20 Park Plaza, Suite 720, Boston, MA 02116

PRIM&R’s Affinity Groups are designed to foster networking and community building among professionals with shared needs and interests. Participants have the option of staying in touch electronically throughout the year. Current Affinity Groups include global research, small research programs, quality assurance/quality improvement, behavioral and social science research, IRB chairs, and institutional officials, but the list grows each year.

People & Perspectives is an online archive that seeks to uncover, collect, preserve, and share the stories of those performing the essential work of advancing ethical research. People & Perspectives features both the oral histories and written reflections of those “in the trenches,” as well as information about the field’s founders. These stories are shared via audio and video recordings, interviews, short narratives, essays, photographs, and content from PRIM&R’s program archives. Contribute to People & Perspectives via any of these mediums.

phone

617.423.4112

fax

617.423.1185

info@primr.org

web

www.primr.org

www.primr.org/affinitygroups

Blog Ampersand, PRIM&R’s blog, is a key source for research ethics and oversight news and commentary for all research professionals. Posts include member interviews, analyses of important events in the field, book reviews, helpful hints, and more. Guest bloggers are welcome. www.primr.org/blog

www.peopleandperspectives.org

social media links www.facebook.com/primrconnect www.twitter.com/primrconnect www.flickr.com/photos/primr/sets www.linkd.in/primrli www.youtube.com/user/PublicResponsibility www.primr.org/blog

IRB Forum The IRB Forum is an active online community for anyone working with HRPPs/IRBs. The IRB Forum strives to create an atmosphere of open and respectful dialogue on the often challenging issues covering the gamut of ethical, regulatory, and policy concerns related to human subjects research. This resource is the go-to place to pose questions, exchange guidance, and share best practices with peers via candid and constructive discussions.

Brochure photos: Alan Decker Photography, Bob Hoffman Photography and Jon Rou Photography