1. IRB and the Community Member How You Can Get Involved Mary Lou Smith Elda Railey Conference Call Series on IRBs and Ethical Issues in Research Co-sponsored by Community-Campus Partnerships for Health & Tuskegee University National Center for Bioethics in Research and Health Care March 14, 2007 1

2. How Are Participants Rights Protected? Scientific review Scientific review Institutional review boards (IRBs) Institutional review boards (IRBs) Data safety and monitoring boards Data safety and monitoring boards Informed consent Informed consent 2

3. Scientific Review All research involving people is overseen by some form of scientific review. Clinical trials with new drugs are subject to FDA review and approval Clinical trials with new drugs are subject to FDA review and approval Clinical trials using approved drugs are subject to funding agency (NIH/NCI) review and approval. Clinical trials using approved drugs are subject to funding agency (NIH/NCI) review and approval. Almost every point in the development of a protocol, is subject to peer review. Almost every point in the development of a protocol, is subject to peer review. 3

4. Informed Consent Before agreeing to take part, patients have the right to understand all that is involved in a clinical trial; Purpose Purpose Procedures and treatments Procedures and treatments Possible risks and benefits Possible risks and benefits Individual rights Individual rights 4

5. Unaffiliated Membership Requirement/Recommendation Unaffiliated Membership Requirement/Recommendation “The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.” … from the IRB Guidebook “The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.” … from the IRB Guidebook In 2001, the National Bioethics Advisory Committee recommended non-affiliated members of each IRB be 20% of its membership In 2001, the National Bioethics Advisory Committee recommended non-affiliated members of each IRB be 20% of its membership 5

6. Non-affiliated Member Role Provides the voice of the participant to the research process Provides the voice of the participant to the research process Participant can be Participant can be healthy volunteer healthy volunteer person with the disease or condition being studied person with the disease or condition being studied Provides balance Provides balance excitement over the new treatment and the reality of an unproven regimen excitement over the new treatment and the reality of an unproven regimen benefit versus risk, taking into consideration quality and quantity of life benefit versus risk, taking into consideration quality and quantity of life 6

7. What does a community member bring? Unique viewpoint Unique viewpoint Non-affiliated – not biased by employment Non-affiliated – not biased by employment Non-scientific – not biased toward the interesting question Non-scientific – not biased toward the interesting question Community representative – the neighborhood, the patients, the public, society Community representative – the neighborhood, the patients, the public, society Practical real world concerns Practical real world concerns 7

8. What does a community member bring? Evaluate Evaluate Benefits to the participant Benefits to the participant Risks to the participant Risks to the participant Answer the Question: Do the benefits outweigh the risks? Answer the Question: Do the benefits outweigh the risks? 8

9. Barriers to Community Participation Clear definition of the role of the community member Clear definition of the role of the community member Time required Time required Complexity and amount of information to be reviewed Complexity and amount of information to be reviewed Lack of public recognition of the work Lack of public recognition of the work How to find willing candidates How to find willing candidates How to train potential members – Don’t know what a non-scientist needs to know How to train potential members – Don’t know what a non-scientist needs to know 9

10. Focus Group Results Mary Lou Smith, JD, MBA Community Member, Rush University Medical Center, Chicago, IL 10

11. FOCUS GROUP RESULTS Background The Research Advocacy Network conducted focus groups using a professional market researcher The Research Advocacy Network conducted focus groups using a professional market researcher We brought together IRB administrators from four major medical centers in Chicago We brought together IRB administrators from four major medical centers in Chicago We invited the community members from those same four centers to a separate focus group We invited the community members from those same four centers to a separate focus group 11

12. FOCUS GROUP RESULTS Value of Community Member IRB Administrators IRB Administrators Different perspective Different perspective Independent of pay, promotion or job status Independent of pay, promotion or job status Drawback – if they didn’t show up and they were needed for quorum the meeting was postponed Drawback – if they didn’t show up and they were needed for quorum the meeting was postponed Community Members Counterbalance scientific minds Provide another voice Reflect the human side Protect ALL participants Drawback – might take more meeting time 12

13. FOCUS GROUP RESULTS Biggest Challenge IRB Administrators IRB Administrators Lack of role definition Lack of role definition What community are they representing What community are they representing Patient in general Patient in general Neighborhood Neighborhood Typical participants Typical participants Non-affiliation with the institution Non-affiliation with the institution Community Members Not knowing expectations of the IRB – chair, members and staff 13

14. FOCUS GROUP RESULTS Other Challenges FOCUS GROUP RESULTS Other Challenges IRB Administrators IRB Administrators Amount of time Amount of time Complexity of material Complexity of material The Chair The Chair Community Members Time Intimidation factor The Chair 14

15. FOCUS GROUP RESULTS Training IRB Administrators IRB Administrators Belmont Report Belmont Report Policies of the institution Policies of the institution The regs The regs Conflict of interest Conflict of interest Vulnerable populations Vulnerable populations Community Members Observed a meeting Class on how to work with the application Online course for IRB members IRB newsletters 15

16. FOCUS GROUP RESULTS Training What the community members would like: What the community members would like: How to read a protocol How to read a protocol Requirements for informed consent documents Requirements for informed consent documents History of patient protections History of patient protections Clinical trial process Clinical trial process Science Science Mentoring Mentoring Glossary of terms and acronyms Glossary of terms and acronyms 16

17. FOCUS GROUP RESULTS Ways to Express Appreciation IRB Administrators IRB Administrators Appreciation lunch or dinner Appreciation lunch or dinner Letters from President Letters from President Money Money Electronic teleconferencing Electronic teleconferencing Community Members Give feedback and evaluation Appreciation Dinner Gift certificates Credits for continuing ed Say Thank You Money 17

18. FOCUS GROUP RESULTS Bottom Line IRB Administrators saw the value of community IRB members and would like to attract more. Retention was less of an issue than recruitment. IRB Administrators saw the value of community IRB members and would like to attract more. Retention was less of an issue than recruitment. Community members felt there was great value in what they did but they would like to know they were meeting the needs of the IRB. Community members felt there was great value in what they did but they would like to know they were meeting the needs of the IRB. 18