1. Finding Common Ground: Community Based-Participatory Research and Institutional Review Boards Public Responsibility in Medicine and Research Social, Behavioral, Educational Research Conference May 10, Broomfield, Colorado Kristine Wong, Program Director Community-Campus Partnerships for Health, Seattle, WA Nancy Shore, Assistant Professor University of New England, Portland, ME

2. Session Objectives Gain a greater understanding of community- based participatory research (CBPR) Understand key challenges facing CBPR projects and IRBs Illustrate tensions on both sides through a participatory case study/exercise Identify promising practices, recommendations

3. Community-Campus Partnerships for Health Mission To promote health through partnerships between communities and higher educational institutions

4. Initiatives & Programs Training Institutes Community Partner Mobilization www.ccph.info Community Engaged Scholarship for Health Collaborative Consultancy Network Annual CCPH Conference April 11 – 14, 2007 Toronto, ON, Canada

5. Community-Based Participatory Research A collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change… -Kellogg Community Health Scholars Program

6. Principles of CBPR Recognizes community as a unit of identity Builds on strengths and resources within the community Facilitates collaborative, equitable partnership in all phases of the research Promotes co-learning and capacity-building among all partners -Israel BA, Schultz AJ, Parker EA, Becker AB 2001). Community-Based Participatory Research: Policy Recommendations for Promoting a Partnership Approach in Health Research. Education for Health 14(2): 182-197.

7. Principles of CBPR (continued) Integrates and achieves a balance between research and the mutual benefit of all partners Emphasizes local relevance of public health problems and ecological perspectives that recognize and attend to the multiple determinants of health and disease Disseminates findings and knowledge gained to all partners and involves all partners in the dissemination process Involves a long-term process and commitment - Israel BA, Schultz AJ, Parker EA, Becker AB 2001). Community0Based Participatory Research: Policy Recommendations for Promoting a Partnership Approach in Health Research. Education for Health 14(2): 182-197.

8. CBPR is - CBPR is not: An approach to research - not a methodology Community-based - not community placed Driven by community needs - not driven by money or publication potential Bottom up - not top down Knowledge and skills exchange - not knowledge and skills transfer

9. The CBPR approach to research represents a continuum of promising practices…

10. Traditional research has failed to solve complex health problems Levels playing field Significant community involvement increases scientific rigor: community are the experts Rationale: Why CBPR?

11. Rationale: Why CBPR? (continued) Research findings can be applied to interventions Approach builds greater trust & respect between researchers and communities

12. CBPR and the IRB Ethical considerations Benefits Challenges Recommendations

13. Examples of challenges with the IRB process Length of time to complete an IRB application and to receive final approval IRB reviewers’ lack of understanding of CBPR Differences regarding what is considered ethical practice Accessibility to & transparency of the IRB

14. Recommendations Committee composition –Reviewers with varied methodological expertise Participatory research Qualitative research –Community representatives Who are these individuals? Are they knowledgeable about possible community risks and benefits? How do IRBs support community representatives in becoming full participants in the review process?

15. Recommendations Checking for biomedical and other assumptions Increased community-based review mechanisms –Community members –Representatives of non-profits –Representatives of academia

16. Recommendations Relationship building –Open communication Mutual understanding –IRB reviewers to understand basics of CBPR –Research teams to understand basics of IRB process Opportunities to exchange ideas & develop resources

17. Recommendations Developing questions to guide the IRB process… –Is there community involvement? How was the partnership formed? Who are the different partners? How are the partners involved? –What are the potential impacts of this project? Who benefits, and what are the short and long term benefits (accounting for both individual and community level)? Who determines what constitutes a “benefit”? What are the short and long term risks (accounting for both individual and community level)? What steps have been taken to minimize these risks? Who determines what constitutes a “risk”? How will the findings be used? Will they be used to effect social change?

18. Other recommendations To be highlighted through the case study example and best practices to be presented at the end of the session

19. Case Study: The PHAT Project African Americans disproportionately affected by tobacco-related diseases CBPR approach emphasizing community-driven work Community research partners (CRP) conducted community survey on obstacles to cessation Protecting the Hood Against Tobacco San Francisco Bayview Hunters Point Community Project Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co- sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

20. Case Study: The PHAT Project Smoking cessation and single cigarette (“loosie”) sales “Loosies” identified by community residents as a major obstacle to cessation CRPs did not realize “loosie” sales were illegal CRP mapped all convenience and liquor stores in community Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co-sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

21. Case Study: The PHAT Project University IRB approved observational study - tobacco advertising density - smoking activity - store sales practices (including single cigarette sales) CRPs concluded observational study was “inadequate” Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co-sponsored by Community- Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

22. Case Study: The PHAT Project Modification to IRB Application sought permission to make single cigarette purchase at each store All data collected (store, owner, clerk) anonymous Findings would only be reported in aggregate form Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co- sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

23. Small Group Exercise (20 minutes) You comprise the Institutional Review Board and receive this appeal from the PHAT project. What will you decide? Stage a mock IRB meeting within your small group. Document the reasons for your decision.

24. Questions for Discussion Was the proposed study an example of human subjects research? What were the different factors involved in the IRB’s decision? How could institutional needs been discussed and negotiated with the PHAT project in order to create a solution that everyone was happy with?

25. What Actually Happened I IRB denied the appeal – stating that: - the study forced CRPs to “commit illegal act(s)” - the anticipated benefits did not justify risk (risk was never specified) IRB did not understand that CRPs were the researchers, not the unit of analysis

26. What Actually Happened II PHAT project submitted a new appeal to IRB supported by: -DA signed grant of immunity -CA Penal Code – buying “loosie” not illegal -State Attorney General: not “entrapment” -Documentation from other studies using similar procedures, letter of support from state tobacco research program Restated the unit of analysis was store: no data collected on individuals working at store Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co-sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

27. What Actually Happened III IRB recommended that PHAT conduct different type of study CRPs felt IRB decision was “protecting community predators” CRPs broke off from PHAT to do study independently – but no publication or reporting of findings allowed Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co-sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

28. Conclusions Interpretation of risk differed when viewing from a biomedical vs. communitarian ethics perspective Biomedical: Risks for store clerks -exposing illegal behavior -psychological risk of feeling deceived -lured into acting illegally Communitarian ethics perspective: Risks for stores -negligible risk for stores compared to potential benefits for community from knowledge generated Power dynamics are embedded in all ethical decision making Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co-sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

29. Conclusions IRBs may need to expand ethical horizons to incorporate CBPR Institutional power/conflicts of interest vs. community empowerment/protection should not be competing factors Modified from: Malone et. al. “Ethical tensions in IRB review of community participatory research: Who is being protected?” Powerpoint presentation presented on April 18, 2007 – Educational Conference Call Series on Institutional Review Boards co-sponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

30. Promising Practices Within Institutional IRBs Non-affiliated/community member involvement & training, population-specific knowledge Partnerships with Community: Community Advisory Boards, Community OHRP- certified IRBs Incremental modification process

31. Citation Malone RE, Yerger VB, McGruder C, Froelicher E (2006). “It's Like Tuskegee in Reverse": A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research. Am J Public Health, 96(11): 1914 - 1919.