Finding Common Ground Community Based-Participatory Research and Institutional

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

Session Objectives • Gain a greater understanding of communitybased 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

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

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

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

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.

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). Community 0 Based Participatory Research: Policy Recommendations for Promoting a Partnership Approach in Health Research. Education for Health 14(2): 182 -197.

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

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

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

CBPR and the IRB • • Ethical considerations Benefits Challenges Recommendations

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

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?

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

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

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?

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

Case Study: The PHAT Project Protecting the Hood Against Tobacco San Francisco Bayview Hunters Point Community 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 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

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

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

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 cosponsored by Community-Campus Partnerships for Health and the Tuskegee University National Center for Bioethics and Health Care

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.

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?

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

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

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

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

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

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

Citation • Malone RE, Yerger VB, Mc. Gruder 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.