finding common ground: community based-participatory research and institutional review boards public...
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Finding Common Ground: Community Based-Participatory Research and
Institutional Review Boards
Public Responsibility in Medicine and ResearchSocial, Behavioral, Educational Research Conference
May 10, Broomfield, Colorado
Kristine Wong, Program DirectorCommunity-Campus Partnerships for Health, Seattle, WA
Nancy Shore, Assistant ProfessorUniversity of New England, Portland, ME
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
Community-Campus Partnerships for Health
Mission
To promote health through partnerships betweencommunities and higher educational institutions
Initiatives & Programs
Training Institutes
Community Partner Mobilization
www.ccph.info
Community Engaged Scholarship for Health Collaborative
Consultancy Network
Annual CCPH ConferenceApril 11 – 14, 2007
Toronto, ON, Canada
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). Community0Based 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…
•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?
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
• 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
Case Study: The PHAT ProjectSmoking 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 co-sponsored 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 OHRP- certified IRBs
• Incremental modification process
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.