Finding Common Ground: Community Based-Participatory Research and Institutional Review Boards Public...

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.