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

1
Finding Common Ground Community
Based-Participatory Research and Institutional
Review Boards Public Responsibility in Medicine
and ResearchSocial, Behavioral, Educational
Research ConferenceMay 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
Community Engaged Scholarship for Health
Collaborative Consultancy Network Annual CCPH
ConferenceApril 11 14, 2007 Toronto, ON,
Canada
www.ccph.info
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
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

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
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
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
  IRBs 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.