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). 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…
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 cosponsored 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 CommunityCampus 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, 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.