Post on 01-Apr-2015
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Looking at CBPR Through the Lens of the IRB
Cornelia Ramsey, PhD, MSPHCornelia Ramsey, PhD, MSPHCommunity Research Liaison, Center for Clinical and Translational Community Research Liaison, Center for Clinical and Translational
Research, Division of Community Engagement, Department of Research, Division of Community Engagement, Department of Epidemiology & Community HealthEpidemiology & Community HealthVirginia Commonwealth UniversityVirginia Commonwealth University
October 30, 2008October 30, 2008
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Seeds for Thought and Discussion…
CBPR design & methods
Ethical issues for the IRB – the current debate
Key points from leaders in the field
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Why the Emphasis on CBPR now? Need for translational research
US health outcomes are no better than outcomes for other industrialized countries
Even though the US is a leader in biomedical research, there is a gap between this research and practice, and ultimately health outcomes
NIH Roadmap – http://nihroadmap.nih.gov Long-term plan to strengthen linkages between
research and practice and practice and communities
One strategy – community engaged research
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Community Engaged ResearchContinuum
(clinical & social/behavioral)
Investigator-Driven
Research
Community-Driven
Research
Community Based
Participatory Research
Community Placed
Research
Community Based
Research
Less Community
involvement
Complete Community
involvement
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Key Strategies – For CBPR: Active engagement and shared decision-making of community
members, academic researchers and funders
Integrated sources of knowledge (e.g., formal & informal)
Iterative data collection and analysis using multiple methods (e.g., qualitative and quantitative etc.)
Utilization of multiple channels for knowledge dissemination
Achievement of common goals: social change, improved health and well-being
(Israel et al 1998)
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Comparison:Traditional Academic Research vs. Community Research
Traditional Research Community Research
Goal of research Advance knowledge Betterment of community
Source of research question Theoretical work Community-identified problem
Designer of research Trained researcher Trained researcher & community
Role of researcher Outside expert Collaborator, learner
Role of community Subject of study Collaborator, learner
Relationship of researcher to participants
Short-term, task-oriented, detached
Long-term, multifaceted, connected
Value of research Acceptance by peers (e.g., publication)
Contribution to community change
Ownership of data Academic researcher Community
Means of dissemination Academic conference, journal
Any and all forums, media, meetings,
community
(Strand K, et al. 2003)
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CER strategies build capacity but…
… also create opportunities for risk to communities
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Why are there Community Risks? Structure and function of communities
Communities have unique politics, beliefs, and values - research may affect these elements
Communities may make decisions collectively, and informed consent from individuals may conflict with the political structure, social networks
Disease treatments may conflict beliefs regarding traditional healing
(Weijer 1999)
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Why risks (continued)…
“Belmont principles… do not appear to cover the scope of ethical considerations that arise in CBPR and thus the IRB’s application of these principles may not provide a relevant or thorough ethical analysis”
In CBPR human protections are not just about individuals but the respect, beneficence and justice for the community.
(Grignon, Wong and Seifer 2008)
“The ethical issues raised by communities in research are not adequately captured by the current ethical framework for human subjects research as articulated in the Belmont Report.”
(Weijer 1999)
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Specific Risks to Communities
Stigmatization Discrimination Research related community identity Fractured social structure
(Dickert et al 2005)
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Two Possible ApproachesEstablishment of New
Set of Guidelines
Document view that promotes community’s values
Add new principle of “respect for communities” or “respect for cultures”
Miller, 1995
Enrichment of Existing Principles
Reinterpretation of the view of the individual in research
Consider the community…
Childress, 1994
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Examples of Existing Guidelines for Communities
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International Guidelines for Ethical Review of Epidemiological Studies
(1) “Investigators must respect the ethical standards of their own countries and the cultural expectations of the societies in which epidemiological studies are under taken”;
(2) when individual informed consent cannot be obtained, consent may be sought from a community representative;
(3) if the study is objectionable to the community, individual informed consent may not be sufficient to render a study ethical;
(4) wherever possible, investigators should not expose groups to harm, including the harm of disruption of social mores;
(5) healthcare may be provided to the community as a benefit; (6) when possible, investigators should train local health workers;
and (7) the community should be represented in the ethics review
process.”
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The Australia National Health and Medical Research Council
Both parties are accorded equal moral status. Community is involved from research genesis to publication of
findings. Community must be consulted in the preparation of the research
proposal Study must be potentially useful to the community Study conducted with sensitivity to the community’s culture and
politics through face-to-face meetings & adequate time to reflect Written informed consent of the community must be obtained
before individual subjects are approached for consent Community will be involved in the actual conduct of the study Community will be reimbursed for any community resources used Use of data and biological samples must be negotiated and requires
the consent of the community. Always credit the community
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However… in the NHMRC
All communities were considered more or less the same as First Nations communities - this is a mistake.
It is an error to blindly apply guidelines written for one community to another community.
(Weijer 1999)
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First Steps…
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Clearly Define the Community Collectivities are “population groups with social
structures, common customs, and acknowledged leadership.”
Collectivities include nations, cultural groups, small indigenous communities and some neighborhood groups. The definition is also explicitly intended to include families.
(Canada Tri-Council Working Group on Ethics, 1996)
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Identify Implications of Strategies- for CBPR
Active engagement and shared decision-making of community members, academic researchers and funders Community involvement BEFORE IRB approval Community ownership of data, findings, results
Iterative data collection and analysis using multiple methods Necessitates changes throughout study – implications for study revisions Timeline of research Timeliness of revisions Qualitative research data monitoring, analysis plan
Utilization of multiple channels for knowledge dissemination Community ownership, community credit
Achievement of common goals: social change, improved health and well-being Impact on risk benefit analysis – not just individual but community level
benefit and risks
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Think About Informed Consent Information about programs, trainings and materials
representing community language & culture & context
Full disclosure about how research incorporates knowledge and strengths of community in recruitment plan, instrument development, intervention development & research design
Confidentiality – for individuals and community relationships and trust
Voluntary participation – no coercion
(Viswanathan et al. 2004)
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Think About Benefits & Risks
Maximize benefits Advance common goals – social action & research
goals Build capacity of community partners in research –
research design to data collection, interpretation & dissemination
Minimize risks Avoid “collaborating with the enemy” Be sensitive to causes of potential fractures in the
community Be aware of how research could further stigmatize
vulnerable communities
(Ball & Janyst 2008)
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Think About Justice Community “insiders” can identify
vulnerable individuals emotionally charged topics appropriate cultural perspectives on research
Equitable distribution of benefits and burdens of research Who is included? Excluded? Why? Who shares resources? (e.g., money)
(Ball & Janyst 2008)
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Review - Clarifying Expectations
Initiate the relationship with awareness of ethical issues for communities
Identify people community members trust including governing bodies and work & spend time in the community to identify & connect with community-defined representatives
Memorandum of Agreements detail everything Expect the draft plan will be revised! For some communities - oral consents are used –
written consent has history of deception and misuse
(Ball & Janyst 2008)
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Questions & Discussion
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ReferencesBall J, Janyst P. Enacting Research Ethics in Partnerships with Indigenous Communities in Canada: Do it in a good Way”. Journal of Empirical
Research on Human Research Ethics 2008 vol.3 (2) 33-52.
Canada Tri-Council Working Group on Ethics,Code of Conduct for Research Involving Humans {draft}: Ottawa: Minister of Supply and Services, 1996
Childress JF, Fletcher JC. Respect for autonomy. Hastings Center Report 1994;24(3):34–5.
Dickert N and Sugarman J Ethical Considerations of Community Consultation in Research . American Journal of Public Health. 2005 vol 95 no.7 2005.
Grignon J, Wong KA, Seifer SD. Ensuring Community-level Research Protections. Proceedings of the 2007 Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research. Seattle, WA:Community-Campus Partnerships for Health, 2008.
Israel A et al. Review of Community-Based Research: Assessing Partnership Approaches to Improve Public Health. Annual Review of Public Health. 1998 19:173-202.
Israel B, et al (Eds.). Methods in Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., 2005.
Miller B. Autonomy. In: Reich WT, ed.Encyclopedia of Bioethics, Rev. ed. New York: Simon & Schuster MacMillan, 1995:215–20.
Minkler M, Wallerstein N (Eds.). Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., 2003
Strand K, et al. Community-Based Research and Higher Education: Principles and Practices. San Francisco: Jossey-Bass & Co., 2003.
Weijer, C. Protecting Communities in Research: Philosophical and Pragmatic Challenges Cambridge Quarterly of Healthcare Ethics (1999), 8, 501–513. Cambridge University Press
Viswanathan M, Ammerman A, Eng E, Gartlehner G, Lohrk N, Griffith D, Rhodes S, Samuel-Hodge C, Mary S, Lux L, Webb L, Sutton SF, Swinson T, Jackman A, Whitener L, Community-Based participatory Research: Assessing the Evidence Evidence Report Technology Assessment No. 00 AHRQ Publication 04-E022-2 Rockville, MD: Agency for Healthcare Research and Quality. July 2004.