Looking at CBPR Through the Lens of the IRB

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Looking at CBPR Through the Lens of the IRB
October 30, 2008
Cornelia Ramsey, PhD, MSPH Community Research
Liaison, Center for Clinical and Translational
Research, Division of Community Engagement,
Department of Epidemiology Community
Health Virginia Commonwealth University
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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)
Less Community involvement
Complete Community involvement
Community- Driven Research
Community Based Participatory Research
Investigator- Driven Research
Community Placed Research
Community Based Research
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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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ComparisonTraditional Academic Research vs.
Community Research
(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 IRBs 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 Approaches

• Establishment of New Set of Guidelines
• Document view that promotes communitys 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

• Investigators must respect the ethical standards
  of their own countries and the cultural
  expectations of the societies in which
  epidemiological studies are undertaken
• when individual informed consent cannot be
  obtained, consent may be sought from a community
  representative
• if the study is objectionable to the community,
  individual informed consent may not be sufficient
  to render a study ethical
• wherever possible, investigators should not
  expose groups to harm, including the harm of
  disruption of social mores
• healthcare may be provided to the community as a
  benefit
• when possible, investigators should train local
  health workers and
• 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
  communitys 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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References

• Ball 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 199424(3)345.
• 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, WACommunity-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 19173-202.
• 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, 199521520.
• 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.