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212460 IRB review of community-based participatory researchMonday, November 9, 2009: 11:20 AM
Ethical review of community based participatory research (CBPR) has been indentified as a significant barrier to the conduct of these studies. In particular, criticism has focused on the traditional human subjects protection paradigm, which requires Institutional Review Board (IRB) (or equivalent) review of each protocol to ensure the ethical treatment of individual subjects.
This presentation will discuss whether the IRB model is appropriately tailored for the ethical review of CBPR. In particular, are the goals and institutional structures associated with IRB review consistent with identification of and protection from group harms? The presentation will begin with a brief discussion of the ethical and regulatory framework in which the IRB is situated, with the aim of exploring what these entities are designed to accomplish. This will be followed by a description of the potential ethical risks associated with CBPR, including “group harms,” and an analysis of how well these risks can be addressed by IRBs as they are currently constituted. The presentation will lay out arguments for and against IRB involvement in review of CBPR, and will explore some alternative proposals designed to create a better system for ethical review of these studies, such as community consent. Examples will be drawn from the presenter's experience working with the National Human Genome Research Institute (NHGRI) and the National Institute of Allergy and Infectious Disease (NIAID) IRBs.
Learning Objectives:
Presenting author's disclosure statement:
Qualified on the content I am responsible for because: I have worked on human subjects research ethics issues for a number of years making regular presentations on a range of topics. I am currently a faculty member in the NIH Department of Bioethics, and the Deputy Director of the NHGRI Bioethics Core. I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.
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