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Improving the Decision Processes of Institutional Review Boards—Reply
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In Reply: I agree with Dr Wagner that evidence-based research designed to identify methods to improve the IRB process could help to protect research participants, and ensure the public that research is being conducted appropriately. Although such data would be invaluable, designing research to assess IRB deliberations and decisions would require creative methods to assess a complicated process. The resulting studies would require substantial time and resources.
Assessment of the quality of IRB review and identification of the factors associated with better reviews would also require appropriate outcome measures. One approach might be to catalog serious research-related adverse events and deaths, and then determine which adverse events could be avoided by changes in the research review process. Consistent with research on improving medical care in hospitals, such efforts should focus on improving the protocol review system and not on identifying and punishing those involved with past problems.
Disclaimer: The opinions . . . [Full Text of this Article]
David Wendler
Department of Clinical Bioethics
Clinical Center, National Institutes of Health
Bethesda, Md
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