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February 13, 2002

How Much Oversight Is Necessary to Protect Human Subjects?—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor

JAMA. 2002;287(6):716-717. doi:10.1001/jama.287.6.711

In Reply: I agree with Dr Foucar that the current IRB system needs reform, and that there is a need for a reliable way for IRBs to distinguish "between research projects for which extensive oversight is likely to benefit research subjects" and those where "brief discussion . . . is perfectly adequate." This may be true, for example, of some studies involving medical record reviews.1 The National Bioethics Advisory Commission (NBAC) emphasized this problem in their August 2001 report. In their words: "Research review and monitoring should be intensified as the risk and complexity of the research increase and at all times should emphasize protecting participants rather than following rigid rules."2 The NBAC would certainly agree that a brief discussion provides enough oversight for many research projects, but would also recommend something that seldom happens for risky research projects: not just review, but oversight during the research itself, including "an ongoing system of education and certification that helps researchers to anticipate and minimize research risks."2 I agree with NBAC that such oversight is likely to help protect human subjects, but Foucar is also correct: we should study the impact of oversight as it is developed and implemented to make sure it is achieving its goal of protecting human subjects.

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