Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor
Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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.
Annas GJ. How Much Oversight Is Necessary to Protect Human Subjects?—Reply. JAMA. 2002;287(6):716-717. doi:10.1001/jama.287.6.711