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Exempting all minimal-risk research from IRB review: pruning or poisoning the regulatory tree?

9 In a commentary published in 2009 in Nature magazine, Kim and colleagues1 argued that the federal regulations governing research with humans (known as the Common Rule2) should be changed to exempt minimal-risk research from review by an institutional review board (IRB). Among other things, they claim that IRB review of minimal-risk studies leads to a costly human subjects oversight system. Their argument is fairly straightforward: any system of oversight ought to be deemed unethical if such a system offers no adequate counterbalancing good when it simultaneously creates a certain degree of financial, scientific, clinical, and ethical hardships on the activities of those practitioners under scrutiny. Thus, for Kim and colleagues, in order for a regulatory framework to be deemed ethical, its system of rules must reveal adequate compensating benefits in light of the oversight demands placed on those under its umbrella. In this article, we contend that the argument Kim and colleagues provide as justification for exempting minimal-risk research from IRB review is unsound and caution against embracing their position. Although we agree that reform may be in order for review of minimal-risk research,3 we think that the approach promoted by Kim and colleagues for pruning the regulatory tree would actually amount to its poisoning.