Exempting All Minimal-Risk Research from IRB Review: Pruning or Poisoning the Regulatory Tree?

IRB: Ethics & Human Research 34 (2):9-14 (2012)
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Abstract

In a recent commentary, Kim and colleagues argued that minimal-risk research should be deregulated so that such studies do not require review by an institutional review board. They claim that regulation of minimal-risk studies provides no adequate counterbalancing good and instead leads to a costly human subjects oversight system. We argue that the counterbalancing good of regulating minimal-risk studies is that oversight exists to ensure that respect for persons and justice requirements are satisfied when they otherwise might not be

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Mahesh Ananth
Indiana University South Bend
Michael Scheessele
Indiana University South Bend

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