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

Author Profiles

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

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