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

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.