Health Law Alert: Are Local IRBs Going the Way of the Dodo? Historic Proposed Changes to the Common Rule


The regulations governing research protections for human subjects across several federal agencies, known collectively as the Common Rule, have remained basically unchanged since their inception in the 1980s. The Department of Health and Human Services (HHS) is now revisiting the Common Rule, however, in an attempt to balance the need for additional protections for human subjects with calls for a more streamlined approval process for frustrated investigators. HHS announced its proposed changes to the Common Rule, entitled Human Subject Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators, on July 22, 2011. Along with the expansive changes proposed in its announcement, HHS posed a series of 75 questions for public comment on potential regulations.

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