In the April 4, 2016, Federal Register, here and here, FDA issued a proposal to amend the
regulation, and, in a direct final rule issued the same day,
amended the regulation describing lesser administrative actions
that may be imposed on an IRB that has failed to comply with
FDA's IRB regulations. FDA clarified that it may require the
IRB to withhold approval of new FDA-regulated studies, stop the
enrollment of new subjects in ongoing studies, and terminate
ongoing studies, or any combination of these actions, until the
noncompliance with FDA's IRB regulations is corrected. FDA is
taking the action to ensure clarity and improve the accuracy of the
regulations. Comments are due June 20, 2016; the rule
is effective August 17, 2016.
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