On April 4, 2016, FDA announced a direct final rule amending and a proposed rule to amend the regulation
describing lesser administrative actions that may be imposed on an
Institutional Review Board ("IRB") that fails to comply
with IRB regulations. The two notices clarify that FDA 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 the IRB regulations is corrected. Specifically,
FDA is amending 21 CFR § 56.120(b) by clarifying that FDA
has authority to require the IRB to withhold approval of new
FDA-regulated studies conducted at the institution or reviewed by
the IRB, direct that no new subjects be added to ongoing studies,
and terminate ongoing studies provided that doing so would not
endanger study subjects. FDA published the direct final rule with
the intention of clarifying an existing regulation and does not
anticipate any significant adverse comment regarding the amendment.
The proposed rule is a companion to the direct final rule and
codifies FDA's interpretation of the regulation, that FDA may
impose restrictions on a noncompliant IRB until the IRB takes
appropriate corrective action. The rule is effective August 17,
2016. Interested parties can submit comments on this direct final
rule or its companion proposed rule by June 20, 2016.
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