After more than five (5) years since the introduction of the proposed rule, FDA is issuing a final rule that adds § 50.22 Exception from informed consent requirements for minimal risk clinical investigations to the regulations. “The final rule amends FDA’s regulations to allow [Institutional Review Boards] IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations.”
“On December 13, 2016, the Cures Act (Pub. L. 114-255) was signed into law. Section 3024 of the Cures Act amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”
The final rule contains five (5) provisions that must be met to permit the IRBs to waive or alter procedures for informed consent, which include:
(a) The clinical investigation involves no more than minimal risk to the subjects;
(b) The clinical investigation could not practicably be carried out without the requested waiver or alteration;
(c) If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format;
(d) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(e) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
FDA received fewer than 50 comments on the proposed rule and the prepublication document in the Federal Register (here) outlines those comments and the Agency’s responses that either agreed or disagreed and along with the FDA’s reasoning for the FDA’s decisions. The comments are quite interesting, as are the Agency’s responses. The question of how the IRBs will be able to quantify minimal risk remains to be seen.
The goal of the rule is to reduce the burden on IRBs and researchers without compromising the safety and protection of the subjects where the proposed clinical testing presents no more than minimal risk.
