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Regulatory Update, October 2017

Sunday, October 1, 2017

FDA Final Guidance on Waiver or Alteration of Informed Consent

In the July 25, 2017, Federal Register, the FDA announced the availability of a final guidance for sponsors, investigators, and institutional review boards (IRBs) titled, “IRB Waiver or Alteration of Informed Consent for Clinical Investigations In­volving No More Than Minimal Risk to Human Subjects.” It informs sponsors, in­vestigators, IRBs and other interested par­ties that the FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, the guidance explains that the FDA does not intend to object to a sponsor initiating, or an inves­tigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance.

The FDA is issuing this guidance con­sistent with its good guidance practices (GGP) regulation and without prior public comment because the FDA has determined that prior public participation is not feasible or appropriate in this case. The FDA made this determination because this guidance presents a less burdensome policy that is consistent with the public health. The FDA believes this guidance will facilitate the conduct of certain minimal risk clinical in­vestigations that are important to address­ing significant public health needs without compromising the rights, safety, or welfare of human subjects. Although this guidance is immediately in effect, it remains subject to comment in accordance with the FDA’s GGP regulation. The FDA will consider all comments received and will revise this guidance when appropriate.

On December 13, 2016, the 21st Century Cures Act was signed into law. It amended certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to pro­vide the FDA the authority to permit an exception from informed consent require­ments when the proposed clinical testing poses no more than minimal risk to hu­man subjects and includes appropriate safeguards to protect the subjects’ rights, safety, and welfare.

Currently, the FDA’s regulations gov­erning the protection of human subjects are stated in Title 21 of the Code of Fed­eral Regulations (21 CFR) parts 50 and 56. The regulations allow exception from the general requirements for informed consent only in life-threatening situations when certain conditions are met (21 CFR 50.23) or when the requirements for emergency research are met (21 CFR 50.24), but do not include an exception from informed consent for minimal risk clinical investi­gations. In light of the FD&C Act amend­ment described above, the FDA intends to revise its informed consent regulations to add a waiver or alteration for minimal risk clinical investigations, under appropriate human subject protection safeguards, to the two existing exceptions from informed consent.

This guidance informs sponsors, inves­tigators and IRBs that until the FDA issues these new regulations, it does not intend to object to an IRB approving a consent pro­cedure that does not include, or that alters, some or all of the elements of informed consent set forth in 21 CFR 50.25; or to an IRB waiving the requirements to obtain informed consent as described in the guid­ance. In addition, the FDA does not intend to object to a sponsor initiating, or an in­vestigator conducting, a minimal risk clin­ical investigation for which an IRB waives or alters the informed consent require­ments as described in the guidance. The FDA believes this enforcement discretion when applied to sponsors, investigators and IRBs that follow what is described in this guidance will facilitate investigators’ ability to conduct studies that may con­tribute substantially to the development of products to diagnose or treat diseases or conditions, or address unmet medical needs, without compromising the rights, safety or welfare of human subjects.

Submit either electronic or written com­ments on FDA guidance documents at any time.

Submit electronic comments at http://www.regulations.gov/ (enter the Docket Number below in the Search box). Sub­mit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Iden­tify your comments with Docket No. FDA-2017-D-3235. FDA also has instructions on how to submit confidential information. If those instructions are not followed, the FDA warns that any submitted confiden­tial information will be made public.

Extended Effective Date for Use of a Single IRB for Multi-Site Research

In the July 6, 2017, Federal Register, the NIH announced that it is extending the ef­fective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research from September 25, 2017 to January 25, 2018. A copy of the NIH Policy was published in the Federal Regis­ter on June 21, 2016.


The Regulatory Update is excerpted from Research Practitioner, Volume 18, Number 05, September-October 2017.

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