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Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations Guidance for Sponsors, Investigators, and Institutional Review Boards October 2018

Final Level 2 Guidance
Docket Number:
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

FDA’s regulations on human subject protection (21 CFR part 50) and Institutional Review Boards (IRBs; 21 CFR part 56) help to ensure that the rights, safety, and welfare of human subjects participating in FDA-regulated clinical investigations are protected. These regulations generally conform to the Department of Health and Human Services’ (HHS’) Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”), which sets forth requirements for the protection of human subjects involved in research that is conducted or supported by HHS.

In a final rule published on January 19, 2017, HHS and a number of federal departments and agencies made revisions to the Common Rule. The general compliance date for the revised Common Rule is January 21, 2019.

FDA intends to undertake notice and comment rulemaking to harmonize, to the extent applicable, FDA’s regulations with the revised Common Rule. Because FDA has not revised its regulations, FDA is issuing this guidance to reduce confusion and burden associated with complying with two different sets of human subject protection regulations. This guidance is intended to address questions from stakeholders regarding the impact of certain provisions of the revised Common Rule on FDA-regulated clinical investigations during FDA’s rulemaking process.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-3551.

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