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Guidance Issuing OfficeOffice of Regulatory AffairsOffice of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical PracticeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies' regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts. In addition, on December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law. Title III, section 3023 of the Cures Act requires the Secretary of HHS to harmonize differences between the HHS human subject regulations and FDA's human subject regulations. This guidance document is consistent with the goals of section 3023 of the Cures Act. This guidance is intended for institutions and institutional review boards (IRBs) responsible for review and oversight of human subject research under the HHS and FDA regulations.
OHRP and FDA believe that when institutions and IRBs develop and follow clear written procedures, there is an increased likelihood that the rights and welfare of human subjects will be protected. The purpose of this guidance is to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures. The guidance includes a Written Procedures Checklist (also referred to in this guidance as the Checklist) that incorporates the HHS and FDA regulatory requirements for written procedures for the IRB and recommendations on the type of operational details to include to support each of these requirements. In addition, the Checklist includes some additional topics the institution/IRB may consider when developing comprehensive procedures.
OHRP's and FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes OHRP's and FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word must in OHRP and FDA joint guidance means that something is required under the HHS regulations at 45 CFR part 46 or the FDA regulations at 21 CFR parts 50 and 56. The use of the word should in OHRP and FDA joint guidance means that something is suggested or recommended, but not required.
Note: References in this guidance to HHS regulations at 45 CFR part 46, subpart A, are to this subpart in effect at the time this guidance is published, and not to subpart A as amended by a final rule published January 19, 2017 (82 Fed. Reg. 7149) and not to an interim final rule published January 22, 2018 (83Fed.Reg. 2885).
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:
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-2016-D-1605.