Regulatory Information

IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects

Guidance for Sponsors, Investigators, and Institutional Review Boards

This guidance is for immediate implementation.

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FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(3) without initially seeking prior comment. The Agency has determined that prior public participation is not feasible or appropriate because this guidance presents a less burdensome policy that is consistent with the public health. Although this guidance document is immediately in effect, it remains subject to public comment in accordance with the Agency’s good guidance practices regulation (21 CFR 10.115).

You may submit comments or suggestions at any time. Submit electronic comments to Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact Janet Norden, 301-796-1127; Carol Drew, 301-796-8510; (CDER) Ebla Ali Ibrahim, Office of Medical Policy, 301-796-3691; (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010; or (CDRH) Office of Device Evaluation, Clinical Trials Program, 301-796-5640.

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Good Clinical Practice (OGCP)
Center for Drug Evaluation and Research (CDER)
Center of Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)

July 2017

Page Last Updated: 07/12/2018
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