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GUIDANCE DOCUMENT

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 July 2017

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-3235
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance is for immediate implementation.

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 https://www.regulations.gov. 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.

Submit Comments

Submit Comments Online

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-2017-D-3235.

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