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Exception from Informed Consent Requirements for Emergency Research Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors April 2013

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
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance is intended to assist Institutional Review Boards (IRBs), clinical investigators and sponsors in the development, conduct, and oversight of investigations to determine the safety and effectiveness of FDA regulated products (e.g., drugs, including biological drug products, devices) in emergency settings when an exception from the informed consent requirements is requested under Title 21, Code of Federal Regulations, Section 50.24 (21 CFR 50.24). The term “emergency research” is used throughout this guidance to refer to these investigations. These investigations involve human subjects who have a life-threatening medical condition that necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of their condition (e.g., traumatic brain injury) cannot provide informed consent. The research must have the prospect of direct benefit to the patient and must involve an investigational product that, to be effective, must be administered before informed consent from the subject or the subject’s legally authorized representative can be obtained and in which there is no reasonable way to identify prospectively individuals likely to become eligible for participation. This guidance finalizes the draft guidance entitled, “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research,” dated July 2006 (published on August 29, 2006).

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-2006-D-0464.

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