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 This guidance finalizes the draft guidance entitled, “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research,” dated July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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.