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HHS/FDA RIN: 0910-AC25 Publication ID: Fall 2002 
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information 
Abstract: FDA is proposing to clarify its regulations about the exception from the general requirement for informed consent in life-threatening situations necessitating the use of a test article. This proposal will explain how the informed consent provisions would apply during emergencies, including a response to chemical or biological terrorism, requiring the use of investigational in vitro diagnostic devices regulated by FDA. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 50.23   
Legal Authority: 21 USC 321    21 USC 351    21 USC 352    21 USC 355    21 USC 360    21 USC 360bbb    21 USC 360c    21 USC 360d    21 USC 360e    21 USC 360f    21 USC 360h    21 USC 360i    21 USC 360j    21 USC 371    21 USC 381   
Legal Deadline:  None

Statement of Need: The agency is proposing this action because of concern that confusion exists about how to apply the informed consent rules during a potential emergency, including a chemical or biological terrorism event. This confusion could delay the immediate use of investigational products thus threatening the rights, welfare, or lives of subjects.

Summary of the Legal Basis: FDA has already determined that the statutory authority provided in the Federal Food, Drug and Cosmetic Act (the Act) allows a limited exception to requiring informed consent in life-threatening situations such as those considered here. Section 505(i) of the Act requires informed consent except where it is not feasible or it is contrary to the best interests of the human beings involved. The Act also provides specifically for an exception from informed consent for investigational devices. Section 520(g)(3)(D) of the Act requires informed consent of the subject unless the clinical investigator determines in writing that: 1) there exists a life-threatening situation involving the human subject of such testing which necessitates the use of such device; 2) it is not feasible to obtain informed consent from the subject; and 3) there is not sufficient time to obtain such consent from his or her representative. Further, a licensed physician uninvolved in the testing must agree with this three-part determination before using the product, unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to get such concurrence.

Alternatives: The other option available to the agency is to work within the existing regulatory scheme. FDA believes that this option may result in improper or no diagnosis, and improper treatment or no treatment for persons with life-threatening illnesses because the health professionals may not use these investigational products.

Anticipated Costs and Benefits: The minimal burdens imposed by this rule are offset by the fact that, in the absence of this rule, the sponsor may be required to obtain informed consent, which is just as burdensome, if not more so. The rule would permit use of investigational products without which patients' lives might be threatened. Because of uncertainty about the nature or extent of any chemical or biological terrorism event, FDA cannot estimate the extent of the benefits of this rule.

Risks: The primary risk addressed by this rule is the risk that patients may go untreated or may be improperly treated because health professionals may not use an investigational product in the absence of informed consent. FDA cannot determine the extent of this risk without knowing the nature or extent of any chemical or biological terrorism event.

Action Date FR Cite
NPRM  04/00/2003    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Bonnie M. Lee
Associate Director for Human Subject Protection Policy
Department of Health and Human Services
Food and Drug Administration
Room 9C24 (HF-34), Office of Good Clinical Practice, Office of Science Coordination & Communication, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-1259
Fax:301 827-1169