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HHS/FDA RIN: 0910-AC25 Publication ID: Fall 2003 
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information 
Abstract: FDA is proposing an amendment to the exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. 
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 it is concerned that, during a potential terrorism event or other public health emergency, delaying testing of specimens to obtain informed consent may threaten the life of the subjects or others who have been exposed to or who may be at risk of exposure to a chemical, biological, radiological, or nuclear agent.

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 the requirement of obtaining informed consent in life-threatening situations such as those considered here. Section 520(g)(3)(D) of the Act provides specifically for an exception from informed consent for investigational devices, subject to such conditions as the agency may prescribe. That section 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 the investigational 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 in writing with this three-part determination before the product is used 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. The investigator must submit the required documentation to the IRB within 5 days after the use of the device.

Alternatives: The other option available to the agency is to work within the existing regulatory scheme. FDA believes that this option may result in delayed, improper or no diagnosis, and delayed, improper or no treatment for persons exposed to these agents because health professionals may not use these investigational products in a timely way or may not use them at all because of their inability to obtain informed consent.

Anticipated Costs and Benefits: The minimal burdens imposed by this rule are offset by the fact that, in the absence of this rule, the investigator 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 or other public health emergency. 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 including receiving delayed treatment, 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  06/00/2004    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Darin Achilles
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426