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HHS/FDA | RIN: 0910-AC25 | Publication ID: Spring 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 clarification will explain how the regulations would apply during emergencies, including a response to chemical or biological terrorism, requiring the use of investigational products 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 |
CFR Citation: 21 CFR 50.23 | |
Legal Authority: 21 USC 321 21 USC 346 21 USC 346a 21 USC 348 21 USC 352 21 USC 353 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 379e 21 USC 381 42 USC 241 42 USC 262 42 USC 263b-263n |
Legal Deadline:
None |
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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. |
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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. The statute states that the exceptions to requiring informed consent are subject to such conditions as the Secretary may prescribe. This proposed rule is not required by statute or court order. |
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Alternatives: The only other option open to the agency is to do nothing. FDA believes that this option is not acceptable because it could result in improper treatment or no treatment for persons with serious illnesses because the health professionals could not use these investigational products in absence of informed consent. |
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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 would 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. |
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Risks: The primary risk addressed by this rule is the risk that patients may go untreated or may be improperly treated because health professionals could 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. |
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Timetable:
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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 Email: blee@oc.fda.gov |