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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.

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.