FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research under 21 C.F.R. § 50.24

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On November 17, 2014, the U.S. Food and Drug Administration (FDA) published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the requirement to obtain informed consent from research subjects for emergency research. Specifically, the Agency updated section 6030.8, INDs: Exception from Informed Consent Requirements for Emergency Research, of its Manual of Policies and Procedures (MAPP) for the Center for Drug Evaluation and Research (CDER) to place a greater emphasis on obtaining consent and to include a detailed checklist for Agency review components.1 Replacing the 2003 version, the additional specifications provided by the new version to sponsors of IND applications, as well as FDA personnel, comes at an opportune time. This exception from informed consent for the use of investigational drugs in emergency research could be sought for public health situations where potential research subjects are incapacitated, in a life-threatening clinical situation, and unable to immediately give consent (e.g., community outbreaks of Ebola virus infection).

Background -

The exception from informed consent for emergency research, provided under 21 C.F.R. § 50.24, is intended to ensure stringent protections in circumstances where, due to the emergency nature of medical care under research, subjects who are to be enrolled in an IND or Investigational Device Exemption (IDE) protocol are anticipated to be incapacitated and largely unable to provide informed consent. It is typically used to enable research of investigational drugs and medical devices regulated by FDA on conditions such as traumatic brain injury or stroke.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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