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FDA Allowed "Emergency Research" on Patients Incapable of Informed Consent

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Press release: “FDA Takes Close Look at Experience Gained from Regulations Allowing Emergency Research With An Exception from Informed Consent Requirements.”

  • “The Food and Drug Administration (FDA) is taking a close look at the implementation of its 1996 regulation, 21 CFR 50.24, which allows clinical emergency research when informed consent cannot be obtained. This federal regulation allows the conduct of research studies to test emergency treatments on patients with specific life-threatening medical conditions (head trauma, cardiac arrest, stroke) when patients cannot give informed consent because of their conditions, and family is not available to give provide consent either. Such emergency research has been allowed under very restricted circumstances since 1996 when FDA regulations went into effect providing for a narrow exception to the informed consent research requirements.”
  • Federal Register, August 29, 2006: “A draft guidance (Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research) is being made available to assist IRBs, clinical investigators, and sponsors in the development and conduct of emergency research.”
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