Emergency Research (Planned and Approved) with Exception from Informed Consent

Aug 31, 2022 10:30 pm


The Food and Drug Administration (FDA) regulation at 21 CFR 50.24, and Office for Human Research Protections (OHRP) Secretary's Waiver, allows a narrow exception to the requirement to prospectively obtain and document informed consent from research participants. According to the regulation, IRBs may approve certain emergency research protocols in which participants are unable to give informed consent at the time of enrollment due to their medical condition.

These studies require additional steps to ensure that potential participants in the communities where the study takes place have adequate opportunity to learn about the study at any time:

  • “Community Consultation” prior to IRB submission of the full study protocol

  • “Public Disclosure” (such as advertisements)

    • before study initiation, of plans for the investigation and its risks and expected benefits

    • after study completion, of study results and the demographics of the study population.

The IRB also approves and oversees these additional steps.

Guidance Documents

Tags: Regulatory

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Last Updated: August 31, 2022 10:30 PM