Guidance

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

Jun 1, 2018 3:00 pm

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency research protocols in which subjects are unable, due to their medical condition, to give informed consent at the time of enrollment.