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FDA Issues Proposed Rule on Waivers of Consent in Minimal Risk Research

The Food and Drug Administration (FDA) is proposing to expand the types of research for which consent may be waived or altered, now generally confined to studies conducted during emergencies. Issued Nov. 15, the proposed guidance would harmonize with some of the Common Rule and implement provisions included in the 21st Century Cures Act.

As FDA explained, the Cures Act provided it “with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This proposed rule, if finalized, would implement this statutory change.”

Currently, FDA regulations “allow exception[s] from the general requirements of informed consent only in life-threatening situations when certain conditions are met (CFR § 50.23) or when the requirements for emergency research are met (CFR § 50.24). In all other cases, FDA regulations require that a human subject provide informed consent before participating in a clinical investigation. At this time, FDA’s regulations do not allow an exception from the general requirements of informed consent for minimal risk clinical investigations.”

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