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# Proposal to Allow Informed Consent Exceptions
- URL: https://www.fdaweb.com/proposal-to-allow-informed-consent-exceptions/
- Published: 2018-11-15T12:00:00.000Z
- Updated: 2026-09-15T00:45:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142830

*Federal Register* proposed rule: FDA is proposing to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an Institutional Review Board to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-15/pdf/2018-24822.pdf?ref=fdaweb.com).