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# IRB Waiver of Informed Consent Guidance Availability
- URL: https://www.fdaweb.com/irb-waiver-of-informed-consent-guidance-availability/
- Published: 2017-07-26T12:00:00.000Z
- Updated: 2026-09-14T22:36:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139223

*Federal Register* notice: FDA has announced the availability of a guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” The document notes that FDA does not intend to object to an IRB waiving or altering informed consent requirements for certain minimal risk clinical investigations. In addition, it explains that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-07-25/pdf/2017-15539.pdf?ref=fdaweb.com).