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# Guidance on IRB Written Procedures
- URL: https://www.fdaweb.com/guidance-on-irb-written-procedures/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136378

*Federal Register* Notice: The Office for Human Research Protections, Office of the Assistant Secretary for Health, and FDA are making available a draft guidance entitled *Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.* Its purpose is to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for IRBs. It is intended for IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both. To download this guidance, click [here](http://www.fda.gov/RegulatoryInformation/Guidances/ucm512760.htm?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-02/pdf/2016-18191.pdf?ref=fdaweb.com)