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# Comments Sought on IRB Records Requirements
- URL: https://www.fdaweb.com/comments-sought-on-irb-records-requirements/
- Published: 2017-05-01T12:00:00.000Z
- Updated: 2026-09-14T22:21:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138588

*Federal Register* notice: FDA is seeking comments on an information collection for “Institutional Review Boards (IRBs) — 21 CFR 56.115 — OMB Control Number 0910–0130.” IRBs are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. Such records include: written procedures describing an IRB’s structure and membership and the methods that the IRB will use in performing its functions; research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; minutes of meetings showing attendance, votes, and decisions made by the IRB, and the basis for requiring changes in or disapproving research, among other records. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-04-25/pdf/2017-08327.pdf?ref=fdaweb.com).