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# Concerns Voiced on IRB Guidance
- URL: https://www.fdaweb.com/concerns-voiced-on-irb-guidance/
- Published: 2016-10-26T12:00:00.000Z
- Updated: 2026-09-14T21:42:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137177

Public Responsibility in Medicine and Research (PRIM&R) says it agrees with the need for additional guidance on institutional review boards (IRBs), but has [concerns](https://www.regulations.gov/document?D=FDA-2016-D-1605-0008&ref=fdaweb.com) about a guidance with an IRB written procedures checklist issued by FDA and the HHS Office for Human Research Protections. The group cautions that “excessive attention to documentation” will lead to unnecessary expenditure of time and effort by both the IRB and investigators at the expense of more meaningful efforts to promote human subject protections by educating reviewers and enhancing reviews. “If satisfying the requirements of the checklist becomes a compliance goal in and of itself,” the letter says, “more valuable opportunities to promote protections may be lost. It is important for the checklist to contribute to improved understanding of regulatory requirements and how these can be translated into practice.”

In its [letter](https://www.regulations.gov/document?D=FDA-2016-D-1605-0009&ref=fdaweb.com), Bristol-Myers Squibbs suggests that the guidance could be strengthened through clarification and differentiation of legal obligations from recommended activities, consideration of sponsors and audits not included in the document, and some additional items.