From the Director: PRIM&R’s Comments in Response to OHRP’s and FDA’s Draft Guidance on IRB Written Procedures

Elisa Hurley

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.”

When the guidance is finalized, it will supersede OHRP’s 2011 “Guidance on Written IRB Procedures” and FDA’s 1998 “Appendix H:  A Self-Evaluation Checklist for IRBs,” originally part of FDA’s Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors.

In the draft guidance, the agencies acknowledge that IRBs’ written procedures will vary depending on factors such as the type of research reviewed by the IRB, administrative practices, and local and state regulations and laws. To assist IRBs in developing and maintaining written procedures that are appropriate for their specific contexts, the guidance provides an “IRB Written Procedures Checklist” that identifies the relevant regulatory requirements and provides recommendations for additional topics that should be included in written procedures.

This is the second time in recent months that OHRP and FDA have released joint draft guidance. (In November 2015, the agencies jointly released draft guidance on IRB meeting minutes.) In its comments, PRIM&R notes that OHRP and FDA’s harmonization of guidance in this area will simplify the process by which IRBs who are answerable to both the DHHS and FDA can comply with both sets of regulations.

PRIM&R agrees with the agencies that additional guidance regarding IRB written procedures will benefit the research community, and that documentation requirements can support human subjects protections by helping to focus attention on critical aspects of human subjects research review. We also recognize that the checklist format may be particularly useful to institutions that currently have little in the way of written procedures in place and are looking to strengthen their research oversight infrastructure.

However, PRIM&R expresses some concerns about the draft guidance. We note that excessive attention to documentation may lead to the 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 review.

We also suggest that the guidance should provide specific examples of responsive answers to several prompts in the checklist that are unclear. Specifically, we point to several prompts that call for written procedures about activities that are at the core of IRB review and deliberation, including the application of the criteria for review, the review and approval of informed consent processes, and the decision to ask for additional safeguards for vulnerable subjects. We point out that, without examples of acceptable practices that will “help regulators understand how the IRB operates,” the prompts may result in documentation that does little more than reiterate the prompt itself. 

PRIM&R also requests that the agencies clarify whether the guidance is intended only for IRBs, and ensure that the content matches the intended audience. Several items in the checklist mention activities that may fall to the IRB committee, but are not strictly IRB committee functions and may instead be administrative responsibilities carried out by an IRB administrative office or by another entity within a larger human research protection program. Without this clarification, the checklist could perpetuate IRB “mission creep,” threatening to divert IRB resources and attention from the core of its work of protecting human subjects.

We encourage and welcome you to share your thoughts on our comments or the draft guidance document by leaving a comment below.