By Melinda Young, Author

New federal guidance on IRB written procedures leave “meaningful content” open to interpretation. The final joint guidance, titled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs,” was issued in May 2018 by the Department of Health and Human Services Office for Human Research Protections (OHRP) and the FDA. (The guidance is available at: http://bit.ly/2LNuJ0r.) IRB Advisor asked the agencies to provide more information on what they are looking for from IRBs.

The following is FDA’s response from Theresa Eisenman, press officer at FDA:

IRB Advisor: In the new guidance, OHRP and FDA state that IRBs develop written procedures that restate 45 CFR 46 regulations, and this does not contain sufficient detail about the IRBs’ operations. How might IRBs develop “meaningful content for written procedures,” and do you have any examples of more thorough written procedures from any IRBs?

FDA: Developing meaningful content for written procedures involves a comprehensive and critical assessment of the IRB’s responsibilities, functions, and operations, and the institution’s organizational structure.

Written procedures should be sufficiently detailed to help IRB members and institutional administrative staff understand how to carry out their duties in a consistent and effective way that ensures that the rights and welfare of subjects are protected and that the IRB operates in compliance with the regulations.

FDA and OHRP recognize that written procedures may vary among institutions and IRBs because of differences in the way organizations are structured, the type of research studies reviewed by the IRB, institutional policy or administrative practices, the number of IRBs at the institution, affiliation with an institution, and local and state laws and regulations. This variability in organizational structure allows for a broad range in content to meet the regulatory requirements for written procedures.

Institutions/IRBs may decide to make their written procedures available to ensure that others (e.g., investigators, sponsors) are aware of their requirements, and to facilitate compliance. Some institutions/IRBs post their written procedures on a website to provide broad access. Such examples may be helpful to institutions/IRBs.

IRB Advisor: What are some links to the guidance documents that could serve as useful resources to IRB staff?

FDA: Footnote 2 in the guidance refers readers to three websites for other guidance documents that may serve as useful resources to institutions and IRBs.

Both FDA websites listed in the guidance include links to other guidance documents that may be useful resources to institutions and IRBs. For example, FDA’s webpage of Selected FDA GCP/Clinical Trial Guidance Documents at: https://bit.ly/2JZx86W includes a section titled “Institutional Review Boards (IRBs) and Informed Consent.”

IRB Advisor: Would use of the Written Procedures Checklist, which is provided in the guidance, suffice to satisfy regulatory requirements during an institutional survey? If not, what else might be needed?

FDA: FDA and OHRP created a Written Procedures Checklist to assist institutions and IRBs in preparing and maintaining detailed written procedures. The checklist is designed to prompt a thorough evaluation of written procedures that helps to ensure the protection of human research subjects. The checklist incorporates the HHS and FDA regulatory requirements for written procedures for the IRB and recommendations about operational details to include to support each of these requirements. It includes some additional topics the institution/IRB may consider when developing comprehensive procedures.

We remind institutions and IRBs that the checklist is intended to facilitate an improved understanding of regulatory requirements for written procedures for the IRB, to provide recommendations on the operational details to include in support of these regulatory requirements, and to provide some additional topics the institution/IRB may consider when developing comprehensive procedures. The checklist is intended to be a tool to assist in determining what information should be covered in written procedures rather than a tool for assessing compliance.

Our guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes FDA’s and OHRP’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

IRB Advisor: How might this guidance change what IRBs/HRPPs do in their daily work?

FDA: FDA and HHS regulations allow flexibility in both format and content of written procedures, which gives IRBs the ability to establish procedures best suited to their own operations, including how much detail to include. The checklist is intended to facilitate an improved understanding of regulatory requirements, provide recommendations on the operational details to include in support of these regulatory requirements, and to provide some additional topics the institution/IRB may consider when developing comprehensive procedures. Institutions and IRBs should use the flexibility afforded by the regulations to adopt written procedures that are suitable for their organizations.

IRB Advisor: Why was this guidance needed?

FDA: FDA and OHRP frequently receive questions about the scope and content of written procedures and issued this guidance to address those concerns. To enhance human subject protection and reduce regulatory burden, we have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.

In addition, on Dec. 13, 2016, the 21st Century Cures Act was signed into law. The Cures Act requires the secretary of HHS to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations.

FDA and OHRP believe that it is most helpful to the regulated community to issue a joint guidance document that describes the agencies’ approach to preparing and maintaining written procedures.