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# Guide on IRB Written Procedures
- URL: https://www.fdaweb.com/guide-on-irb-written-procedures/
- Published: 2025-02-10T12:00:00.000Z
- Updated: 2026-09-14T14:52:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158631

FDA has released a [final guidance](https://www.fda.gov/media/185365/download?ref=fdaweb.com) entitled “Institutional Review Board (IRB) Written Procedures” that is intended to harmonize FDA and HHS’ Office for Human Research Protections (OHRP) regulatory requirements on clinical trial human subject protections. The document says FDA and OHRP believe that when institutions and IRBs develop and follow clear written procedures, there is an increased likelihood that human subjects will be better protected. It also includes a written procedures checklist that adheres to regulatory requirements for IRBs and recommends operational details to include to support each of the requirements. Additionally, the checklist includes topics the institution/IRB may consider when developing comprehensive procedures.

The guidance notes that HHS and FDA regulations allow flexibility in both format and content of written procedures so IRBs can establish procedures best suited to their own operations. “Written procedures may be maintained electronically or may be paper-based and formatted in a style that conforms to the needs of the institution,” it says. “Institutions/IRBs may choose to create written procedures that focus solely on the regulatory responsibilities of the IRB, or they may choose to also incorporate institutional policies and procedures that are a function of the institution’s human research protections program.”

The agencies say that detailed administrative procedures for IRB support staff may be included, or may be managed through other locally written policies and procedures (e.g., work instructions, standard operating procedures, or a staff operations manual). They note that some IRBs develop written procedures for the IRB that simply restate the regulations. In general, this approach is not encouraged because it does not provide sufficient detail about an IRB’s operations to ensure it meets the applicable regulatory requirements. “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,” the guidance says, adding that written procedures should be sufficiently detailed to help IRB members and institutional administrative staff understand how to carry out their duties.