The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > FDA Unveils IRB Draft Guidance on Written Procedures

FDA Unveils IRB Draft Guidance on Written Procedures

Posted 02 August 2016 | By Michael Mezher 

FDA Unveils IRB Draft Guidance on Written Procedures

The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow.

IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected.

Under federal regulations, IRBs are required to maintain and follow written procedures for certain activities.

According to the agencies, the new guidance, once finalized, is intended to supersede two previous guidance documents on the subject: OHRP's 2011 Guidance on Written IRB Procedures and FDA's 1998 Appendix H: A Self Evaluation Checklist for IRBs.

"The IRB Written Procedures Checklist is designed to prompt a thorough evaluation of procedures essential for ensuring the protection of human research subjects … When IRBs develop and follow clear written procedures, we believe there is a greater likelihood that the rights and welfare of human subjects are protected," the agencies write.

In order to support both HHS and FDA requirements, the new 59-section checklist features a number of ways to indicate which requirements are met by an activity, and specifically references other guidance that may be useful in conducting certain activities.

Figure 1. Checklist Items Indicating HHS/FDA Requirements

IRB Checklist

The guidance also notes that "HHS and FDA regulations do not provide additional detail on the content of IRB written procedures, which gives IRBs the flexibility to establish procedures best suited to their own operations."

As such, the agencies say that the "amount and nature of the detail included in IRB written procedures may vary across IRBs," and that some IRBs may add or omit activities from their checklists where appropriate.



© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.