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by Jim Gearhart

Together, FDA and OHRP Propose a “Must-Have” List for IRB Written Procedures

Update 5.23.2018

Last week first-cousin regulatory agencies for medical research FDA and OHRP issued joint guidance about which written procedures institutional review boards (IRBs) should have. The guidance has changed little from its draft version (on which both Quorum and Kinetiq commented), and the core of the guidance document still is an eight-page checklist that prompts an IRB to confirm (and document) that it has sufficient written procedures for its operation. The distinctions between which requirements apply to OHRP/HHS regulations, which come from the FDA requirements, and which apply to both should prove especially useful. This guidance should provide a useful resource to avoid one of the most common findings in governmental audits of IRBs: “a lack of written procedures.” The final guidance can be viewed here.


As reported last week by Kinetiq, the consulting and technology division of Quorum, on August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly released a draft guidance document about written procedures for an IRB. The agencies intend for the guidance’s unified checklist to replace two separate lists that each office maintained.


The draft document does not establish any new requirements, but it does consolidate the two agencies’ expectations into one policy as well as a checklist. In fact, the checklist is the core of this draft guidance document, and it brings together the often overlapping, sometimes differing, expectations that the FDA and OHRP have for an IRB’s written procedures.

This consolidation may help IRBs avoid receiving warning letters like this one in the future:

“Your procedures currently only address the requirements of 45 CFR Part 46 for federally funded or supported research. These do not meet the requirements of 21 CFR 56.108.”
FDA Warning Letter


A Closer Look

This is the second time in a year that the FDA and OHRP have collaborated on a policy statement about IRB operations. In November 2015, the two agencies issued a similar document about IRB minutes. These announcements show that the offices are sticking to their commitment to increase policy harmonization. It is also a welcome update; while OHRP produced a “Guidance on Written IRB Procedures” in 2011, the FDA’s most recent tool for an IRB’s self-evaluation dates to 1998.

Since an IRB could end up under the jurisdiction of either agency, this consolidation of requirements looks like a positive step. While the draft document does not break any new policy ground, it does demonstrate the fundamental importance of a comprehensive set of written procedures for any successful IRB operation.

An audit of existing documentation with this checklist promises to be thorough. The checklist has twenty-nine specific items and takes up ten of the document’s eighteen pages. The document’s drafters note that not every item is specifically required, and that not every IRB needs a written procedure for each item. The ten-page checklist, however, explicitly lays out the expectations of these two regulatory agencies.

Was this guidance document necessary?

How often, really, do IRBs lack written procedures? With the help of our summer intern, I reviewed five years’ worth of FDA Warning Letters and OHRP Letters of Determination to see how frequently they listed “lacks written procedures.” My findings are shown in the table below.

Letter TypeTotal Sent to IRBs
Included "Lack of Written Procedures" findingPercent
FDA Warning Letter261454%
OHRP Letter of Determination311445%

Among all letters issued from 2011 through 2015, missing procedures were an issue about half the time. From the FDA, Warning Letters mentioned missing procedures in fourteen of twenty-six letters, and in OHRP’s Determination Letters, that number was fourteen out of thirty-one.

At the time of the inspection, you indicated that the IRB was using their bylaws and guidebook; however, you acknowledged that the IRB was operating without any type of written procedures.
-FDA Warning Letter


The severity of the omissions varied. In a small (but, to me, surprising) number of FDA cases, an IRB apparently had few to no written guidelines. More frequently, though, for both OHRP and FDA, one or two specific  processes was not documented. Most often, the missing procedure(s) involved receiving or communicating safety information.

“We have found that…written IRB procedures do not cover the reporting of serious or continuing noncompliance with 45 CFR part 46 involving IRB acts or omissions.”
-OHRP Determination Letter



This new checklist looks like a useful reference for any IRB to confirm or establish its compliance with two sets of interrelated regulations. And missing written procedures do appear to be a notable enough issue for IRBs to ensure they are in compliance.

FDA and OHRP are accepting comments on the draft guidance until October 3, 2016.


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