HHS Final Guidance on IRB Written Procedures Clarifies Required Versus Recommended Provisions, Includes 55-Item Checklist Tool

May 21, 2018

HHS published final guidance providing a checklist identifying regulatory requirements for IRB-written procedures and providing recommendations on the type of information to include.

The final guidance is largely unchanged from FDA draft guidance issued in August 2016, with the biggest change being clarifications for which provisions are required as opposed to which are recommended, according to David Borasky, vice president of IRB compliance at Copernicus Group IRB.

An IRB “that’s not sure whether or not it really has the level of detail could look at that table to identify different areas where they might want to add more detail,” Borasky said. “The most important thing is a reminder that there is a discreet set of written policies IRBs are required to have and this is a good opportunity to confirm that an IRB has those things in place.”

The final guidance will primarily be helpful for IRBs “that are unsure of whether they’ve got things covered,” Borasky told CWWeekly.

The 55-item checklist is described as a tool to help determine what information should be covered in written procedures rather than a tool for assessing compliance. It includes sections on initial and continuing review of research, verification of changes, reporting of unanticipated problems and suspension or termination of IRB approval, among other topics.

The guidance further notes that written procedures should not simply restate the regulations to which they correspond, he said.

The final guidance, issued jointly by the HHS Office for Human Research Protections and the FDA, replaces OHRP’s July 1, 2011, Guidance on Written IRB Procedures. The guidance implements provisions in the 21st Century Cures Act requiring the HHS Secretary to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations.

As both OHRP and the FDA have issued several guidance documents covering more specific topics for the research process, institutions and IRBs should review the relevant documents when preparing their written procedures, the guidance states.

“We 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,” OHRP and FDA said.

When preparing written procedures, IRBs should ensure they specify who carries out specific duties by title rather than by name, to avoid the need for unnecessary updates if membership or duties change, the guidance recommends. The procedures should be detailed enough to help staff understand how to do their jobs consistently while protecting subjects.

-By James Miessler