A flurry of U.S. Food and Drug Administration (FDA) Warning Letters in 2015 related to institutional review boards (IRBs) and their meeting minutes can be taken as an alert about the agency’s seriousness on the matter.
“You should always read Warning Letters to see where the FDA is focusing,” says Glenda Guest, CCRA, RQAP-GCP, TIACR, vice president of Norwich Clinical Research Associates, Inc. (NCRA).
The agency just issued a guidance that should be of particular interest to physician investigators, as it reaffirms some FDA expectations regarding how IRBs take and archive meeting minutes.
“The purpose of the guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings that meet the regulatory requirements for minutes set forth in FDA and [U.S. Department of Health and Human Services (HHS)] regulations,” FDA says. The guidance also provides general recommendations on the type and amount of information to be included in the minutes.
For example, Guest often finds that an IRB hasn’t recorded proof that the person who proposed a certain study protocol recused themselves from voting on its suitability for the research site in question. In the vast majority of cases, the IRB has probably made certain the person did recuse themselves, but without a record, FDA will act as if it never happened.
Another example: IRBs don’t always include a membership roster, and that’s dangerous, Guest says. “Without a roster, I can’t tell if they’re in compliance,” she notes. The roster should show that the IRB contains at least one scientific member and another who is not associated with the facility. IRBs nearly always compose boards that meet these criteria. However, it’s another case of “if it isn’t documented, it didn’t happen” as far as the FDA is concerned.
FDA issued the guidance in concert with the Office for Human Research Protections (OHRP). To enhance human subject protection and reduce regulatory burden, OHRP and FDA 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 December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114–255) was signed into law. Title III, section 3023 of the Cures Act requires the Secretary of HHS to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations.
In other regulatory news, the International Council for Harmonization (ICH) just issued some revisions to several steps of its process. The updates are relatively minor, Guest says, but might be deserving of a quick look for those with international operations.
Author: Michael Causey