Do the minutes reflect well-run meetings?
Better organization, details are needed
It's important that IRB meetings are run efficiently, keeping discussions brisk and on the important human subjects protection issues. But it's also important that these discussions are well-documented in the IRB meeting minutes. If a discussion takes place and there is no mention of it in the minutes, then the IRB could run into problems during an accreditation review or regulatory survey visit.
As one IRB director notes, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) is paying particular attention to what is recorded in IRB minutes.
"We thought we were doing fairly well in that department, and then we were surveyed [by AAHRPP] and we were told we needed further monitoring of the IRB," says Stephanie Gaudreau, CIP, IRB administrator for the Ochsner Institutional Review Board of Ochsner Health Systems in New Orleans.
So the Ochsner IRB began a review process in which two quality assurance staff members review all IRB meeting minutes every six months. They also review a sample of approval letters, checking to make certain all letters match information in the IRB's electronic database, including the IRB meeting minutes.
"Then I meet with the IRB chair once a month and we go over the set of minutes approved by the panel for the previous month," Gaudreau says. "We make sure we've captured all required elements; if there are any problems, we go back and fix them."
The IRB's process of a thorough, biannual review of meeting minutes will be re-evaluated in January, she adds.
"We might change it to a spot check or just pick one month and three sets of minutes to review," she says.
There were three areas in the IRB minutes that AAHRPP plays close attention to, Gaudreau says. They are as follows:
- Make sure the vulnerable populations are documented correctly in the minutes.
- Ensure that privacy and confidentiality issues are discussed at the IRB meeting and documented in the minutes.
- Make certain all unanticipated problems involving risks to subjects and others and any noncompliance issues are properly documented in the minutes.
"We revised our policies and procedures and created a new checklist that differentiates correctly between a review of unanticipated problems and potential noncompliance and whether these are serious and continuing," Gaudreau says.
Previously, both unanticipated problems and instances of noncompliance were grouped together with the term "protocol event," she says.
The AAHRPP surveyor said these should be separate categories in the minutes documentation, she adds.
The IRB created several IRB minutes templates to assist staff with improving documentation of meeting discussions.
Gaudreau networked with other IRB professionals and looked at the templates they used before creating the meeting minutes templates. She also worked with the IRB staff and the IRB chair to select the best template language and to make the information consistent between similar studies.
"What we found in looking at the minutes was the language was slightly different each time we made the determination," Gaudreau says. "It wasn't consistent, but the intent was the same."
The goal was to make it simple: The person writing the minutes could cut and paste template language into the minutes, keeping these consistent.
"We tried to do that for all vulnerable populations, for informed consents, waiver of consents, and all the elements required to approve a study," Gaudreau says.
"We've also used our minutes as a running timeline of what happened at the meeting, so we've divided them up with one template for continuing review, one for amendments, and one for new studies," she explains. "They're specific for one study, so one new study will have one set of minutes, and if we review two new studies at a panel meeting then all are combined in one set of minutes for that date."
The IRB office keeps a signed paper and electronic copy of the full minutes, which are sent to the whole IRB committee.
The IRB monitors reviewing the meeting minutes have already seen evidence the templates are being successfully used, she notes.
"They say the minutes are much easier to review now," Gaudreau says. "It's easier to find the information they are looking for related to a specific study."
It's important that IRB meetings are run efficiently, keeping discussions brisk and on the important human subjects protection issues. But it's also important that these discussions are well-documented in the IRB meeting minutes.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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