Expert makes case for using minutes template

Here’s why it would help

IRBs should have both a minutes process and a minutes template, an expert says.

“A minutes template would direct the minutes taker to ensure that all of the issues that were discussed are recorded,” says Cheryl A. Savini, CIP, principal and chief operating officer for HRP Consulting Group Inc. of Clifton Park, NY.

“IRBs also should have a process — and this is very important — on how to run the IRB meeting,” she adds. “This is so the person taking the notes has the ability to document the discussions correctly and provides an opportunity for them to say, ‘Hold on a minute — we didn’t discuss a particular issue such as equitable subject selection,’ which is one of the criteria for approval under the federal regulations.”

A process keeps the IRB on track, making certain all of the important decisions and discussions occur.

“In addition to that documentation, the minutes should be very clear on what the investigator will be told,” Savini says. “The IRB can determine whether they need clarification, changes to the protocol, or require stipulations; and the minutes should be very clear about exactly what the investigator will see in their review letter.”

Think of the IRB meeting minutes as a part of the IRB’s history and record, she suggests.

“When regulatory agencies come into an institution to conduct an audit, whether for cause or not, the minutes provide a full history of the IRB’s discussions and actions,” Savini says. “Two or three years down the road there is documentation of what took place at the meeting.”

While a template is helpful in ensuring compliance, it’s also important to have the right person taking the meeting minutes, Savini says.

“This should be a person who has experience in human research protection so they understand what the regulatory requirements are and they understand the discussions about the type of research being discussed,” she says. “They should know medical terms if reviewing medical research and be a detail-oriented person.”

“You could even have several people doing the work; having one person documenting the criteria for approval and one person making changes to the informed consent document,” she says. “Another person could keep track of IRB members coming in and out of the room to make sure there is quorum, because if quorum is not met and recorded as proof, then the meeting could be considered invalid.”

When creating a template, it’s important to customize it for the type of research the IRB sees most often. So if an institution never conducts research that is regulated by the Food and Drug Administration (FDA), then it’s unnecessary to include regulatory language for those types of studies, Savini says.

Some basic elements of an IRB meeting minutes, in addition to the regulatory requirements under 45 CFR 46.111, include:

  • What time did the meeting start?
  • Who is present at the meeting?
  • Who is the non-scientific member of the IRB?
  • Who is the chair of the IRB?
  • Which alternate board members are present and who are they replacing at the meeting?
  • Are there members with any conflicts of interest?
  • Is there quorum for the meeting to proceed?

Another big issue IRBs should note when creating a minutes template and training staff in writing minutes involves the overall strategy for writing the minutes: “The minutes need to reflect what happens during the meeting — not before and not after,” Savini says.

For instance, an IRB might say a research protocol is approvable pending the receipt of additional information. By the time the minutes are drafted and brought back to the IRB for review and acknowledgement, the investigator has submitted the necessary information and the protocol is approved. But it would be a mistake for the minutes to say that the protocol was approved at the meeting when the protocol was actually approved after the meeting, she explains.

“It’s a matter of making sure that you don’t document something if it didn’t happen at the meeting,” Savini says.