Save hours on minutes: How to hone the process
No short-cuts, but efficiency possible
There might not be any shortcuts to creating the most accurate and thorough IRB reviews and meeting minutes, but it is possible to make these consistent and accurate with a well-thought-out process.
When the Office of Protocol Research at the University of Texas M.D. Anderson Cancer Center in Houston, TX, worked with IRB chairs to develop protocol review guidelines five years ago, greater consistency was a chief goal.
"We have five IRBs, and we needed consistency in the way the information was being presented," says Marion Olson, CIP, supervisor of human subject research regulations in the Office of Protocol Research.
The aim was to help IRB members remember to provide all of the essential information in their protocol presentations and to help IRB coordinators take more accurate and thorough meeting minutes.
The IRB approval process includes having a scientific editor at each IRB meeting. The scientific editor is part of the research regulations editorial staff, says Martha Matza, MS, CIP, CIM, director of operations of protocol research in the Office of Protocol Research.
"The scientific editor is focused on the consent document, making sure all risks are included and bringing it down to a sixth or eighth grade reading level," Matza says.
There are 25 to 30 IRB members at each IRB meeting, says Wanda Quezada, CIP, manager of human subject research regulations in the Office of Protocol Research.
The support staff attending these meetings includes one IRB meeting coordinator, one IRB coordinator who handles only continuing review discussions, the scientific editor, and Olson, Quezada, and Matza, Quezada says.
"I saw that IRB meeting coordinators were struggling with what exactly needed to be captured," Olson says.
"IRB coordinators in previous years had a lot of IRB experience," she adds. "So when our organization started growing larger, we had more people who had generalized knowledge of the IRB, but who needed specifics."
Likewise, some IRB members, including MDs and PhDs, who present protocols have a great deal of experience, and others are relatively new at the role. IRB chairs assisted with the development of presenter guidelines that would help the newer IRB members in particular.
The Office of Protocol Research staff and IRB meeting coordinators also provide points to consider, helping with the presentation.
For example, if a protocol features an investigational new drug (IND), then the IRB staff would highlight that question in the protocol review guidelines, suggesting that the presenter could focus a little more attention on that issue, Matza says. Also, IRB meeting coordinators might cue the board if a presenter has omitted an important regulatory point.
"I meet with IRB meeting coordinators before the IRB meetings to make suggestions," Olson says.
For example, a study that will enroll a pediatric population will need a pediatric risk assessment, Olson says.
"If the presenter misses bringing that issue to the committee's attention, then the coordinator will whisper to the chair, 'Don't forget about pediatric risk assessment,' and the chair will ask the presenter about it," Olson explains.
The presenter guidelines are part of the institution's strategies for improving both IRB meetings and IRB minutes.
"We started with the IRB presenter guidelines, a template for presenting to the IRB," Quezada says. The guidelines provide the framework for beginning a protocol discussion. For example, the first section of the guidelines contains protocol information with a question about the objectives/purpose of the study.
Breaking down the process
The presenter guidelines feature these main sections:
1. Protocol information: "This section includes objectives, rationale, description, the investigator's brochure, treatment plan, and summary of procedures," Olson says. "They need to let us know if M.D. Anderson is the lead site and whether the study involves a grant that M.D. Anderson applied for."
Protocol information also might cover radioactive materials used and whether the study has been approved by the institution's radioactive safety committee, and whether the protocol uses a new drug or new device, Olson adds.
2. Study population and recruitment practices: Questions for this section include whether the subject selection is equitable and whether the study includes vulnerable subjects and has adequate procedures in place for ensuring their protection.
There also are questions about recruitment practices, including recruitment materials and compensation to study participants.
3. Scientific review process: At M.D. Anderson, the review process is divided into two parts, with the first review being a scientific review made by a separate committee, Olson explains.
"Once they make a determination, it's forwarded on to the IRB," Olson adds.
So this section asks about the important points identified by the scientific review committee, the principal investigator's responses, and how these were resolved. It also addresses any remaining issues and proposed future amendments, and it serves as documentation that the scientific review board did review and approve the protocol.
4. Informed consent document: "The guidelines have questions about consent, risks, side effects, and whether the waiver was appropriate," Olson says. "Also it asks about tissue banking."
5. Recommendation: This last section asks whether the presenter recommends the protocol for IRB approval and/or has any contingencies. If the presenter recommends that the board defer or disapprove the protocol, this section asks that the presenter provide a formal rationale for this position.
The guidelines are not mandatory, but IRB members are encouraged to use them, Olson and Quezada say.
"The reviewer has to give a detailed description of what the protocol is about," Quezada says. "The guidelines give reviewers reminders to touch on all regulatory aspects, including categorizing risk."
Presenters find that the guidelines help them give a detailed presentation, and so some IRB members will type their presentation in advance, giving a copy to the office of protocol research, Quezada says.
"Then that written presentation becomes part of our minutes documentation," she adds.
Not all presenters will have hard copies of their presentation, but when they do it serves as a useful tool for educating the IRB meeting coordinators, Olson notes.
"Our meeting minutes are very good and capture most of what's said," Olson says. "But often there are concepts and ideas you might need to see on paper."
There was no need for obtaining IRB member buy-in on the guidelines since the IRB chairs were involved in creating the guidelines, Quezada says.
"If you get buy-in from the chairs first then the committee members are easy to convince," she says. "The IRB members seem to like these a lot."
While physician and scientist IRB members are experts at research and medicine, they might not be regulatory experts, Quezada says.
"So we give them all of the regulatory information they need," she adds. "The more experienced IRB members can get through our two-page [IRB presenter] template in 10 minutes, but new members might take 20 to 30 minutes to get through the template."
There might not be any shortcuts to creating the most accurate and thorough IRB reviews and meeting minutes, but it is possible to make these consistent and accurate with a well-thought-out process.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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