Remember IRB Review Criteria When Updating Application Design
The IRB had been working with application materials that had not been updated in years and were less flexible than current regulations allow.
One of the IRB’s basic jobs is to make sure criteria are met, but the application’s old design made IRB reviewers’ work more challenging, says Robert S. Bienkowski, PhD, CIP, CHRC, director of the office of research compliance at Central Michigan University.
“We found the old application material to be repetitive in different sections. Information was scattered all over the place, so the reviewer had to piece information together,” says Deborah Geasler, CIM, IRB coordinator at Central Michigan University.
Investigators sometimes wondered why the IRB application asked particular questions, so the IRB asked reviewers to link their comments to specific regulatory criteria, says Katherine Rosier, PhD, chair of the IRB and professor of sociology at Central Michigan University.
“This was difficult for reviewers to do,” Rosier notes. “We were getting better at it, but this led us to consider reorganizing the application in such a way that it had a checklist of each of the 111 criteria.”
The process of revising the IRB application took about a year and a half. The new application is organized in criteria headings, based on federal regulations under 45 CFR § 46.111. (The regulations can be viewed at: http://bit.ly/2tIlxT9.)
If there is a request for information that is not common to all applications, such as enrolling children, it is handled through a hyperlink to a specific form.1 (See checklist of 111 criteria in this issue.)
The revised application served as an educational tool for researchers, and it helped reviewers focus on the 111 criteria and avoid bringing extraneous questions into their review, Geasler says. It has tightened up the review process, decreasing the amount of time spent from study submission to IRB approval.1
“The total review time from submission to approval was cut to one-third of what it was, although we can’t make a causal argument that it was only the change in the application form that led to that decrease,” Rosier says.
Other factors possibly contributing to the decrease in review time are changes in the board’s membership, reviewers’ experience, and IRB leadership, she adds.
One of the unexpected benefits of the application revision process was that the IRB added IT representatives to the board, Geasler says.
Investigators can work upfront with the IRB IT members as they prepare application materials, which helps them establish appropriate data security protections, she says.
“It’s been a win-win, and the information technology crew now better understands research on campus,” Geasler adds. “They’re a tremendous addition to our board.”
Another positive outcome is that IRB reviewers and investigators say they find the new application to be a great improvement to the IRB review process, Rosier says.
“Our reviewers are finding the review of the application easier because our investigators are now used to the forms and they know ahead of time what’s expected of them,” Geasler says. “Applications are becoming better written, which makes the review process easier for our reviewers.”
It has had a big impact on reviews overall, she adds.
“We’re finding that when a protocol is deferred for additional information, we can get it through the approval process in about two reviews, versus three or four reviews as it was with the old application materials,” Geasler explains.
From a quality improvement perspective, the new application form and checklist make it easier to assess whether a new IRB reviewer understands what is required and includes appropriate responses, Bienkowski notes.
“It has highlighted some cases where reviewers did not understand conditional approval and requirements for modifications; we have addressed that with several tutorials,” he says.
Investigators and IRB reviewers were offered an opportunity to submit comments on the new application form as it was being developed, Rosier says.
“The comments we received were uniformly positive from both,” she says.
From Rosier’s perspective as the IRB chair, the application and accompanying worksheet are a major improvement, she adds.
This process was part of the institution’s continuous quality improvement, Bienkowski says.
“We are very conscious of an obligation to not only adhere to regulations, but to also not settle for what we’ve been doing and always be thinking about how to improve things,” he explains. “This is part of our process of introspection: What are we doing? How can we do it? And how can we better protect human subjects?”
REFERENCE
1. Geasler D, Rosier K, Bienkowski RS. Reimagining the application form. Poster presented at PRIM&R’s Advancing Ethical Research Conference, Nov. 14-17, 2018, San Diego. Poster:51.
A revised application served as an educational tool for researchers, and it helped reviewers focus on the 111 criteria and avoid bringing extraneous questions into their review.
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