Pre-review process results in faster IRB review process
All submissions are pre-reviewed
IRBs could improve and expedite their review process by hiring someone to pre-review submissions, an expert suggests.
About five years ago, the IRB at the University of Tennessee Graduate School of Medicine (UTGSM) in Knoxville added an office position of research associate, says Reni Leslie, CIM, IRB associate director. The IRB has 15 members plus four alternates and mainly handles biomedical studies.
"Our research associate pre-reviews all prospective submissions, whether they are minimal risk, expedited review or full review," Leslie says. "She looks at the applications, works with investigators, and whether or not we need more clarification it is worked out before it's submitted for IRB approval."
This pre-review process speeds up the entire approval process, especially if submissions go to the full board, she adds.
"In general, very rarely do we have a study that is deferred," Leslie says. "Studies usually receive provisional approval pending minor corrections or clarifications that can be reviewed and approved by the chair."
The IRB meets monthly to conduct full board reviews of all studies with more than minimal risk. The board also has an expedited agenda containing annual reviews, expedited reviews, revisions, safety reports, and other items that need to be processed and approved, she says.
With the pre-review process, the hold-ups common at other IRBs almost never happen at UTGSM.
"I hear horror stories of different IRBs, where it can take a month or two to get approval, and that rarely happens here," Leslie says. "Our policy states the approval process takes five to 10 working days after we receive the submission and review the application."
The IRB's research associate's chief role is to assist investigators with submissions. She often works with first-time investigators who have basic questions about completing the submission forms.
"She also does random audits on protocols," Leslie adds.
Here's how the pre-review process works:
• Submission calendar:"We send out a submission calendar in October/November for the following year," Leslie says. "It gives the date and deadlines for greater-than-minimal-risk studies that receive full board pre-review, the date it's due to be processed, the date of the IRB meeting, and it's sent out to all IRB members."
• Electronic submissions: Investigators submit protocol applications electronically, and the research associate reviews the application and informed consent.
"She makes sure all questions are answered and if something was left out, or if she has an issue with the language in the consent form, she works with the investigator or coordinator," Leslie explains. "When everything is completed and she's satisfied with the explanation, she signs off on it, and this is usually a week to 10 days before it's due to be submitted to the IRB."
Most questions can be answered prior to the IRB meeting, she notes.
The UTGSM website contains a checklist for IRB applications. It lists items that are part of the IRB submission process, including any or all of these:
- application signed by all study personnel and the principal investigator's department chair;
- protocol;
- investigators brochure;
- consent;
- budget;
- collaboration forms;
- radiation safety review;
- advertisements;
- grants;
- letters of support;
- curriculum vitae for all study personnel (first IRB submission only).
"By doing the pre-review we get most of the kinks worked out," she says.
• IRB pre-review: In addition to the research associate's pre-review process, there is a system in which IRB reviewers look at the new protocol or the amendment sent to the full board for review.
"We try to get the reviewer's comments back before the meeting because if there's a question that the investigator can answer before it goes to the board, then this will help cut down on time," Leslie says. "I like to get all of the answers before the board meets."
For instance, the IRB reviewer might have some minor questions about the inclusion criteria, the numbers enrolled, or the lab work.
• Informed consent: "It's very helpful for investigators who have never conducted research to have someone work with them to develop an informed consent document," Leslie says. "There are times when she helps them write the consent document and the application because not everyone knows how to do this."
• Investigator assistance: Besides expediting the approval process, having a research associate position has been a tremendous help to physicians, residents, and others new to research, Leslie notes.
"To me, it's the best thing that ever happened," she says. "It seems like people really appreciate it."
Each year when new residents arrive, Leslie, the IRB chair, and the research associate speak with the residents and give them an inservice about the IRB.
"We pull up our website and show them the IRB submission flowchart," Leslie says. "We show them which forms to submit."
IRBs could improve and expedite their review process by hiring someone to pre-review submissions, an expert suggests.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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