University creates new model for shared review
IRBshare seeks to simplify the process
In June 2011, representatives from various IRBs and federal regulatory bodies met to discuss the development of a new model to improve the multisite study model. Lead by researchers from Vanderbilt University in Nashville, the team developed IRBshare to streamline the multisite review process and reduce headaches for IRB members.
IRBshare is a Web portal for shared multisite study review. Participating institutions can upload IRB-approved shared review documents and view those of other members, such as redacted meeting minutes, protocol, approved consent documents, and IRB applications. Local IRB forms and submission processes remain the same. The Federal Drug Administration (FDA)- and Office of Human Research Protections (OHRP)-approved IRBshare model, says Emily Sheffer, brings simplicity to multisite studies, improves IRB efficiency for multisite studies, and saves money by reducing the manpower needed to get a study approved.
“With IRBshare, IRB members can talk to one another and are now connecting with each other and relying on each other in a very open way,” says Sheffer, project manager for IRBshare at Vanderbilt University. “They’re reviewing other IRB approved documents and are able to communicate and consult with one another. The hope is that it will enhance communication and cooperation and result in more efficient and consistent IRB determinations.”
The IRBshare model was born of experiences with multisite studies, where every site’s IRB must review the same protocol. “When this many [reviews] happen, different IRBs may find different things wrong with the exact same protocol. It’s not the most practical model,” Sheffer says. “The current regulations are not designed for multisite review.”
Gordon Bernard, MD, vice chancellor for research at Vanderbilt University, received a R13 conference grant from the National Institutes of Health (NIH) to develop the model. In June 2011, representatives from 37 Clinical Translational Science Award (CTSA) sites, OHRP, the Association for the Accreditation of Human Reasearch Protection Programs (AAHRPP), and independent IRBs met to discuss options to form the new multisite research agreement. “The idea behind this grant was to bring together multiple stakeholders and industry folks and IRB personnel to talk about what they need to get multisite studies off the ground,” Sheffer says.
After outlining the goals for the IRBshare model, the team decided to start small and establish the process only for initial study review. “We wanted to start small and think about what the biggest concern is, and we targeted initial study review.”
In his presentation at the 2013 AAHRPP conference in Miami in April, Bernard outlined some of the goals of IRBshare:
—reduced administrative costs;
—faster review cycle time;
—faster study initiation;
—increased number of IRB approvals;
—fewer differences in number and type of changes requested for study documents;
—increased partnership satisfaction levels;
—learning from collaborations.
IRBshare is open to all organizations with a Federalwide Assurance with OHRP and has its own master agreement, the IRBshare Master Agreement (IMA), which establishes the temporary reliance required to conduct a joint review of a multi-site study. The IMA is the same for every IRB and does not make changes for individual institutions. Reliance is only for initial study review and local sites become the IRBs of record again. “The idea for the master agreement was to have one single agreement instead of a separate agreement for every study,” Sheffer says. “The local IRB is going to maintain control of the study.”
Once they are part of the system, participating institutions can take one of two paths for review: the shared review process or the traditional review path. In a shared review, an IRB will access the shared full board review in the system and rely on one single full board review of their choice via a subcommittee review (an IRB chair or designated IRB member) of the shared documents and an administrative review of local context issues. With traditional review path, a full board review can still be used if the subcommittee has any questions or concerns with the initial review.
Full board review documents are shared and can be viewed by all IRBshare members. Once a review is shared, anyone who is part of IRBshare can view it — users cannot select who can and cannot rely on the review.
When users log on to IRBshare, there is a user-specific dashboard screen that shows what projects the user is following, how many projects are registered at the user’s site, and how many users are at the site. Users can also search for projects or create new one.
From there, the IRBshare project page is organized around the types of reviews completed by each institution (full board review, shared review, and undecided). For full board review sites, the documents uploaded by the local IRB are listed. The required documents include the study protocol, IRB determination letter, meeting notes, IRB application, and consent forms. Users can also upload any other documents that show that the study was approved without contingencies.
Member sites that are not currently part of a study can view any uploaded documents. An unexpected benefit, Sheffer says, is that IRBs can learn from other institutions’ documents and adapt them to meet the needs of their IRB. For example, an IRB user at an institution not taking part in a study in IRBshare was able to log in, review another site’s meeting minutes, and modify its own meeting minutes template for an AAHRPP application. “People are reviewing how others are documenting things and adapting their processes if they find better ones,” Sheffer says.
So far, IRBshare, still in the pilot phase until more evaluative data are available, has 25 participating institutions and four studies. One institution, Duke University in Durham, NC, has completed a shared review, relying upon the review of Vanderbilt. “They thought the process was really easy and had no problems with the shared review,” Sheffer says. The study was reviewed and received IRB approval in one day.
Sheffer says the team is reaching out to principal investigators and study teams as well as other IRBs. “Because this is a multiparty agreement, it’s hard to get through the institutions. We’re letting the investigators know they can also use IRBShare.” One institution, according to Bernard, reduced paperwork for PIs by creating an abbreviated IRB application for locally submitted studies after the full board approval was uploaded to IRBshare. The PIs would then submit the shorter application, consent form, and cover letter.
“We have 25 members, and a lot already collaborate. We’re contacting other sites to say they can use it — there’s a process of educating and recruiting that needs to happen,” Sheffer says.
While the IRBshare team continues outreach to more institutions to participate, Sheffer acknowledges the model is not for everyone. “Not everyone is quite ready for this type of system yet,” Sheffer says. “Joint review models create reluctance around issues of liability, accountability, responsibility, control, and quality, and those will be things we continue to work on.”
Institutions have different concerns with joining IRBshare, such as having only one IRB member review and approve a study. “Sites have been really creative with coming up with solutions,” Sheffer says. “They know they can always kick it [a study] back to the full board for review if they’re not comfortable with shared review. They’re getting used to it and understand that it’s a thorough review of a study that has already been reviewed. Processes don’t change very much for the local site. They can conduct local context review, then instead of waiting to get to full board, have the IRB chair or any IRB members do any of the shared review.”
Sheffer says other IRBs have expressed interest in signing the master agreement if IRBshare includes continuing review and amendments — something that Sheffer says is on the horizon. IRBshare has already received verbal regulatory support for continuing review, and the team is working out ways to integrate it into the system and the master agreement. “We’ve heard from people who say they’ll join when we get continuing reviews in place,” she says. “We already started meeting with the system developer to make changes in the system as we work through kinks and nuances of regulatory piece. The biggest piece is making sure regulatory experts are on board. We need time to review and make sure things meet their standards.”
In June 2011, representatives from various IRBs and federal regulatory bodies met to discuss the development of a new model to improve the multisite study model.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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