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Independent IRBs grow larger, meet increased demand

Monday, June 19, 2017

Chesapeake IRB, an independent IRB that provides study review services across North America, has acquired MaGil IRB and the Institutional Biosafety Corporation, (IBC) both based out of Rockville, Maryland. These acquisitions are merely the most recent for Chesapeake, who has taken on five AAHRPP-accredited IRBs since 2013, including Compass IRB last year.

“Joining with Chesapeake allows [our] customers to benefit from Chesapeake’s innovative cloud-based IRB platform, CIRBI, while continuing the joint mission of safeguarding the rights and welfare of clinical research participants,” said Gil Price, M.D., co-founder and CEO of both MaGil IRB and IBC, in a news release.

Said Jeff Wendel, M.B.A., president and CEO of Chesapeake, in the release, “Together, we are even better positioned to deliver unparalleled human subject protections and oversight and exceptional client service.”

The announcement indicated that IBC will expand Chesapeake’s services more deeply into “research utilizing recombinant or synthetic DNA molecules, including clinical trials involving genetic engineering and gene therapy.” MaGil IRB will bring to Chesapeake its cost-effective, centralized IRB services and experience working with underserved populations.

Chesapeake is already one of the largest independent IRBs in the U.S. The company, founded in 1993, has 10 U.S. satellite offices beyond its Columbia, Maryland, headquarters. Its Canadian subsidiary, IRB Services, extends the company’s footprint into Toronto and Montreal.

Chesapeake’s acquisitions reflect an ongoing trend in the industry toward IRB consolidation. With each new acquisition, IRBs are growing in size and scope. Some are taking on additional clinical support services to assume a more central role in the industry.

“This type of consolidation is inevitable, as it is difficult for small IRBs to survive in today’s highly competitive market,” said Cami Gearhart, J.D., CEO, Quorum Review IRB. “In contrast, as one of the largest IRB operations, we are able to invest in IT and other services to support research participants and researchers.” Quorum recently launched an electronic informed consent—Q Consent—to extend its own reach into the marketplace beyond traditional IRB services.

Other IRBs have followed suit and expanded offerings. WIRB-Copernicus Group, which began independent ethical review in 1968, has grown to include a family of companies including Copernicus IRB, Midlands IRB, Aspire IRB and New England IRB, among others. Just last month, WIRB-Copernicus Group acquired MedAvante, ProPhase and ThreeWire. The acquisitions expand the group’s place specifically in the clinical research sector; central nervous system and behavioral health assessments; and participant recruitment services.

Independent IRB expansion may be driven, in part, by an uptick in multicenter clinical trials. Efficacy trials enrolling hundreds of participants often require several study sites, and trials enrolling niche populations may require even more. According to the NIH, multicenter trials “help increase the number and diversity of the participants, improve operational efficiencies and accelerate the generation of research results.”  Yet a mix of local IRB rules and regulations can create a “bottleneck” at study startup. FDA regulations require that each study site gain IRB approval before they can begin. Sponsors of multicenter trials involving sites with local IRBs—like universities—can find themselves juggling multiple review board schedules and watching their timelines stretch. Even with the most efficient IRBs on-site, each review adds time—and therefore cost.

“For multicenter trials, it would be easier if every site was with a central IRB, so there is no hold up on approvals, or questions related to workflow. Plus, CROs can interact directly with a central IRB for questions that impact all the sites,” said Karen Arters, BSN, RN, CCRP, Clinical Research Coordinator, University Hospitals Cleveland Medical Center. Arters has had mixed experiences working with centralized IRBs versus local boards, and cites pros and cons to each.

“It streamlines the process for the sponsor when a central IRB is used,” she said. “But, coming from an institution where we have our own local IRB, it can make sense to use your own. Sometimes centralized IRBs just don’t have the same vested interest the way the local boards do.”

Many institutions, including Chesapeake, have joined SMART IRB to help centralize IRB review processes. The platform links institutions participating in multicenter studies, including all 64 CTSA hubs, and is supported by the National Center for Advancing Translational Sciences. Participating institutions can use the system to request, track and document IRB reliance agreements on a study-by-study basis. Reliance agreements through SMART IRB may be one way that local IRBs can keep up, and even collaborate with, larger independent IRBs.

SMART IRB will certainly help institutions comply with changing regulations related to the use of a single IRB for multisite research. Last year, the NIH released a new policy aimed at streamlining the IRB review process and eliminating redundancies. The new policy “establishes the expectation” that NIH-funded human subject research involving multiple U.S. sites use a single, central IRB to comply with FDA regulations. The policy goes into effect September 25, 2017. The shift in regulations could increase demand for independent IRBs—like Chesapeake, Quorum and the WCG group—and may drive further growth and consolidation in the sector. 

 

This article was reprinted from Volume 21, Issue 24, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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