This is the second blog of a series of blogs about the Clinical Trials Transformation Initiative’s (CTTI) research on central IRBs . This entry summarizes a presentation from CTTI’s recent webinar: Research Institution Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States. In this presentation, Professor Daniel Nelson shares results of a pilot program using central IRBs at the University of North Carolina, Chapel Hill.
In 2012, Professor Daniel Nelson and his colleagues at the University of North Carolina, Chapel Hill had questions about central IRB review. As Director of the Office of Human Research Ethics, Nelson wanted to understand better the pros and cons of using central IRBs in a bigger way than most universities had attempted. Could external IRBs really improve efficiencies? Could they ensure all regulatory requirements were met? Would an external board consider the same ethical and procedural issues as a local board?
For anyone involved in clinical research, what better way to answer these kinds of questions than to launch a carefully-designed study? In mid-2012, Nelson and staff did just that. They launched a six-month pilot program aimed at comparing reviews by external IRB with reviews conducted by the university’s own IRBs. True to the rigors of clinical research, the pilot established eligibility criteria, randomized the selection of studies, and blinded the participants.
Choosing IRBs to Participate
Under the pilot program, the university allowed an independent IRB to have oversight of an industry-sponsored study if the external IRB:
(1) Was already contracted with the sponsor or Contract Research Organization (CRO) to oversee the study centrally; and
(2) Met eligibility requirements. “Eligibile” for these purposes meant AAHRPP accredited; in good standing with FDA and OHRP; and willing to have a services agreement with the university.
CTTI Researchers then compared the timing and conduct of external IRB reviews with a control group of locally reviewed studies. During the six-month pilot, the program’s entry criteria resulted in 48 studies coming from 32 sponsors that utilized eight central IRBs. The team then compiled data about the speed of reviews, the issues identified by the reviewing IRBs, and the experiences of the clinical research teams.
In the CTTI webinar Professor Nelson shared what they learned from the pilot.
- Over those six months, one-third of the studies at UNC Chapel Hill qualified for external IRB review. The other research seen by the local IRBs were locally-initiated, single-site or federal-funded studies.
- The review results were largely the same for both types of IRBs and the concerns raised were mostly administrative or editorial. (Nelson discussed two studies where the local IRBs had serious concerns and deferred a review. Neither case presented serious problems, on futher examination, suggesting that central IRBs were not missing substantive issues.)
- 85% of the study staff who participated said that external IRBs would be advantageous, once initial processes were ironed out.
- The numbers from the pilot confirmed this impression. Professor Nelson reported that reliance on external IRBs saved up to 20 days during study startup.
A New Policy
UNC Chapel Hill subsequently changed its policy regarding external IRB review. Research teams now may choose a UNC Chapel Hill-approved independent IRB whenever
that IRB has oversight of a multi-site study. In discussing the new policy, Professor Nelson emphasized the importance of working with multiple IRBs rather than remaining exclusive to one. An exclusive arrangement, he said, would be like ‘trading one IRB for another.” In contrast, using numerous IRBs capitalizes on the efficiencies identified in the pilot.
Other Lessons Learned
Professor Nelson closed with some other observations about central IRBs:
- Having a services agreement in place was essential. Negotiating an agreement specifically for any one study could erase any time savings.
- Local IRBs often serve as “gatekeeper” for institutional requirements beyond ethical review (e.g., HIPAA, Radiation Safety Committee, Institutional Biosafety Committee, etc. Cynthia Hahn’s presentation in this webinar also explores this issue further.)
The submission process changes with a central IRB. Rather than submitting a new protocol and study plan to a local board, study staff typically provide site-specific information to a central board that already understands the protocol. Nelson characterized this as changing from a ‘protocol submission process to a site registration process.’
Join the Discussion
Are you excited, concerned, intrigued, or do you simply have questions about the use of Central IRBs by institutions? If so, please share your thoughts and questions with us in the comments below. Or email us, if you’d like to be contacted directly.This blog is the second in a four part series discussing the use of Central IRBs in Multicenter Clinical Trials. The first blog in this series is available here.