quality and efficiency of clinical trials.
CTTI Project Cateogy: Study Start-Up
Project Status: Complete
The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multicenter trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections1 recommending this approach.
CTTI's Definition of Central IRB: A single IRB of record for all sites involved in a multi-center protocol. A range of entities may serve as a central IRB (e.g. another institution’s IRB, a federal IRB, an independent IRB).
Before a clinical trial gets underway, the protocol (study plan) needs to be reviewed by someone not connected to the research to be sure it is ethical, provides potential benefits, and does not cause unnecessary harm to participants. This review is done by Institutional Review Boards (IRBs). In multicenter trials, where a study to answer a single research question is carried out at several different sites (locations), each site’s IRB usually reviews the protocol separately. This can take a long time, cause duplicate work, and can even result in the protocol being changed by individual sites so that it is no longer the same across all sites. One solution to this would be for all of the sites in a multicenter trial to use the same IRB (a central IRB). Use of a single, central IRB may save time and money and make sure the research is being done in the same way at each site. The U.S. Food and Drug Administration (FDA) and the U.S. Office of Human Research Protections (OHRP) have both encouraged the use of a single, central IRB for multicenter trials, rather than each site using its own. However, some research sites are hesitant to use a single, central IRB.
More about IRBs
IRBs do many other things in addition to making sure a study protocol is ethical and not unnecessarily risky. They may also:
Identify potential solutions to address barriers to the adoption of central IRBs for multicenter clinical trials
We found that one of the main barriers to using central IRBs is that local sites use IRBs not only for approving protocols, but also for various site-specific tasks related to clinical trials, such as training staff, making sure investigators comply with research protocols, and making sure HIPAA privacy rules are being followed. There is confusion about how a central IRB could handle all the tasks that a typical site-specific IRB handles. To clarify this issue, we produced a “considerations document” that outlines how site-specific IRBs and a central IRB would interact in a multicenter trial using a central IRB. The document outlines which tasks—such as approving the protocol—would be taken care of by the central IRB and which tasks—such as conducting a conflict-of-interest review—would be taken care of by the site-specific IRBs. CLICK HERE to download a PDF version of the Considerations Document.
We discovered that sites that had used central IRBs were more comfortable with them than sites that had never used a central IRB. One way to give sites more experience with central IRBs would be for government and commercial sponsors to require the use of a central IRB as a condition for participating in a particular multicenter trial. The National Institute of Neurological Disorders and Stroke has done this. CLICK HERE to download the Official Recommendations resulting from this project.