Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature

Abstract

There is limited empirical work on the use of central IRBs for multicenter trials in the United States. Most published studies focused on problems in efficiency associated with redundant local reviews of multicenter studies and the potential benefits of a centralized system. Because the absence of studies on the use of central IRBs may be due to their infrequent use, additional work is needed to generate data on the use of central IRBs and to elucidate and address the concerns that research institutions have about deferring ethical review to a central IRB.

Clinical Trials in Neurovirology: Successes, Challenges, and Pitfalls

“…Emanuel et al [70] (adapted by Lane et al [71]) formulated core ethical and scientific principles for trial conduct in an outbreak setting in developing countries: 1) ethical conduct to avoid exploitation, including respect for volunteers, local community engagement, and carefully informed consent involving the community to establish recruitment procedures and incentives; 2) partnership with investigators and officials in affected countries, including the identification of interested local investigators, strengthen the local trial infrastructure, and shared best practices of regulator oversight; 3) scientific validity, including a favorable risk-benefit ratio to the study population and sound trial design; 4) independent review and scientific oversight, ensuring public accountability through transparency and mandated reviews, including the oversight of an independent and skilled Data and Safety Monitoring Board; and 5) transparency, including the prompt sharing of data with practitioners and affected communities. To improve clinical trial Breadiness^in outbreak settings, prospective planning may include the installation of clinical trial networks, centralized institutional review board approvals [72], as well as novel trial designs such as platform trials, which allow a rapid implementation of therapies once they become available [73].…”

More Consistent Site Institutional Review Board (IRB) Input–More Consistent Site IRB Output*

“…Across the eight studies evaluating the local IRB process for multicenter clinical trials (only one was in critical care [8]), there was a consistent appeal for the need for clarification of federal regulations and the need for educational efforts for IRBs. In seven of eight studies, there was an appeal for use of a central IRB to decrease the inconsistency and redundant review (7).…”

Institutional Review Boards

“…Yet, reform eff orts have been somewhat paralyzed by the tension between those who fi nd the current system inadequate and those who fi nd it too overreaching. 36,37 Nonetheless, many grant that multiple reviews for a single study are duplicative, lead to significant delays in research without adding meaningful protections, and can result in inconsistencies that bias the science. 38,39 Additional reasons for considering reform of the current oversight system include inherent confl icts of interest, inadequate resources, the emergence of new research methodologies, and insuffi cient expertise of members, among others.…”

“…Multiple reviews also have the possibility of jeopardizing the science by introducing bias. 37 Institutions participating in multisite studies are permitted by federal regulations 68 to use arrangements that centralize or share reviews, yet relatively few employ these options. Many proposals for reforming or updating guidance and regulations have recommended single or central review for multisite studies.…”