Using Central IRBs for Multicenter Clinical Trials in the United States

Kathryn E Flynn,Jane Perlmutter,Soo Bang,Felix A Khin-Maung-Gyi,Judith M Kramer,Carrie B Dombeck,Devon K Check,Cynthia L Hahn,Kevin P Weinfurt,T Mark Doherty

doi:10.1371/journal.pone.0054999

Abstract

Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation’s capacity to efficiently conduct the large number of high-quality trials.

Highlights

Maximizing the efficiency of multicenter clinical trials so they can provide high-quality evidence to answer important medical questions is an important public health interest
As multicenter clinical trials have become more common, researchers have begun to question whether the goal of protecting research participants is enhanced by having each site’s local institutional review board (IRB) conduct a full review of multicenter protocols, which can add significant delays to study start-up [1,2]
Need to Clarify Terms Based on the initial expert discussions, an early finding was the need to clarify the term ‘‘central IRB.’’ many people refer to an independent or commercial IRB as a central IRB, an independent or commercial IRB can be contracted by an institution to serve as the institution’s ‘‘local’’ IRB

Summary

Introduction

Maximizing the efficiency of multicenter clinical trials so they can provide high-quality evidence to answer important medical questions is an important public health interest. To improve the efficiency of conducting multicenter clinical trials in the United States, the Food and Drug Administration (FDA), the Office of Human Research Protections (OHRP), and the Department of Health and Human Services (DHHS) support the use of central IRBs [3,4,5]. In July 2011, the DHHS invited commentary on their proposal to change the Common Rule to include mandated centralized review for multicenter trials [3]. Despite this support, research institutions differ in their willingness to defer to centralized IRB review [6,7]

Objectives

Methods

Results

Conclusion