title: Using central IRBs for multicenter clinical trials in the United States.
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.
authors: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
authors: Kathryn E
authors: KE
authors: Flynn
authors: Cynthia L
authors: CL
authors: Hahn
authors: Judith M
authors: JM
authors: Kramer
authors: Devon K
authors: DK
authors: Check
authors: Carrie B
authors: CB
authors: Dombeck
authors: Soo
authors: S
authors: Bang
authors: Jane
authors: J
authors: Perlmutter
authors: Felix A
authors: FA
authors: Khin-Maung-Gyi
authors: Kevin P
authors: KP
authors: Weinfurt
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D006801:Humans; D020407:Internet; D015337:Multicenter Studies as Topic / Q000941:ethics*; D010344:Patient Advocacy / Q000941:ethics; D035502:Trust; D014481:United States
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