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

作者：Check Devon K; Weinfurt Kevin P; Dombeck Carrie B; Kramer Judith M; Flynn Kathryn E^*

来源：Clinical Trials, 2013, 10(4): 560-567.

DOI：10.1177/1740774513484393

Background To improve the efficiency of conducting multicenter clinical trials, the Food and Drug Administration, the Office of Human Research Protections, and the Department of Health and Human Services have expressed support for using a centralized institutional review board (IRB) process. However, research institutions differ in their willingness to defer to central IRBs. %26lt;br%26gt;Purpose We aimed to review and describe peer-reviewed journal articles on the use of central IRBs for multicenter clinical trials in the United States in an effort to inform the policy discussion about central IRBs. %26lt;br%26gt;Methods We used a PubMed search and consulted IRB experts and the bibliographies of other reviews to identify relevant commentaries and empirical studies. %26lt;br%26gt;Results Our search identified 33 articles related to the use of central IRBs for multicenter trials in the United States. Of these, 22 were commentary pieces and 11 were empirical studies. %26lt;br%26gt;Limitations Our review was restricted to journal articles about the use of central IRBs for multicenter clinical trials in the United States. %26lt;br%26gt;Conclusions 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.

• 出版日期2013-8