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. 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. METHODS: We used a PubMed search and consulted IRB experts and the bibliographies of other reviews to identify relevant commentaries and empirical studies. 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. LIMITATIONS: Our review was restricted to journal articles about the use of central IRBs for multicenter clinical trials in the United States. 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.
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. 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. METHODS: We used a PubMed search and consulted IRB experts and the bibliographies of other reviews to identify relevant commentaries and empirical studies. 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. LIMITATIONS: Our review was restricted to journal articles about the use of central IRBs for multicenter clinical trials in the United States. 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.
Authors: Scott L Weiss; Julie C Fitzgerald; Edward Vincent Faustino; Marino S Festa; Ericka L Fink; Philippe Jouvet; Jenny L Bush; Niranjan Kissoon; John Marshall; Vinay M Nadkarni; Neal J Thomas Journal: Pediatr Crit Care Med Date: 2014-09 Impact factor: 3.624
Authors: Pankaja Desai; Priyanka Nasa; Jackie Soo; Cunhui Jia; Michael L Berbaum; James H Fischer; Timothy P Johnson Journal: J Empir Res Hum Res Ethics Date: 2017-04-16 Impact factor: 1.742
Authors: Michael P Diamond; Esther Eisenberg; Hao Huang; Christos Coutifaris; Richard S Legro; Karl R Hansen; Anne Z Steiner; Marcelle Cedars; Kurt Barnhart; Tracy Ziolek; Tracey R Thomas; Kate Maurer; Stephen A Krawetz; Robert A Wild; J C Trussell; Nanette Santoro; Heping Zhang Journal: Clin Trials Date: 2018-10-24 Impact factor: 2.486
Authors: Holly A Massett; Sharon L Hampp; Jacquelyn L Goldberg; Margaret Mooney; Linda K Parreco; Lori Minasian; Mike Montello; Grace E Mishkin; Catasha Davis; Jeffrey S Abrams Journal: J Clin Oncol Date: 2018-01-31 Impact factor: 44.544