title: Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute Working Group's report on optimizing the IRB process.
abstract: The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened a working group in June 2011 to examine alternative institutional review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported research and the proliferation of multicenter clinical trials where multiple individual reviews may be inefficient. Group members included experts in heart, lung, and blood research, research oversight, bioethics, health economics, regulations, and information technology (IT). The group discussed alternative IRB models, ethical concerns, metrics for evaluating IRBs, IT needs, and economic considerations. Participants noted research gaps in IRB best practices and in metrics. The group arrived at recommendations for process changes, such as defining specific IRB performance requirements in funding announcements, requiring funded researchers to use more efficient alternative IRB models, and developing IT systems to facilitate information sharing and collaboration among IRBs. Despite the success of the National Cancer Institute's central IRB (CIRB), the working group, concerned about the creation costs and unknown cost-efficiency of a new CIRB, and about the risk of shifting the burden of dealing with multiple IRBs from sponsors to research institutions, did not recommend the creation of an NHLBI-funded CIRB.
authors.affiliation: Office of Special Projects, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD 20892-7940, USA. Alice.Mascette@NIH.gov
authors.forename: Alice M
authors.initials: AM
authors.lastname: Mascette
authors.forename: Gordon R
authors.initials: GR
authors.lastname: Bernard
authors.forename: Donna
authors.initials: D
authors.lastname: Dimichele
authors.forename: Jesse A
authors.initials: JA
authors.lastname: Goldner
authors.forename: Robert
authors.initials: R
authors.lastname: Harrington
authors.forename: Paul A
authors.initials: PA
authors.lastname: Harris
authors.forename: Hilary S
authors.initials: HS
authors.lastname: Leeds
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Pearson
authors.forename: Bonnie
authors.initials: B
authors.lastname: Ramsey
authors.forename: Todd H
authors.initials: TH
authors.lastname: Wagner
mesh_terms: D035843:Biomedical Research / Q000592:standards; D016265:Conflict of Interest; D017598:Efficiency, Organizational; D028744:Ethics Committees, Research / Q000191:economics / Q000458:organization & administration* / Q000592:standards; D005380:Financing, Government; D006801:Humans; D017146:Models, Organizational; D016134:Organizational Policy; D012109:Research Support as Topic; D014481:United States