title: Streamlining IRB review in multisite trials through single-study IRB Cooperative Agreements: experience of the Beta-Carotene and Retinol Efficacy Trial (CARET).
abstract: With their extensive data and specimen repositories, clinical trials are a long-term, valuable resource to health researchers. However, assuring protection of participants' rights can be challenging, particularly when such trials are conducted at multiple sites with multiple Institutional Review Boards (IRBs). One little-used mechanism that can streamline IRB review in multisite trials while maintaining participants' protections is the single-study IRB Cooperative Agreement. This agreement is entirely different from reciprocity agreements between institutions. Beginning in 1996, the Beta-Carotene and Retinol Efficacy Trial established single-study IRB Cooperative Agreements among its performance sites, which reduced the average time to complete IRB approval from over 6 months to 1 month for each of many substudies. We describe our experience and make recommendations for other multisite clinical trials.
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. mthornqu@fhcrc.org
authors.forename: Mark D
authors.initials: MD
authors.lastname: Thornquist
authors.forename: Cim
authors.initials: C
authors.lastname: Edelstein
authors.forename: Gary E
authors.initials: GE
authors.lastname: Goodman
authors.forename: Gilbert S
authors.initials: GS
authors.lastname: Omenn
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003299:Cooperative Behavior; D028744:Ethics Committees, Research; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D014801:Vitamin A; D019207:beta Carotene
chemical_list: D019207:beta Carotene; D014801:Vitamin A