title: The role of the data coordinating center in the IRB review and approval process: the DIG trial experience.
abstract: Before any clinical trial can begin to recruit patients, participating clinical centers must obtain approval from their institutional review board (IRB). When studies are federally funded, such as by the U.S. Department of Health and Human Services (DHHS), centers must also have or obtain a federal compliance agreement from the Office of Human Research Protections (formerly the Office for Protection from Research Risks [OPRR]). The Digitalis Investigation Group trial was a large, international, double-blind, DHHS-funded randomized trial on the effect of digoxin on mortality in heart failure. Due to the anticipated number of centers (>200), the study's data coordinating center (DCC) was requested to assume additional responsibilities that included: (1) acting as a liaison between the OPRR and all study centers; (2) reviewing and correcting all assurance statements before submission to the OPRR; (3) reviewing and approving all centers' informed consent forms; and (4) helping the many research-inexperienced centers to establish IRBs or to locate an IRB in their region that would accept IRB responsibility for them. Although a heavy burden was placed on the DCC, the IRB and OPRR approval process was probably shortened by many weeks at those centers not already possessing a federal compliance agreement. This enabled the study to be completed on schedule and within budget.
authors.affiliation: Department of Veterans Affairs, Cooperative Studies Program, Perry Point, Maryland 21902, USA. joseph.collins2@med.va.gov
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Collins
authors.forename: Rekha
authors.initials: R
authors.lastname: Garg
authors.forename: Koon K
authors.initials: KK
authors.lastname: Teo
authors.forename: William O
authors.initials: WO
authors.lastname: Williford
authors.forename: Cindy L
authors.initials: CL
authors.lastname: Howell
mesh_terms: D002170:Canada; D002316:Cardiotonic Agents / Q000627:therapeutic use; D004077:Digoxin / Q000627:therapeutic use; D028744:Ethics Committees, Research; D005568:Forms and Records Control; D006333:Heart Failure / Q000188:drug therapy; D007258:Informed Consent; D015337:Multicenter Studies as Topic / Q000379:methods*; D009934:Organization and Administration; D010344:Patient Advocacy; D017712:Peer Review, Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012308:Risk Management; D014481:United States
chemical_list: D002316:Cardiotonic Agents; D004077:Digoxin