title: An Institutional Review Board dilemma: responsible for safety monitoring but not in control.
abstract: Clinical trials have become a major research tool to evaluate new medical interventions. Most trials require some level of data monitoring for quality control and many trials require special monitoring for participant safety. For national multicenter trials, independent data monitoring committees have become the standard for monitoring for evidence of participant benefit or harm in trials with irreversible outcomes such as death or serious morbidity. The Institutional Review Board (IRB) is held responsible for monitoring local trials. Often local institutions do not have an infrastructure in place to meet this responsibility, and therefore local IRBs cannot fulfill this obligation. In addition, IRBs are currently inundated with individual safety reports from local and multi-institutional trials which may appear to provide some level of safety monitoring, but in fact gives a false sense of security. We propose the establishment of institutional data monitoring committees and appropriate informatics infrastructure to monitor local trials.
authors.affiliation: Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, K6/446 CSC, Madison, WI 53792-4675, USA. demets@biostat.wisc.edu
authors.forename: David L
authors.initials: DL
authors.lastname: DeMets
authors.forename: Norman
authors.initials: N
authors.lastname: Fost
authors.forename: Madison
authors.initials: M
authors.lastname: Powers
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research / Q000941:ethics*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics*; D014481:United States