title: Research misconduct among clinical trial staff.
abstract: Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations.
authors.affiliation: College of Nursing, Wayne State University, Cohn Building, Suite 112, 5557 Cass Ave., Detroit, MI 48202, USA. ae9080@wayne.edu
authors.forename: Barbara K
authors.initials: BK
authors.lastname: Redman
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Templin
authors.forename: Jon F
authors.initials: JF
authors.lastname: Merz
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D032984:Ethics, Research; D005260:Female; D006801:Humans; D008297:Male; D016134:Organizational Policy; D010559:Personnel Management; D010560:Personnel Selection; D012106:Research / Q000193:education / Q000458:organization & administration*; D015871:Scientific Misconduct; D014481:United States; D016526:Workload