Clinical study reflections: another view: Commentary on: "Raising suspicions with the Food and Drug Administration: detecting misconduct".
Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff contributions; and implementing a systems and partnership approach would foster quality and advance clinical research.
The Public Sector Consortium, Cambridge, MA, USA. pas@public-sector.org
Patricia
P
Spitzig
D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D009316:National Institutes of Health (U.S.); D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards*; D012108:Research Personnel; D015871:Scientific Misconduct / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D035642:Whistleblowing / Q000941:ethics*