- 期刊
- OpenAccess
Legal Distinctions between Clinical Research and Clinical Investigation: Lessons from a Professional Misconduct Trial
並列摘要
A senior Fellow of the Royal College of Physicians, London was accused of professional misconduct and ordered to be erased from the U.K. medical register following a fitness to practice trial by the General Medical Council (GMC). He was charged with performing clinical research without ethical approval. The Defendant claimed his actions were based on clinical need to investigate his patients' atypical symptoms and signs. Flaws are described in the trial that favoured the GMC to win the case after five years of trial. These included lack of impartiality, bias against the Defendant's Expert Witness, restricted access to evidence and unwarranted time delays. At Appeal before the High Courts in London the charges and sanctions by the GMC were quashed within four days of public hearings. The difficulty of defining clinical research as distinct from clinical investigation of patients is discussed with reference to the GMC trial and subsequent ruling by the High Courts.