Legal liability in clinical trials from the viewpoint of the clinician
Luft, F.C.
Zeitschrift für Arztliche Fortbildung 89(6): 646-8; Discussion 649-52
1995
ISSN/ISBN: 0044-2178 PMID: 8588439 Document Number: 450188
After a long-term work in the U.S., the liability for clinical trials is explained. The researching physician carries the responsibility for new drugs. He has to apply for the license for the study by the appropriate authority and he carries the responsibility for the consent of the volunteers which have to be informed before the trial. The studies initiated by the pharmaceutical companies relieve the researching physician from some of the responsibilities. They exert a strong control during the drug tests. The researching physician has the responsibility as a "scholarly mediator". The ethic commission inspects all stages of the study.