[Medicolegal aspects of therapeutic trials in neuroanesthesia and reanimation].
The achievement of therapeutical experiments is from now on submitted to the December 20, 1988 Law which specifies that an agreement must be obtained from the consultative Committee for the Protection of People in biomedical research (Comité consultatif de Protection des Personnes), in order to appreciate the relevance of the project, its research validity and the practical conditions of the experiment. Penal sanctions are estimated for transgressors. In neurosurgery, two specific points are worth stressing: the obtainment of consent and the technical specificity of further investigations. Whereas this consent can be easily obtained from patients still conscious, coma makes its application more difficult, even impossible in case of chronic coma or brain death. Para clinical investigations in neurosurgery entail risks for the patient which must be taken into account and which do not seem in keeping with medical ethics, when they are used in the unique purpose of research.
Piva
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Laboratoire de médecine légale, Faculté de médecine, Limoges.
D000758:Anesthesia; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004992:Ethics, Medical; D005602:France; D006801:Humans; D007883:Legislation, Medical; D009422:Nervous System Diseases / Q000628:therapy*; D012151:Resuscitation
Aspects médico-légaux des essais thérapeutiques en neuro-anesthésie-réanimation.