[Guidelines and practice aspects of conducting clinical trials in schizophrenia].
In metropolitan France, clinical trials on human beings are governed by the law of the December 20th 1988 (Huriet's law), the purpose of which is to protect persons who are acting as subjects for clinical research. This law gives a patient freedom to choose whether or not to be part of a clinical trial and this without committing himself for the whole duration of the trial. Before the trial starts, the practitioner is obliged to explain the purpose of the experiment (its objectives, methodology, duration, limitations and risks). The principal concerns and requirements of this law are that clinical trials be based upon the most up-to-date scientific knowledge, the necessity of obtaining the subject's consent, and the advice from the regional Consultative Committee for the Protection of Persons in Medical Research (CCPPRB). Any error in the application of this law may lead to prescribed penalties, both for the investigator and the programme director. This law applies to all medical disciplines and it is therefore necessary to find out how it might be applied to the specialty in question, which is psychiatry. Consent, prior to the clinical trial, presents a real ethical problem. To what degree, in fact, is acceptance of participation in a clinical trial applicable in a schizophrenic type of psychotic disorder, where the subject's symptoms hinder the legitimacy of his decision-making ability before the trial, and his evaluative judgement, from a results point of view, in the longer term? This is the heart of the ethical paradox.(ABSTRACT TRUNCATED AT 250 WORDS)
Waterreus
F
F
Psychiatre des hôpitaux, Centre Hospitalier, Cholet.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003134:Commitment of Persons with Psychiatric Disorders / Q000331:legislation & jurisprudence; D005602:France; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016743:Mental Competency / Q000331:legislation & jurisprudence; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology
Aspects réglementaires et pratiques de la conduite d'essais cliniques dans la schizophrénie.