Malavaud B
Service d'Urologie et de Transplantation Rénale, CHU Toulouse-Purpan.
Prog Urol. 1994 Apr;4(2):181-4.
In France, therapeutic trials are governed by the so-called Huriet Law of December 20, 1988 concerning the "protection of subjects participating in biomedical research". Urologists must be familiar with this Law to preserve their responsibility. We must make sure that the Sponsor fulfils his obligations and that the information which we give to our patients guarantees the validity of their consent. The authors recall the legal penalties associated with failure to comply with this law.
在法国,治疗性试验受1988年12月20日所谓的《于里埃法》(Huriet Law)管辖,该法涉及“保护参与生物医学研究的受试者”。泌尿科医生必须熟悉该法律以履行其职责。我们必须确保申办者履行其义务,并且我们向患者提供的信息能保证他们同意的有效性。作者回顾了不遵守该法律所涉及的法律处罚。