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[精神病学中患者的知情同意。生物医学研究中的后果]

[Informed consent of patients in psychiatry. Consequences in biomedical research].

作者信息

Poirier-Littré M F

机构信息

S.H.U., Hôpital Sainte-Anne, Paris.

出版信息

Encephale. 1990 Jul-Aug;16(4):277-9.

PMID:2209482
Abstract

After the Huriet law (December 20th 1988) a free, informed and explicit consent procedure has become compulsory in biomedical research. This obligation is particularly uneasy with mental patients. Stricto sensu it excludes from research all psychotic patients unable to become "informed" and to "consent" to something. Moreover age, understanding, the quantity of informations, the personality of investigators and above all patients' suggestibility may be biases when recruiting subjects willing to participate in a trial. It is only after marketing that a thorough knowledge of the scope of a new drug will be established in terms of efficacy. Furthermore, patients informed about the possible ingestion of a placebo may become less responsive to the placebo as well as to the active drug. In a double-blind trial the physician will be unable to explain the effects experienced during the treatment period. The Huriet law should be adjusted taking into account the specificity of the field of psychiatry and being aware of the treatment and investigational problems within the framework of psychiatric emergencies.

摘要

在《于里埃法》(1988年12月20日)颁布之后,自由、知情且明确的同意程序在生物医学研究中成为强制要求。对于精神病患者而言,这项义务执行起来格外棘手。严格来说,它将所有无法“知情”并对某事“同意”的精神病患者排除在研究之外。此外,在招募愿意参与试验的受试者时,年龄、理解能力、信息量、研究人员的个性,尤其是患者的易受暗示性都可能成为偏差因素。只有在药品上市后,才能在疗效方面全面了解一种新药的适用范围。此外,被告知可能服用安慰剂的患者对安慰剂以及活性药物的反应可能会降低。在双盲试验中,医生将无法解释治疗期间所经历的效果。应考虑到精神病学领域的特殊性,并意识到精神科急诊框架内的治疗和研究问题,对《于里埃法》进行调整。

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