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[精神病学研究与立法限制]

[Research in psychiatry and legislative restrictions].

作者信息

Bougerol T

机构信息

Service hospitalo-universitaire de psychiatrie d'Adultes, Hôpital Sainte-Marguerite, Marseille.

出版信息

Encephale. 1996 May;22 Spec No 1:63-8.

PMID:8767029
Abstract

Over the last few weeks decades research in psychiatry has undergone a considerable efflorescence. Experimental projects in fields as different as neurobiology or psychopathology, neuro-anatomy or epidemiology, or even cognitive psychology are of course subject to precise conditions which may derive from ethical guidelines as well as different legal systems. These legislative contexts therefore represent a parallel set of restrictions in the path of research activities and may in some cases curb their development. Restrictions of an ethical or deontological type are direct heirs of necessity. They emerged on the eve of the second world war when it became apparent that precisely defined conditions in which research could be conducted in humans were required, and derived for the most part from the recommendations of the Nuremberg Code on the one hand, and the Helsinki declaration on the other. The last version of the Code of Medical Deontology applicable to medical practice in France, and published by decree in September 1995, devoted an article to the question of experimentation. Each country has its own specific legislation which, in France, was explicitly formulated with the publication of the Loi Huriet in December 1988. The European Union is currently attempting to produce a homologous version of the various legislative documents and recommendations should soon be forthcoming which will be applicable to all member countries of the Community. Another area of limitation is less clearly formulated and involves the technical and occasionally methodological framework within research projects take place. Technical demands are highly variable depending on the field of investigation and chiefly revolve around a dogged hunt for statistically significant results (statistical significance sometimes seems to dispense with the need to determine the real meaning of results!); in some cases they too may curb inventiveness. This last type restriction is particularly apparent in drug trials where imperatives of industrial development as viewed by the sponsor may not always coincide with the investigators' desire to mark therapeutic progress. The increasing rigidity of strategies for assessing new substances which has become obvious over the last few years may in the end risk penalizing the discovery of innovative treatments. Promoting a return to clinical practice in the setting of these research projects would indisputably provide some novel solutions. Although many of the restrictions which currently stand in the way of psychiatric research are, so to speak, natural limitations and difficult to debate, excessive formalism in some areas should be spoken out against. Much thought has been given to this subject, a trend which is likely to inject some dynamism into psychiatric research at the dawn of the third millennium just around the corner.

摘要

在过去几十年里,精神病学研究经历了相当大的发展。神经生物学、精神病理学、神经解剖学、流行病学乃至认知心理学等不同领域的实验项目,当然都受到精确条件的限制,这些条件可能源于伦理准则以及不同的法律制度。因此,这些立法背景在研究活动的道路上构成了一系列并行的限制,在某些情况下可能会抑制其发展。伦理或道义层面的限制是必要性的直接产物。它们出现在第二次世界大战前夕,当时人们明显意识到需要明确界定在人体上进行研究的条件,这些条件在很大程度上一方面源于《纽伦堡法典》的建议,另一方面源于《赫尔辛基宣言》。适用于法国医疗实践的最新版《医学道义法典》于1995年9月以法令形式发布,其中有一篇文章专门讨论了实验问题。每个国家都有自己的具体立法,在法国,随着1988年12月《于里埃法》的发布,相关立法得以明确制定。欧盟目前正试图制定各种立法文件的同源版本,很快就会出台适用于共同体所有成员国的建议。另一个限制领域的表述不太明确,涉及研究项目开展所处的技术以及偶尔的方法框架。技术要求因研究领域而异,差异很大,主要围绕着对具有统计学显著意义的结果的执着追求(有时统计学显著性似乎无需确定结果的实际意义!);在某些情况下,它们也可能抑制创造力。这种最后的限制类型在药物试验中尤为明显,赞助商所认为的产业发展需求可能并不总是与研究人员希望彰显治疗进展的愿望一致。在过去几年中变得明显的评估新物质策略的日益僵化,最终可能会对创新治疗方法的发现造成不利影响。在这些研究项目中推动回归临床实践无疑会提供一些新颖的解决方案。虽然目前阻碍精神病学研究的许多限制可以说是自然限制,难以进行辩论,但在某些领域的过度形式主义应该受到批判。人们已经对这个问题进行了很多思考,这一趋势可能会在即将到来的第三个千年之初为精神病学研究注入一些活力。

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