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临床研究中的伦理问题:对临床试验过程进行实证研究的必要性。

Ethical problems in clinical research: the need for empirical studies of the clinical trials process.

作者信息

Mackillop W J, Johnston P A

出版信息

J Chronic Dis. 1986;39(3):177-88. doi: 10.1016/0021-9681(86)90022-6.

DOI:10.1016/0021-9681(86)90022-6
PMID:3949942
Abstract

Society's demand for progress in medicine is expressed in the form of large sums of money poured into medical research by national governments and voluntary agencies. It is widely accepted within the medical profession that society has a right to expect continuing progress in medical practice and it has been argued that the doctor must therefore sometimes weigh society's interests against those of his individual patient. This essay discusses the origin of the concept of the societal obligation of the physician and the difficult position of the clinician-scientist who attempts to meet society's demands for progress while maintaining his traditional loyalty to the individual patient. Empirical studies which describe the impact of the clinical trials process on the practice of medicine are discussed and it is shown that the large scale clinical trials of today may influence aspects of medical practice far removed from the immediate problems which they are designed to study. It is concluded that further research is needed to study the process of clinical experimentation and its societal implications and that the debate must extend beyond the medical profession to involve the general public.

摘要

社会对医学进步的需求表现为各国政府和志愿机构将大量资金投入医学研究。医学界普遍认为,社会有权期望医学实践不断进步,有人认为,医生因此有时必须权衡社会利益与个别患者的利益。本文讨论了医生社会义务概念的起源,以及临床科学家在试图满足社会对进步的需求同时又要保持对个别患者的传统忠诚时所面临的困境。文中讨论了描述临床试验过程对医学实践影响的实证研究,结果表明,如今的大规模临床试验可能会影响医学实践的诸多方面,而这些方面与它们旨在研究的直接问题相去甚远。得出的结论是,需要进一步研究临床实验过程及其社会影响,并且这场辩论必须超越医学界,让普通公众参与进来。

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Ethical problems in clinical research: the need for empirical studies of the clinical trials process.临床研究中的伦理问题:对临床试验过程进行实证研究的必要性。
J Chronic Dis. 1986;39(3):177-88. doi: 10.1016/0021-9681(86)90022-6.
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Informed consent in human experimentation: bridging the gap between ethical thought and current practice.人体实验中的知情同意:弥合伦理思想与当前实践之间的差距。
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J Clin Oncol. 1999 May;17(5):1601-17. doi: 10.1200/JCO.1999.17.5.1601.
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Informed consent: the physicians' perspective.知情同意:医生的观点。
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