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医学研究中的利益冲突:多大程度的冲突会超越法律界限?

Conflicts of interest in medical research: how much conflict should exceed legal boundaries?

作者信息

Klanica Kaley

机构信息

Boston University School of Public Health, USA.

出版信息

J Biolaw Bus. 2005;8(3):37-45.

Abstract

This article addresses the current plague of financially conflicted research from various perspectives including the research community, the medical community, patients/subjects, the Food and Drug Administration (F.D.A.), and other government agencies. Part one lays out the current conflicts of interest within medical research. Part two explains the actual and potential effects of these conflicts, highlighting the conflict of interest associated with the death of Jesse Gelsinger. Part three describes how conflicts of interest are currently regulated by government agencies and within individual institutions. Lastly, part four concludes by recommending a system of seven balanced reform measures that protect research subjects and the scientific integrity of medical research while encouraging scientific progress.

摘要

本文从多个角度探讨了当前存在的经济利益冲突对研究的困扰,这些角度包括研究界、医学界、患者/受试者、美国食品药品监督管理局(F.D.A.)以及其他政府机构。第一部分阐述了医学研究中当前存在的利益冲突。第二部分解释了这些冲突的实际和潜在影响,重点强调了与杰西·格尔辛格之死相关的利益冲突。第三部分描述了政府机构和各个机构目前对利益冲突的监管方式。最后,第四部分通过推荐一套由七项平衡的改革措施组成的体系得出结论,该体系在鼓励科学进步的同时,保护研究受试者以及医学研究的科学诚信。

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