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临床研究中的利益冲突。

Conflict of interest in clinical research.

作者信息

Ghooi Ravindra B

机构信息

Scientia Clinical Services, Pune, Maharashtra, India.

出版信息

Perspect Clin Res. 2015 Jan-Mar;6(1):10-4. doi: 10.4103/2229-3485.148794.

Abstract

Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC) members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country.

摘要

对研究伦理审查的更多关注要求对现有系统进行一些改进。尽管这些改进正在实施,但过去较少受到关注的一些因素仍可加以审视。其中之一就是利益冲突。此类冲突可能存在于研究者、伦理委员会(EC)成员甚至监管机构之中。许多国家已发布了关于识别和管理利益冲突的指南,印度的相关规定也提及了这些冲突。更清晰的界定将有助于研究者和伦理委员会更有效地管理利益冲突。诚然,利益冲突无法消除,但对其及时识别、披露和管理能够降低其影响,并为该国的试验带来更高的透明度和问责制。

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