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机构审查委员会——利弊参半。

Institutional review boards - a mixed blessing.

作者信息

Saleem Taimur, Khalid Umair

机构信息

Medical College, Aga Khan University, Stadium Road, Karachi 74800, Pakistan.

出版信息

Int Arch Med. 2011 Jun 20;4:19. doi: 10.1186/1755-7682-4-19.

Abstract

Institutional Review Boards (IRBs) are an important checkpoint for all types of research in medicine. Although these bodies originated primarily in the developed world, they have special contemporary consideration in the context of developing countries due to the large number of clinical trials being conducted in these regions with the financial support of large pharmaceutical companies. IRBs are vital to ensure that all scientific investigation is conducted in a manner that is transparent, scientifically feasible and ethically sound. However, they have also been variably criticized for introducing unnecessary and often protracted bureaucracy and red tape into the system. There is a need to reorganize and better delineate the exact functions of the IRBs in view of the dynamic changes in the realm of research so that they can function in a more efficient, judicious and effective fashion.

摘要

机构审查委员会(IRBs)是医学领域各类研究的重要关卡。尽管这些机构主要起源于发达国家,但由于在大型制药公司的资金支持下,这些地区正在进行大量临床试验,因此在发展中国家的背景下,它们具有特殊的当代考量。机构审查委员会对于确保所有科学研究以透明、科学可行且符合伦理道德的方式进行至关重要。然而,它们也因给系统引入不必要且往往冗长的官僚作风和繁文缛节而受到不同程度的批评。鉴于研究领域的动态变化,有必要对机构审查委员会的具体职能进行重组并更好地界定,以便它们能够以更高效、明智和有效的方式运作。

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本文引用的文献

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Working with the institutional review board.与机构审查委员会合作。
Am J Health Syst Pharm. 2009 Jan 15;66(2):176-84. doi: 10.2146/ajhp070066.
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Rules of the game: institutional review boards.游戏规则:机构审查委员会
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Institutional review boards: changing with the times?机构审查委员会:与时俱进?
J Public Health Manag Pract. 2000 Nov;6(6):19-27. doi: 10.1097/00124784-200006060-00005.
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Institutional review boards: friend, not foe.机构审查委员会:是朋友,而非敌人。
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