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[伦理委员会对生物医学研究项目的差异化审查]

[Differentiated review of biomedical research projects by ethics committees].

作者信息

Portales María Bernardita, Michaud Patricio, Salas Sofía P, Beca Juan Pablo

机构信息

Centro de Bioética, Facultad de Medicina, Universidad del Desarrollo, Santiago, Chile.

Comité de Ética en Investigación, Hospital Sótero del Río, Santiago, Chile.

出版信息

Rev Med Chil. 2017 Mar;145(3):386-392. doi: 10.4067/S0034-98872017000300014.

Abstract

Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.

摘要

在规范人类科学研究的智利法案(第20120号法律)获批十年后,考虑到许多研究伦理委员会(REC)目前的认证和培训状况,有必要分析它们的表现。我们分析了智利在研究伦理委员会方面的经验,旨在根据对研究参与者的风险提出一种差异化的审查类型。为提高审查质量和这些委员会的效率,我们建议根据项目类型、其方法及其风险来区分审查。最初,审查类型应分为委员会豁免审查、快速审查和全面审查。在本提案中,审查类型在对项目进行初步审查后可由委员会指定成员确认或修改。这样,委员会的审议和审查时间可以得到优化,避免审查延误。

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本文引用的文献

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Reform of Clinical Research Regulations, Finally.临床研究法规终于迎来改革。
N Engl J Med. 2015 Dec 10;373(24):2296-9. doi: 10.1056/NEJMp1512463. Epub 2015 Nov 4.
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What makes clinical research ethical?临床研究的伦理准则是什么?
JAMA. 2000;283(20):2701-11. doi: 10.1001/jama.283.20.2701.
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Ethics and clinical research.伦理与临床研究
N Engl J Med. 1966 Jun 16;274(24):1354-60. doi: 10.1056/NEJM196606162742405.

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