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实现观察性研究的前瞻性注册。

Making prospective registration of observational research a reality.

机构信息

Clinical Research Program, Pasqual Maragall Foundation, E-08003 Barcelona, Spain.

出版信息

Sci Transl Med. 2014 Feb 19;6(224):224cm1. doi: 10.1126/scitranslmed.3007513.

Abstract

The vast majority of health-related observational studies are not prospectively registered and the advantages of registration have not been fully appreciated. Nonetheless, international standards require approval of study protocols by an independent ethics committee before the study can begin. We suggest that there is an ethical and scientific imperative to publicly preregister key information from newly approved protocols, which should be required by funders. Ultimately, more complete information may be publicly available by disclosing protocols, analysis plans, data sets, and raw data.

摘要

绝大多数与健康相关的观察性研究都没有进行前瞻性注册,因此尚未充分认识到注册的优势。尽管如此,国际标准要求在研究开始前,由独立伦理委员会批准研究方案。我们认为,从新批准的方案中公开预先注册关键信息具有伦理和科学上的必要性,这应该是由资助者要求的。最终,通过披露方案、分析计划、数据集和原始数据,可能会公开更完整的信息。

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