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动物研究预注册通用标准宣言——加速科学进步

Declaration of common standards for the preregistration of animal research-speeding up the scientific progress.

作者信息

Heinl Céline, Scholman-Végh Anna M D, Mellor David, Schönfelder Gilbert, Strech Daniel, Chamuleau Steven, Bert Bettina

机构信息

German Federal Institute for Risk Assessment, German Centre for the Protection of Laboratory Animals (Bf3R), 10589 Berlin, Germany.

Netherlands Heart Institute, 3511 EP Utrecht, The Netherlands.

出版信息

PNAS Nexus. 2022 Mar 16;1(1):pgac016. doi: 10.1093/pnasnexus/pgac016. eCollection 2022 Mar.

Abstract

Preregistration of studies is a recognized tool in clinical research to improve the quality and reporting of all gained results. In preclinical research, preregistration could boost the translation of published results into clinical breakthroughs. When studies rely on animal testing or form the basis of clinical trials, maximizing the validity and reliability of research outcomes becomes in addition an ethical obligation. Nevertheless, the implementation of preregistration in animal research is still slow. However, research institutions, funders, and publishers start valuing preregistration, and thereby level the way for its broader acceptance in the future. A total of 3 public registries, the , , and already encourage the preregistration of research involving animals. Here, they jointly declare common standards to make preregistration a valuable tool for better science. Registries should meet the following criteria: public accessibility, transparency in their financial sources, tracking of changes, and warranty and sustainability of data. Furthermore, registration templates should cover a minimum set of mandatory information and studies have to be uniquely identifiable. Finally, preregistered studies should be linked to any published outcome. To ensure that preregistration becomes a powerful instrument, publishers, funders, and institutions should refer to registries that fulfill these minimum standards.

摘要

研究的预先注册是临床研究中一种公认的工具,用于提高所有获得结果的质量和报告。在临床前研究中,预先注册可以促进将已发表的结果转化为临床突破。当研究依赖动物试验或构成临床试验的基础时,提高研究结果的有效性和可靠性此外还成为一项伦理义务。然而,动物研究中预先注册的实施仍然缓慢。不过,研究机构、资助者和出版商开始重视预先注册,从而为其未来更广泛的接受铺平道路。共有3个公共注册机构,即[此处原文缺失机构名称]、[此处原文缺失机构名称]和[此处原文缺失机构名称]已经鼓励对涉及动物的研究进行预先注册。在此,它们共同声明通用标准,以使预先注册成为推动更好科学发展的宝贵工具。注册机构应满足以下标准:公众可访问性、资金来源的透明度、变更跟踪以及数据的保证和可持续性。此外,注册模板应涵盖一组最低限度的强制信息,并且研究必须具有唯一可识别性。最后,预先注册的研究应与任何已发表的结果相链接。为确保预先注册成为一个有力工具,出版商、资助者和机构应参考符合这些最低标准的注册机构。

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