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建立行业资助研究的作者选择实践共识:医学出版专业人员专家工作组的建议。

Building consensus on author selection practices for industry-sponsored research: recommendations from an expert task force of medical publication professionals.

机构信息

GlaxoSmithKline, Collegeville, PA, USA.

Bristol Myers Squibb, Princeton, NJ, USA.

出版信息

Curr Med Res Opin. 2022 Jun;38(6):863-870. doi: 10.1080/03007995.2022.2050111. Epub 2022 Apr 19.

Abstract

BACKGROUND

Many biomedical journals follow the International Committee of Medical Journal Editors (ICMJE) recommendations and criteria for authorship. ICMJE criterion 1 provides the basis for selecting authors according to their substantial contributions to the work reported in the publication. Identifying substantial contributions and their application for author selection can be challenging, especially for multicenter studies with large numbers of investigators and contributors. Contributions are not frequently documented during study conduct and authorship decisions may lack transparency, objectivity, and context.

METHODS

The International Society for Medical Publication Professionals (ISMPP) Authorship Task Force surveyed members on authorship practices, reviewed the literature defining substantial contributions to ICMJE criterion 1, and assessed existing tools or algorithms for determining authorship in industry-sponsored research. Contributions were categorized under the four sub-categories of ICMJE criterion 1: study concept and design, acquisition of data, data analysis, and data interpretation.

RESULTS

Survey findings and literature review confirmed the need for clear and consistent interpretation, application, and documentation of ICMJE criterion 1 for transparent decisions about authorship. The Task Force reached consensus on definitions of substantial contributions to be considered when selecting authors of industry-sponsored research. The subsequent recommendations were grouped according to the sub-categories of ICMJE criterion 1. In addition, the Task Force developed recommendations regarding contributions that do not merit authorship designation.

CONCLUSIONS

The Task Force recommendations for objective and consistent interpretation of ICMJE criterion 1 will facilitate an author selection process grounded in the core principles of substantial intellectual contribution to the work's conception or design, or to the acquisition, analysis, or interpretation of data. While these recommendations are focused on author selection practices for industry-sponsored research, they may be applicable to publications in other areas of scientific and biomedical research.

摘要

背景

许多生物医学期刊遵循国际医学期刊编辑委员会(ICMJE)的建议和标准来确定作者。ICMJE 标准 1 为根据他们对出版物中报告的工作的实质性贡献来选择作者提供了依据。确定实质性贡献及其用于选择作者的方法可能具有挑战性,特别是对于有大量研究人员和贡献者的多中心研究。在研究过程中,贡献通常没有记录,并且作者选择可能缺乏透明度、客观性和背景。

方法

国际医学出版专业人员协会(ISMPP)作者任务组对成员的作者实践进行了调查,回顾了定义 ICMJE 标准 1 中实质性贡献的文献,并评估了行业资助研究中用于确定作者身份的现有工具或算法。贡献分为 ICMJE 标准 1 的四个子类别:研究概念和设计、数据获取、数据分析和数据解释。

结果

调查结果和文献综述证实,需要明确和一致地解释、应用和记录 ICMJE 标准 1,以透明地决定作者身份。任务组就选择行业资助研究的作者时应考虑的实质性贡献定义达成了共识。随后的建议根据 ICMJE 标准 1 的子类别进行分组。此外,任务组还制定了关于不应授予作者身份的贡献的建议。

结论

任务组关于客观和一致地解释 ICMJE 标准 1 的建议将有助于作者选择过程,该过程基于对工作的构思或设计,或对数据的获取、分析或解释有实质性智力贡献的核心原则。虽然这些建议侧重于行业资助研究的作者选择实践,但它们可能适用于其他科学和生物医学研究领域的出版物。

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