BioMed Central, 236 Gray's Inn Road, London WC1X 8HL, UK.
Trials. 2010 Jan 29;11:9. doi: 10.1186/1745-6215-11-9.
In recognition of the benefits of transparent reporting, many peer-reviewed journals require that their authors be prepared to share their raw, unprocessed data with other scientists and/or state the availability of raw data in published articles. But little information on how data should be prepared for publication - or sharing - has emerged. In clinical research patient privacy and consent for use of personal health information are key considerations, but agreed-upon definitions of what constitutes anonymised patient information do not appear to have been established. We aim to address this issue by providing practical guidance for those involved in the publication process, by proposing a minimum standard for de-identifying datasets for the purposes of publication in a peer-reviewed biomedical journal, or sharing with other researchers. Basic advice on file preparation is provided along with procedural guidance on prospective and retrospective publication of raw data, with an emphasis on randomised controlled trials.
为了认识到透明报告的益处，许多经过同行评审的期刊要求作者准备好与其他科学家共享原始、未处理的数据，并在已发表的文章中说明原始数据的可用性。但是，关于如何准备数据以供发布或共享的信息很少。在临床研究中，患者隐私和同意使用个人健康信息是关键考虑因素，但似乎尚未就构成匿名患者信息的内容达成一致定义。我们旨在通过为参与出版过程的人员提供实用指导来解决这个问题，我们提议制定一个最低标准，用于将数据集去标识化，以便在同行评审的生物医学期刊上发表，或与其他研究人员共享。我们提供了有关文件准备的基本建议，以及关于前瞻性和回顾性发布原始数据的程序指南，重点是随机对照试验。
