Huh Sun
Department of Parasitology and Institute of Medical Education, Hallym University College of Medicine, Chuncheon, Korea.
Neurointervention. 2019 Mar;14(1):1-8. doi: 10.5469/neuroint.2019.00031. Epub 2019 Feb 19.
It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans' personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects' privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects' personal information.
其目的是依据韩国保护个人信息的法律，阐述个人信息的定义，并根据国际医学期刊编辑委员会和出版伦理委员会的指南，介绍期刊出版中个人信息的保护流程。韩国有两部法律涉及人体研究中的个人信息保护：《个人信息保护法》和《生物伦理与安全法》。这些法律旨在防止包括医疗信息在内的韩国人个人信息被未经授权使用。个人信息可分为包括居民登记号码在内的可识别个人信息和包括健康信息在内的敏感信息。为在期刊出版中保护个人信息，在临床研究中建议或强制要求获得机构审查委员会（IRB）批准并征得患者的知情同意。然而，回顾性病历审查可能无需IRB批准，而对于所有病例报告，建议征得知情同意。由于出版伦理委员会指南未特别建议收集知情同意书副本，因此期刊政策在是否从作者处收集知情同意书副本方面可能存在差异。在讨论采用临床数据共享政策时，将包括不可识别个人信息的数据转移到另一个国家是一个未解决的问题。此外，韩国应设立一个公共数据存储库网站用于数据存储。为保护受试者隐私并防止因隐私问题可能引发的法律问题，编辑和出版商应尽力在对受试者个人信息进行适当监督的情况下发表文章。
