Neurointervention.  2019 Mar;14(1):1-8. 10.5469/neuroint.2019.00031.

Protection of Personal Information in Medical Journal Publications

• Huh S

• KMID: 2446776
• DOI: http://doi.org/10.5469/neuroint.2019.00031

Abstract

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.

Keyword

Informed consent; Personally identifiable information; Privacy; Republic of Korea; Ethics committees, Research

MeSH Terms

Bioethics
Computer Security
Consent Forms
Ethics
Ethics Committees, Research
Humans
Informed Consent
Jurisprudence
Korea
Personally Identifiable Information
Privacy
Publications
Republic of Korea
Retrospective Studies

Figure

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  Fig. 1. Diagram of the institutional review board exemption process of retrospective chart reviews, adapted from chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply? Modified from International Committee of Medical Journal Editors[8].

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