PreprintReviewVersion 1Preserved in Portico This version is not peer-reviewed
Clarifying Guidelines for the Use of Medical Data for Research in South Korea: Reconciling the Bioethics and Safety Act and Personal Information Protection Act
Version 1
: Received: 4 March 2024 / Approved: 5 March 2024 / Online: 5 March 2024 (10:56:17 CET)
How to cite:
Kim, J.S. Clarifying Guidelines for the Use of Medical Data for Research in South Korea: Reconciling the Bioethics and Safety Act and Personal Information Protection Act. Preprints2024, 2024030232. https://doi.org/10.20944/preprints202403.0232.v1
Kim, J.S. Clarifying Guidelines for the Use of Medical Data for Research in South Korea: Reconciling the Bioethics and Safety Act and Personal Information Protection Act. Preprints 2024, 2024030232. https://doi.org/10.20944/preprints202403.0232.v1
Kim, J.S. Clarifying Guidelines for the Use of Medical Data for Research in South Korea: Reconciling the Bioethics and Safety Act and Personal Information Protection Act. Preprints2024, 2024030232. https://doi.org/10.20944/preprints202403.0232.v1
APA Style
Kim, J.S. (2024). Clarifying Guidelines for the Use of Medical Data for Research in South Korea: Reconciling the Bioethics and Safety Act and Personal Information Protection Act. Preprints. https://doi.org/10.20944/preprints202403.0232.v1
Chicago/Turabian Style
Kim, J.S. 2024 "Clarifying Guidelines for the Use of Medical Data for Research in South Korea: Reconciling the Bioethics and Safety Act and Personal Information Protection Act" Preprints. https://doi.org/10.20944/preprints202403.0232.v1
Abstract
The 2020 revision of South Korea’s Personal Information Protection Act (PIPA) updated procedures for the use of medical data for research. The PIPA provision allowing “pseudonymized information” to be used without the consent of the data subject for scientific research introduced ambiguity regarding the applicability of the PIPA versus the Bioethics and Safety Act (BSA), which allows “anonymized information” to be used for research only after data-subject consent and IRB approval for human-subject research are obtained. The main points requiring clarification include the distinction between “human-subject” and “scientific” research, the definition of anonymization and pseudonymization, the requirements for data-subject consent, and the procedures for institutional review boards (IRBs) and data review boards (DRBs). After reviewing the legal concepts and processes, this article recommends clarification of the guidelines for the use of medical data in research by distinguishing the concept and, in the long run, categorizing medical data based on the degree of risk.
Keywords
medical data; human-subject research; scientific research; consent; PIPA; BSA
Subject
Social Sciences, Law
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
