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Developing a Framework for Self-regulatory Governance in Healthcare AI Research: Insights from South Korea

Authors
 Junhewk Kim  ;  So Yoon Kim  ;  Eun-Ae Kim  ;  Jin-Ah Sim  ;  Yuri Lee  ;  Hannah Kim 
Citation
 ASIAN BIOETHICS REVIEW, Vol.16(3) : 391-406, 2024-03 
Journal Title
ASIAN BIOETHICS REVIEW
ISSN
 1793-8759 
Issue Date
2024-03
Keywords
AI governance ; Healthcare AI research ; Interdisciplinary approach ; Research ethics ; Research governance ; Self-regulation
Abstract
This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the 'Research Ethics Guidelines for AI Researchers in Healthcare' published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers identified similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers' ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future.
Files in This Item:
T202404542.pdf Download
DOI
10.1007/s41649-024-00281-w
Appears in Collections:
2. College of Dentistry (치과대학) > Dept. of Dental Education (치의학교육학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Medical Humanities and Social Sciences (인문사회의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Others (기타) > 1. Journal Papers
Yonsei Authors
Kim, So Yoon(김소윤) ORCID logo https://orcid.org/0000-0001-7015-357X
Kim, Junhewk(김준혁)
Kim, Han Nah(김한나)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/200256
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