Toward Effective Human Research Protection: The Current Status and Limitations of the Human Research Protection Program in Korea (실질적인 임상시험 대상자 보호를 위하여: 한국 내 임상시험 대상자 보호 프로그램도입의 현황과 한계)

Junho Jung (정준호); Jeong-Hyun Kim (김정현); JUNG，SeHee (정세희); Kim, Ock Joo (김옥주)

doi:10.35301/ksme.2017.20.2.163

Toward Effective Human Research Protection: The Current Status and Limitations of the Human Research Protection Program in Korea

Korean Journal of Medical Ethics
Abbr : 의료윤리
2017, 20(2), pp.163-175
DOI : 10.35301/ksme.2017.20.2.163
Publisher : The Korean Society For Medical Ethics
Research Area : Medicine and Pharmacy > General Medicine
Received : May 14, 2017
Accepted : June 5, 2017
Published : June 30, 2017

Junho Jung ¹, Jeong-Hyun Kim ², JUNG，SeHee ³, Kim, Ock Joo ¹

¹서울대학교
²분당서울대학교병원
³서울특별시보라매병원 재활의학과

Accredited

ABSTRACT

Korea has witnessed rapid growth in the clinical trial industry in past 10 years. Public concern regarding the rights and safety of human research participants has been a major issue in the field. As the need for a more effective system of protection for human subjects grows, one which surpasses the scope of the Institutional Review Board (IRB), the Korean Ministry of Food and Drug Safety (MFDS) has issued its “Operation Guidelines for Human Research Protection Program (HRPP)” in 2014. It is the first government- initiated adoption of a HRPP in the world. This study shows that there is great deal of variation in clinical trial institutes in terms of their size and systems of operation and that many small- to mediumsized clinical trial institutes are not willing to adopt HRPP. The current MFDS HRPP policy does not reflect the differences in the various clinical trial institutes, which leads to a low adoption rate in HRPP in Korea. Furthermore, the government-initiated HRPP policy may puts more burdens on smaller organizations. Despite the limitations of the current HRPP policy, it is argued in this article that strong leadership to promote HRPP by the Korean government can improve clinical trial participant protection and the quality of clinical trials in Korea. Future policy for establishing and promoting HRPP in Korea should encompass considerations of the variability in the characteristics of clinical trial institutes as well as measures for enhancing the understanding of HRPP in the research community.

KEYWORDS

human research protection program, clinical trials, institutional review board

Citation status

* References for papers published after 2023 are currently being built.

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Korean Journal of Medical Ethics 2023 KCI Impact Factor : 1.21

Toward Effective Human Research Protection: The Current Status and Limitations of the Human Research Protection Program in Korea

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Citation status

* References for papers published after 2023 are currently being built.

Korean Journal of Medical Ethics 2023 KCI Impact Factor : 1.21

Toward Effective Human Research Protection: The Current Status and Limitations of the Human Research Protection Program in Korea

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KEYWORDS

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