Ethical Process for Development and Clinical Application of an Innovative Medical Procedure (새로운 의료시술의 도입과 임상적용 시의 윤리적 절차)

Myoung Sheen Kang (강명신); Lee, Yoon-seong (이윤성); 최보문; Lee, Dong Soo (이동수); Sang Moo Lee (이상무); Lee, Seon Heui (이선희); Koo， Young-Mo (구영모); PARK JAE HYUN (박재현); Ilhak LEE (이일학); Jiyong Park (박지용); KOH YS (고윤석)

doi:10.35301/ksme.2013.16.1.92

Ethical Process for Development and Clinical Application of an Innovative Medical Procedure

Korean Journal of Medical Ethics
Abbr : 의료윤리
2013, 16(1), pp.92-116
DOI : 10.35301/ksme.2013.16.1.92
Publisher : The Korean Society For Medical Ethics
Research Area : Medicine and Pharmacy > General Medicine
Published : April 30, 2013

Myoung Sheen Kang ¹, Lee, Yoon-seong ², 최보문 ³, Lee, Dong Soo ², Sang Moo Lee ⁴, Lee, Seon Heui ⁴, Koo， Young-Mo ⁵, PARK JAE HYUN ⁶, Ilhak LEE ⁷, Jiyong Park ⁷, KOH YS ⁵

¹강릉원주대학교
²서울대학교
³가톨릭대학교
⁴한국보건의료연구원
⁵울산대학교
⁶경희대학교
⁷연세대학교

Accredited

ABSTRACT

Medical care largely depends on developments of medical sciences and technologies. Development of innovative medical procedure have to be based on medical evidence. And ethical climate among individual physicians, academic societies, specialists' organization, and healthcare institution which applies the procedure is as much critical as the ethical stance of the developer. Therefore, it is necessary to make decisions on clinical application and evaluation, social costs and benefits, reimbursement through rational procedure and standards taking into account issues like medical evidence and conflict of interests. Especially, in the case of innovative surgical and surgico-medical procedure, the adoption has almost been up to non-formal studies until recently. Formal review process based on basic principles of biomedical research ethics and evidence-based medicine, is to be proposed for development of innovative surgical and medical procedures. And this process is to be an integral part of biomedical technology assessment and ethical regulation. This paper suggests an ethical guideline for ethical review and evaluation of a new medical procedure from its initial attempt to clinical application. Though focused on innovations, this suggested guideline is also applicable to a new medical procedure. The paper consists of four parts. Firstly, it outlines the general discussion about surgical innovations from the ethical viewpoint. Secondly, prior researches about the need of guideline are reviewed. Thirdly, under this background, basic principles for process of review and evaluation, and fourthly, the very process is proposed. Lastly, the further suggestions in connection with health care policy are given.

KEYWORDS

surgical procedures, operative, ethical review, human experimentation, medical ethics, health technology assessment, innovative procedures

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

Ethical Process for Development and Clinical Application of an Innovative Medical Procedure

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KEYWORDS

Citation status

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

Korean Journal of Medical Ethics 2023 KCI Impact Factor : 1.21

Ethical Process for Development and Clinical Application of an Innovative Medical Procedure

ABSTRACT

KEYWORDS

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