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KMID : 1025620130160010092
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Korean Journal of Medical Ethics
2013 Volume.16 No. 1 p.92 ~ p.116
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Ethical Process for Development and Clinical Application of an Innovative Medical Procedure
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Kang Myoung-Sheen
Lee Yoon-Seong
Choi Bo-Moon
Lee Dong-Soo
Lee Sang-Moo
Lee Seon-Heui
Koo Young-Mo
Park Jae-Hyun
Lee Il-Hak
Park Ji-Yong
Koh Youn-Suck
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Abstract
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Medical care largely depends on developments of medical sciences and technologies. Development of innovative medical procedure has to be based on medical evidence. And the ethical climate among individual physicians, academic societies, specialists’ organization, and healthcare institution 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 clinical evidence and conflict of interests. Especially, in the case of innovative surgical and surgico-medical procedure, the development and 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 supposed 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 ethical guidelines from its initial attempt to clinical application with regard to the ethical review and evaluation of a new medical procedure. Though focused on innovations, these suggestions are also applicable to a new medical procedure. 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 are proposed. Lastly, the further suggestions regarding relevant health care policy issues are given.
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KEYWORD
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surgical procedures, operative, ethical review, human experimentation, medical ethics, health technology assessment, innovative procedures
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