새로운 의료시술의 도입과 임상적용 시의 윤리적 절차*

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.