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의료적 의사결정 과정에서 공유의사 결정과 설명·동의 법제

Shared Decision-Making and Informed Consent Legislation in Clinical Decision Making

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주제분류의학일반

초록

이 논문은 의료적 의사결정과정에서 환자 자기결정권 보장을 위한 사전동의나 충분한 정보에 근거한 동의에서 더 나아가 환자와의 ‘상호성’을 포함하는 개념인 공유의사결정에 대한 연구이다. 이를 위하여 다양한 영역의 의료적 의사결정과정에 공유의사결정을 도입하기 위해 그 기반이 되는 설명·동의 법제 의 내용을 살펴보았다. 기존의 설명·동의 법제는 공유의사결정과 구별되는 충분한 정보에 의한 동의에 기반한 법제도이기 때문에 이것이 공유의사결정 과정에 적용될 수 있을지 그 수용가능성과 법제도적 측 면에서의 정합성을 검토하였다. 설명·동의 법제에 근거하여 공유의사결정의 ‘참여자’의 범위와 공유되 는 정보의 내용, 공유의사결정 과정에서 하자 발생으로 인한 법적 책임의 발생 가능성을 살펴보았다. 이 과정에서 보건의료법체계 하의 설명·동의 법제의 공유의사결정에 적용하기 위해 설명의무 관련 판례에 서 법적 쟁점과 그 해석의 내용을 살펴, 이후 공유의사결정 제도화에 필요한 정책적 제안을 하였다.

Abstract

This article examines shared decision-making, a concept that extends beyond informed consent to safeguard patients’ right to self-determination in medical decision-making, emphasizing mutuality with patients. After reviewing the relevant legislation concerning consent, we argue that there are limitations to using this legislation as a basis for integrating shared decision-making across various medical domains. We assess the applicability, acceptability, and consistency of this legislation within the medico-legal system. In particular, we scrutinize the roles of so-called “participants” in shared decision-making, the content of shared information, and potential legal liabilities stemming from deficiencies in this process. Through this examination, we analyze legal precedents concerning the duty to inform and propose policy adjustments necessary for the institutionalization of shared decision-making within the medico-legal framework.

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