시체이용연구 관련 법적 기준 변경의 의의와 향후 과제
Implications of Changes in Legal Standards Related to Cadaver Research and Future Tasks
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최근 「시체해부 및 보존 등에 관한 법률」이 개정되었다. 이에 시체이용연구의 범위가 의학연구에서 의생명과학연구로까지 확대되었고, 시체일부제공기관에 대한 허가제도가 마련되었으며, 시체를 의과대학에서의 교육과 연구라는 1 차적 목적을 위해 기증하는 일뿐만 아니라 시체일부가 다른 연구자의 연구라는 2차적 목적을 위해 제공되는 일에 대해서까지도 본인이나 그 유족에게 동의권이 있음을 명확히 하였다. 또한, 개정된 법에 따라 연구자는 시체이용연구의 윤리적 과학적 측면에 대해 기관생명윤리위원회의 심의를 거쳐 승인을 받아야 한다. 이러한 새로운 기준들이 시체기증, 시체이용연구, 시체일부제공 등의 활성화에 실제로 기여할 수 있으려면 이러한 기준들이 제대로 지켜질 수 있도록 하면서 그한계점을 파악하여 보완해나갈 수 있어야 할 것이다. 이에 기관생명윤리위원회의 역량 강화, 기관생명윤리위원회에 대한 운영 지원, 시체일부제공 관련 일부 기준과 절차의 조정, 시체일부제공기관에 대한 지원, 시체일부제공기관 간의 협력지원을 통한 연구 인프라 강화가 향후 과제로 제안된다.
Abstract
Recently, the 「Act on Dissection and Preservation of Cadaver」 was amended. So, the scope of research using cadaver has been widened from the medical research to the biomedical science research, a permit system has been established for the institution to offer a part of a cadaver, and it has been clarified that the person or the bereaved family of the deceased had the right to consent not only about donating cadaver for the primary purpose of education and research at medical schools, but also about providing a part of the cadaver for the secondary research purpose by other researchers. Also, under the amended Act, the researcher must obtain the IRB approval for the cadaver research after reviewing its ethical and scientific aspects. In order for the new standards to actually contribute to the vitalization of cadaver donation, cadaver research, providing a part of a cadaver for research purposes and so on, these standards should be properly observed while identifying and supplementing the limitations. In this regard, future tasks are to strengthen the capacity of the IRB to review, approve, investigate and oversee the cadaver research, to support the operation of the IRB, to adjust some standards and procedures for providing a part of a cadaver for research purposes, to support the cadaver offering institution and to strengthen the research infrastructure by supporting cooperation between the cadaver offering institutions.
참고문헌 (17)
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