미국 단일 IRB 제도 검토를 통한 국내 기관생명윤리위원회의 합리적 운영을 위한 정책 제언
Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule
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최근 개정된 미국의 45CFR46(common rule)에서 다기관이 참여하는 공동연구에 대하여 하나의 IRB, 이른바 단일 IRB(single IRB)의 이용이 의무화됨에 따라, 소위 중앙 IRB, 공동 IRB 등 다기관 연구의 합리적 심의를 위한 IRB 운영에 대한 관심이 높다. 하지만 면밀한 검토 없이, 이러한 제도적 변화를 섣불리 다기관 공동연구에 대한 효율적 심의를 위한 대안으로 이해하는 것은 위험하다. 이에, 본 글은 미국의 연구윤리심의 체계와 관련한 변화와 논의 과정을 살펴보고, 다기관 공동연구에 대한 심의의 중복 등 비효율성을 개선하기 위해 취해진 노력과 그 시기에 제정 내지 개정된 정책과 법제에서 단일 IRB를 어떻게 규정하고 있는지를 살펴보았다. 또한, 국내 「의약품임상시험관리기준」과 「생명윤리 및 안전에 관한 법률」에 따른 연구관리 및 규정을 비교·검토하며, 다기관 공동연구에 대한 심의나 관리 방안이 각각의 규제와 제도에 따라 달리 검토되어야 함을 제안하였다. 미국과 국내 연구의 심의 및 연구관리 체계에 대한 올바른 이해를 바탕으로, 본 글은 다기관 공동연구에 대한 제도 개선을 위한 정책 제언으로서, 국내 임상시험 및 인간대상연구 등 관련 법제와 제도에 따라 부여된 연구자와 수행기관의 책임에 대한 명확한 검토와 책임분담에 대한 논의가 심의 일원화보다 선행되어야 한다는 점을 강조했다. 더불어, 무조건적인 심의 일원화보다는 각 수행기관 단위별 심의 부담을 덜어줄 수 있는, 컨설팅 및 초기심의 지원 등 자율에 근거한 제도 보완의 검토가 필요함을 제언하였다.
Abstract
In accordance with the recent revision of the Common Rule (Subpart A of the U.S. Department of Health and Human Service’s regulations for the protection of human subjects in research at 45 CFR 46), the use of single IRB has become mandatory for cooperative research in the U.S. Thus, interest has grown in operating alternative IRB models, including central IRBs and/or joint IRBs. However, since the single IRB mandate has risks as well as benefits, such revision should be carefully considered before adopting it. Accordingly, this study examined the institutional changes and progress of the U.S. research ethics review system, the efforts that have been made to avoid inefficiencies caused by duplicate reviews for multi-center cooperative research, and the single IRB-related policies and regulations that have been enacted or revised thereafter. Additionally, this study compared the differences between the regulations and guidelines in the Korean Good Clinical Practice (KGCP) and those in the Bioethics and Safety Act. On the basis of this examination, it is argued that before a single IRB review model is adopted in Korea, it is necessary for all relevant parties to conduct a full review of the current responsibilities of researchers and institutions under existing laws and regulations and to determine how those responsibilities would be shared in the event of a single IRB review model.
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