기관생명윤리위원회 신속심의에 대한 법정책적 기준 마련에 관한 제언
A Study on the Legal Standards and Policy about the Expedited Review by the Institutional Review Board
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초록
연구대상자 보호를 위해 기관생명윤리위원회가 연구에 대해 심의를 함에 있어 정식심의 절차라는 원칙 외에 신속심의 절차라는 예외를 두어 운영하고 있다. 이 두 가지 절차 모두 국제적으로 인정되고 있고, 국내에서도 이미 상당수의 기관생명윤리위원회가 이러한 절차들을 도입하고 있다. 그러나 「생명윤리 및 안전에 관한 법률」에 의해 연구에 대한 심의가 법적으로 의무화 되어 있음에도 불구하고, 이와 직결되는 실제 절차 중 하나인 신속심의 절차에 대한 법정책적 기준은 거의 전무하다고 볼 수 있는 상태이다. 하지만 신속심의 절차의 운영은 상대적으로 정식심의 절차 적용대상 연구의 수를 감소시킬 수 있어 정식심의 절차의 운영에 대한 부담을 줄여주면서도 정식심의 절차 적용대상 연구에 대한 적절한 심의가 가능하도록 할 뿐만 아니라 심의 결과를 빠르게 도출할 수 있다는 데에 의의가 있다. 이에 신속심의 절차의 공식적 인정과 실제 운영의 적절성 평가를 위하여, 그리고 신속심의 절차의 오남용 방지와 적절한 활용을 위하여 신속심의에 대한 법정책적 기준이 마련될 필요가 있다. 이에 이 논문에서는 신속심의 절차가 보다 공정하면서도 원활하게 활용될 수 있도록 하기 위해 신속심의에 대한 법정책적 기준을 마련함에 있어 연구로 인한 위험의 수준과 유형, 연구대상자의 취약성 등을 고려하여야 한다는 점을 제언하였다.
Abstract
For the research review to protect the research participants, the Institutional Review Board (“IRB”) has been using two procedures: one is the review procedure by full institutional review board (“full board review procedure”) as the principled research review procedure, the other is the expedited review procedure as the exceptional research review procedure. Both procedures are recognized internationally, and they have been introduced by significant numbers of Korean IRBs. But, despite the legal requirement of the research review under the Bioethics and Safety Act, there is almost nothing about the legal standards and policy related to the expedited review unlike the full board review. Operating the expedited review procedure can greatly contribute to improved IRB task efficiency because it is possible to relatively reduce the burden on the operation of the full board review procedure relatively and make it possible to make appropriate review on the research that needs the full board review because of its risk, participation of vulnerable persons, sensitiveness of collected information and so on. Besides, the review result can be derived quickly by the expedited review procedure. Therefore, to recognize the expedited review officially, to assess the appropriateness of the actual operation, to prevent abuse and misuse of the expedited review procedure, and to make the expedited review procedure used properly, the legal standards and policy about the expedited review should be established. So in this article, I propose some considerations for establishing the legal standards and policy about the expedited review such as the level and types of research risk, vulnerability of the research participant and so on.
참고문헌 (22)
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