기관생명윤리위원회 신속심의에 대한 법정책적 기준 마련에 관한 제언

• 영문명: A Study on the Legal Standards and Policy about the Expedited Review by the Institutional Review Board
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: 김은애(Eunae Kim)
• 간행물 정보: 『생명윤리정책연구(Asia Pacific Journal of Health Law & Ethics)』Vol.10 No.1, 129~156쪽, 전체 28쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2016.12.30

영문 초록

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.

목차

Abstract

Ⅰ. 들어가며

Ⅱ. 신속심의의 개념 및 의의

Ⅲ. 신속심의에 대한 법정책적 기준 마련의 필요성

Ⅳ. 신속심의에 대한 법정책적 기준 마련 시 고려하여야 하는 사항

Ⅴ. 마치며

References

키워드

Institutional Review Board Research Review procedure Expedited Review Bioethics And Safety Act Research Risk Minimal Risk Human Research Human Material Research