미국 임상시험심사위원회(Institutional Review Board) 인증체계에 대한 연구:

• 영문명: A Study on the Accreditation of Institutional Review Board in the United States: focused on the Association for the Accreditation of Human Research Protection Programs(AAHRPP)
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: 김수정(Soo-Jung KIM)
• 간행물 정보: 『생명윤리정책연구(제 9권 제 3호 이전)』제1권 제2호, 157~181쪽, 전체 25쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2007.12.30

영문 초록

The goal of this paper is to introduce the accreditation system of human research protection programs. This paper will trace the origin of AAHRPP and examine its standard for the accreditation, including requirements, guidelines, resources for the accreditation. The overview of its accreditation program includes its detailed information on IRB organization, membership, accreditation procedure, kinds of accreditation, and its benefit. The introduction to AAHRPP will guide our consideration on the introduction of IRB accreditation and its potential benefit in Korea. As shown in the accreditation system of AAHRPP, its success depends on the expertise and effectiveness. Institutions which received AAHRPP’s accreditation claim that they received practical help in improving their human participants protection program. AAHRPP’s tailored approach toward each institution seems to be met each institution’s demand and need. Due to large pool of expertise AAHRPP could identify primary issues and update its resources. AAHRPP’s accreditation system gives us an insight in improving human participant protection program. However, the development of accreditation system in Korea might not be the same as in US. AAHRPP originated from the society which is market-oriented and emphasizes individual autonomy rather than communal values. We need to consider the necessity, possibility, and limit of accreditation system in Korea in order to develop successful accreditation system which contributes to the protection of human participants.

목차

Ⅰ. 역사적 배경

II. AAHRPP의 소개

III. 인증제의 효과

IV. 마무리

키워드

인증(Accreditation) 인간피험자보호프로그램을 위한 인증협회(The Association for the Accreditation of Human Research Protection Programs, AAHRPP) 임상시험심사위원회(IRB, Institutional Review Board) 인간피험자(Human Participant)