미국 임상시험심사위원회(Institutional Review Board) 인증체계에 대한 연구: 인간피험자보호프로그램을 위 한 인증협회(The Association for the Accreditation of Human Research Protection Programs, AAHRPP)1)를 중심으로

Abstract

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.