「생명윤리 및 안전에 관한 법률」에 따른 대학 생명윤리위원회의 구성․운영에 대한 제언 : 국내외 인증기준 상의 요구사항을 반영한 실질적 방안을 중심으로

According to the amendment of the Bioethics and Safety Act, the institution that the researcher who conducts the human research and the human material research belongs to the university has the obligation to establish and operate its Institutional Review Board(hereinafter referred to as "IRB"). Some universities that have established and operated its IRB for the last few years have to reorganize or rearrange the composition and the operation of its IRB because the scope of the research that they have to review has expended to the human research and the human material research. And, except these universities, most universities are at a preparatory stage to establish its IRB or an early stage to operate its IRB newly. But in the Bioethics and Safety Act, there are only basic standards that has to be complied with when the IRB is composed and operated. Considering that the composition and the operation of IRB must to be based on the autonomy because the IRB can exist as the self-regulatory organization, not only the basic standards in the Bioethics and Safety Act but also the situation of each institution and the magnitude and character of the research that the IRB has to review can be reflected to the composition and the operation of IRB. To play a role as the infra structure within the institution for the protection of the research participants, the IRB must set the standards that the IRB has to comply with as well as the substantial measures that the IRB can take. So, in this article, according to the basic standards in the Bioethics and Safety Act, and considering the standards of the national accreditation pilot program and international accreditation program, I suggest the practical way that the university and the IRB can consider to compose and operate the IRB inter-organization and the IRB member.