「생명윤리 및 안전에 관한 법률」에 따른 연구에 대한 기관생명윤리위원회(IRB)의 심의면제 근거규정에 대한 고찰

Internationally, to protect the rights and welfare of the human research participants and human material donor, the Institutional Review Board (hereinafter referred to as 'IRB') that has the authority to review and approve the research as well as to manage and oversee the approved research has been considered the most important infrastructure for the voluntary restriction. In Korea, the totally amended Bioethics and Safety Act has to be implemented from 2013, not only the range of the research that this act applies to has been extended to the human research and human material research but also all institutions that the researcher who conducts these researches belongs to has the legal obligation to establish and operate the IRB. Also, the researcher who will conduct the research involving human and its material has the legal liability to submit the research protocol to the IRB for the review and obtain the approval by the IRB. But some human research and human material research that meet the conditions settled down this act can be exempted from the IRB review. However the provisions of this act related to the exemption of the research review contain the vague expression of 'trifling risk' and the inappropriate term of 'personal information' instead of 'personally identifiable information'. Furthermore, some provisions are utterly incompatible with each other and the subject that confirms whether the research meets the legal criteria for the exemption of the review by the IRB is not specified in these provisions. The exemption of the research review by IRB is the exceptional measure, so whether the research can be exempted the review should be carefully decided according to the accurate criteria and by the subject that has the authority and expertise to make a judgment. So, these provisions have to be revised. And, before the revision, the IRB designated by the Korean Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention as the subject that is in charge of the confirmation about the exemption of the review has make an effort to decide properly because the exempted research will be able to be related to the human research participants and human material donor directly and indirectly.