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[학술저널]

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

  • 학술저널

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

Study on the provisions of the Bioethics and Safety Act related to the exemption of the research review by IRB

김은애(이화여자대학교)

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초록

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.

목차

Ⅰ. 들어가며
Ⅱ. 연구에 대한 심의의 개념 및 의의 : 연구대상자 등의 보호를 위한 제도적 절차적 방법으로서의 심의
Ⅲ. 심의면제의 개념 및 의의 : 심의에 대한 예외로서의 심의면제
Ⅳ. 「생명윤리법」상 연구에 대한 심의면제 근거규정의 주요 내용
Ⅴ. 심의면제 근거규정의 문제점과 개선방향에 대한 제언
Ⅵ. 마치며
참고문헌
Abstract

참고문헌(18)

  • 1.

    , , 「생명윤리 및 안전에 관한 법률」 및 동법 하위법령

  • 2.

    , , 「약사법」 및 동법 하위법령 : 「의약품 등의 안전에 관한 규칙」 및 <의약품 임상시험관리기준> 포함

  • 3.

    , , 「의료기기법」 및 동법 하위법령 : <의료기기 임상시험 관리기준> 포함

  • 4.

    , , 미국 Code of Federal Regulations Title 45 Public Welfare Part 46 Protection of Human Subjects , US Department of Health and Human Services

  • 5.

    , 2014 , 미국의 Association for the Accreditation of Human Research Protection Program의 국제인증프로그램 인증기준 , Evaluation Instrument for Accreditation

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