인간대상연구에 있어 동의 관련 규범적 문제; 「생명윤리 및 안전에 관한 법률」 상의 동의 관련 규정을 중심으로 = Study on the provisions of the Bioethics and Safety Act related to obtaining informed consent for the human research : Focusing on the principal of obtaining informed consent and the allowance of exceptions to the principle

다국어 초록 (Multilingual Abstract)

To obtain the written informed consent from the research participant after providing enough information and explaining about the research is the principle that has to be requested for observance on a global level as well as the duty of the researcher under the domestic law for the respect of the research participant`s autonomy and the protection of the research participant from the research risk. According to the amendment of the Bioethics and Safety Act, the scope of the human research regulated by this law has been extended to the human research that is to be conducted by the physical intervention, to be conducted through the interaction such as the communication physical contact or other means and to be conducted using the information with which individuals can be identified, so the type and the characteristics of the research has to be diversified considerably. Therefore, these changes have led to the occasional situation that the exceptions to the principle related to obtaining informed consent for the human research such as the exemption of obtaining informed consent and waiver or alternation of documentation of obtaining informed consent have to be allowed in legally to enable the research practically as well as to protect the privacy of the research participant and to ensure the confidentiality of the research participant. Already, the international norms such as the Declaration of Helsinki and WHO CIOMS Guideline have some provisions and contents to allow these exceptions. And both for the Institutional Review Board Members who have to review the research protocol and to decide the way to obtain informed consent from the research participant and the researcher who have to obtain informed consent from the research participant, US DHSS 45CFR46, especially Subpart A, has some provisions in which are specific standards to allow these exceptions. But, in the Bioethics and Safety Act, there are the clearly defined provisions related to researcher`s observance duty of the obtaining of informed consent, but there are not enough provisions providing a basis for the allowance of these exceptions. So, in this article, to find the problems, I consider the provisions of the Bioethics and Safety Act related to obtaining informed consent for the human research focusing on the principal of obtaining informed consent and the allowance of exceptions to the principle. And referring to the provisions and contents in the international norms and 45CFR46, I suggest the way to improve the provisions in the Bioethics and Safety Act for the allowance of exceptions to the principle of obtaining informed consent.

참고문헌 (Reference)

1 "약사법"

2 보건복지부, "생명윤리법 관련 기관 운영지침"

3 "생명윤리 및 안전에 관한 법률"

4 "「의약품 등의 안전에 관한 규칙」및 [별표4 의약품 임상시험 관리기준]"

5 "「의료기기법」및 동법 시행규칙 [별표2의2 의료기기 임상시험 관리기준]"

6 "World Medical Association Declaration of Helsinki : Ethical Principles for Medical Research Involving Human Subjects" 2013

7 "WHO Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects"

8 Susan M. Labott, "Psychological and Social Risks of Behavioral Research" The Hastings Center 26 (26): 11-15, 2004

9 National Research Council, "Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences" National Academy Press 45-49, 2014

10 Joan E. Sieber, "Planning research: Basic ethical decision-making, Ethics in Research with Human Participants" American Psychological Association 13-26, 2000

11 Folstein, Susan F., "Out of darkness: Contemporary perspectives on family violence" Sage Publications, Inc 271-281, 1997

12 Elizabeth A, "Institutional Review Board Management and Functio n" Jones & Bartlett Pub 2006

13 Elana Newman, "Ethical Issues in Trauma-Related Research: A Review" University of California Press 1 (1): 29-46, 2006

14 "Code of Federal Regulations Title 45 Public Welfare Part 46 Protection of Human Subjects"

15 Check, Devon K, "Certificates of Confidentiality and Informed Consent: Perspectives of IRB Chairs and Institutional Legal Counsel" The Hastings Center 36 (36): 1-8, 2014

16 (재)국가생명윤리정책연구원, "(2013-15 기관위원회 시범평가) 기관위원회 평가인증기준 해설서 : 평가위원용"