인체유래물연구에 있어서의 자기결정권과 동의면제 연구

Abstract

WThe combination of artificial intelligence technology and biomedical medicine has increased the need for research on human materials to secure genetic information. In Korea, the Bioethics Act was amended in 2012 to introduce the donor consent system and the consent waiver system for research on human materials including genetic information. According to the amended law, in order to research human materials, a researcher must obtain written consent from a person who has the right to consent, such as a donor or a representative, before conducting research, and before obtaining written consent, the person with the right to consent must provide sufficient have to explain In addition, the exception to written consent was recognized, and if the statutory requirements were met, the written consent could be exempted with the approval of the Institutional Bioethics Committee established in the institution to which the researcher of human materials belongs. Exemption is not recognized if written consent is obtained from the agent. Consent to human material is to be given a sufficient explanation and to decide whether to consent in a situation where autonomy is guaranteed. However, the law does not stipulate the protection device in case the donor does not properly understand the contents and sufficient explanation of the written consent form and whether or not the results of the research on human materials are attributable to them. In the form of 'Consent Form', it is stipulated that all rights are rather waived. Biomedical science should be developed for a healthy life, and for this, research on human materials should be activated and related industries should be promoted. In order to achieve this purpose, the requirements should be relaxed so that the collection, collection, and utilization of human materials are carried out smoothly. While revitalizing research on genetic information and promoting related industries, the guarantee of donors' right to self-determination must be strengthened. In addition, the public use of research results should be expanded. Researchers of human materials, donors and society should be fair and equitable, proportionate, and harmonious in the performance of research on human materials. However, while the requirements for research on human materials have been relaxed and the requirements for exemption of consent have been expanded to allow for various research and utilization, the right to access or request information disclosure on research results is not guaranteed, and the research results cannot be used for the public interest. There are no regulations for In order to solve these problems, in this article, the concept of the right to self-determination, the constitutional basis, and the concept and legal nature of the right to self-determination in the study of human materials are reviewed (Ⅱ), reviewing the donor's consent and waiver of consent in research on human materials, focusing on the method of consent (Ⅲ), and analyzing the effect of consent and waiver of consent recognized in research on human materials on the right to self-determination (IV) To contribute to the expansion of public and commercial use of human materials and vitalization of research.