현행 인체유래물은행 기증 동의의 문제점과 그 개선방안

다국어 초록 (Multilingual Abstract)

The Human Material Bank is in charge of promoting the activation of research by collecting and preserving not only human materials but also related information such as genetic information, epidemiological information, and clinical information from donors. It goes without saying that prior consent must be obtained by sufficient explanation of related information in addition to human materials. However, even considering the purpose of the Human Material Bank as a research infrastructure, the current Bioethics And Safety Act on the consent to donate human materials and related information is insufficient in the consent principle. This study is to propose improvement measures by analyzing the deficiencies of the current law from the perspective of the principle of consent. First, the law only provides clear regulations on the consent to donate human materials and other related information, but does not have a clear basis for consent to donate other related information, causing confusion not only about the role category of the Human Material Bank but also the category of the target to be provided. In this regard, it is proposed to use the terms 'human resource' or 'human materials, etc.' that encompass related information. Second, the law only receives broad consent that does not specify or limit the researchers or researchers to which the donor's human materials and related information will be used, and there are no special regulations to guarantee the right to self-determination in case it is used or provided for unexpected purposes at the time of donation. In addition to the legal form, a separate explanation should be made, and the donor's choice should be given more than broad consent to ensure the right to self-determination as much as possible. Third, the law also includes consent from electronic documents in written consent, and in this case, there is controversy over whether electronic copies are allowed in the provision of copies of consent, but it is reasonable to assume that this is permitted.