유럽의 인체유래물 연구에 있어서의 동의 및 면제제도-EU와 독일의 제도를 중심으로-

Abstract

The emergence of precision medicine and personalized medicine inevitably requires the construction of a medical platform through expansion of large-scale analysis of genetic information, a population-based cohort, and human materials research. Therefore, activation of Consent and Consent Exemption is required within the scope of not invading the Self-Determination Right to medical information provider. Many laws, such as the Bioethics Act, Organs Transplant Act, Safety of the Human Tissue Act and Blood Management Act, is supposed to receive written consent includinf the objectives of research, procedure of research, foreseen risks and benefits of research, protection of personal information, preservation and discarding, withdrawal of consent, provision of personal information, etc. from the research participants and the donor. This is to respect the dignity and autonomy of the research participants and the donor. On the other hand, if it is determined that obtaining consent from a human subject of research is impracticable in the course of research or is likely to seriously affect the validity of research and if there is no ground to find that a human subject of research will decline consent or the risk to a human subject of research is very low even if the project is exempted from consent. a research project may be exempted from obtaining written consent of a human subject of research, subject to approval from the competent institutional committee. However, the 2019 revised Bioethics Act stipulates that a notice system, rather than a consent system, should be used to provide the human material bank with the remaining samples used by medical institutions. As long as the subject does not indicate rejection of the offer, a method that can be provided, that is, an opt-out method, has been introduced. The European Union has enacted the “DIRECTIVE 2004/23 / EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells” with a donor's consent and consent exemption system. And in EU, Seven countries are opting for the opt-in method, or the consent system(Zustimmungslösung), while 23 are opting for the opt-out method, or the contradiction system(Widerspruchlösung). Recently, the opt-out method has been expanded. Germany also enacted the 'Human Tissue Act(Gewebegesetz)' and accepted the European Union Directive 2004/23/EC as a domestic law. Germany has been adopting a "extended consent system(erweiterte Zustimmungslösung)." However, in 2019, the transplantation Act was revised to introduce an opt-out method, or an contradiction system for organ transplants of a deceased person. However, the expansion of the consent exemption system, including the notification system, and the expansion of the opt-out method in the donation or transplantation of organs of the deceased person greatly help human materials research. It is a great trend to create a good environment that can ensure the development of human materials research along with the guarantee of the right to personality. Therefore, in human subjectsor human materials research project, the opt-in method that personality rights can be well guaranteed can be widely applied to the research participation and organ donation and extraction. However, the opt-out method should be expanded within the scope of not infringing on the right of personality to improve the research environment of human materials research project.