의료기관에 의한 잔여검체 제공 관련 피채취자 권리 보호: 거부의사표시방식(일명 'opt-out방식')의 절차적 내용적 문제점을 중심으로

This paper intended to address the issue of the protection of the donor's rights in the collection of residual human materials by medical institutions and the provision of them to the biobank under the ˹Bioethics & Safety Act˼ as amended in October 2019. In particular, we examined the procedural content issues regarding the adoption of the optout system, and also argued that the opt-in system was more appropriate. Of course, we agree that the medical institutions, which are intended to be amended by the law, will use the residual human materials for treatment and diagnosis purposes to lay the foundation for more efficient and active disease research for research purposes. In addition, the CIOMS guidelines stipulate that residual human materials can be stored and used in research, unless explicitly stated by the person who is the source of the residual human materials, and the conditions are set forth. That is opt-out system. However, the relevant details of the revised legislation suggest that the opt-out system, in which the residual human materials is donated to the biobank, unless the objector rejects it, will make it difficult for the informed consent to make integrated autonomous decisions. Because it is necessary to express the objection of rejection through the information received in writing, it is difficult for the patient to acknowledge that he has obtained enough information and understood and agreed to it. And, due to the subordinate hierarchical difficulties arising from the doctor-patient relationship, it is difficult to guarantee voluntary rejection of the donor. In addition, within three days after the human materials is collected, it is necessary to clarify the rejection of the offer, which is cumbersome and inconvenient to express the objection. Finally, privacy issues related to residual human materials may arise. Therefore, it is appropriate to adopt an opt-in system for protecting the donor's rights, which is more important than the effective progress of disease research and the result of excellent scientific results. First of all, we argued that sufficient training and information were required for the Institutional Review Board Member under consideration according to the revised law to work in consideration of this problems. [ABSTRACT FROM AUTHOR]