[인체유래물은행으로부터 제공(분양)받은] 인체유래물등의 재(再)제공: 실정법의 한계와 입법론 - 인체유래물 및 관련 데이터의 이용 가능성 확장에 대한 고찰 -

In response to the rapidly growing demand for the establishment and utilization of platforms that integrate and share human materials and related information, this article examines the interpretation of the current Bioethics and Safety Act (BioAct, 2024) with regard to the issue of the so-called “re-provision of human materials,” namely, the transfer of human materials and related information that have been provided (distributed) by a human-derived material bank to a human materials researcher to another biobank. On this basis, the article explores appropriate legal and policy directions. Under the BioAct, the regulatory framework governing the provision of human materials by biobanks is premised on a review of the intended use plan. For this reason, it is difficult to regard the existing provisions as applicable to the re-provision to another biobank. Furthermore, although the BioAct contains provisions concerning the transfer of human materials between biobanks, their scope is clearly limited to procedural transfer (handover) rather than re-provision. Likewise, the provisions governing the provision of human materials by a human materials researcher to a third party cannot be regarded as providing a legal basis for the re-provision by a researcher of human materials originally obtained from a biobank. The consent for third-party provision contemplated therein cannot reasonably be interpreted, in light of the purpose of the biobank’s review system for provision, as encompassing consent to re-provision. In addition, interpreting the provisions on written consent obtained by collectors of human materials as including biobanks within the scope of such collectors not only runs counter to legislative intent but also lacks systematic coherence. Accordingly, it must be concluded that there exists a legislative gap under the current law with respect to the re-provision of human materials and related information from one biobank to another when such materials have been originally provided by a biobank. Considering the practical necessity and added value of re-provision, it would be desirable to explicitly define appropriate requirements within a reasonable scope. To legislate such requirements, it is particularly necessary to revise consent forms and related regulations used in the process of collecting human materials or related information so as to clearly confirm the data subject’s consent to re-provision. In addition, the procedure by which the head of the biobank that initially provided the human materials grants approval for re-provision should be explicitly structured. Moreover, review procedures for re-provision by the Institutional Review Board (IRB) of the researcher’s affiliated institution, or by a centralized IRB, as well as comprehensive safeguards for the protection of the data subject’s information, should also be established.