Comparative Legal Study on Attribution of Research Outcomes Involving Human Biological Materials

2021 Fiscal Year Final Research Report

• Project/Area Number: 20K22066
• Research Category: Grant-in-Aid for Research Activity Start-up
• Allocation Type: Multi-year Fund
• Review Section: 0105:Law and related fields
• Research Institution: Waseda University
• Principal Investigator: HARADA Kana 早稲田大学, 社会科学総合学術院(先端社会科学研究所), 助手 (90879826)
• Project Period (FY): 2020-09-11 – 2022-03-31
• Keywords: ヒト生体試料 / 比較法 / 判例研究 / 生殖補助医療 / ヒト配偶子 / ヒト胚 / 法的判断基準 / 医療情報

Outline of Final Research Achievements

The purpose of this study was to examine the legal criteria for the attribution of the outcomes of scientific research involving human biological materials, such as cells and tissues, and the accompanying information and benefits resulting from them.
In this study, I classified human biological materials into two different categories according to their purpose: (1) the general human biological materials provided and used by third parties in research and medical care; and (2) the human gametes and embryos produced by them, which are collected for the purpose of assisted reproductive technology. By examining these two categories side by side and comparing Japanese cases with the judicial precedents of other countries, I have pointed out the current problems in Japan and, as a conclusion of this study, I have pointed out the current problems in Japan and developed a model plan that can lead to solutions.

Free Research Field

法学(民事法学・新領域法学)

Academic Significance and Societal Importance of the Research Achievements

本研究の学術的意義として、ヒト生体試料等を用いる医学・生物学研究の成果の帰属に関して、他国判例との比較法的研究に基づき、試料・目的による分類をおこない、各類型の要件および効果の整理をとおして、法的な判断基準の傾向を明らかにし、今後のわが国における法整備に向けた規制モデルの一案を提示した。
社会的意義としては、試料等の提供・移転について、試料の種類・提供の態様ごとにわが国の契約類型に照らした整理をし、具体的な留意点等を指摘した。特に生殖補助医療における配偶子・胚の保管契約に言及し、これらの取扱いに関する法的規律、提供と医療実施情報の管理・開示を担う機関、そして公的なシステムの整備の必要性を示した。