Thaldar Donrich
Dev World Bioeth. 2025 Mar;25(1):16-23. doi: 10.1111/dewb.12443. Epub 2024 Jan 31.
This article considers the practical question of how research institutions should best structure their legal relationship with the human genomic data that they generate. The analysis, based on South African law, is framed by the legal position that although a research institution that generates human genomic data is not automatically the owner thereof, it is well positioned to claim ownership of newly generated data instances. Given that the research institution exerts effort to generate the data, it can be argued that it has a moral right to claim ownership of such data. Combined with the fact that it has an interest in having comprehensive rights in such data, it appears that the prudent policy for research institutions is to claim ownership of the human genomic data instances that they generate. This policy is tested against two opposing policy positions. The first opposing policy position is that research participants should own the data that relate to them. However, in light of data protection legislation that already provides extensive protections to research participants, bestowing data ownership on research participants would offer little benefit to such individuals, while leading to significant practical problems for research institutions. The second opposing policy position is that the concept of ownership should be abandoned in favour of data custodianship. This opposing position is problematic, as avoiding reference to ownership is a denial of legal reality and hence not a useful policy. Also, avoiding reference to ownership will leave research institutions with limited legal remedies in the event of appropriation of data by third parties. Accordingly, it is concluded that the wisest policy for research institutions is indeed to explicitly claim ownership of the human genomic data instances that they generate.
本文探讨了研究机构应如何最佳构建其与所产生的人类基因组数据的法律关系这一实际问题。基于南非法律的分析,其框架依据的法律立场是,尽管产生人类基因组数据的研究机构并非自动成为该数据的所有者,但它很有资格主张对新产生的数据实例拥有所有权。鉴于研究机构付出努力来生成数据,可以认为它在道德上有权主张对此类数据的所有权。再加上其对在此类数据上拥有全面权利存在利益关系,似乎研究机构的审慎政策是主张对其产生的人类基因组数据实例拥有所有权。这一政策与两种对立的政策立场进行了检验。第一种对立政策立场是研究参与者应拥有与其相关的数据。然而,鉴于数据保护立法已为研究参与者提供了广泛保护,将数据所有权赋予研究参与者对此类个人几乎没有益处,同时会给研究机构带来重大实际问题。第二种对立政策立场是应摒弃所有权概念,转而采用数据托管。这种对立立场存在问题,因为回避提及所有权是对法律现实的否认,因此并非一项有用的政策。此外,回避提及所有权会使研究机构在第三方挪用数据的情况下法律补救措施有限。因此,得出的结论是,研究机构最明智的政策确实是明确主张对其产生的人类基因组数据实例拥有所有权。