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Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research
Journal of Law and the Biosciences ( IF 3.4 ) Pub Date : 2023-06-29 , DOI: 10.1093/jlb/lsad018
Donrich Thaldar 1, 2 , Bonginkosi Shozi 3
Affiliation  

Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored—but foundational—question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly ‘no’. South African law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens—except for reimbursement of reasonable costs incurred. Accordingly, benefit sharing would be unlawful. The ramifications of this conclusion are far-reaching. Most pertinently, should any benefit-sharing agreements with research be put into practice, such agreements would be unenforceable and would expose all parties involved—including foreign collaborators—to criminal prosecution. The solution for proponents of benefit sharing in South Africa would be to lobby the South African government to revise the relevant law. However, as long as the law remains as it currently is, institutions and individuals all over the world who are involved in genomics research in South Africa would be well advised to comply with the law by not engaging in benefit sharing with research participants.

中文翻译:

在南非与研究参与者分享利益是否合法?基因组学研究治理中尚未探索的问题

尽管在南非进行的基因组学研究中提倡与研究参与者分享利益,但这一概念几乎没有受到法律的重视。这就是本文通过提出迄今为止尚未探讨但基本的问题所提供的内容:与研究参与者分享利益在南非是否合法?答案显然是“不”。南非法律规定,向研究参与者捐赠生物样本提供任何经济或其他奖励都是非法的,但报销所产生的合理费用除外。因此,利益分享将是非法的。这一结论的影响是深远的。最相关的是,如果任何与研究相关的利益分享协议付诸实践,此类协议将无法执行,并使所有相关方(包括外国合作者)面临刑事起诉。南非利益分享支持者的解决方案是游说南非政府修改相关法律。然而,只要法律保持不变,世界各地参与南非基因组学研究的机构和个人就应该遵守法律,不要与研究参与者进行利益分享。
更新日期:2023-06-29
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