Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research

Author:

Thaldar Donrich123ORCID,Shozi Bonginkosi4ORCID

Affiliation:

1. School of Law, University of KwaZulu-Natal , Durban , South Africa

2. Petrie-Flom Center for Health Law Policy , Biotechnology, and Bioethics, , Cambridge, MA , USA

3. Harvard Law School , Biotechnology, and Bioethics, , Cambridge, MA , USA

4. Institute for Practical Ethics, University of California San Diego , San Diego, CA , USA

Abstract

Abstract 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.

Funder

National Institute of Mental Health

US National Institutes of Health

Harnessing Data Science for Health Discovery and Innovation in Africa

Publisher

Oxford University Press (OUP)

Subject

Law,Biochemistry, Genetics and Molecular Biology (miscellaneous),Medicine (miscellaneous)

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