An ethico-legal analysis of broad consent for biobank research in South Africa: Towards an enabling framework
Date
2024
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
University of the Witwatersrand, Johannesburg
Abstract
Biobanks preserve collections of human biological material and data for the benefit of medical research. Using and transferring human biological data and materials both inside and outside of South Africa is often a requirement of biobank research. Broad consent is allowed by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for legitimate, definite, and clearly stated purposes. There is room for several interpretations of the Act because of this discord between the two instruments. Given the connection between the transfer of samples and data, the long-term nature of biobanking, which makes it impractical to provide too much or adequate information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, I aim to respond to the following question: How should South Africa’s current regulatory framework appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated?
The research question is addressed by applying ethical principles and theories, as well as analysing and evaluating relevant ethico-legal frameworks and literature. The study involves no research participants and no collection or analysis of any new data. Arguments for and against using broad consent for biobank research are discussed by demonstrating the potential for biobank research to do a great deal of good for humanity; the ambiguity in the current regulatory framework regarding whether broad consent is permissible for personal information/data; and the ethical justifiability of broad consent. In summary, the proposed regulatory framework amendments are those that would be required to allow for ethically justifiable biobank research broad consent use. These include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template as specified in the National Department of Health Ethics Guidelines
Description
A Thesis submitted in fulfillment of the requirements for the degree of Doctor of Philosophy in Bioethics and Health Law, Steve Biko Centre for Bioethics, Faculty of
Health Sciences, University of the Witwatersrand, Johannesburg 2024
Keywords
Ethico-legal analysis, Biobank research, South Africa, UCTD
Citation
Maseme, Mantombi Rebecca. (2024). An ethico-legal analysis of broad consent for biobank research in South Africa: Towards an enabling framework [PhD thesis, University of the Witwatersrand, Johannesburg]. WireDSpace.