Browsing by Author "Maseme, Mantombi Rebecca"

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    An ethico-legal analysis of broad consent for biobank research in South Africa: Towards an enabling framework
    (University of the Witwatersrand, Johannesburg, 2024) Maseme, Mantombi Rebecca
    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
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    Sharing of biomaterials and data for biobank use in exchange for funding in South Africa in international collaborative health research: an ethico-legal analysis.
    (2020) Maseme, Mantombi Rebecca
    The development of biobanks over the years have raised ethico-legal controversies and concerns particularly in the context of cross-border transfers of human material. This is due not only to different values, beliefs and notions on commodification of human biomaterials, but also as a result of inadequacies in national and international regulations in addressing this crucial aspect of biobanking. It is common practice for South African biobanks and biobank researchers to seek funding from agencies that are independent of the biobank that often stipulate conditions requiring researchers to grant access and share biomaterials and data as part of the agreement, in particular, in international collaborative health research. As yet, to the author’s knowledge, there has been no study conducted to examine whether these conditions could result in the commercialization of biomaterials and data and whether such practice is considered ethical. This study therefore seeks to answer the question whether such sharing of biomaterials and data for biobank research in exchange for funding from sponsors and funders in international collaborative health research is ethically justified. The research question is answered through the use of ethical principles and theories as well as an analysis and evaluation of relevant ethico-legal frameworks and literature. No research participants are involved in the study and no new data is collected or analysed. Arguments against and for sharing of biomaterials and data in exchange for funding are discussed through exploring fundamental ethical issues that could arise as a result of such sharing, which in turn leads to commodification of the human body and its parts. In countering the effects of such commodification, there is a requirement for an all inclusive benefit sharing model for all stakeholders concerned. Benefit sharing is therefore explored. Ownership of biomaterials is discussed as it has been associated with issues of benefit sharing, with the same ethico-legal issues of ownership apparent in both High Income as well as Low and Middle Income countries. There is a need for the development of a national ethico-legal framework that addresses sharing of biomaterials and data where funding is concerned as a means of protecting against biobank sample exploitation as well as exploitation of the researchers themselves. This study concludes that it is unethical to share biomaterials and data in exchange for funding because this has the potential for exploitation of the participants due to a lack of respect for their dignity and human rights.