Sharing of biomaterials and data for biobank use in exchange for funding in South Africa in international collaborative health research: an ethico-legal analysis.
Date
2020
Authors
Maseme, Mantombi Rebecca
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Abstract
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.
Description
A research report submitted in partial fulfilment for the degree of Masters of Science in Medicine in Bioethics and Health Law, Steve Biko Centre for Bioethics to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, 2020