OPEN SCIENCE OP-ED
Why South Africa needs a national Data Transfer Agreement for health research
South Africa needs to consider the development of a national Data Transfer Agreement that integrates both legal and ethical principles for transfers of health research data, including how data will be protected from misuse.
Data sharing and open science encourage research and innovation, which results in improving patient care. Developments in technology mean that we can now use large data sets to advance methods of treatment and ultimately improve health outcomes.
We have seen this during Covid-19 where rapid transfers of biological samples and data allowed scientists to quickly understand the disease and its spread. See for example, this 2021 editorial on Genomic sequencing in pandemics in The Lancet.
There should be the same speed and ease of sample and data sharing in general health research outside of pandemics. But, while the rapid transfers of data bring great hope for advancing research, we first need robust mechanisms to protect the rights and interests of our research participants and researchers so as to safeguard them from possible abuse.
Current regulatory framework
In South Africa, different laws influence how researchers use samples and data for health research purposes.
For example, the National Health Act regulates research and experimentation with humans. According to the Act, a registered Human Research Ethics Committee must approve and review all health research projects. In addition, the National Department of Health’s 2015 Ethics Guidelines (National Department of Health. Ethics in Health Research, Principles, Processes and Structures, 2015) instruct researchers to inform research participants how their samples and data will be used, including how their privacy will be protected.
More recently, the Protection of Personal Information Act 4 of 2013 (Popia), has added further legal protections to research participants’ data. However, Popia focuses on privacy and consent, with very little consideration given to other issues, like the rights to non-discrimination, to dignity and also to benefit from scientific progress. After all, without research participants, the research would not be possible.
Historically, research participants in Africa, including South Africa have had these rights and interests largely ignored when participating in research projects (see: Ethics Dumping: Case Studies From North-South Research Collaborations). Without regulating data transfers, it is likely that the disregard for participants’ rights and interests may continue.
An integrated bioethics approach
Research participants stand to be exploited if the research processes are not fair. Take the lack of benefit sharing, for instance, which occurs when participants and communities do not get to benefit from research they were part of.
There are too few strategies to encourage benefit sharing in health research. For research to benefit society, it needs to be founded on reciprocity, justice and solidarity, and these principles should be embedded in the framework that guides the management and use of data obtained from research participants. See for an example “A framework for the promotion of ethical benefit sharing in health research” (British Medical Journal Global Health 2022;7)
Therefore, we need a streamlined and integrated bioethics approach to the use of such data to help ensure ethical values and principles are respected and not just the legal right to privacy and informed consent. This may be achieved by integrating bioethics into Data Transfer Agreements (DTAs).
The need for a national DTA
Currently, South Africa has a Material Transfer Agreement for Human Biological Materials (Government Notice 719, Government Gazette 41781 of 20 July 2018), which guides researchers with respect to transferring samples and data outside the country. But it is very limited in how to deal with data. We therefore need to consider the development of a national DTA that integrates both legal and ethical principles for transfers of data, including how data will be protected from misuse.
To start discussions on how this could be done, the Department of Science and Innovation and the South African Medical Research Council will bring together a diverse set of stakeholders including members of the public to deliberate on developing a national DTA for South Africa on 23 June.
To participate, engage and reflect further in these discussions, please register for the webinar by using the following link: Webinar Registration – Zoom DM/MC
This article is based on the following publication: Mahomed S, Loots G, Staunton C, The role of Data Transfer Agreements in ethically managing data sharing for research in South Africa | Mahomed | South African Journal of Bioethics and Law (sajbl.org.za)
Safia Mahomed, School of Law, University of South Africa & Steve Biko Centre for Bioethics, University of the Witwatersrand. Glaudina Loots, Director – Health Innovation, Department of Science and Innovation, South Africa. Ciara Staunton, Institute for Biomedicine, Eurac Research, Italy. Glenda Gray, President and CEO of the SAMRC. Ames Dhai, University of the Witwatersrand and Chair of the MRC Bioethics advisory panel. Melodie Labuschaigne, School of Law, University of South Africa. Mongezi Mdhluli: Chief Research Operation Officer, SAMRC