The role of Data Transfer Agreements in ethically managing data sharing for research in South Africa

Article Sidebar

PDF
Published: May 19, 2022
DOI: https://doi.org/10.7196/SAJBL.2022.v15i1.807
Keywords:
data transfer agreements, research, south africa

Main Article Content

S Mahomed
School of Law, Department of Jurisprudence, UNISA, Pretoria; Steve Biko Centre for Bioethics, University of the Witwatersrand, Johannesburg, South Africa
G Loots
Department of Science and Innovation, Pretoria, South Africa
C Staunton
Institute for Biomedicine, Eurac Research, Bolzano, Italy

Abstract

A multitude of legislation impacts the use of samples and data for research in South Africa (SA). With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 (POPIA) in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement (DTA) that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders.

Article Details

How to Cite
The role of Data Transfer Agreements in ethically managing data sharing for research in South Africa. (2022). South African Journal of Bioethics and Law, 15(1), 26-30. https://doi.org/10.7196/SAJBL.2022.v15i1.807
Issue
SAJBL Vol. 15 No. 1
Section
Research Articles
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The SAJBL is published under an Attribution-Non Commercial International Creative Commons Attribution (CC-BY-NC 4.0) License. Under this license, authors agree to make articles available to users, without permission or fees, for any lawful, non-commercial purpose. Users may read, copy, or re-use published content as long as the author and original place of publication are properly cited. 

Exceptions to this license model is allowed for UKRI and research funded by organisations requiring that research be published open-access without embargo, under a CC-BY licence. As per the journals archiving policy, authors are permitted to self-archive the author-accepted manuscript (AAM) in a repository. 

 

How to Cite

The role of Data Transfer Agreements in ethically managing data sharing for research in South Africa. (2022). South African Journal of Bioethics and Law, 15(1), 26-30. https://doi.org/10.7196/SAJBL.2022.v15i1.807

References

Staunton C, Barragán CA, Canali S, et al. Open science, data sharing and solidarity: who benefits? HPLS 2021;43:115. https://doi.org/10.1007/s40656-021-00468-6

Mulder N, Adebamowo CA, Adebamowo SN, et al. Genomic research data generation, analysis and sharing – challenges in the African setting. Data Sci J 2017;16:49. https://doi.org/10.5334/dsj-2017-049

Kalkman S, van Delden J, Banerjee A, et al. Patients’ and public views and attitudes towards the sharing of health data for research: A narrative review of the empirical evidence. J Med Ethics 2022;48(1):3-13. https://doi.org/10.1136/ medethics-2019-105651

Genomic sequencing in pandemics. Editorial. Lancet 2021;397(10273):445. https://doi.org/10.1016/S0140-6736(21)00257-9

Singh S, Cadigan RJ, Moodley K. Challenges to biobanking in LMICs during

COVID-19: Time to reconceptualise research ethics guidance for pandemics and public health emergencies? J Med Ethics 2021. https://doi.org/10.1136/medethics-2020-106858

South Africa. National Health Act No. 61 of 2003.

South Africa. Material Transfer Agreement for Human Biological Materials. Government Notice 719, Government Gazette 41781 of 20 July 2018.

South Africa. Protection of Personal Information Act No. 4 of 2013.

South Africa. National Department of Health. Ethics in Health Research, Principles, Processes and Structures, 2015.

Staunton C, R Adams, M Botes, et al. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act 2013. S Afr Med J 2019;109(7):468. https://doi.org/10.7196/SAMJ.2019.v109i7.14148

Thaldar DW, Townsend B. Genomic research and privacy: A response to Staunton et al. S Afr Med J 2020;110(3):172-174. https://doi.org/10.7196/SAMJ.2020.v110i3.14431

Thaldar DW, Townsend BA. Exempting health research from the consent provisions of POPIA. PER J 2021;24. https://doi.org/10.17159/1727- 3781/2021/v24i0a10420

Staunton C, Tschigg K, Sherman G. Data protection, data management, and data sharing: Stakeholder perspectives on the protection of personal health information in South Africa. PLoS One 2021;16(12): e0260341. https://doi.org/10.1371/journal.

pone.0260341

Staunton C, Slokenberga S, Parziale A, Mascalzoni D. Appropriate safeguards and Article 89 of the GDPR: Considerations for biobank, databank and genetic research. Front Genet 2022;13:719317. https://doi.org/10.3389/fgene.2022.719317

Adams R, Adeleke F, Anderson D, et al. POPIA code of conduct for research. S Afr J Sci 2021;117(5-6):1-12. https://doi.org/10.17159/sajs.2021/10933

Mahomed S, Staunton C. Ethico-legal analysis of international sample and data sharing for genomic research during COVID-19: A South African perspective. Biolaw J 2021;(1):261-276. https://doi.org/10.15168/2284-4503-785

Thaldar DW, Botes M, Nienaber AG. South Africa’s new standard material transfer agreement: Proposals for improvement and pointers for implementation. BMC Med Ethics 2020;21(85). https://doi.org/10.1186/s12910-020-00526-x

Steytler M, Thaldar DW. Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing. S Afr J Bioethics Law 2021;14(3):101-106.

Moodley K, Sibanda N, February K, et al. ‘It’s my blood’: Ethical complexities in the use, storage and export of biological samples: Perspectives from South African research participants. BMC Med Ethics 2014;15(4). https://doi.org/10.1186/1472-6939-15-4

Moodley K, Singh S. It’s all about trust: Reflections of researchers on the complexity and controversy surrounding biobanking in South Africa. BMC Med Ethics 2016;17(57). https://doi.org/10.1186/s12910-016-0140-2

BusinessTech. Controversy over proposed internet and data changes for South Africa. https://businesstech.co.za/news/cloud-hosting/504715/controversy-overproposed-internet-and-data-changes-for-south-africa/ (accessed 28 February 2022).

South African Department of Science and Innovation. Draft National Open Science Policy v19 24.01.2022.

United Nations Organization. Department of Economic and Social Affairs. The 17 Goals. https://sdgs.un.org/goals (accessed 1 March 2022).

Department of Science and Innovation, South Africa. Section 11 of the Draft National Open Science Policy v19.

Rheeder AL. Benefit-sharing as a global bioethical principle: A participating dialogue grounded on a Protestant perspective on fellowship. Skriflig 2019;53(1):a2502. https://doi.org/10.4102/ids. v53i1.2502

Schroeder D, Cook J, Hirsch F. Ethics Dumping: Case Studies From North-South Research Collaborations. New York: Springer International, 2017.

Bedeker A, Nichols M, Allie T, et al. A framework for the promotion of ethical benefit sharing in health research. BMJ Global Health 2022;7: e008096. https://doi.org/10.1136/ bmjgh-2021-008096

Sudoi A, De Vries J, Kamuya D. A scoping review of considerations and practices for benefit sharing in biobanking. BMC Med Ethics 2021;22(1):102. https://doi.org/10.1186/s12910-021-00671-x

H3Africa. Ethics and governance framework for best practice in genomic research and biobanking in Africa. https://h3africa.org/wp-content/uploads/2018/05/Final-Framework-for-African-genomics-and-biobanking_SC-.pdf (accessed 4 March 2022).

Similar Articles

You may also start an advanced similarity search for this article.