Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing

Steytler, Michaela; Thaldar, Donrich

doi:10.7196/sajbl.2021.v14i3.772

Cited by 4 publications

(7 citation statements)

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“…The template has received criticism [17] and the fact that it is a guidance document only may cause sections of it to be regarded as unimportant and excluded by researchers when completing it. [18] We therefore advocate that a national DTA, that is POPIA compliant, complement the current SAMTA with a view to having one consolidated document for the transfer of samples and data in the long term, and propose the following roadmap to achieve this.…”

Section: Regulatory Framework For Sharing Data For Research In Samentioning

confidence: 99%

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

Mahomed

Loots²,

Staunton

2022

S Afr J Bioethics Law

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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.

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Section: Regulatory Framework For Sharing Data For Research In Samentioning

confidence: 99%

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

Mahomed

Loots²,

Staunton

2022

S Afr J Bioethics Law

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“…Donrich Thaldar 1,2 Lukman Abdulrauf 1,3,4 Paul Ogendi 1,5 Amy Gooden 1 Dusty-Lee Donnelly 1 Beverley Townsend 1,6 as being inadequate, as Brand et al do. By contrast, Nigeria, Africa's largest economy 6 , includes Ghana in its adequacy list (the South African Information Regulator has not yet issued a South African adequacy list).…”

Section: Authorsmentioning

confidence: 97%

“…In 2021, Steytler and Thaldar published a review of recommendations for legal reform in South Africa relating to, inter alia, data sharing during public health emergencies. 1 These recommendations include, in respect of health data: (a) the creation of an African Data Corridor, (b) the adoption of open access research data, and (c) the development of data trusts, as suggested by the Organisation for Economic Co-operation and Development (OECD), and in respect of geospatial data used for health research: (d) an amendment to the Space Affairs Act 84 of 1993. 1 Recommendations (a) to (c) were based on the work of Townsend 2 , and (d) on the work of Botes 3 .…”

Section: Introductionmentioning

confidence: 99%

Response to Brand et al. (2022) ‘Data sharing governance in sub-Saharan Africa during public health emergencies’

Thaldar,

Abdulrauf,

Ogendi

et al. 2023

S. Afr. J. Sci.

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Various aspects of Brand et al.'s (S Afr J Sci. 2022;118(11/12), Art. #13892) overview of Africa's data protection legislation require clarification. Most pertinently, we provide the following clarifications:• Ghanaian law does provide for cross-border data transfers; statements about the law being "inadequate" ought to be well substantiated.• Nigerian law provides for adequacy decisions -not authorisations -in respect of cross-border data transfers.• Kenyan law provides for an important exception relevant to public health emergencies.• South African law currently requires, amongst others, prior authorisation from the Information Regulator for cross-border transfers of health data.• South Africa does not yet have a code of conduct for research.

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“…The only saving grace was that the SA MTA described itself as a “framework,” hence leaving latitude for parties that are legally forced to use it to amend the substantive provisions—and hopefully in the process resolve the problematic aspects ( Thaldar et al, 2020 ; Steytler and Thaldar, 2021 ; Thaldar and Shozi, 2021 ; Swales et al, 2023a ). Using this latitude, a group of South African law academics developed a revised version of the SA MTA in an attempt to rectify the most serious issues while remaining within the bounds of the framework of the original version of the SA MTA ( Pope, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Forcing a square into a circle: why South Africa’s draft revised material transfer agreement is not fit for purpose

Esselaar,

Swales,

Bellengère

et al. 2024

Front. Pharmacol.

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The South African National Health Research Ethics Council (NHREC) recently released a final draft revision of the standard material transfer agreement (MTA) that was promulgated into law in 2018. This new draft MTA raises pertinent questions about the NHREC’s mandate, the way in which the draft MTA deals with data and with human biological material, and its avoidance of the concept of ownership. After South Africa’s data protection legislation, the Protection of Personal Information Act (POPIA), became operational in mid 2021, the legal landscape changed and it is doubtful that the NHREC has a residual mandate to govern personal information in health research. Furthermore, data is dealt with in a superficial, throw-away fashion in the draft MTA. The position with human biological material is not substantially better, as the draft MTA fails to recognise that human biological material can contain pathogens, which has important legal and ethical ramifications that are not sufficiently addressed. A central problem with the draft MTA is its use of the term ‘steward’, and avoidance of the legal concept of ‘ownership’. This is not only misaligned with the South African legal framework, but also fails to consider the ethical case for recognising ownership. Finally, a call to embrace decolonial thinking in health research underscores the importance of recognising ownership in order to foster the growth of the local bio-economy. Key recommendations to reshape the draft MTA include: Making use of the eventual revised MTA optional, and allowing it to evolve with input from scientific and legal communities; regulating the transfer of associated data in a separate data transfer agreement that can be incorporated by reference in the MTA; enhancing guidance on liability and risk management in respect of human biological material that contains pathogens; and, finally, adopting a decolonial approach in health research governance, which requires recognising the ownership rights of South African research institutions.

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Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing

Cited by 4 publications

References 0 publications

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

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

Response to Brand et al. (2022) ‘Data sharing governance in sub-Saharan Africa during public health emergencies’

Forcing a square into a circle: why South Africa’s draft revised material transfer agreement is not fit for purpose

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