Exempting Health Research from the Consent Provisions of POPIA

Thaldar, Donrich; Townsend, Beverley

doi:10.17159/1727-3781/2021/v24i0a10420

Cited by 16 publications

(31 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This paper uses personal information and data interchangeably. As POPIA seeks to give effect to the constitutional right to privacy, these initial discussions have primarily focused on participants' privacy, the role of consent and legal status of broad consent, [10][11][12] with limited consideration of the wider issues related to the use of personal information for research in SA. [13] The protection of participants' privacy in research is essential, but it is not the only risk at stake for participants in the use and sharing of personal information.…”

mentioning

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

View full text Add to dashboard Cite

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.

show abstract

mentioning

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

View full text Add to dashboard Cite

show abstract

“…preferences, and received ongoing information about their data use. (8,10,10,11,23) In the context of cross-border transfers of data that require speci c consent to that speci c data transfer, dynamic consent would enable the ease of contact with participants to obtain their consent to the data transfer. While dynamic consent could be a solution, its implementation requires investment into infrastructure, including software and security systems, but also the availability of mobile phones, internet connections and digital literacy.…”

Section: Additional Requirements From Ethics Frameworkmentioning

confidence: 99%

Cross-border data sharing for research in Africa: An analysis of the data protection and research ethics requirements in 12 jurisdictions

Staunton,

Edgcumbe,

Abdulrauf

et al. 2024

Preprint

View full text Add to dashboard Cite

Background In recent years, there has been a notable uptake in genomic and health-related research activities across the African continent. Similarly, there has been increased introduction of data protection legislation that affects the sharing of personal data such as health data and genomic data, including for research. Many of these statutes have stricter requirements when sharing personal data across borders. Consequently, the cross-border sharing of health data that includes genetic data requires careful navigation of the pertinent data protection legislation, in particular concerning the sharing of such data for research purposes. To help researchers navigate these legal frameworks, 12 African countries were analysed to develop country guides on cross-border data sharing.Results Of the 12 countries that were analysed, ten have data protection laws in place (Botswana, Ghana, Kenya, Malawi, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe), while two countries (Cameroon and The Gambia) do not. With the exception of Ghana, all countries with data protection statutes or bills had additional requirements to be met when sharing personal data across borders. Consent and adequacy are the most common grounds for justifying the sharing of personal data across borders.Conclusion Given the limitations of the current models of consent, consent is not a suitable basis to transfer large quantities of data for research. Adequacy is a common ground, but there are national differences in the implementation of this ground. Researchers must therefore analyse each national legal framework and make decisions on a case-by-case and country-by-country basis.

show abstract

“…Health research is a special case. 12 Consider that all health research must be approved by a health research ethics committee and that these committees have a statutory duty to ensure that health research will ‘promote health, contribute to the prevention of communicable or non-communicable diseases or disability or result in cures for communicable or non-communicable diseases’ 13 . The outcome is that all health research conducted in South Africa is prima facie in the public interest.…”

Section: Applicationmentioning

confidence: 99%