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- The CIOMS consensus report on clinical research in resource-limited
settings
Authors: L Rägo, M Zweygarth
Pages: 1 - 3
Abstract: Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the global research and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants or the communities involved.
Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.
Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.
Results. This article summarises the Working Group’s report.
Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promote collaboration between policymakers, regulators, researchers and funders.
PubDate: 2023-05-06
Issue No: Vol. 15, No. 3 (2023)
- How is South Africa going to implement NHI when corruption is so
rampant'
Authors: Ames Dhai
Pages: 76 - 76
Abstract: No Abstract.
PubDate: 2023-05-06
Issue No: Vol. 15, No. 3 (2023)
- The evolving role of research ethics committees in the era of open data
Authors: S Mahomed, M Labuschaigne
Pages: 80 - 83
Abstract: While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking.
PubDate: 2023-05-06
Issue No: Vol. 15, No. 3 (2023)
- The right to family life: Why the genetic link requirement for surrogacy
should be struck out
Authors: D Thaldar
Pages: 84 - 91
Abstract: Background. South African surrogacy law includes a provision, known as the genetic link requirement, that commissioning parents must use their own gametes for the conception of a surrogate child. As a result, infertile persons who cannot contribute gametes for the conception of a child are prohibited from accessing surrogacy as a way to establish families. The genetic link requirement was previously the subject of a constitutional challenge, but the challenge was rejected by a divided Constitutional Court bench with a seven-to-four majority. The genetic link requirement is again being challenged in a new lawsuit.
Objective. In light of the history of the issue, this article investigates the viability of relying on infertile persons’ right to family life in the new lawsuit.
Method. The investigation takes the form of a human rights analysis.
Results. The right to family life was not considered in the previous case. As such, the right to family life constitutes a new legal issue that falls outside the scope of the precedent set by the Constitutional Court, and can therefore be relied upon. The genetic link requirement is a clear violation of infertile persons’ right to family life, which includes the right to establish a family. Potential justifications for such violation are considered, but found wanting. Accordingly, the genetic link requirement is unconstitutional and should be struck out.
Conclusion. The outcome of the previous lawsuit was an injustice towards infertile persons. The new lawsuit presents an opportunity for this injustice to be rectified by vindicating infertile persons’ right to family life.
PubDate: 2023-05-06
Issue No: Vol. 15, No. 3 (2023)
- Justice in the provision of healthcare services – a stifled right in
the private sector
Authors: S Mahomed, M Labuschaigne, M Slabbert
Pages: 92 - 95
Abstract: Private medical aids are essentially non-profit organisations that aim to fund the delivery of speedy treatment, and should protect members from unexpected, out-of-pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa (SA) are members of medical aid schemes, making the promise of private healthcare accessible to a small percentage of the population, they are not without their own unique set of challenges. The restrictions that exist within the private sector have a direct bearing on the types of healthcare services patients can access, which in turn impacts on the fundamental right to access healthcare. Using a recent High Court decision, this article seeks to explore justice in the provision of healthcare services, specifically within the private sector in SA.
PubDate: 2023-05-06
Issue No: Vol. 15, No. 3 (2023)
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