South African Journal of Bioethics and Law

Publisher:: Sabinet African Journals
Publication date:: 2021-07-20

ISBN:: 1999-7639

Description:

The South African Journal of Bioethics and Law is a bi-annual journal for health professionals dealing with bioethics, law, human rights and related topics.

Issue Number

Latest documents

Mandatory reporting obligations within the context of health research: Grappling with some of the ethical-legal complexities
Mandatory reporting of various forms of abuse, from violence to corruption, is an attempt by the state to intervene in circumstances where there is a public or a private interest that ought to be protected. This intrusion of the state into what is often a very personal space, such as the home, is largely justified on the basis of the need to provide protection to prevent further harm, and in services to vulnerable populations such as children, the disabled or the elderly. In some instances, researchers and other members of the study team may encounter reportable information requiring the consideration of mandatory reporting in the design, implementation and review of health research. This is not simple. There are complex and competing interests at play, particularly as there are differing approaches in law and ethical guidelines. This article aims to describe the mandatory reporting obligations in South African law, discussing the ways in which these provisions apply within the context of health research, and to propose some factors that could be used to determine whether it is ethical or not to report information.
Race in health research: Considerations for researchers and research ethics committees
This article provides ethical guidance on using race in health research as a variable or in defining the study population. To this end, a plain, non-exhaustive checklist is provided for researchers and research ethics committees, preceded by a brief introduction on the need for justification when using race as a variable or in defining a study population, the problem of exoticism, that distinctions pertain between race, ethnicity and ancestry, the problematic naming of races, and that race does not serve well as a presumed biological construct in genetic research.
Towards a data transfer agreement for the South African research community: The empowerment approach
The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. While developing such a DTA template is certainly a worthwhile project, questions regarding the project’s practical execution should be addressed, including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that an empowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approach followed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entail government making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowerment approach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community and making the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisions are analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certainty regarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractual constraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.
Vaccine production in Africa: Will initiatives survive?
For decades, there have been huge concerns at the lack of vaccine production in Africa. Africa is the only major world region that does not have significant vaccine manufacturing capacity.[1] Early on during the COVID-19 pandemic, it became evident that once again there was an acute need to develop local manufacturing capacity, and to increase that capacity where already present. For a significant period, Africa received only relatively small doses of vaccines. Frequently, the supplies were unpredictable, and there was little warning on when the vaccines would arrive and what type of vaccines they would be.[2]
April 2023
Choose as many answers as are correct per question. Some questions may have more than one correct answer – select all that are applicable.
Bioethics of childbirth for another (surrogate motherhood) in the Civil Code of Kosovo
Transformations in the biological, medical and legal processes of infertility, substantial modifications in family structure and the advancement of methods and techniques of reproductive technology will affect the next step in both legal and medical terms to address the regulation of bioethics and law in Kosovo. There is a need to establish perspectives in both ethical and professional terms, since the Republic of Kosovo is in the process of drafting a Civil Code. Many of these issues have been raised and addressed during the review and evaluation of family law in the context of harmonisation and inclusion of this law in the Civil Code of the Republic of Kosovo. During the several meetings of official members with different interest groups regarding family law, the need has been raised to regulate family law to be included in the Civil Code for motherhood and fatherhood in the case of reproduction with biomedical assistance, as well as for the birth contract as a donation for another person (so-called surrogate motherhood). These bioethical and legal issues indicate the urgent need for legal harmonisation of a multidimensional platform specifically based on the principles of public health and universal human rights.
Strengthening research ethics oversight in Africa: The Kenyan example
Background Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level.Objectives To describe the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country.Methods This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals.Results Proposed activities of the project are presented. Implementation of the activities described is ongoing.Conclusion Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity.
How is South Africa going to implement NHI when corruption is so rampant?
As 2022 came to a close, it became patently clear that the fight against corruption in South Africa (SA) was no longer an uphill battle, but a mammoth crusade. The reality that corruption had become endemic and pervasive was overwhelming, tarnishing and even ruining the festive period for most people in the country. Despite SA having the third-largest economy in Africa and a strong history of activism, because of corruption it has been rated the most unequal country in the world.[1] Improper use of public resources for private ends has become progressively rampant since the dawn of our democracy, is a shameful reflection of the failure and betrayal of the ruling party, and has resulted in a huge trust deficit developing between the state and its citizens. Characterised by lack of transparency, weak accountability and inefficiency, corruption is a typical outcome of poor governance.[2]
The evolving role of research ethics committees in the era of open data
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.
The CIOMS consensus report on clinical research in resource-limited settings
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, public-private 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.