W. van Staden, A. Nienaber, T. Rossouw, A. Turner, C. Filmalter, A. E. Mercier, J. Nel, B. Bapela, M. Beetge, R. Blumenthal, C. Castelyn, T. D. de Witt, A. G. Dlagnekova, C. Kotzé, J. Mangwane, L. Napoles, R. Sommers, L. Sykes, W. B. Van Zyl, M. Venter, A. Uys, N. Warren
{"title":"Race in health research: Considerations for researchers and research ethics committees","authors":"W. van Staden, A. Nienaber, T. Rossouw, A. Turner, C. Filmalter, A. E. Mercier, J. Nel, B. Bapela, M. Beetge, R. Blumenthal, C. Castelyn, T. D. de Witt, A. G. Dlagnekova, C. Kotzé, J. Mangwane, L. Napoles, R. Sommers, L. Sykes, W. B. Van Zyl, M. Venter, A. Uys, N. Warren","doi":"10.7196/sajbl.2023.v16i1.440","DOIUrl":"https://doi.org/10.7196/sajbl.2023.v16i1.440","url":null,"abstract":"\u0000\u0000\u0000\u0000This 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.\u0000\u0000\u0000\u0000","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42716001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Parens patriae jurisdiction and religious beliefs of parents in medical treatment of a minor: Examining the Supreme Court’s decision in Tega Esabunor v Faweya & Ors (2019) LPELR 46961 (SC) in light of international practice","authors":"U. Anyamele","doi":"10.7196/sajbl.2023.v16i1.828","DOIUrl":"https://doi.org/10.7196/sajbl.2023.v16i1.828","url":null,"abstract":"Recently, the Supreme Court of Nigeria in Tega Esabunor v Faweya & Ors (2019) LPELR 46961 (SC) dismissed an appeal seeking to quash the order of a magistrate court for the transfusion of blood to a baby. The appellants contended that the court had no jurisdiction to make theorder. The crux of the case was whether the parents’ right to consent to the child’s treatment based on religious beliefs supersedes the child’s right to live, thus reflecting the tension between a parent’s right to give consent to the choice of treatment for their child, and the court’s power to override such rights through the inherent parens patriae jurisdiction of the state. The case also reflects the tension between the freedom of a parent to practise their religion and the right of a child to live, in the medical context. This article examines the findings of the Supreme Court in Tega Esabunor’s case, considering whether the court’s decision is in line with the generally accepted practice on when the state can intervene if persons with parental responsibility refuse medical treatment for an incompetent child because of religious beliefs.Cases from other jurisdictions are analysed to ascertain the position of foreign courts. It is submitted that the Supreme Court’s judgmentreflects accepted international practice regarding parental refusal of consent for medical treatment of a child.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48390022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L. Omutoko, MSc Global Bioethics B Amugune PhD, PgDip Res. Ethics, T. Nyawira, C. Muchoki, M. Masika, PhD MB ChB, G. Omosa-Manyonyi, MSc MB ChC, C. Kamau, MSc L K’Apiyo, Mba Jaoko, W. Jaoko
{"title":"Strengthening research ethics oversight in Africa: The Kenyan example","authors":"L. Omutoko, MSc Global Bioethics B Amugune PhD, PgDip Res. Ethics, T. Nyawira, C. Muchoki, M. Masika, PhD MB ChB, G. Omosa-Manyonyi, MSc MB ChC, C. Kamau, MSc L K’Apiyo, Mba Jaoko, W. Jaoko","doi":"10.7196/sajbl.2023.v16i1.199","DOIUrl":"https://doi.org/10.7196/sajbl.2023.v16i1.199","url":null,"abstract":"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.\u0000Objectives. 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.\u0000Methods. 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.\u0000Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing.\u0000Conclusion. 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.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42537987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vaccine production in Africa: will initiatives survive?","authors":"A. Dhai","doi":"10.7196/sajbl.2023.v16i1.1040","DOIUrl":"https://doi.org/10.7196/sajbl.2023.v16i1.1040","url":null,"abstract":"<jats:p>-</jats:p>","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42648133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bioethics of childbirth for another (surrogate motherhood) in the Civil Code of Kosovo","authors":"B. Bahtiri, Qenan Maxhuni, R. Ferizi","doi":"10.7196/sajbl.2023.v16i1.342","DOIUrl":"https://doi.org/10.7196/sajbl.2023.v16i1.342","url":null,"abstract":"\u0000\u0000\u0000\u0000Transformations 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\u0000\u0000\u0000\u0000\u0000Conclusion. These bio-ethical and legal interferences indicate the urgent need for legal harmonization of a multidimensional platform specifically designed based on the principles of public health and universal human rights.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46210292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Towards a data transfer agreement for the South African research community: The empowerment approach.","authors":"L Swales, M Botes, D Donnelly, D Thaldar","doi":"10.7196/SAJBL.2023.v16i1.827","DOIUrl":"https://doi.org/10.7196/SAJBL.2023.v16i1.827","url":null,"abstract":"<p><p>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>i</i>) have clarity and legal certainty regarding their ownership of data, where relevant; (<i>ii</i>) be able to commercialise their research findings without unnecessary contractual constraints; (<i>iii</i>) avoid falling into the trap of unlawful benefit sharing with research participants; and (<i>iv</i>) be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.</p>","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"16 1","pages":"13-18"},"PeriodicalIF":0.9,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10299799/pdf/nihms-1908954.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9726336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The right to family life: Why the genetic link requirement for surrogacy should be struck out","authors":"D. Thaldar","doi":"10.7196/sajbl.2022.v16i1.818","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v16i1.818","url":null,"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. \u0000Method. 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.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"1 1","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41534448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How is South Africa going to implement NHI when corruption is so rampant?","authors":"","doi":"10.7196/sajbl.2022.v15i3.741","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i3.741","url":null,"abstract":"<jats:p>-</jats:p>","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46172097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Justice in the provision of healthcare services – A stifled right in the private sector","authors":"S. Mahomed, M. Labuschaigne, M. Slabbert","doi":"10.7196/sajbl.2022.v15i3.371","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i3.371","url":null,"abstract":"Private medical aids are essentially non-profit organisations that aim to deliver speedy treatment and should prevent members from unexpected, out of pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa were 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 Case decision, this article seeks to explore whether there is justice in the provision of healthcare services, specifically within the private sector in South Africa.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43227961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The CIOMS consensus report on clinical research in resource-limited settings","authors":"L. Rägo, M. Zweygarth","doi":"10.7196/sajbl.2022.v15i3.472","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i3.472","url":null,"abstract":"Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the globalresearch 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 promotecollaboration between policymakers, regulators, researchers and funders.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43822545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}