South African Journal of Bioethics and Law最新文献

英文中文

Race in health research: Considerations for researchers and research ethics committees 健康研究中的种族问题：研究人员和研究伦理委员会的考虑

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-05-08 DOI: 10.7196/sajbl.2023.v16i1.440

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

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.

这篇文章提供了在健康研究中使用种族作为变量或定义研究人群的伦理指导。为此，我们为研究人员和研究伦理委员会提供了一份简单而非详尽的清单，在此之前，我们简要介绍了在使用种族作为变量或定义研究人群时需要证明的理由，异国情调的问题，种族、民族和祖先之间的区别，种族命名的问题，在基因研究中，这个种族并不能很好地作为一个假定的生物学结构。

引用次数: 0

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 父母在未成年人医疗中的父系管辖权和宗教信仰：根据国际惯例审查最高法院在Tega Esabunor v Faweya&Ors（2019）LPELR 46961（SC）一案中的裁决

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-05-08 DOI: 10.7196/sajbl.2023.v16i1.828

U. Anyamele

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.

最近，尼日利亚最高法院在Tega Esabunor v Faweya&Ors（2019）LPELR 46961（SC）一案中驳回了一项上诉，该上诉旨在撤销地方法院为婴儿输血的命令。上诉人辩称，法院无权作出判决。本案的关键是，父母基于宗教信仰同意儿童治疗的权利是否取代了儿童的生存权，从而反映了父母同意儿童治疗选择的权利与法院通过国家固有的父系管辖权推翻这些权利之间的紧张关系。该案件还反映了父母信奉宗教的自由与儿童在医疗方面的生存权之间的紧张关系。本文审查了最高法院在Tega Esabunor案件中的调查结果，考虑法院的决定是否符合普遍接受的惯例，即如果负有父母责任的人因宗教信仰拒绝为不称职的儿童提供医疗服务，国家何时可以进行干预。对其他司法管辖区的案件进行了分析，以确定外国法院的立场。据认为，最高法院的判决反映了关于父母拒绝同意儿童医疗的公认国际惯例。

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引用次数: 0

Strengthening research ethics oversight in Africa: The Kenyan example 加强非洲的研究伦理监督:肯尼亚的例子

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-05-08 DOI: 10.7196/sajbl.2023.v16i1.199

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

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.

背景非洲大陆正在进行的健康研究项目数量有所增加，特别是临床试验。理想情况下，这应该伴随着研究伦理审查能力的相应提高，以胜任提供急需的研究伦理监督。不幸的是，许多非洲国家的情况并非如此，这些国家仍在努力应对国家层面和机构层面研究伦理监督能力薄弱的问题。目标。描述肯尼亚国家研究伦理监管机构国家科学技术与创新委员会（NACOSTI）提出的建设其国家科学与伦理委员会（NSEC）能力的建议，该委员会负责在该国提供所需的研究伦理监督。方法。这是NACOSTI向欧洲和发展中国家临床试验伙伴关系提交的提案，旨在资助题为“加强肯尼亚的研究伦理和监督”（STReK）的项目。它描述了加强NSEC以在国内提供所需研究伦理的活动，以及通过培训和指导计划建立其认可的研究伦理委员会（REC）的研究伦理能力，使其能够有效审查研究提案。后果介绍了该项目的拟议活动。正在执行所述活动。结论这方面的经验教训可能有利于资源有限国家的其他研究伦理监管机构，旨在加强其研究伦理监督能力。

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引用次数: 0

Vaccine production in Africa: will initiatives survive? 非洲的疫苗生产:倡议能否存活?

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-05-08 DOI: 10.7196/sajbl.2023.v16i1.1040

A. Dhai

引用次数: 0

Bioethics of childbirth for another (surrogate motherhood) in the Civil Code of Kosovo 《科索沃民法典》中关于为他人生育（代孕母亲）的生物伦理学

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-05-08 DOI: 10.7196/sajbl.2023.v16i1.342

B. Bahtiri, Qenan Maxhuni, R. Ferizi

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 rightsConclusion. 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.

不孕不育的生物学、医学和法律过程的转变、家庭结构的重大改变以及生殖技术方法和技术的进步，将影响到在法律和医学方面解决科索沃生物伦理和法律管理问题的下一步工作。由于科索沃共和国正在起草一部《民法典》，因此有必要从道德和专业两方面确立观点。在审查和评价家庭法并将其纳入《科索沃共和国民法典》的过程中，提出并处理了许多这些问题。在与不同利益集团就家庭法举行的几次官方成员会议上，提出有必要对家庭法进行规范，以便将在生物医学协助下生育的母亲和父亲以及作为对另一个人的捐赠(所谓的代孕母亲)的生育合同纳入《民法》。这些生物伦理和法律问题表明，迫切需要在法律上协调一个具体以公共卫生和普遍人权原则为基础的多维平台。这些生物伦理和法律上的干扰表明，迫切需要在法律上协调一个专门根据公共卫生和普遍人权原则设计的多维平台。

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引用次数: 0

Towards a data transfer agreement for the South African research community: The empowerment approach. 迈向南非研究界的数据转移协议:授权方法。

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-04-01 DOI: 10.7196/SAJBL.2023.v16i1.827

L Swales, M Botes, D Donnelly, D Thaldar

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.

为南非(SA)研究界建立数据传输协议(DTA)模板的想法正受到越来越多的关注。虽然开发这样一个DTA模板当然是一个有价值的项目，但应该解决有关项目实际执行的问题，包括如何最好地操作所设想的DTA模板，以及所设想的DTA模板的内容。建议在实施设想的DTA模板时采用授权方法，这与卫生部长于2018年颁布的材料转让协议所采用的监管方法形成对比。虽然监管方法需要政府强制使用预期的DTA模板，而不管该模板的质量如何，相反，授权方法需要重点为SA研究界开发一个高质量的，专业起草的DTA模板，并使其使用成为自己选择的问题。关于设想的DTA模板的内容，分析了四个热点内容条款，并认为应授权SA研究机构和研究人员:(i)在相关情况下，对其数据所有权具有明确和法律确定性;(ii)能够将其研究成果商业化，而不受不必要的合同限制;(iii)避免落入与研究参与者非法分享利益的陷阱;以及(iv)意识到他们作为相关责任方的法律角色不能通过DTA外包出去。

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引用次数: 1

The right to family life: Why the genetic link requirement for surrogacy should be struck out 家庭生活的权利:为什么应该取消代孕的遗传联系要求

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-02-06 DOI: 10.7196/sajbl.2022.v16i1.818

D. Thaldar

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.

背景。南非代孕法包括一项被称为遗传联系要求的规定，即委托父母必须使用自己的配子来孕育代孕孩子。因此，不能为孩子受孕提供配子的不孕者被禁止通过代孕来建立家庭。基因联系要求此前曾是一项宪法挑战的主题，但宪法法院以7比4的多数意见否决了这一挑战。在一起新的诉讼中，基因联系要求再次受到挑战。本文结合问题的历史，探讨了在新的诉讼中依靠不孕症患者的家庭生活权的可行性。方法。调查采取了人权分析的形式。在前一个案件中没有考虑到家庭生活的权利。因此，家庭生活的权利构成了一个新的法律问题，不属于宪法法院规定的先例的范围，因此是可以依靠的。遗传联系的要求显然侵犯了不孕症人的家庭生活权利，其中包括建立家庭的权利。考虑了这种违规行为的潜在理由，但发现不足。因此，遗传联系要求是违宪的，应该被废除。上一次诉讼的结果是对不孕症患者的不公正。新的诉讼为这种不公正提供了一个机会，通过维护不孕症患者的家庭生活权利来纠正这种不公正。

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引用次数: 0

How is South Africa going to implement NHI when corruption is so rampant? 腐败如此猖獗，南非如何实施国民健康保险?

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-02-06 DOI: 10.7196/sajbl.2022.v15i3.741

引用次数: 0

Justice in the provision of healthcare services – A stifled right in the private sector 提供保健服务方面的公正——私营部门被扼杀的权利

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-02-06 DOI: 10.7196/sajbl.2022.v15i3.371

S. Mahomed, M. Labuschaigne, M. Slabbert

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.

私人医疗辅助机构本质上是非营利组织，旨在提供快速治疗，并应防止成员在医疗保健方面出现意外的自付费用。然而，尽管最新统计数据显示，南非16.2%的人是医疗援助计划的成员，这使得一小部分人口可以获得私人医疗保健的承诺，但他们也面临着自己独特的挑战。私营部门内部存在的限制直接影响到患者可以获得的医疗服务类型，这反过来又影响到获得医疗服务的基本权利。利用高等法院最近的一项案件裁决，本文试图探讨医疗服务的提供是否公正，特别是在南非私营部门。

引用次数: 0

The CIOMS consensus report on clinical research in resource-limited settings CIOMS关于资源有限环境下临床研究的共识报告

IF 0.9 Q4 MEDICAL ETHICS

South African Journal of Bioethics and Law

Pub Date : 2023-01-03 DOI: 10.7196/sajbl.2022.v15i3.472

L. Rägo, M. Zweygarth

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.

背景负责任的临床研究推动了医疗保健的发展。尽管自20世纪50年代以来，全球研发环境有了巨大改善，但中低收入国家往往被甩在后面。这有几个原因。首先，LMIC的运营、社会、伦理和监管挑战使研究人员很难在符合国际要求的环境中进行临床研究。其次，许多生活在资源匮乏环境中的人不信任研究，因为过去的一些研究没有使参与者或相关社区受益。目标。介绍国际医学科学组织理事会工作组就如何在资源有限的环境中推进高质量、合乎道德的临床研究提出的一致建议。方法。CIOMS召集了一个由来自药品监管机构、制药行业、产品开发公私伙伴关系和学术界的高级科学家组成的工作组。后果本文总结了工作组的报告。结论该报告的建议可以促进建立一个更有利的临床研究生态系统，并促进政策制定者、监管机构、研究人员和资助者之间的合作。

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