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To vaccinate or not to vaccinate: Mandatory COVID-19 vaccination in the workplace 接种或不接种:工作场所强制接种COVID-19疫苗
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-08-16 DOI: 10.7196/SAJBL.2021.v14i2.781
A. Dhai
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引用次数: 1
How can research ethics committees help to strengthen stakeholder engagement in health research in South Africa? An evaluation of REC documents 研究伦理委员会如何帮助加强利益相关者对南非健康研究的参与?REC文件评估
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00698
Abigail Wilkinson, C. Slack, C. Crews, N. Singh, J. Salzwedal, D. Wassenaar
Background. All health researchers in South Africa (SA) are explicitly encouraged by the ethicolegal framework to engage stakeholders meaningfully in their research. Research ethics committees (RECs) have a role to play in shaping researchers’ practices in this regard, but very little research has explored how RECs might best achieve this.  Objectives. To explore whether SA REC documents are prompting researchers to plan sound stakeholder engagement in health research.  Methods. We reviewed publicly available documents of RECs registered with the SA National Health Research Ethics Council. Of the 46 registered RECs as of November 2019, the documents of 37 were publicly accessible. These comprised 72 documents (e.g. standard operating procedures and application forms). We coded these according to ethical reasons mentioned for engagement, stakeholders and strategies highlighted for engagement. We used semantic coding, staying close to the actual wording of REC documents. We utilised thematic analysis to identify key themes.  Results. We found that many REC documents encouraged researchers to plan engagement in a way that resonates with ethics guidance (theme 1: ‘encouraging sound engagement’). However, we found many wasted opportunities in this regard (theme 2: ‘missing opportunities’). For some RECs, there was little harmonisation across their key documents regarding this important issue (theme 3: ‘moving towards harmonisation’).  Conclusion. In the short term, we recommend that RECs should amend their application forms in particular to better ‘trigger’ researchers to thoughtfully plan sound stakeholder engagement. In the longer term, we recommend that RECs’ documents be better harmonised internally regarding their stance on stakeholder engagement.
背景伦理法律框架明确鼓励南非的所有卫生研究人员让利益相关者有意义地参与他们的研究。研究伦理委员会(REC)在塑造研究人员在这方面的实践方面可以发挥作用,但很少有研究探讨REC如何最好地实现这一点。目标。探讨SA REC文件是否促使研究人员计划让利益相关者参与健康研究。方法。我们审查了在SA国家健康研究伦理委员会注册的REC的公开文件。截至2019年11月,在46家注册的REC中,有37家的文件可以公开获取。其中包括72份文件(例如标准作业程序和申请表)。我们根据提到的参与的道德原因、利益相关者和强调的参与策略对这些进行了编码。我们使用了语义编码,接近REC文档的实际措辞。我们利用主题分析来确定关键主题。结果。我们发现,许多REC文件鼓励研究人员以与伦理指导产生共鸣的方式计划参与(主题1:“鼓励良好的参与”)。然而,我们发现在这方面浪费了许多机会(主题2:“错失机会”)。对于一些区域经济共同体而言,其关于这一重要问题的关键文件几乎没有协调一致(主题3:“走向协调”)。结论。在短期内,我们建议REC应修改其申请表,特别是更好地“触发”研究人员深思熟虑地规划合理的利益相关者参与。从长远来看,我们建议REC的文件在内部更好地协调其对利益相关者参与的立场。
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引用次数: 5
Legal issues in posthumous conception using gametes removed from a comatose male: The case of Ex Parte SN 从昏迷男性身上取下配子的死后受孕的法律问题:单方个案
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00728
B. Shozi
In only the second case dealing with posthumous conception in South Africa – Ex Parte SN – a woman approached the High Court seeking an urgent order allowing her to have sperm removed from the body of her comatose husband, so that she could use it for reproductive purposes after his death. This raised two separate legal issues: ( i ) whether gamete removal may occur where the person from whom the gametes are being removed is unable to consent; and ( ii ) whether gametes removed in this way could be used for posthumous conception. The court held that the woman was allowed to have the gametes removed, but did not engage with whether she could use them for posthumous reproduction. The court did not provide reasons, as this case was determined on an urgent basis. This article provides a background to this case, and analyses the main arguments surrounding each of these legal issues. It concludes that the law allows that a person who has the authority to give consent to health services on the comatose patient’s behalf may also give consent to gamete removal. However, whether these gametes may then be used for posthumous conception should be determined by a court, by balancing the various rights and legal interests at play. Three criteria that should guide a court’s determination in cases of posthumous conception are provided.
在南非处理死后受孕的第二个案件中,一名妇女向高等法院寻求紧急命令,允许她从昏迷丈夫身上取出精子,以便在丈夫去世后用于生殖目的。这引发了两个独立的法律问题:(i)如果被摘除配子的人无法同意,是否会进行配子摘除;以及(ii)以这种方式去除的配子是否可以用于死后受孕。法院认为,这名妇女被允许摘除配子,但没有考虑是否可以在死后使用配子进行繁殖。法院没有提供理由,因为本案是在紧急情况下裁定的。本文提供了本案的背景,并分析了围绕每一个法律问题的主要论点。它的结论是,法律允许有权代表昏迷患者同意医疗服务的人也可以同意摘除配子。然而,这些配子是否可以用于死后受孕,应由法院通过平衡各种权利和法律利益来决定。在死后受孕的案件中,有三个标准应该指导法院的裁决。
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引用次数: 0
ACT-Accelerator data governance framework: Balancing individual rights with the public interest in responding to COVID-19 COVID-19加速计划数据治理框架:在应对COVID-19中平衡个人权利与公共利益
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00756
C. Staunton
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引用次数: 0
A critical review of the South African legal framework on adolescent access to HIV prevention interventions 对南非青少年获得艾滋病毒预防干预措施法律框架的批判性审查
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00716
J. Toohey, A. Strode
HIV remains a leading cause of death globally, with adolescents continuing to be one of the most at-risk population groups. Effective public health responses require an enabling legal environment to facilitate adolescent access to HIV prevention tools. South Africa (SA) is a good case study of a country with legislative reforms supporting public health HIV prevention programmes. A desktop review was conducted of relevant SA laws compared with key international norms such as age of independent consent and the right to confidentiality. This article reflects on whether the SA legal framework is a facilitator or barrier to adolescent access to key HIV prevention services such as HIV testing and HIV education. The findings indicate a clear recognition of evolving capacity and the inclusion of protections aimed at enhancing decisionmaking. International legal norms are, however, scattered, and not comprehensive enough to inform certain national policy choices. As such, developing a coherent approach to the evolving capacity and protection relating to age-appropriate decision-making can be a challenge for states legislating on adolescent access to HIV prevention interventions. This article highlights the fact that SA has largely created an enabling legal environment for adolescent access to HIV prevention. Nevertheless, there are a number of weaknesses in the SA legal framework, such as the divergent approaches between criminal and civil law regarding sexual activity among adolescents. It is recommended that further research be conducted on legal reform toward a coherent approach to support adolescent access to HIV prevention services.
艾滋病毒仍然是全球死亡的主要原因,青少年仍然是最危险的人群之一。有效的公共卫生对策需要一个有利的法律环境,以便利青少年获得艾滋病毒预防工具。南非是一个很好的案例研究,该国的立法改革支持公共卫生艾滋病毒预防方案。对SA的相关法律与独立同意年龄和保密权等关键国际规范进行了桌面审查。这篇文章反思了SA法律框架是促进还是阻碍青少年获得关键的艾滋病毒预防服务,如艾滋病毒检测和艾滋病毒教育。调查结果表明,人们清楚地认识到能力的不断发展,并纳入了旨在加强决策的保护措施。然而,国际法律规范分散,不足以为某些国家政策选择提供信息。因此,制定一种连贯的方法来发展与适龄决策相关的能力和保护,可能是各州就青少年获得艾滋病毒预防干预措施进行立法的一项挑战。这篇文章强调了这样一个事实,即SA在很大程度上为青少年获得艾滋病毒预防创造了一个有利的法律环境。然而,SA法律框架中存在一些弱点,例如刑法和民法在青少年性活动方面的做法不同。建议对法律改革进行进一步研究,以采取一致的方法支持青少年获得艾滋病毒预防服务。
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引用次数: 0
Forms to capture child consent to surgical procedures: Time to focus on function rather than form 获取儿童对外科手术同意的表格:是时候关注功能而不是形式了
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00696
A. Strode, C. Badul
It is uncontroversial that no form of treatment, including a surgical operation, can be undertaken without the consent of the patient/proxy. The Children’s Act deals expressly with consent to ‘surgical operations’ on children. Section 129 creates a framework based on the principles of child participation and protection. Nevertheless, obtaining consent from children remains complex: firstly, children are legal minors and have limited capacity to act independently. Secondly, there may be risks or longer-term consequences of surgery that distinguish it from medical treatment. Third, a child’s capacity to understand risks is not static: it evolves with age, and limited tools exist to access capacity. Fourth, there are at least three parties to the consent procedure – the child, the parent/guardian and the medical practitioner, all of whom may have different interests. Fifth, in some instances there is the added complication of child parents who need to provide consent for their own child. This article aims to provide guidance to surgeons and other medical practitioners performing surgery on children. It does this through setting out the legal norms relating to child consent to an operation. It critically examines the pro forma consent forms (forms 34 and 35) found in the regulations issued in terms of the Children’s Act that are to be used to document the consent process, and identifies key gaps and weaknesses. It concludes with recommendations for the adaptation of these forms through the use of a checklist to ensure that all the requirements for valid consent are documented, protecting children and medical practitioners.
没有争议的是,未经患者/代理人同意,任何形式的治疗,包括外科手术,都不能进行。《儿童法》明确规定同意对儿童进行“外科手术”。第129条建立了一个基于儿童参与和保护原则的框架。然而,取得儿童的同意仍然很复杂:首先,儿童是合法的未成年人,独立行动的能力有限。其次,手术可能存在风险或较长期的后果,这将其与医学治疗区分开来。第三,儿童理解风险的能力不是一成不变的:它随着年龄的增长而发展,而获取这种能力的工具有限。第四,同意程序至少有三方——儿童、父母/监护人和医生,他们都可能有不同的利益。第五,在某些情况下,孩子的父母需要为自己的孩子提供同意,这增加了复杂性。本文旨在为外科医生和其他从事儿童手术的医疗从业人员提供指导。它通过规定与儿童同意手术有关的法律规范来做到这一点。它严格审查了根据《儿童法》颁布的规章中用于记录同意过程的形式同意表(表格34和35),并确定了主要差距和弱点。报告最后提出了修改这些表格的建议,方法是使用核对表,确保有效同意的所有要求都记录在案,以保护儿童和医务人员。
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引用次数: 0
Access to COVID-19 vaccines as a global public good: A co-ordinated global response based on equality, justice and solidarity is key 获得新冠肺炎疫苗作为全球公共产品:基于平等、正义和团结的全球协调应对是关键
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00768
A. Dhai
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引用次数: 1
Critiquing the ethics review process in the 2019 Nieuwoudt et al. study on the impact of age and education on cognitive functioning among coloured South African women 2019年Nieuwudt等人关于年龄和教育对南非有色人种女性认知功能影响的研究中对道德审查过程的批评
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00703
A. Strode, W. Freedman, Z. Essack, H. Rooyen
In April 2019, Nieuwoudt et al . published an article on the impact of age and education on cognitive functioning among coloured women in the Western Cape Province, South Africa (SA). The study reported that coloured women in SA have increased risk for low cognitive functioning, as a result of limited education and unhealthy lifestyles. The article was widely criticised, and the journal subsequently withdrew the piece. It was argued that the study was unethical as it perpetuated racial stereotypes through its failure to recognise the distinction between race and ethnicity when undertaking biological research on a race group. The study had received ethical approval, which raised pertinent questions about the ethics review process. This article looks at ( i ) the role of research ethics committees (RECs); and ( ii ) the normative framework within which ethics committees operate. It avers that an understanding of the ethical issues of scientific validity, fair subject selection and minimising harms must be viewed in the light of the complex social issues surrounding the construction of coloured identity in SA. The article finds that the REC should have considered this study unapprovable, because its methodology was based on racist assumptions, and its focus on one race or ethnic group posed social risks for that community. The REC ought to have interrogated why researchers were unclear in their distinction between race and ethnicity, and have been mindful of race being a social rather than a biological construct.
2019年4月,Nieuwudt等人。发表了一篇关于年龄和教育对南非西开普省有色人种妇女认知功能的影响的文章。该研究报告称,由于受教育程度有限和生活方式不健康,南非有色人种女性认知功能低下的风险增加。这篇文章受到广泛批评,《华尔街日报》随后撤回了这篇文章。有人认为,这项研究是不道德的,因为它在对种族群体进行生物学研究时没有认识到种族和民族之间的区别,从而使种族刻板印象长期存在。该研究已获得伦理批准,这引发了对伦理审查过程的相关问题。本文着眼于(i)研究伦理委员会(REC)的作用;二道德操守委员会运作的规范性框架。它断言,必须从围绕南非有色人种身份构建的复杂社会问题来看待对科学有效性、公平的受试者选择和最大限度地减少危害等伦理问题的理解。文章发现,REC本应认为这项研究不受欢迎,因为其方法论基于种族主义假设,它对一个种族或族裔群体的关注给该社区带来了社会风险。REC应该质疑为什么研究人员不清楚种族和民族之间的区别,并注意到种族是一种社会结构,而不是一种生物学结构。
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引用次数: 0
Physician-assisted suicide and euthanasia – who are the vulnerable? 医生协助自杀和安乐死——谁是弱势群体?
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00701
A. Donkin
The most widely voiced concern about physician-assisted suicide (PAS) and euthanasia is the risk that they pose to the wider community and the vulnerable, if legalised. No matter how well intentioned are the creators of the initial safeguards of PAS or euthanasia, there seems to be no sustainable way to maintain restrictions on them. It is pertinent, then, to examine the ways in which the legalisation of PAS or euthanasia, in their ever-broadening scope, might increase vulnerability to suicide and decrease the safety of members of a community.
关于医生协助自杀(PAS)和安乐死,最广泛表达的担忧是,如果合法化,它们会给更广泛的社区和弱势群体带来风险。无论PAS或安乐死的最初保障措施的创造者的意图有多好,似乎都没有可持续的方法来维持对它们的限制。因此,研究PAS或安乐死的合法化在其不断扩大的范围内,可能会增加自杀的脆弱性并降低社区成员的安全性,这是相关的。
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引用次数: 0
The Brave New World: Should we tread down the path to human germline editing? 美丽新世界:我们应该踏上人类生殖细胞编辑的道路吗?
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-04-19 DOI: 10.7196/SAJBL.2021.V14I1.00713
S. Soni
Gene-editing tools such as the CRISPR-Cas9 system create an opportunity for individuals to have their DNA edited for specific purposes. Somatic cell editing targets specific cells in an individual, and is aimed at providing a therapeutic mechanism to correct a genetic disease or condition. Germline editing refers to the editing of the DNA of embryos or gametes, which creates edits that are heritable. Following the announcement in 2018 that the Chinese scientist He Jiankui had proceeded to gene-edit human embryos, a moratorium on germline editing was quickly proposed. While an objective of the moratorium was to prevent clinical application of germline editing, it also served as an opportunity to engage in global debate on the issues inherent in gene editing. Heritable editing has become an ethically controversial topic in bioethics, and this article undertakes to provide a primer in the existing national and international legal framework for gene editing, as well as description of the prominent current views of heritable germline editing.
CRISPR-Cas9系统等基因编辑工具为个人创造了一个为特定目的编辑DNA的机会。体细胞编辑针对个体中的特定细胞,旨在提供一种治疗机制来纠正遗传疾病或状况。种系编辑是指对胚胎或配子的DNA进行编辑,从而产生可遗传的编辑。2018年,中国科学家贺建奎宣布对人类胚胎进行基因编辑后,很快就提出了暂停种系编辑的建议。虽然暂停的目的是防止种系编辑的临床应用,但它也为参与关于基因编辑固有问题的全球辩论提供了机会。遗传编辑已成为生物伦理学中一个在伦理上有争议的话题,本文致力于为现有的国家和国际基因编辑法律框架提供一本入门读物,并描述当前对遗传种系编辑的突出观点。
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引用次数: 1
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South African Journal of Bioethics and Law
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