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COVID-19 child vaccinations: Promoting children’s right to equality, education, food and health 新冠肺炎儿童疫苗接种:促进儿童平等、教育、食物和健康的权利
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/SAJBL.2022.v15i1.796
Z. Sujee, S. Ndlela
The pandemic has adversely impacted children. The vaccine roll-out to children aged 12 - 17 years is important to curb the spread of the virus and allow children to revert to some form of normality. Children’s rights to equality, education, health and food have been impeded during the pandemic. However, there is a persistent hesitancy towards the vaccine roll-out. This is apparent from a case before the High Court in Pretoria, in the pending matter between the African Christian Democratic Party and others v The Minister of the National Department of Health: Dr M Phaahla and Others. SECTION27’s intervention as amicus curiae highlights the importance of vaccines, and provides evidence to illustrate the adverse impact of the pandemic on learners’ rights to equality, education, food and health. Further, the evidence illustrates the inequalities that exist among learners.
这一流行病对儿童产生了不利影响。向12至17岁儿童推广疫苗对于遏制病毒的传播和使儿童恢复某种形式的正常非常重要。在疫情期间,儿童享有平等、教育、保健和食物的权利受到阻碍。然而,人们对疫苗的推广一直犹豫不决。这一点从比勒陀利亚高等法院审理的非洲基督教民主党等人诉国家卫生部部长:M . Phaahla博士等人的未决案件中可以明显看出。第27节作为法庭之友的介入强调了疫苗的重要性,并提供证据说明大流行病对学习者平等、受教育、食物和健康权利的不利影响。此外,证据表明学习者之间存在不平等。
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引用次数: 0
Cherry-picking, selective reading and the creation of straw arguments? 樱桃采摘,选择性阅读和稻草论点的创造?
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/sajbl.2022.v15i1.810
M. de Roubaix
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引用次数: 0
The role of Data Transfer Agreements in ethically managing data sharing for research in South Africa 数据传输协议在南非研究数据共享伦理管理中的作用
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/sajbl.2022.v15i1.807
S. Mahomed, G. Loots, C. Staunton
A multitude of legislation impacts the use of samples and data for research in South Africa (SA). With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 (POPIA) in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement (DTA) that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders.
许多立法影响了南非(SA)研究样本和数据的使用。随着《2013年个人信息保护法》第4号(POPIA)于2021年7月生效,研究参与者的个人信息保护受到了关注。在研究中保护参与者的隐私是必不可少的,但这并不是使用和共享个人信息的唯一风险。其他必须考虑和维护的权益包括不受歧视的权利、尊严的权利和享受科学进步成果的权利。这可以通过确保将支撑研究前景的道德价值观和普遍原则,即公平、互惠、正义和团结,纳入管理和使用个人信息的监管框架来实现。本文提倡综合生物伦理学的方法来使用个人信息的研究在SA。嵌入这种方法的一个关键特征是数据传输协议(DTA),当个人信息用于研究目的时,该协议将我们的监管框架所规定的保障措施与生物伦理规则和程序适当地整合在一起。因此,本文呼吁在为研究目的共享数据时,制定一个以关键伦理原则为指导的国家数据分析。本文之后将于2022年6月23日由科学与创新部和南澳医学研究理事会主办的网络研讨会,在那里,相关利益相关者将解开本文中列出的建议和建议,进行讨论和辩论。
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引用次数: 3
That only the elite should have children is a worrying argument 只有精英阶层才应该生孩子,这是一个令人担忧的论点
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/sajbl.2022.v15i1.793
P. Msimang
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引用次数: 0
Legal reflections on the doctor-patient relationship in preparation for South Africa’s National Health Insurance 南非国家医疗保险筹备过程中医患关系的法律思考
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/sajbl.2022.v15i1.786
M. Slabbert, M. Labuschaigne
The doctor-patient relationship is the foundation of any medical intervention. Over time, the relationship has changed, from the era of paternalism to the era of self-determination or patient autonomy, following changes resulting from consumerism and lately, in South Africa, socialised medicine as a result of the proposed National Health Insurance (NHI). The premise of this article is that patient autonomy is invariably limited by a determination of who will carry the cost of a medical intervention. In recent years, legislative developments have affected the understanding of a patient and doctor through the introduction of new references, such as ‘user’, ‘data subject’ and ‘consumer’ for a patient, and ‘service provider’ and ‘responsible party’ for a doctor, each giving different meanings to the doctor-patient relationship. Recent statutory additions also include new remedies available to aggrieved patients as parties in the doctor-patient relationship. The article concludes with brief observations on how the NHI will alter the essence and nature of the doctor-patient relationship in future.  
医患关系是任何医疗干预的基础。随着时间的推移,这种关系发生了变化,从家长式时代转变为自决或患者自主的时代,这是由于消费主义以及最近在南非,由于拟议的国家健康保险(NHI),医学社会化所导致的变化。这篇文章的前提是,患者的自主权总是受到由谁承担医疗干预费用的决定的限制。近年来,立法的发展通过引入新的提法影响了对患者和医生的理解,如患者的“用户”、“数据主体”和“消费者”,医生的“服务提供者”和“责任方”,每一种提法都赋予了医患关系不同的含义。最近增加的法定条款还包括作为医患关系当事人的受害患者可以获得的新补救措施。文章最后就国家健康保险将如何改变未来医患关系的本质和性质进行了简要的观察。
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引用次数: 0
Midwives’ ethical practice in selected labour units in Tshwane, Gauteng Province, South Africa 南非豪登省茨瓦内选定劳动单位助产士的道德实践
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/sajbl.2022.v15i1.765
J. Mathibe-Neke, M. Mashego
Background. Midwives provide the majority of maternal and child healthcare in South Africa (SA). The care provided by midwives during childbirth is a unique life experience for women, and in order to provide safe care, midwives are expected to comply with ethical principles, policies and legislation governing their profession, as guided by the International Confederation of Midwives. Objective. To establish midwives’ perception of ethical and professional practice in selected labour units of public healthcare, in Tshwane District, Gauteng Province, SA. Methods. A qualitative, exploratory, descriptive cross-sectional design was applied by use of in-depth interviews. Non-probability purposive sampling was used to draw a sample from midwives with 2 or more years of experience working in the labour units. Data saturation was reached with the eighth participant. The digitally recorded interviews were transcribed verbatim. Data analysis was based on interpretive description. Results. The findings revealed that midwives do understand the ethical code of conduct. They experience challenges such as staff shortages, non-compliance with policies and lack of managerial support, which compromise ethical conduct to a certain extent. Conclusion. It is hoped that the suggested administrative, midwifery practice and research recommendations will guide the process of empowering midwives in ethical practice.
背景在南非(SA),助产士提供了大部分妇幼保健服务。助产士在分娩期间提供的护理对妇女来说是一种独特的生活体验,为了提供安全的护理,助产士应遵守国际助产士联合会指导下的职业道德原则、政策和立法。客观的在南非豪登省茨瓦内区选定的公共医疗机构中,建立助产士对道德和专业实践的看法。方法。采用定性、探索性、描述性的横断面设计,采用深度访谈法。采用非概率目的抽样法,从有2年或2年以上劳动经验的助产士中抽取样本。第八名参与者的数据达到饱和。数字记录的采访被逐字转录。数据分析基于解释性描述。后果调查结果表明,助产士确实了解道德行为准则。他们面临着人员短缺、不遵守政策和缺乏管理支持等挑战,这在一定程度上损害了道德行为。结论希望所建议的行政、助产实践和研究建议将指导在道德实践中赋予助产士权力的过程。
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引用次数: 1
Is protest action in South Africa bringing positive change or is it threatening our human right to security? 南非的抗议行动是带来正面的改变,还是威胁到我们的人权与安全?
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2022-05-19 DOI: 10.7196/sajbl.2022.v15i1.795
T. Carmichael
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引用次数: 2
Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries (BERC-Luso): A pioneering project 非洲葡语国家生物医学伦理和监管能力建设伙伴关系(BERC-Luso):一个开创性项目
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-12-31 DOI: 10.7196/sajbl.2021.v1431.749
M. P. Patrão Neves, J. Batista
Biomedical research has a strong impact on a country’s scientific-technological and socioeconomic development. It can make a significant contribution at three different levels: promotion of public health; the exchange of knowledge within the scientific community; and economic/ financial profitability. Africa only attracts ~3.3% of the world’s clinical research. This small proportion is due to, among several factors, the absence of two fundamental aspects: specific robust legislation and capacity for regulatory and ethical evaluation. There are five Portuguese- speaking African countries – Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Despite presenting different degrees of clinical research development, these countries show a common serious insufficiency in the minimum conditions necessary for hosting, collaborating or leading biomedical research projects. These countries are also excluded from the support of international organisations for capacity building because of the language barrier. The Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries (BERC-Luso) project has developed methods to build capacity and partnership through research on national law, comparisons with international standards and by issuing recommendations at a national level. Through collaborative intensive training, trainees are taught to become educators at a national level. This, in turn, creates a sustainable impact at country level. BERC-Luso is a pioneering project, owing to a combination of innovative features. The partnership project: (i) was developed exclusively in Portuguese; (ii) involves a large number of African countries, and national and international institutions; (iii) has been further enhanced by the diversity and complementarity of its action plans; and (iv) has also benefited from a broad participatory methodology based on resolution of recipients’ problems by the recipients themselves. It thus stands out as a model for similar future projects.
生物医学研究对一个国家的科技和社会经济发展具有重要影响。它可以在三个不同层面作出重大贡献:促进公共卫生;科学界内部的知识交流;以及经济/财务盈利能力。非洲只吸引了全世界约3.3%的临床研究。这一比例很小是由于缺乏两个基本方面的因素:具体有力的立法和监管和道德评价的能力。非洲有五个葡语国家,分别是安哥拉、佛得角、几内亚比绍、莫桑比克和奥托马斯和Príncipe。尽管这些国家的临床研究发展程度不同,但它们在主持、合作或领导生物医学研究项目所需的最低条件方面普遍存在严重不足。由于语言障碍,这些国家也被排除在国际组织的能力建设支持之外。非洲葡语国家生物医学伦理和监管能力建设伙伴关系(BERC-Luso)项目通过对国家法律的研究、与国际标准的比较以及在国家一级发布建议,制定了建设能力和伙伴关系的方法。通过合作强化培训,学员被教导成为国家一级的教育工作者。这反过来又在国家一级产生可持续的影响。BERC-Luso是一个开创性的项目,因为它结合了创新的特点。合作项目:(i)完全以葡萄牙语开发;涉及大量非洲国家以及国家和国际机构;因其行动计划的多样性和互补性而得到进一步加强;并且(四)也受益于一种广泛参与的方法,这种方法的基础是由受援者自己解决受援者的问题。因此,它作为未来类似项目的典范脱颖而出。
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引用次数: 0
Involuntary admission and treatment of mentally ill patients – the role and accountability of mental health review boards 精神病患者的非自愿入院和治疗——心理健康审查委员会的作用和责任
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-12-31 DOI: 10.7196/sajbl.2021.v14i3.770
M. Botes
No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.
目前还没有已知的治愈COVID-19的方法,医生们已经筋疲力尽,绞尽脑汁,试图找到防止患者住院或重症监护,甚至死亡的治疗方法。医生尝试的各种治疗方法包括标准注册药物、研究或所谓的实验、未经批准或预先批准的药物、紧急或同情使用授权药物和上市前批准药物。然而,可以通过每一类获得的药物都处于功效测试和对副作用、剂量和风险的了解的不同阶段。为了获得道德和法律上的知情同意,医疗从业人员必须处理许多医学上的不确定性,并且必须注意确保患者了解他们可能愿意承担的风险的差异,这取决于药物的发展阶段。通常需要额外的信息来获得道德上的同意而不是法律上的同意。对知情同意采取纯粹法律的做法,特别是在处理突发卫生事件和大流行病的医疗不确定性时,可能导致患者的同意缺乏足够的实质内容,无法真正被视为合法和合乎道德的。从这个意义上讲,知情同意作为对自主权的尊重,需要的不仅仅是患者明确同意或遵守某种治疗建议。本文解释了一种药物开发的每个不同阶段附带的同意内容的差异,特别是考虑到在特征、治疗和解决办法不确定的大流行期间获得真正知情同意所带来的额外困难。
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引用次数: 1
Mechanisms for sustainable post-trial access: A perspective 可持续的审判后获取机制:一个视角
IF 0.9 Q4 MEDICAL ETHICS Pub Date : 2021-12-31 DOI: 10.7196/sajbl.2021.v14i3.782
P. Naidoo, V. Rambiritch
Clinical trials are essential to establish the safety and efficacy of investigational products, contributing to risk/benefit assessments that ultimately determine whether these products meet the criteria for market authorisation. Clinical trials are also an important source of revenue and expertise generation for countries in which they are conducted. In developing countries, they represent substantial foreign direct investment. In spite of the substantial capital input that clinical trials require, the issue of funding post-trial access to beneficial therapies remains contentious, especially in resource-limited settings. In this article, we explore this situation and propose mechanisms to establish ‘win-win’ situations where both patients and clinical trial sponsors derive benefit from post-trial access programmes in low- and middle-income countries.
临床试验对于确定研究产品的安全性和有效性至关重要,有助于进行风险/效益评估,最终确定这些产品是否符合市场授权标准。对于进行临床试验的国家来说,临床试验也是收入和产生专门知识的重要来源。在发展中国家,它们代表着大量的外国直接投资。尽管临床试验需要大量的资本投入,但为试验后获得有益疗法提供资金的问题仍然存在争议,特别是在资源有限的情况下。在本文中,我们探讨了这种情况,并提出了建立“双赢”局面的机制,使患者和临床试验发起人都能从低收入和中等收入国家的试验后获取计划中获益。
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引用次数: 1
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South African Journal of Bioethics and Law
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