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Uma pesquisa clínica não ética e a politização da pandemia da COVID-19 no Brasil: o caso da Prevent Senior 不道德的临床研究与巴西 COVID-19 大流行病的政治化:Prevent Senior 案例。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2022-09-06 DOI: 10.1111/dewb.12369
Fernando Hellmann, Núria Homedes

O Senado Federal brasileiro criou uma Comissão Parlamentar de Inquérito (CPI) para investigar as irregularidades do governo Bolsonaro na gestão da pandemia da COVID-19. Um dos casos que chamou a atenção foi a pesquisa realizada pela Prevent Senior, uma seguradora privada de saúde, sobre o tratamento precoce da COVID-19. O artigo analisa a validade científica da pesquisa e os problemas éticos relacionados à sua implementação. Baseia-se na análise do relatório do ensaio clínico da Prevent Senior, dos registros do ensaio clínico em plataformas do Brasil e dos EUA, do relatório da CPI do Senado e nas informações divulgadas pela mídia. Esse caso de fraude científica e viés político-ideológico exemplifica como a Prevent Senior, usando um protocolo questionável para melhorar sua reputação e ganhar o apoio do governo, foi fundamental na construção da narrativa do “tratamento precoce” para a COVID-19, e mostra como serviu de base para uma política pública governamental que promoveu o uso de drogas ineficazes.

巴西联邦参议院成立了一个议会调查委员会(CPI),调查博尔索纳罗政府在管理 COVID-19 大流行病方面的违规行为。其中一个引起关注的案例是私营医疗保险公司 Prevent Senior 对 COVID-19 的早期治疗进行的研究。这篇文章分析了这项研究的科学性及其实施过程中的伦理问题。文章基于对 Prevent Senior 临床试验报告、巴西和美国平台的临床试验登记、参议院 CPI 报告以及媒体发布的信息的分析。这一科学欺诈和政治意识形态偏见的案例说明了 Prevent Senior 如何利用有问题的方案来提高其声誉并获得政府的支持,如何在为 COVID-19 建立 "早期治疗 "论调的过程中发挥了重要作用,并说明了它如何成为政府公共政策的基础,促进无效药物的使用。
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引用次数: 0
Ethical Progress on the Abortion Care Frontiers on the African Continent 非洲大陆堕胎护理前沿的伦理进展
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-09-03 DOI: 10.1111/dewb.12364
Udo Schuklenk
<p>The Supreme Court of the United States of America has overridden 50 years of legal precedent and reversed constitutional protections1 for abortion in the country that were the result of the 1973 landmark Roe v Wade ruling. Pregnant women in the country do not enjoy a constitutional right to abortion any longer. Broadly speaking the result of this ruling results in a split of the country in terms of access to abortion care based on whether a woman lives in a Republican party controlled state or a Democratic party controlled state. The verdict has been widely condemned by associations of health care professionals, medical journals and the like, as much as it was celebrated by religious leaders like the Pope.2,3 None of that is terribly surprising.</p><p>Among secular bioethicists support for liberal access to abortion care has always been strong. The main ethical reasons for this have to do with respecting women's rights to control over their own bodies,4 as well as consequentialist ethical reasons that take cognizance of worse health care outcomes for the most vulnerable women in societies where restrictive access to abortion care regimes are in place.5 The liberalization of laws on abortion, on the other hand, has demonstrably led to improved health outcomes for these women.6 The ethical arguments on abortion have been debated endlessly by bioethicists, and there is little point in rehashing them here in any great detail.7</p><p>What is perhaps worth noting is that – unlike in the United States – access to abortion care has become in recent years easier in a number of countries on the African continent, including some of its very poorest. Much of this is the result of the so-called Maputo Protocol, or, more formally, the African Union's Protocol to the African Charter on Human and Peoples’ Rights on the Rights of Women in Africa.8 Since the Maputo Protocol came into effect in 2005, seven sub Saharan countries have taken steps to liberalise their abortion related legislation in order to bring their laws in line with the Protocol. To give just a few examples, since 2012 Benin is permitting abortion care even for economic and social reasons up to the 12<sup>th</sup> week after conception. Cape Verde permits abortion on demand up to the 12<sup>th</sup> week after conception, too. The Democratic Republic of Congo has taken to publishing the full text of the Protocol in the government gazette, thereby making it law.9 The result of this has been truly sweeping changes liberalizing the country's abortion regime. Sierra Leone's government introduced a bill in the country's parliament that would, if passed, decriminalize abortion, and expand access to contraceptives as well as other reproductive health services. While this won't change the country's staggeringly high maternal deaths’ rate of around 10% over night, that is a result of unsafe abortion practices, it is an important start to bring about much needed change.10</p><p>Much more needs to be done
美国最高法院推翻了50年来的法律先例,推翻了1973年具有里程碑意义的罗伊诉韦德案裁决所产生的宪法对堕胎的保护。该国的孕妇不再享有宪法赋予的堕胎权利。从广义上讲,这项裁决的结果导致了国家在获得堕胎护理方面的分裂,这取决于一名妇女是生活在共和党控制的州还是民主党控制的州。这一判决受到了卫生保健专业人士协会、医学期刊等的广泛谴责,同时也受到了教皇等宗教领袖的庆祝。在世俗的生物伦理学家中,对自由获得堕胎护理的支持一直很强烈。造成这种情况的主要伦理原因与尊重妇女控制自己身体的权利有关4,也与结果主义的伦理原因有关,因为考虑到在限制获得堕胎护理制度的社会中,最脆弱的妇女的保健结果更差5另一方面,放宽堕胎法显然改善了这些妇女的健康状况关于堕胎的伦理争论已经被生物伦理学家们无休止地争论着,在这里重述任何细节都没有什么意义。也许值得注意的是,与美国不同的是,近年来,在非洲大陆的一些国家,包括一些最贫穷的国家,获得堕胎护理变得更容易了。这在很大程度上是所谓的《马普托议定书》的结果,或者更正式地说,《非洲联盟关于非洲人权和人民权利宪章关于非洲妇女权利的议定书》。自从《马普托议定书》于2005年生效以来,七个撒哈拉以南国家已经采取措施放宽了与堕胎有关的立法,以使其法律与《议定书》保持一致。举几个例子,自2012年以来,即使出于经济和社会原因,贝宁也允许在怀孕后12周内进行堕胎护理。佛得角也允许在受孕后12周内进行堕胎。9 .刚果民主共和国已在政府公报上公布《议定书》全文,从而使其成为法律其结果是彻底改变了该国的堕胎制度。塞拉利昂政府向该国议会提交了一项法案,该法案如果获得通过,将使堕胎合法化,并扩大获得避孕药具和其他生殖健康服务的机会。虽然这不会改变该国一夜之间高达10%的孕产妇死亡率,这是不安全堕胎行为的结果,但这是一个重要的开始,可以带来急需的改变。非洲大陆以及南半球其他地方需要做的还有很多。获得堕胎护理是高质量生殖保健的一个基本特征,但虽然可以说这是一个必要条件,但肯定不是充分条件。正如Moodley和akinsoto所指出的那样,即使在南非这样一个拥有自由堕胎护理制度的国家,“也有必要更加重视向妇女提供有效的避孕服务和生殖健康教育。”我很想在这里加上一句,“和男人”。不出所料,在美国,支持推翻罗伊诉韦德案的政治人物也热衷于使获得避孕药具变得更加困难选择的法律工具是出于良心的反对。13,14在推动强迫生育政策承诺的意识形态中,妇女的健康和福祉仍然是次要考虑因素。
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引用次数: 0
Regulation concerns of supply and demand sides for aesthetic medicine from Chinese perspective 中国视角下美容医学供需双方的监管问题
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-08-29 DOI: 10.1111/dewb.12366
Longfei Feng, Xiaomei Zhai

Aesthetic medicine has become a booming industry in the world. However, there are widespread social and health risks posed by aesthetic medicine, including illegal practice, and misleading information from aesthetic medicine institutes. Social media and advertisement play important roles in leading to appearance anxiety among young people nowadays. Regarding the chaotic situation in the aesthetic medical field, there is a fact that the practice of aesthetic medicine has been marginally regulated, even in some developed countries. China has the largest population in the world as well as the large number of aesthetic medical customers. Regarding the protection of people from harm, there is a great challenge for the Chinese government. So, China has enacted the toughest governance these years both on the supply and demand side. Some of the strategies may be useful for health authorities in certain countries.

美容医学已成为世界上一个蓬勃发展的产业。然而,美容医学带来了广泛的社会和健康风险,包括非法执业和美容医学机构提供的误导性信息。社交媒体和广告在导致当今年轻人的外表焦虑方面发挥了重要作用。关于美容医学领域的混乱局面,有一个事实是,即使在一些发达国家,美容医学的实践也没有得到多少监管。中国拥有世界上最多的人口,也拥有大量的美容医疗客户。在保护人民免受伤害方面,中国政府面临着巨大的挑战。因此,中国在供给和需求方面实施了近年来最严厉的治理。其中一些战略可能对某些国家的卫生当局有用。
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引用次数: 0
Obstetric violence as immigration injustice: A view from the United States and Colombia 产科暴力作为移民不公正:来自美国和哥伦比亚的观点
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-08-29 DOI: 10.1111/dewb.12365
Allison B. Wolf

In September 2020, Project South, along with numerous other organizations, released a report detailing abuses in a Georgia Detention Center – including forced hysterectomies. Whatever other factors are at play, one of them is an intrinsic connection between obstetric violence against pregnant migrants and immigration injustice. It is not incidental that these acts – in US detention centers, along the US-Mexico border, in Colombian hospitals and clinics – are being perpetrated on immigrant bodies. And it is not accidental or random which immigrant bodies are vulnerable to these violations. Understanding and confronting obstetric violence directed at pregnant migrants, though, requires reconceptualizing the nature of obstetric violence itself. In particular, we must recognize that obstetric violence against pregnant Latin American migrants in the United States and Colombia is a type of immigration injustice, a means to perpetrate immigration injustice, and a product of immigration injustice. As such, bioethicists need to collaborate with immigration scholars to resist it.

After providing some background on the nature of obstetric violence and some ways it is perpetuated against pregnant migrants in the United States and Colombia, I will give a brief overview of how I conceptualize immigration justice. From there, I explain how this type of obstetric violence constitutes a type of immigration injustice, a means to perpetrate immigration injustice, and a product of immigration injustice. My hope is that this analysis motivates bioethicists throughout the Americas to engage with immigration scholars and activists to confront the issue more forcefully.

2020年9月,南方项目与许多其他组织一起发布了一份报告,详细介绍了佐治亚州拘留中心的虐待行为,包括强迫子宫切除术。无论其他因素如何起作用,其中之一是针对怀孕移民的产科暴力与移民不公正之间的内在联系。在美国拘留中心、美墨边境、哥伦比亚医院和诊所,这些针对移民尸体的行为并非偶然。移民机构容易受到这些侵犯并非偶然或偶然。然而,理解和应对针对怀孕移民的产科暴力需要重新定义产科暴力本身的性质。特别是,我们必须认识到,对美国和哥伦比亚怀孕的拉丁美洲移民的产科暴力是一种移民不公正,是实施移民不公正的手段,也是移民不公正的产物。因此,生物伦理学家需要与移民学者合作来抵制它。在提供了一些关于产科暴力的本质的背景,以及它在美国和哥伦比亚对怀孕移民的一些长期存在的方式之后,我将简要概述我如何概念化移民正义。从这里,我解释了这种类型的产科暴力如何构成一种移民不公正,一种实施移民不公正的手段,以及移民不公正的产物。我希望这一分析能激励整个美洲的生物伦理学家与移民学者和活动人士合作,更有力地面对这个问题。
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引用次数: 0
An ethics of anthropology-informed community engagement with COVID-19 clinical trials in Africa 人类学伦理——知情社区参与非洲新冠肺炎临床试验。
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-08-09 DOI: 10.1111/dewb.12367
Sarah J. L. Edwards, Blessing Silaigwana, Danny Asogun, Julius Mugwagwa, Francine Ntoumi, Rashid Ansumana, Kevin Bardosh, Jennyfer Ambe

The COVID-19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio-political context in which the research is proposed; and 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio-political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa.

新冠肺炎大流行加强了伦理和社区参与在传染病爆发期间设计和进行临床研究的关键作用,在传染病暴发期间,还没有疫苗或治疗方法。在审查非洲各地的现行做法时,我们区分了社区参与临床研究的三个不同角色,这三个角色经常被混为一谈:1)社区参与对识别和尊重文化敏感性的重要性;2) 认识到提出研究的社会政治背景的重要性;以及3)根据自己的观点和价值观,了解什么符合被招募进行研究的社区的利益的重要性。通过做出这些区别,我们表明,当前的临床研究实践可以借鉴人类学的方式,有时不需要征求当地的文化价值观,忽视社会政治背景和更广泛的社会结构的重要性,这可能有助于加强不公正的政治或社会制度,并有可能使人们对这项研究的可信度产生怀疑。我们认为,迫切需要更敏锐的人类学参与,以及与其他社会科学家和人文学科工作者的更广泛合作,以改善非洲当前生物医学和药物研究实践的伦理。
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引用次数: 0
Reflections on research ethics in a public health emergency: Experiences of Brazilian women affected by Zika 突发公共卫生事件中对研究伦理的反思:受寨卡病毒影响的巴西妇女的经历
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-06-28 DOI: 10.1111/dewb.12361
Ilana Ambrogi, Luciana Brito, Sergio Rego

In Brazil, the epicenter of the Zika crisis, brown, black, and indigenous poor women living in municipalities with scarce resources were disproportionally affected. The gendered consequences of the epidemic exposed how intersectional lenses are central to understand the impact of public health emergencies in the lives of women and girls. The demand for Zika-affected children and women to be research participants is relevant for an ethical analysis of participant protection procedures during a crisis. We investigated how women experienced research participation by analyzing their narratives. Two-year-long longitudinal qualitative study in Brazilian sites located in the epidemic's epicenter was performed using mixed methods: ethnography with women from two distinct states and individual semi-structured interviews with five women in different Zika-affected states, four of which were community leaders. All women in the study were mothers or grandmothers of Zika-affected children. Thematic analysis was used for data evaluation. Women perceived being pressured to participate in research and a lack of benefit sharing. Structural determinants of gender inequality, such as its effect on power distribution, were found to impact research participant protection. Formal procedures for research protocols approvals were insufficient in protecting participants because these instruments were unable to account for structural aspects. Communitarian mobilization, through WhatsApp groups, was found to be an important mechanism to create conditions to challenge oppressive structures. Strengthening public health, effective community-based participation in research planning and implantation of ethical strategies that promotes gender equality can have transformative effect on unequal power structures and promote participant protection.

在寨卡病毒危机的中心巴西,生活在资源匮乏的城市中的棕色人种、黑人和土著贫困妇女受到了不成比例的影响。这一流行病的性别后果暴露了跨部门视角是如何理解公共卫生紧急情况对妇女和女孩生活影响的核心。要求受寨卡病毒影响的儿童和妇女成为研究参与者,这与危机期间参与者保护程序的伦理分析有关。我们通过分析女性的叙述来调查她们是如何体验研究参与的。在位于疫情中心的巴西地点进行了为期两年的纵向定性研究,采用了混合方法:对来自两个不同州的女性进行民族志研究,并对不同寨卡病毒感染州的五名女性进行了个人半结构化访谈,其中四名是社区领袖。研究中的所有女性都是寨卡病毒感染儿童的母亲或祖母。专题分析用于数据评估。妇女感到参与研究的压力很大,而且缺乏利益分享。性别不平等的结构性决定因素,如其对权力分配的影响,被发现会影响研究参与者的保护。研究方案批准的正式程序不足以保护参与者,因为这些文书无法考虑结构方面。通过WhatsApp群组进行的社群主义动员被发现是创造条件挑战压迫性结构的重要机制。加强公共卫生、以社区为基础有效参与研究规划和实施促进性别平等的道德战略,可以对不平等的权力结构产生变革性影响,并促进参与者保护。
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引用次数: 0
An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior 巴西COVID-19大流行的不道德试验和政治化:以预防老年人为例
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-06-28 DOI: 10.1111/dewb.12363
Fernando Hellmann, Núria Homedes

The Brazilian Federal Senate created a Parliamentary Inquiry Commission (CPI) to investigate the Bolsonaro government's irregularities in the management of the COVID-19 pandemic. One of the cases that drew attention was the research conducted by Prevent Senior, a private health insurance company, on the early treatment of COVID-19. The article analyzes the scientific validity of the research and the ethical problems related to its implementation. It is based on analysis of Prevent Senior's report of the clinical study, the Brazilian and USA clinical trial registries, the Senate's CPI report, and on the information reported by the media. This case of scientific fraud and political-ideological bias exemplifies how Prevent Senior, using a questionable protocol to enhance its reputation and gain government support, was instrumental in building the “early treatment” narrative for COVID-19, and shows how it served as a basis for a government public policy that promoted the use of ineffective drugs.

巴西联邦参议院成立了议会调查委员会(CPI),调查博尔索纳罗政府在新冠肺炎疫情管理方面的违规行为。民间健康保险公司“预防老人”(Prevent Senior)对新冠肺炎的早期治疗进行的研究就是其中一个备受关注的案例。文章分析了该研究的科学有效性及其实施中存在的伦理问题。它是基于对prevention Senior的临床研究报告、巴西和美国的临床试验注册、参议院的CPI报告以及媒体报道的信息的分析。这一科学欺诈和政治意识形态偏见的案例表明,预防老年机构利用一项有问题的方案来提高其声誉并获得政府支持,在构建COVID-19“早期治疗”叙事方面发挥了重要作用,并表明它如何成为政府公共政策的基础,从而促进了无效药物的使用。
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引用次数: 5
Is there a human right to essential health care? 享有基本医疗保健是一项人权吗?
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-06-28 DOI: 10.1111/dewb.12362
Daniel M. Hausman

In Global Health Impact, Nicole Hassoun joins the ranks of those defending a right to health. Unlike the World Health Organization, which views this right expansively, Hassoun would limit the right to the health needed to enjoy a minimally good life. This essay argues that this right is difficult to specify and insufficient to support the policies Hassoun defends. The essay sketches an alternative view of the obligations of institutions to address health problems that derives from imperfect individual duties to aid those who are doing badly or who are at risk of harm.

在《全球健康影响》一书中,妮可-哈松加入了捍卫健康权的行列。与世界卫生组织对这一权利的宽泛看法不同,哈松将这一权利限定为享受最低限度美好生活所需的健康。本文认为,这一权利难以明确,不足以支持哈松所捍卫的政策。本文对机构解决健康问题的义务提出了另一种观点,这种观点源于不完善的个人义务,即帮助那些表现不佳或面临伤害风险的人。
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引用次数: 0
Ethical analysis of cadaver supply and usage processes for research within the scope of the Helsinki Declaration 在赫尔辛基宣言范围内对尸体供应和使用过程进行伦理分析
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-06-21 DOI: 10.1111/dewb.12360
Banu Buruk, Güneş Aytaç

Recent technological developments have considerably transformed the supply, storage, and transportation processes of cadavers, creating new and previously unforeseen ethical challenges regarding cadaver usage. In this study, we analyzed two aspects of the cadaver processing system—cadaver supply and its use in research. Thereafter, we highlighted the major ethical concerns underlying these stages and correlated our search results with the ethical principles outlined in the Declaration of Helsinki (DoH), or Helsinki Declaration. To ensure the reliability and continuity of medical progress, human—especially cadaver—research depends on the ethical priorities as outlined in the DoH: respect for autonomy, privacy/confidentiality, risks/burdens/benefits, and the protection of vulnerable groups. According to our ethics analysis, which also corresponds with the ethics guidelines of the Consensus Panel on Research with the Recently Dead, the most ignored values were respect for autonomy and privacy/confidentiality issues. Based on these ethical concerns, we provide recommendations to address these challenges in anatomy research.

最近的技术发展极大地改变了尸体的供应、储存和运输过程,对尸体的使用产生了新的和以前无法预见的伦理挑战。在本研究中,我们分析了尸体处理系统的两个方面——尸体供应和尸体在研究中的应用。此后,我们强调了这些阶段背后的主要伦理问题,并将我们的搜索结果与赫尔辛基宣言(DoH)或赫尔辛基宣言中概述的伦理原则相关联。为了确保医学进步的可靠性和连续性,人类——尤其是尸体——研究取决于卫生部概述的伦理优先事项:尊重自主权、隐私/保密、风险/负担/利益以及对弱势群体的保护。根据我们的伦理分析,这也符合最近死亡研究共识小组的伦理准则,最被忽视的价值观是尊重自主权和隐私/保密问题。基于这些伦理问题,我们提出了解决解剖学研究中这些挑战的建议。
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引用次数: 0
“By only considering the end product it means that our participation has always been in vain”: Defining benefits in HIV vaccine trials in Tanzania "只考虑最终产品就意味着我们的参与一直是徒劳的":确定坦桑尼亚艾滋病毒疫苗试验的益处
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2022-06-16 DOI: 10.1111/dewb.12359
Godwin Pancras, Mangi Ezekiel, David Nderitu, Bege Dauda, Erasto Vitus Mbugi

Debates about what constitutes benefits in human research continue to be less informed due to a lack of empirical evidence from the developing world. This study aimed to explore what constitutes benefits in HIV vaccine trials in Tanzania and examine inherent ethical implications. A qualitative case study design was deployed and a total of 29 purposively selected study participants comprising of experienced researchers, institutional review board members and community advisory board members were included. Collected data were analyzed by thematic analysis aided by computer software: MAXQDA version 20.4.0. The study findings indicate that there is a growing appreciation of benefits beyond actual vaccines to include 1) capacity building at individual, community, institutional and regulatory levels; and 2) non-capacity building related benefits such as strengthened collaborations, ancillary care and employment opportunities. So, as the struggle for viable HIV vaccines continues, other benefits that have accrued from such trials are not to be blindsided especially for developing countries like Tanzania.

由于缺乏来自发展中国家的经验证据,关于什么是人类研究中的益处的争论仍然很少。这项研究的目的是探讨坦桑尼亚艾滋病毒疫苗试验的益处是什么,并审查其内在的伦理影响。采用定性案例研究设计,有目的地选择29名研究参与者,包括经验丰富的研究人员、机构审查委员会成员和社区咨询委员会成员。收集的数据采用主题分析法,辅以MAXQDA 20.4.0版本计算机软件进行分析。研究结果表明,越来越多的人认识到,除了实际接种疫苗之外,还包括1)个人、社区、机构和监管层面的能力建设;2)非能力建设相关的好处,如加强合作、辅助护理和就业机会。因此,随着研制可行的艾滋病毒疫苗的斗争继续进行,这些试验所带来的其他好处不应被忽视,尤其是对坦桑尼亚这样的发展中国家。
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引用次数: 2
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Developing World Bioethics
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