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Oocyte cryopreservation for non-medical reasons: Ethical and regulatory concerns in China 非医学原因的卵母细胞冷冻:中国的伦理和监管问题。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-08-09 DOI: 10.1111/dewb.12418
Yu Lanyi, Zhai Xiaomei PhD

Assisted reproductive technology is a complex medical intervention with many potential social sensitivities. Within this domain, oocyte cryopreservation has emerged as an important research area for preserving female fertility. Against the backdrop of the hotly debated first legal case in China of a single woman wishing to freeze her eggs, and the implementation of the ‘three-child policy’ in China, there is an urgent need to evaluate policies and address ethical considerations surrounding oocyte cryopreservation for non-medical reasons. This review examines current policies, explores China's practices and research, and examines the latest ethical challenges surrounding non-medical oocyte cryopreservation. It develops strategies and recommendations that will be relevant in China and other developing countries seeking to navigate this complex landscape.

辅助生殖技术是一项复杂的医疗干预措施,具有许多潜在的社会敏感性。在这一领域,卵细胞冷冻保存已成为保存女性生育能力的一个重要研究领域。在中国发生了首例单身女性希望冷冻卵子的法律案件并引发激烈争论,以及中国实施 "三胎政策 "的背景下,迫切需要对相关政策进行评估,并解决与非医疗原因的卵母细胞冷冻相关的伦理问题。本综述研究了当前的政策,探讨了中国的实践和研究,并研究了围绕非医疗性卵母细胞冷冻的最新伦理挑战。它为中国和其他发展中国家在这一复杂的环境中寻求发展提出了相关的策略和建议。
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引用次数: 0
When medical professionalism and culture or the law collide: Gay patients in homophobic societies 当医疗专业与文化或法律发生冲突:同性恋恐惧症社会中的同性恋患者
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2023-08-08 DOI: 10.1111/dewb.12420
Udo Schuklenk

Medical professionalism faces serious challenges in homophobic societies. A case in point: Uganda. The country has gained global notoriety for having implemented one of the toughest anti-LGBTQ laws in the world. It includes the death penalty for something called ‘aggravated homosexuality’, as well as a 20-year prison sentence for ‘promoting’ homosexuality.1

When issuing a different, less draconian anti-gay legislation some years back, the country's health minister assured Ugandans, as well as the international community, that all people, regardless of sexual orientation, would receive ‘full treatment’ and added that ‘health workers will live up to their ethics of keeping confidentiality of their patients’.2 Gay patients experienced a quite different reality. In 2017 the activist group Sexual Minorities Uganda issued a report under the title ‘Even if they spit at you, don't be surprised’.3 I recommend the document to your attention. It's replete with first-person accounts of unprofessional conduct by health care professionals. It ranges from the use of derogatory language to refusal of service provision to actual physical attacks. There is also evidence of medical school training containing scientific misinformation on homosexuality.

While unusual by today's global standards, Uganda isn't the only country with anti-gay legislation on its books. Less draconian legislation can be found in homophobic societies like Jamaica, for instance. There is a high number of former British colonies with such laws, but it's unclear whether that's mere correlation or whether there is a causation-type relationship. While the legislation in place oftentimes is a relic of colonial era laws, there also appears to be widespread societal support for such measures in these predominantly Christian societies. While some Caribbean nations have recently decriminalized consensual same-sex relations, six Caribbean countries, among them larger countries like Jamaica, still criminalise consensual same-sex sexual relations. They are not alone, some 66 countries reportedly criminalise consensual same-sex relations.4 The World Medical Association saw it fit, against this background, to issue a strong statement condemning the participation of medical professionals in anal examinations ostensibly designed to assist in determinations of same-sex sexual activities.5 Apparently such examinations actually happen in certain societies, even though they are based on humbug science.6

This raises a number of important issues regarding the health care that patients who identify as gay or queer, or who participate in same-sex sexual relations, can reasonably expect in such societies. The uncontroversial objective of health care provision is to increase or maximise the number of life-years a person can live with a good quality of life that makes their life worth living, in their own considered judgment. Health care professionals value judgments about the lifest

在恐同社会,医疗专业精神面临严峻挑战。乌干达就是一个很好的例子。该国因实施了世界上最严厉的反lgbtq法律之一而享誉全球。它包括对所谓的“严重同性恋”的死刑,以及对“促进”同性恋的20年监禁。几年前,乌干达卫生部长颁布了一项不同的、不那么严厉的反同性恋立法,当时他向乌干达人民以及国际社会保证,所有人,无论性取向如何,都将得到“充分的治疗”,并补充说,“卫生工作者将遵守为病人保密的道德规范”同性恋患者经历了一个完全不同的现实。2017年,乌干达性少数群体活动组织发布了一份题为“即使他们向你吐口水,也不要感到惊讶”的报告我建议你注意这份文件。书中充斥着医疗专业人员不专业行为的第一人称描述。它的范围从使用贬损的语言到拒绝提供服务,再到实际的人身攻击。也有证据表明,医学院的培训中包含有关同性恋的科学错误信息。虽然以今天的全球标准来看,这是不寻常的,但乌干达并不是唯一一个有反同性恋立法的国家。例如,在牙买加这样的恐同社会,可以找到不那么严厉的立法。有很多前英国殖民地都有这样的法律,但尚不清楚这是单纯的相关性还是因果关系。虽然立法往往是殖民时代法律的遗迹,但在这些以基督教为主的社会中,这些措施似乎也得到了广泛的社会支持。虽然一些加勒比国家最近将双方同意的同性关系合法化,但六个加勒比国家,其中包括牙买加这样的大国,仍然将双方同意的同性性关系定为犯罪。他们并不孤单,据报道,大约有66个国家将双方同意的同性关系定为犯罪在此背景下,世界医学协会认为有必要发表一项强烈声明,谴责医学专业人员参与表面上旨在协助确定同性性活动的肛门检查显然,这样的考试在某些社会中确实存在,尽管它们是基于骗人的科学。这就提出了一些重要的问题,关于那些认为自己是同性恋或同性恋的病人,或者那些参与同性性关系的病人,在这样的社会中可以合理地期望得到的医疗保健。医疗保健提供的无可争议的目标是增加或最大限度地延长一个人能够以良好的生活质量生活的生命年数,使他们的生活有价值,根据他们自己的考虑判断。卫生保健专业人员重视对患者生活方式的判断,不应影响他们得到的护理;其他任何行为都可能构成不专业行为,因为这可能对提供保健服务产生负面影响。顺便说一句,这句话不仅对-à-vis酷儿患者是正确的,对所有患者都是正确的。例如,超重病人长期以来一直抱怨卫生保健环境中体重歧视的影响,以及这种歧视对他们所接受的卫生保健质量的有害影响类似的问题也出现在“难相处的病人”身上卫生保健专业人员的隐性偏见已被证明会增加健康差异其中一个显而易见的解决方案是敏感性培训,即假定医疗保健专业人员在意识到自己的偏见后,会主动监控自己,以确保他们的偏见不会影响他们提供的医疗保健。当然,如果乌干达的医疗保健专业人员的偏见导致他们对同性恋患者进行身体攻击,人们不得不怀疑这种培训是否会对专业行为产生重大影响,但这可能值得一试。响应性卫生保健系统可以实施的另一项措施是,增加那些受到内隐偏见负面影响的群体的专业人员数量。显然,如果有的话,这些解决方案中只有第一种有机会在世界乌干达取得成功。当局需要确保,不管他们对酷儿人群有多鄙视,这些患者都能获得医疗保健。例如,乌干达医学协会也有责任确保其成员的专业行为。该组织在其网站上宣称,它提倡“尽可能高的医学道德标准,并为医生提供道德指导”。它的愿景是:“乌干达所有人都能获得高质量的健康和保健服务”这当然包括乌干达的同性恋患者。 碰巧,乌干达医学协会也是世界医学协会的组成成员。世界医学协会公开谴责乌干达的反同性恋立法,并呼吁其组成成员也这样做医学专业精神和专业人士对酷儿患者的偏见是不相容的。今天,那些歧视性少数群体的人倾向于以尊重文化多样性为借口,为他们侵犯人权的行为辩护,但这在我们正在考虑的情况下是行不通的,因为病人把专业人士看作是他们的专业角色,而不是普通公民。专业价值观决定了专业咨询过程中的正确行为,而不是特殊的个人价值观,无论它们在社会上多么普遍。专业协会有责任履行他们对社会做出的承诺,并对那些达不到专业要求的成员进行纪律处分。偏见、文化、甚至歧视性法律都不能成为专业人员个人偏见造成的次优保健服务的理由,即使这些偏见在其特定文化中广泛存在。
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引用次数: 0
Surveying the Indian research ethics committee response to the COVID-19 pandemic 调查印度研究伦理委员会对 COVID-19 大流行病的反应。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-08-04 DOI: 10.1111/dewb.12417
Yashashri C. Shetty, Sudha Ramalingam, Paresh Koli, Karthikeyan Shanmugam, Rajmohan Seetharaman

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics.

在 COVID-19 大流行期间,研究伦理委员会 (REC) 在加快审查研究方案方面发挥了至关重要的作用。为了提高伦理委员会的绩效并确定需要加强的领域,亚洲和西太平洋地区伦理审查委员会论坛 (FERCAP) 在印度开展了一项多中心研究。该研究旨在评估印度区域医疗中心在 COVID-19 爆发期间进行方案审查的准备情况,并了解它们遇到的挑战。在获得伦理委员会批准后,研究人员使用两份经过验证的调查问卷进行了横断面观察研究,其中一份针对区域协调中心成员秘书/主席,另一份针对区域协调中心成员。问卷包括 13 道选择题、10 道 "是 "或 "否 "题和 2 道开放式问题。研究报告分发给了多个区域经济委员会。共有 109/200 人同意参与研究,其中包括来自 34 个区域经济共同体的 13 名区域经济共同体成员秘书、12 名主席和 84 名区域经济共同体成员。在 COVID-19 大流行期间,23/25(92%)个区域执行委员会举行了在线会议。区域医疗中心面临的最常见挑战包括风险效益分析(12/25 个区域医疗中心)、知情同意书审查(12/25 个区域医疗中心)和涉及弱势群体的方案(10/25 个区域医疗中心)。65% 的 REC 成员表示需要接受伦理审查培训,66/84 的 REC 成员同意或非常同意 REC 需要接受 COVID-19 方案审查培训。此外,62/84 名区域执行委员会成员同意或非常同意中央/联合区域执行委员会应审查多中心 COVID-19 方案。印度的 REC 在审查风险效益分析、知情同意文件 (ICD) 和 COVID-19 方案时遇到了困难,他们建议提供有关这些主题的培训。
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引用次数: 0
An African moral approach against the perverted faculty argument: Ukama, partiality and homophobia in Africa 反对变态教师论的非洲道德方法:非洲的乌卡马、偏袒和同性恋恐惧症。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-08-02 DOI: 10.1111/dewb.12419
Luis Cordeiro-Rodrigues

In Africa, homosexuality is routinely understood as a form of immoral behaviour. This has great implications for the physical and psychological well-being of homosexuals in Africa. One of the reasons why homosexuals are sometimes understood to be behaving immorally is because it is believed that same-sex relations are unnatural. I think that this conception of unnatural is grounded on the perverted faculty argument, although this is not often expressed in such terms. In this article, I will develop a concept of natural grounded on the concept of Ukama. I will show that despite Ukama implying a functional conception of nature, just like in the perverted faculty argument, it does not imply that homosexuality is immoral.

在非洲,同性恋通常被理解为一种不道德行为。这对非洲同性恋者的身心健康有很大影响。同性恋者有时被理解为行为不道德的原因之一是,人们认为同性关系是不自然的。我认为,这种不自然的概念是以变态的能力论点为基础的,尽管这种论点并不经常以这种方式表达出来。在本文中,我将以 Ukama 概念为基础发展自然概念。我将说明,尽管乌卡马意味着一种功能性的自然概念,就像在变态能力论证中一样,但它并不意味着同性恋是不道德的。
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引用次数: 0
What has Kant got to say about conscientious objection to reproductive health in South Africa? 康德对南非出于良心拒绝生殖健康有什么看法?
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-07-21 DOI: 10.1111/dewb.12416
E. Lekunze Fritz

A woman's right to a safe legal abortion in South Africa conflicts with a health care professional's freedom of conscience. Conscientious objection or treatment refusal on the basis of conscience may be protected by the constitution but its morality has not been explored. This study uses Kantian Deontology to elucidate the ethical duties of health care professionals based on the Physician's Pledge. It concludes that conscience is morally empty and that health care professionals have a duty to treat all patients equally irrespective of the condition they present. Drawing on Kantian promise keeping, the study also concludes that health care professionals should place patients health and wellbeing above all other considerations. Using the categorical imperative, the study shows that health care professionals have a perfect duty not to refuse treatment. The study recommends that conscientious objection be rejected in all circumstances except where the psychological wellbeing of the health care professional will be affected. This can be achieved through legislative and professional body regulation of conscientious objection.

在南非,妇女安全合法堕胎的权利与保健专业人员的良心自由相冲突。基于良知的良心反对或拒绝治疗可能受到宪法保护,但其道德性尚未得到探讨。本研究使用康德责任论来阐明医护专业人员基于医生誓言的道德责任。研究的结论是,良心在道德上是空洞的,医护人员有责任平等对待所有病人,无论其病情如何。根据康德式的信守承诺,研究还得出结论,医护专业人员应将病人的健康和福祉置于所有其他考虑因素之上。研究利用绝对命令论,表明医护专业人员完全有责任不拒绝治疗。研究建议,除非会影响到医护专业人员的心理健康,否则在任何情况下都应拒绝依良心拒绝治疗。这可以通过立法和专业机构对依良心拒治的监管来实现。
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引用次数: 0
Ethical consumerism, human rights, and Global Health Impact 道德消费主义、人权和全球健康影响。
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2023-07-18 DOI: 10.1111/dewb.12415
Brian Berkey

In this paper, I raise some doubts about Nicole Hassoun's account of the obligations of states, pharmaceutical firms, and consumers with regard to global health, presented in Global Health Impact. I argue that it is not necessarily the case, as Hassoun claims, that if states are just, and therefore satisfy all of their obligations, then consumers will not have strong moral reasons, and perhaps obligations, to make consumption choices that are informed by principles and requirements of justice. This is because there may be justice-based limits on what states can permissibly and feasibly do both to promote access to existing drugs for all of those who need them, and to promote research and development for new drugs that could treat diseases that primarily affect the global poor. One important upshot of my argument is that there can be reasons for organizations like the Global Health Impact Organization to exist, and to do the kind of work that Hassoun argues is potentially valuable in our deeply unjust world, even in much less unjust worlds in which states and firms largely, or even entirely, comply with their obligations.

在本文中,我对《全球健康影响》一书中妮可-哈苏恩关于国家、制药公司和消费者在全球健康方面的义务的论述提出了一些质疑。我认为,不一定像哈松所说的那样,如果国家是公正的,因而履行了所有的义务,那么消费者就不会有强烈的道德理由,也许还有义务,根据公正的原则和要求做出消费选择。这是因为,在促进所有需要药物的人获得现有药物,以及促进新药研发以治疗主要影响全球贫困人口的疾病这两方面,国家所能做的事情可能会受到基于正义的限制。我的论点的一个重要结果是,像全球健康影响组织这样的组织是有理由存在的,并有理由在我们这个极不公正的世界中开展哈松所认为的那种有潜在价值的工作,即使在国家和企业基本甚至完全遵守其义务的不公正程度要低得多的世界中也是如此。
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引用次数: 0
Ethics and professionalism among community health workers in Tamil Nadu, India: A qualitative study 印度泰米尔纳德邦社区卫生工作者的职业道德和专业精神:定性研究。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-07-18 DOI: 10.1111/dewb.12414
Vijayaprasad Gopichandran, Sudharshini Subramaniam, Balasubramanian Palanisamy, Priyadarshini Chidambaram

Community health workers (CHW) are the backbone of the public health system in developing countries. Little is known about the practice of ethics and professionalism in their work. This study was conducted to explore the experiential wisdom of ethics and professionalism among CHWs in Tamil Nadu. We conducted a qualitative study among 125 CHWs in six districts of Tamil Nadu. We found that the CHWs went beyond the call of their duty to do good to the community. Their conceptualization of autonomy ranged from shared to full paternalistic decision making. The CHWs were sensitive to issues of privacy and confidentiality, but the discussion on these topics were limited. They reflected the societal norms of gender, class, and caste hierarchies in their work. They had to work amidst difficult power struggles and had their own innovative strategies to subvert power. In conclusion, there is a need for framing a code of ethics and professionalism for CHWs and training in ethics and professionalism for them to help them effectively deliberate on ethical issues.

社区保健工作者(CHW)是发展中国家公共卫生系统的中坚力量。人们对他们在工作中践行职业道德和专业精神的情况知之甚少。本研究旨在探索泰米尔纳德邦社区保健工作者在职业道德和专业精神方面的经验智慧。我们对泰米尔纳德邦六个地区的 125 名社区保健工作者进行了定性研究。我们发现,社区保健工作者超出了他们的职责范围,为社区做好事。他们对自主权的概念从共同决策到完全家长式决策不等。社区保健工作者对隐私和保密问题很敏感,但对这些问题的讨论很有限。她们在工作中反映了性别、阶级和种姓等级的社会规范。他们不得不在艰难的权力斗争中工作,并有自己的创新策略来颠覆权力。总之,有必要为社区保健工作者制定职业道德和专业精神守则,并对他们进行职业道德和专业精神培训,以帮助他们有效地讨论职业道德问题。
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引用次数: 0
Fighting the COVID-19 pandemic: A socio-cultural insight into Pakistan 抗击 COVID-19 大流行:巴基斯坦的社会文化洞察
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-07-18 DOI: 10.1111/dewb.12413
Sualeha Siddiq Shekhani, Farhat Moazam, Aamir Jafarey

During the COVID-19 pandemic, healthcare professionals around the world were driven by universal values of solidarity and duty to provide care. However, local societal norms and existing healthcare systems influenced interactions among physicians, and with patients and their families. An exploratory qualitative study design using in-depth interviews was undertaken with physicians working at two public sector hospitals in Karachi, Pakistan. Using the constant comparison method of data analysis, several key themes were identified highlighting norms of kinship and interdependencies characteristic of collectivistic societies that influenced professional interactions. The role of seniors in the hierarchical society of Pakistan played a major role in provision of care. Physicians reported numerous challenges in dealing with patients and their families amidst public denial fueled due to ill-formed government policies. This included interruption of funeral rites which undermined public trust. The study provides insights into the local moral world of two healthcare institutions in Pakistan.

在 COVID-19 大流行期间,世界各地的医疗保健专业人员在团结一致、尽职尽责的普世价值观的驱使下开展工作。然而,当地的社会规范和现有的医疗保健系统影响了医生之间以及医生与患者及其家属之间的互动。本研究采用探索性定性研究设计,对巴基斯坦卡拉奇两家公立医院的医生进行了深入访谈。采用不断比较的数据分析方法,确定了几个关键主题,突出了集体主义社会特有的亲缘关系和相互依存关系规范对职业互动的影响。在巴基斯坦这个等级森严的社会中,长者的角色在提供医疗服务方面发挥着重要作用。医生们报告说,由于政府政策不完善,在公众的否认声中,医生在与病人及其家属打交道时面临着许多挑战。这包括破坏公众信任的葬礼仪式的中断。这项研究提供了对巴基斯坦两家医疗机构当地道德世界的深入了解。
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引用次数: 0
Neuroethics and cultural context: The case of electroconvulsive therapy in Argentina 神经伦理学与文化背景:阿根廷的电休克疗法案例。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-07-12 DOI: 10.1111/dewb.12412
Paula Castelli, Salvador M. Guinjoan, Abel Wajnerman-Paz, Arleen Salles

As neuroethics continues to grow as an established discipline, it has been charged with not being sufficiently sensitive to the way in which the identification, conceptualization, and management of the ethical issues raised by neuroscience and its applications are shaped by local systems of knowledge and structures. Recently there have been calls for explicit recognition of the role played by local cultural contexts and for the development of cross-cultural methodologies that can facilitate meaningful cultural engagement. In this article, we attempt to fill this perceived gap by providing a culturally situated analysis of the practice of electroconvulsive therapy (ECT) in Argentina. ECT was introduced as a psychiatric treatment in Argentina in the 1930s but it is largely underutilized. While the use of ECT remains low in several countries, what makes the Argentinian case interesting is that the executive branch of government has taken a stance regarding both the scientific and moral appropriateness of ECT, recommending its prohibition. Here, we begin with a recent controversy over the use of ECT in Argentina and explain the legal recommendation to ban its application. Next, we offer an overview of some of the salient aspect of the international and local discussions on ECT. We argue that the governmental recommendation to ban the procedure should be rethought. While acknowledging the role that contexts and local conditions play in shaping the identification and assessment of the relevant ethical issues, we caution against using contextual and cultural considerations to avoid a necessary ethical debate on controversial issues.

随着神经伦理学作为一门成熟学科的不断发展,人们指责神经伦理学对神经科学 及其应用所引发的伦理问题的识别、概念化和管理方式不够敏感,而这些问题是由当地 的知识体系和结构所决定的。近来,人们呼吁明确承认当地文化背景所发挥的作用,并开发能够促进有意义的文化参与的跨文化方法。在本文中,我们试图通过对阿根廷电休克疗法(ECT)的实践进行文化情景分析来填补这一认知空白。阿根廷于 20 世纪 30 年代引入电休克疗法作为精神病治疗手段,但该疗法在很大程度上未得到充分利用。虽然电休克疗法在一些国家的使用率仍然很低,但阿根廷的情况之所以有趣,是因为政府行政部门对电休克疗法的科学性和道德适当性都采取了立场,建议禁止使用电休克疗法。在此,我们首先介绍阿根廷最近关于使用电痉挛疗法的争议,并解释禁止使用该疗法的法律建议。接下来,我们概述了国际和当地关于电痉挛疗法讨论的一些突出方面。我们认为,政府提出的禁止该程序的建议应当重新考虑。我们承认背景和当地条件在确定和评估相关伦理问题方面所起的作用,但我们告诫不要利用背景和文化因素来避免就有争议的问题进行必要的伦理辩论。
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引用次数: 0
Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity 生物库研究中的伦理、法律和社会影响:应对复杂性的清单。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2023-07-10 DOI: 10.1111/dewb.12411
Olga Tzortzatou-Nanopoulou, Kaya Akyüz, Melanie Goisauf, Łukasz Kozera, Signe Mežinska, Michaela Th. Mayrhofer, Santa Slokenberga, Jane Reichel, Talishiea Croxton, Alexandra Ziaka, Marina Makri

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

生物库活动的基础不仅是确保收集和储存人类生物样本的技术,还包括编制正式文 件,使其能够安全地用于科学研究。在这种情况下,知情同意、偶然发现的报告和转让协议的使用仍然是一个巨大的挑战。本文旨在为合作和跨国生物库研究中的这些问题提供第一手切实可行的解决方案。本文提出了一份四步核对表,旨在帮助研究人员在设计研究、招募参与者、处理样本和数据以及交流研究成果和意外发现时遵守适用的法律和伦理准则。虽然本文反映了 H2020 B3Africa 项目的成果,并以欧盟为案例研究了从欧盟转移和向欧盟转移的情况,但它提出了一份可在欧盟以外使用的全球核对表。
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引用次数: 0
期刊
Developing World Bioethics
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