Informed Consent

知情同意
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    不孕不育仍然是一个全球性的挑战,随着辅助生殖技术(ART)在发展中国家的重要性逐渐提高,包括加纳。然而,相关的伦理法律挑战没有得到必要的政策关注。本研究探讨了加纳ART实践的法律和道德挑战。
    该研究采用了探索性现象学方法来检查加纳的ART,专注于规范这种做法的道德和法律。
    受访者是ART从业者,经理,设施所有者,代孕/配子捐助机构的代表,和监管机构代表。
    使用了半结构化的访谈指南来收集数据。深度采访被录音了,通过编码转录分析的响应,其次是主题和子主题的产生,支持直接报价。
    加纳没有艺术实践的道德和法律框架,这对艺术实践产生了不利影响。道德挑战确定了知情同意的边界,客户隐私和临床数据保护,gamete捐赠问题,多个妊娠,单身父母,社会和宗教问题。确定的法律挑战包括不存在规范ART实践的法律制度,以及缺乏具有明确的ART实践准则的专业机构。在加纳缺乏法律和道德框架的情况下,医生暗示他们在医疗实践中遵守国际公认的原则和一般道德。
    加纳没有关于ART的规定。法律和道德准则对于提供安全和成功的ART实践以保护提供者和用户至关重要。政府监管加纳的努力需要优先考虑。
    这项研究没有外部资金支持。它是由研究人员的捐款私人资助的。
    UNASSIGNED: Infertility remains a global challenge, with assisted reproductive technology (ART) progressively gaining relevance in developing countries, including Ghana. However, associated ethico-legal challenges have not received the needed policy attention. This study explored the legal and ethical challenges of ART practice in Ghana.
    UNASSIGNED: The study employed an exploratory phenomenological approach to examine ART in Ghana, focusing on ethics and law governing this practice.
    UNASSIGNED: Respondents were ART practitioners, managers, facility owners, representatives of surrogacy/gamete donor agencies, and regulatory body representatives.
    UNASSIGNED: A semi-structured interview guide was used to collect data.The in-depth interviews were audiotaped, and responses transcribed for analysis through coding, followed by generation of themes and sub-themes, supported with direct quotes.
    UNASSIGNED: It emerged that there are no ethical and legal frameworks for ART practice in Ghana, and this adversely affects ART practice. Ethical challenges identified border on informed consent, clients\' privacy and clinical data protection, gamete donation issues, multiple gestations, single parenting, and social and religious issues. The legal challenges identified include the non-existence of a legal regime for regulating ART practice and the absence of a professional body with clear-cut guidelines on ART practice. In the absence of legal and ethical frameworks in Ghana, practitioners intimated they do comply with internationally accepted principles and general ethics in medical practice.
    UNASSIGNED: There are no regulations on ART in Ghana. Legal and ethical guidelines are essential to the provision of safe and successful ART practices to protect providers and users. Governmental efforts to regulate Ghana need to be prioritized.
    UNASSIGNED: This study had no external funding support. It was funded privately from researchers\' contributions.
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  • 文章类型: Journal Article
    患者需要获得相关信息才能给予知情同意,这可能需要披露临时诊断。然而,如果患者知道此信息存在但选择不要求,则没有义务向患者提供信息。放射诊断技师和医疗保健科学家通常负责确保患者对他们进行的调查给予知情同意,但这是其他临床医生要求的。在这里,我们检查他们是否有义务披露由转诊临床医生做出的患者的临时诊断,如果患者要求将此信息作为诊断调查的知情同意过程的一部分。我们首先考虑英国法律的各个方面,专业指导和突出的道德原则,强调,虽然专业实践守则强调需要为患者的最大利益行事,他们不需要向患者提供他们不需要或没有要求的检查信息。然后,我们建议处于这种位置的放射诊断技师和医疗保健科学家使用“最低限度的必要披露”框架。该框架履行了他们对患者的承诺和真实性原则,同时尊重他们专业职责的界限。该框架确保向患者提供足够的细节,以便他们能够给予知情同意,在承担诊断专业人员全面披露的同时,这是转诊临床医生的职责。
    Patients need to be given the relevant information to be able to give informed consent, which might require the disclosure of a provisional diagnosis. Yet, there is no duty to give information to a patient if that patient is aware that this information exists but chooses not to request it. Diagnostic radiographers and healthcare scientists are often responsible for ensuring that patients have given informed consent for the investigations they undertake, but which were requested by other clinicians. Here we examine if they have a duty to disclose a patient\'s provisional diagnosis made by a referring clinician if the patient asks for this information as part of the informed consent process to a diagnostic investigation. We first consider aspects of UK law, professional guidance and salient ethical principles, emphasising that while professional codes of practice highlight the need to act in the patient\'s best interest, they do not require giving patients information they do not require for the examination or have not requested. We then propose that diagnostic radiographers and healthcare scientists placed in such a position use a \'minimally necessary disclosure\' framework. This framework fulfils their commitment to their patient and the principle of veracity, while respecting the boundaries of their professional duties. The framework ensures that enough detail is given to the patient for them to be able to give informed consent, while shouldering the diagnostic professional from making a full disclosure, which is the duty of the referring clinician.
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  • 文章类型: Journal Article
    理查德·格里菲斯,斯旺西大学卫生法高级讲师,讨论了同意在护理中的重要性,并概述了确保患者在提供治疗前给予有效同意的关键要素。
    Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment.
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    文章类型: Journal Article
    在过去的十年里,因可能的性别烦躁不安而转诊到性别诊所的儿童和青少年数量大幅增加.性别确认护理模式,在加拿大占主导地位的治疗方法,是基于低质量的证据。其他国家正在意识到这一点,并将社会心理治疗和/或探索性心理治疗作为年轻患者性别相关痛苦的一线治疗方法。心理动力学(探索性)心理治疗已经确立了对一系列疾病的疗效,并已用于患有性别烦躁不安的年轻人和成年人。在加拿大,一些学者认为,采用心理动力学心理疗法治疗性别焦虑受到阻碍,他们认为这可能违反了反对转化疗法的法律。心理动力心理治疗不是转化疗法,应在加拿大作为性别烦躁不安的治疗方式提供。
    Over the last ten years, there has been a substantial increase in the number of children and adolescents referred to gender clinics for possible gender dysphoria. The gender affirming model of care, a dominant treatment approach in Canada, is based on low quality evidence. Other countries are realizing this and making psychosocial treatments and/or exploratory psychotherapy a first line of treatment for gender related distress in young patients. Psychodynamic (exploratory) psychotherapy has established efficacy for a range of conditions, and has been used in youth and adults with gender dysphoria. In Canada, the adoption of psychodynamic psychotherapy for gender dysphoria is impeded by some academics who argue that it may violate laws against conversion therapy. Psychodynamic psychotherapy is not conversion therapy and should be made available in Canada as a treatment modality for gender dysphoria.
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  • 文章类型: Journal Article
    背景:缺乏调查COVID-19住院治疗方法在语言偏好方面的差异的研究。这项研究的主要目的是评估使用英语(LOE)以外的语言的患者与说英语的患者相比,使用新型COVID-19疗法治疗的可能性是否不同。
    方法:这是一项回顾性观察性队列研究,研究对象是2020年3月1日至2022年6月30日期间住院的COVID-19患者,在一个单一的非营利性卫生系统内的11家医院中。评估了首选语言对接受新型COVID-19治疗的影响的多变量相对风险:baricitinib,remdesivir,托珠单抗,和恢复期血浆。
    结果:这项研究包括12,510名住院的成年人,英语是最常见的首选语言(92.3%),其次是西班牙语(3.1%)。索马里(1.3%),俄罗斯(0.9%),和苗族(0.6%)。与说英语的人相比,说西班牙语的人更有可能接受任何新型COVID-19疗法(RR1.45;CI1.32-1.59)。苗族的估计,索马里,俄语,和其他语言组没有统计学意义,更接近于null(aRR范围,0.89-1.12)。
    结论:健康结局中的语言模式暴露了种族和族裔群体固有的异质性。我们的研究发现,与说英语的人相比,说西班牙语的人接受四种新型住院COVID-19疗法中任何一种的可能性高出近1.5倍。未来的研究需要探索异质性发现的原因,包括时间影响,文化因素,知情同意理解,和治疗上的犹豫。
    BACKGROUND: There is a paucity of research investigating disparities in utilization of inpatient therapeutics for COVID-19 by language preference. The primary aim of this study was to assess if the likelihood of treatment with novel COVID-19 therapies differed for patients using a language other than English (LOE) relative to English-speaking patients.
    METHODS: This was a retrospective observational cohort study of COVID-19 patients hospitalized between March 1, 2020, and June 30, 2022, across 11 hospitals within a single not-for-profit health system. Multivariable relative risks were estimated for the impact of preferred language on the receipt of novel COVID-19 therapies: baricitinib, remdesivir, tocilizumab, and convalescent plasma.
    RESULTS: This study included 12,510 hospitalized adults with English as the most common preferred language (92.3%) followed by Spanish (3.1%), Somali (1.3%), Russian (0.9%), and Hmong (0.6%). Spanish speakers were more likely to receive any of the novel COVID-19 therapies compared to English speakers (RR 1.45; CI 1.32-1.59). Estimates for Hmong, Somali, Russian, and Other language groups were not statistically significant and closer to the null (aRR range, 0.89-1.12).
    CONCLUSIONS: Linguistic patterns in health outcomes expose inherent heterogeneity within racial and ethnic groups. Our study found that Spanish speakers were nearly 1.5 times more likely to receive any of the four novel inpatient COVID-19 therapeutics in comparison to English speakers. Future research is needed to explore the reasons for the heterogeneous findings including temporal influence, cultural factors, informed consent comprehension, and therapeutic hesitancy in all groups.
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  • 文章类型: Journal Article
    背景:尽管白内障手术是一种安全的手术,围手术期并发症发生率低,知识贫乏,对治疗有效性和手术成本效益分析的担忧显著阻碍了非洲白内障手术的吸收率。这项研究描述了决策辅助对非洲白内障患者知识和决策冲突的影响。
    方法:120名在加纳一家三级医院报告的白内障患者被随机分配接受包含白内障手术可能结果信息的决策援助,或包含白内障一般知识但不包含白内障手术信息的对照手册。测量的主要结果是决策辅助对他们白内障手术知识的影响。分数大于6/12(50%)被认为是足够的知识。次要结果是使用决策冲突量表评估的参与者所经历的决策冲突。
    结果:与对照组相比,干预组参与者在问卷的所有部分中得分较高(“背景”部分为2.92vs2.7,p=0.042;“材料”部分为2.62vs1.77,p<0.001;“结果”部分为1.87vs1.55,p=0.03)。干预组的平均总分高于对照组(36.7%,p<0.001)。干预组参与者的决策冲突得分也低于对照组(13.00vs37.17;p<0.001)。
    结论:决策帮助增加了对白内障手术的了解,并减少了发展中国家患者之间的决策冲突。
    BACKGROUND: Despite cataract surgery being a safe procedure with a low incidence of perioperative complications rates, poor knowledge, concerns about the effectiveness of treatment and cost-benefit analysis of the procedure significantly hinder cataract surgery uptake rates in Africa. This study describes the effect of a decision aid on knowledge and decision conflict on cataract patients in Africa.
    METHODS: 120 patients with cataracts reporting to a tertiary hospital in Ghana were randomly assigned to receive a decision aid containing information on the possible outcomes of cataract surgery or a control booklet containing general knowledge about cataracts without information about cataract surgery. The primary outcome measured was the effect of the decision aid on their knowledge of cataract surgery. A score greater than 6/12 (50%) was deemed adequate knowledge. The secondary outcome was the decision conflict experienced by the participants assessed using the Decision Conflict Scale.
    RESULTS: Compared to the control group, the participants in the intervention group scored higher marks across all sections of the questionnaire (2.92 vs 2.7, p = 0.042 in section \"Background\"; 2.62 vs 1.77, p < 0.001 in section \"Materials\"; 1.87 vs 1.55, p = 0.03 in section \"Results\"). The average total score was higher in the intervention group than in the control (36.7% difference; p < 0.001). Participants in the intervention group also demonstrated lower decision conflict scores than those in the control group (13.00 vs 37.17; p < 0.001).
    CONCLUSIONS: The decision aid increased knowledge of cataract surgery and reduced decision conflict among patients in a developing country.
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  • 文章类型: Journal Article
    本文考察了研究设计的伦理和研究的启动(例如,招募参与者)涉及难民参与者。我们的目标是为研究人员和IRB成员提供一套道德考虑和务实的建议,以解决以难民为中心的研究中的挑战,因为它是为IRB审查而开发和准备的。我们讨论了挑战,包括如何定义和识别难民;他们之前的脆弱性,during,以及影响其研究参与的重新安置;招募;同意做法,包括同意和无人陪伴的未成年人;和利益冲突。国际机构提供的道德指导和监管监督,联邦政府,和IRB对于加强对参与者的保护很重要。我们描述了需要额外的道德指导和意识,如果不是由美国国立卫生研究院(NIH)伦理研究指导原则指导的对难民人口的特殊保护。
    This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.
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  • 文章类型: Letter
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  • 文章类型: English Abstract
    Sexual violence constitutes a form of gender-based violence, to the extent that the victims are mainly women. Other groups of vulnerable people are also more affected, in particular gender and sexual diversity persons. Sexual and gender-based violence can also occur in healthcare. To respect the legal framework and people\'s rights, but also to promote safety and quality in healthcare, it is essential to obtain and respect consent. Consent must be informed, explicit, freely given, and reiterated throughout the consultation. This article reviews the concept of consent and offers practical tools for its application in healthcare.
    Les violences sexuelles constituent une violence de genre, dans la mesure où les victimes sont principalement des femmes et les auteurs des hommes. D’autres groupes de personnes vulnérables sont également davantage concernés, en particulier les personnes de la diversité sexuelle et de genre. Ces violences sexuelles et de genre existent également dans les soins. Afin de respecter le cadre légal et les droits des personnes, mais aussi de favoriser des soins de qualité et en sécurité, il est primordial de recueillir et respecter le consentement. Celui-ci doit être éclairé, explicite, libre et réitéré tout au long de la consultation. Cet article fait le point sur le concept du consentement et offre des outils pratiques pour son application dans les soins.
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