Informed Consent

知情同意
  • 文章类型: Journal Article
    在美国,临床知情同意的实践受超过100年的判例法管辖。尽管行为分析师的主要伦理资源为提供临床知情同意提供了一些指导,这种指导仍然有限。因此,本文的目的是通过提供相关判例法的历史和当代指南,扩展有关行为分析中临床知情同意的当代文献。本文将重点介绍有关临床知情同意的判例法历史上的开创性时刻,讨论它们在行为分析中对临床知情同意过程的适用性,并加强对治疗背景下与知情同意相关的伦理和法律义务的理解。
    在线版本包含补充材料,可在10.1007/s40617-023-00902-0获得。
    The practice of clinical informed consent in America is governed by over 100 years of case law. Although predominant ethics resources for behavior analysts offer some guidance regarding the provision of clinical informed consent, such guidance remains limited. The goal of this article is thus to expand the contemporary literature on clinical informed consent in behavior analysis by providing a historical and contemporary guide to relevant case law. The article will highlight seminal moments in the history of case law regarding clinical informed consent, discuss their applicability to the process of clinical informed consent in behavior analysis, and provide an enhanced understanding of the ethical and legal obligations related to informed consent in the therapeutic context.
    UNASSIGNED: The online version contains supplementary material available at 10.1007/s40617-023-00902-0.
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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
    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
    行为轻推经常受到批评,因为它们“在黑暗中效果最好”。然而,最近的实验证据表明,当轻推透明地传递时,它们的有效性不会降低。大多数人也赞同透明的推动。然而,透明的轻推可能会破坏人类的自主性-少数人可能会反对被轻推并感到被操纵,即使他们知道发生了什么.我们提出了一种保持自治的替代方法,这种方法不能简化为透明度:可以询问个人是否事先同意被轻推。为了评估自愿推动是否有效,我们要求1518名英国公民同意。随后,我们默认所有参与者捐赠给他们选择的慈善机构,无论自我报告的同意。我们发现,默认微调对同意和不同意的个人都同样有效,平均捐款差异可忽略不计。然而,与同意的人相比,未同意的人报告的怨恨和遗憾程度更高,幸福和支持程度更低。基于这些发现,我们认为,忽视同意会对轻推决策产生严重的道德后果。
    Behavioural nudges are often criticised because they \"work best in the dark\". However, recent experimental evidence suggests that the effectiveness of nudges is not reduced when they are delivered transparently. Most people also endorse transparent nudges. Yet, transparent nudging may undermine human autonomy-a minority may oppose to being nudged and feel manipulated, even if they know what is happening. We propose an alternative way of maintaining autonomy that is not reducible to transparency: individuals can be asked if they consent in advance to being nudged. To assess whether consensual nudges are effective, we ask consent from 1518 UK citizens to be nudged. Subsequently, we default all participants into donating to a charity of their choice, irrespective of self-reported consent. We find that the default nudge is equally effective for both consenting and non-consenting individuals, with negligible difference in average donations. However, non-consenting individuals report higher levels of resentment and regret and lower levels of happiness and support compared to the consenting group. Based on these findings, we argue that ignoring consent can have serious ethical ramifications for policy-making with nudges.
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  • 文章类型: Journal Article
    在紧急情况下,患者及其近亲必须迅速及时地做出复杂的医学和伦理决定。
    描述患者和接受过急诊手术的患者近亲的知情同意期间的决策过程。
    在乌干达的两家三级教学医院进行了39名参与者的连续抽样和深入的半结构化访谈。在24-72小时内接受急诊手术的患者有22例和17例近亲。使用社会建构主义理论和现象学方法将有关决策的反应编码为主题。
    有四个紧急主题;决策者,人们咨询,同意文件和影响决策的因素。大多数患者和近亲自己做出决定,并记录了自己的同意。在决策过程中咨询了其他家庭成员和医生。决策受到手术良好结果的保证和医生披露的影响。
    与中心的患者合作做出决定,但有卫生人员的投入,近亲和其他家庭成员。社区主义方法与医生与患者和近亲之间的共同决策相结合,并以简单的语言进行充分的讨论和信息披露,将改善患者及其近亲的决策。
    UNASSIGNED: In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way.
    UNASSIGNED: To describe the decision-making process during informed consent for emergency surgery among patients and the next of kin of patients who have undergone emergency surgery.
    UNASSIGNED: Consecutive sampling of 39 participants and in-depth semi-structured interviews were conducted at two tertiary teaching hospitals in Uganda. There were 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24-72 h. Responses about decision-making were coded into themes using the social constructivist theory and phenomenological approach.
    UNASSIGNED: There were four emergent themes; decision-makers, people consulted, documentation of the consent and factors influencing decision-making. Most patients and next of kin made decisions on their own and documented the consent for themselves. Other family members and doctors were consulted during the decision-making process. Decision-making was influenced by reassurance of good outcomes of surgery and disclosure by the doctors.
    UNASSIGNED: Decisions were made collaboratively with the patient at the center but with input of health personnel, the next of kin and other family members. A communitarian approach combined with shared decision-making between the doctor and the patient and next of kin with adequate discussion and disclosure of information in simple language would improve decision-making for patients and their next of kin.
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  • 文章类型: Journal Article
    背景:Edentulism仍然是世界范围内的主要残疾,尤其是老年人群,尽管在过去的几十年中,完全无名氏的患病率有所下降。在乌干达,20岁及以上人群的无牙症患病率为1.8%。无牙患者的治疗可以通过使用传统的可移动全口义齿来实现,植入物支持的假体,计算机辅助设计和计算机辅助制造(CADCAM),然而,提供可移动的全口义齿仍然是无牙患者的主要康复方法。然而,没有发表的研究探索乌干达人口中使用可移动全口义齿的生活经历。本研究的目的是探索在Makerere大学牙科医院就诊的乌干达无牙患者中使用可移动全口义齿的生活经验。
    方法:这是一种使用目的抽样的定性研究方法。在社会人口统计学中选择了十五(15)名受访者。记录和转录访谈,并生成主题,以加深对可移动全口义齿的使用的意义。定性统计软件包,AtlasTi软件用于从访谈中生成主题,然后对生成的数据进行解释,结果以文本和表格形式显示。
    结果:报告的由于可摘全口义齿康复的主要积极经验是言语改善,进食能力,恢复良好的面部外观,更好的口腔卫生管理,自尊和自信在公共场合微笑,和完整的感觉。然而,受访者抱怨由于假牙松动引起的疼痛和不适,不能吃某些食物,定期清洁假牙。受访者在获得可移动的完整假牙之前没有经过适当的知情同意程序。
    结论:研究发现,由于注册的积极经验,患者对其可摘全口义齿康复感到满意,比如吃饭和说话的能力,恢复自尊,所有这些都提高了他们的生活质量。然而,由于假牙的松动,他们会感到疼痛和不适。
    BACKGROUND: Edentulism remains a major disability worldwide, especially among the elderly population, although the prevalence of complete edentulism has declined over the last decades. In Uganda, the prevalence of edentulism in people aged 20 years and above is 1.8%. The therapy for edentulous patients can be realized through the use of conventional removable complete dentures, implant-supported prostheses, and computer-aided design and computer-aided manufacturing (CADCAM), however, the provision of removable complete dentures continues to be the predominant rehabilitation for edentulous patients. However, no published study has explored the lived experiences with removable complete dentures among the Ugandan population. The aim of the present study was to explore patients\' lived experiences on the usage of removable complete dentures among Ugandan edentulous patients attending Makerere University Dental Hospital.
    METHODS: This was a qualitative study approach using purposive sampling. Fifteen (15) respondents were selected across social demographics. Interviews were recorded and transcribed and themes were generated to draw a deeper meaning to the usage of removable complete dentures. A qualitative statistical package, Atlas Ti software was used to generate themes from the interviews followed by an interpretation of the generated data and the results were presented as text and in a table.
    RESULTS: The reported key positive experiences due to removable complete denture rehabilitation were the improvement in speech, eating ability, regaining good facial appearance, better oral hygiene management, self-esteem and confidence to smile in public, and a feeling of completeness. However, respondents complained of pain and discomfort due to the looseness of dentures, inability to eat certain foods, and regular cleaning of dentures. The respondents did not go through proper informed consent processes before getting removable complete dentures.
    CONCLUSIONS: The study found that patients were satisfied with their removable complete dentures rehabilitation due to the positive experiences registered, such as the ability to eat and talk well, and restoration of self-esteem, all of which improved their quality of life. However, they experience pain and discomfort due to the looseness of dentures.
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  • 文章类型: Journal Article
    背景:证据表明,试验参与者经常难以理解临床试验的参与者信息传单(PILs),包括随机化的概念。我们分析了用于描述PIL中随机化的语言,并通过公众和参与者的反馈确定了最可理解和可接受的描述。
    方法:我们从爱尔兰和英国的临床研究机构/临床试验单位收集了280份PILs/知情同意书和一份视频动画。我们提取了关于如何描述随机化的文本,加上审判特点。我们进行了内容分析,对随机化短语进行了归纳分组。然后,我们排除了不止一次出现或与其他人非常相似的短语。然后将随机化短语的最终列表呈现给参与者和公众的在线小组。小组成员被要求以5分的李克特量表对每个短语进行评分,以了解他们对该短语的理解,对他们对这句话的理解和可接受性充满信心。
    结果:二百八十个PIL和来自一个视频动画的转录文本代表了229个正在进行或结束的试验。语用内容分析产生了五个归纳类别:(1)解释为什么在试验中需要随机化;(2)随机化的同义词;(3)比较随机化短语;(4)随机化的详细短语(5)和描述随机化过程的短语。我们有48个独特的短语,与73名参与者和公众分享。很好理解的短语不一定是可以接受的。参与者理解,但不喜欢,引用赌博的比较短语,例如掷硬币,像彩票一样,一卷骰子。他们还不喜欢将决策归因于计算机或自动化系统的短语。参与者喜欢简单的语言描述什么是随机化,以及那些不使用比较短语的描述。
    结论:潜在的试验参与者在描述PILs中的随机化时清楚自己的好恶。我们为实践提出了五点建议。
    BACKGROUND: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback.
    METHODS: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase.
    RESULTS: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases.
    CONCLUSIONS: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.
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  • 文章类型: Journal Article
    个人健康数据的广泛利用是现代医学研究的关键成功因素之一。在临床护理期间获得对此类数据使用的同意,然而,承担低和不平等的批准率的风险,以及在科学使用数据时随之而来的方法问题的风险。鉴于这些缺点,以及人们通过共享个人健康数据为医学研究做出贡献的事实证明,知情同意的范式需要重新考虑.《欧洲通用数据保护条例》在允许未经同意使用健康数据的研究方面给予了欧洲成员国相当大的回旋余地。然而,遵循这种方法将需要提供替代信息,以弥补医疗期间缺乏与专家的直接沟通。因此,我们引入了“健康数据素养”的概念,\"定义为查找的能力,理解,并评估有关个人健康数据研究使用的风险和收益的信息,并采取相应行动。具体来说,健康数据素养包括有关数据丰富的医学研究的目标和方法以及数据保护的可能性和局限性的基本知识。尽管开发必要资源的责任主要在于那些直接参与数据丰富的医学研究的人,提高健康数据素养最终应该是每个对此类研究成功感兴趣的人都关心的问题。
    UNASSIGNED: The extensive utilization of personal health data is one of the key success factors of modern medical research. Obtaining consent to the use of such data during clinical care, however, bears the risk of low and unequal approval rates and risk of consequent methodological problems in the scientific use of the data. In view of these shortcomings, and of the proven willingness of people to contribute to medical research by sharing personal health data, the paradigm of informed consent needs to be reconsidered. The European General Data Protection Regulation gives the European member states considerable leeway with regard to permitting the research use of health data without consent. Following this approach would however require alternative offers of information that compensate for the lack of direct communication with experts during medical care. We therefore introduce the concept of \"health data literacy,\" defined as the capacity to find, understand, and evaluate information about the risks and benefits of the research use of personal health data and to act accordingly. Specifically, health data literacy includes basic knowledge about the goals and methods of data-rich medical research and about the possibilities and limits of data protection. Although the responsibility for developing the necessary resources lies primarily with those directly involved in data-rich medical research, improving health data literacy should ultimately be of concern to everyone interested in the success of this type of research.
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  • 文章类型: Journal Article
    人工智能(AI)是一门与计算机科学交叉的多学科领域,认知科学,和其他学科,能够解决创建执行通常需要人类智能的任务的系统。它由算法和计算方法组成,允许机器从数据中学习,做决定,执行复杂的任务,旨在开发一个可以独立工作或与人类协作的智能系统。由于人工智能技术可以帮助医生预防和诊断危及生命的疾病,并使治疗更智能,更有针对性,它们正在卫生服务中传播。的确,人类和机器具有独特的优势和劣势,可以在提供和优化医疗保健方面相互补充。然而,这些技术的医疗保健实施与新兴的伦理和道义问题有关,这些问题可怕地减少了医生的决策自主权和行动自由裁量权,通常受到有关特定临床病例的认知因素的强烈制约。此外,这一新的操作维度还修改了通常的责任分配制度,以防因医疗渎职而发生不良事件,因此,可能会对已建立的医疗专业责任的医学法律评估标准进行重新定义。本文概述了AI医疗保健集成带来的新挑战以及克服这些挑战的可能方法,专注于意大利的法律框架。在这种不断发展和过渡的背景下,需要平衡人的维度与人造的维度,没有相互排斥,对于医学的新概念“用”机器而不是“用”机器。
    Artificial intelligence (AI) is a multidisciplinary field intersecting computer science, cognitive science, and other disciplines, able to address the creation of systems that perform tasks generally requiring human intelligence. It consists of algorithms and computational methods that allow machines to learn from data, make decisions, and perform complex tasks, aiming to develop an intelligent system that can work independently or collaboratively with humans. Since AI technologies may help physicians in life-threatening disease prevention and diagnosis and make treatment smart and more targeted, they are spreading in health services. Indeed, humans and machines have unique strengths and weaknesses and can complement each other in providing and optimizing healthcare. However, the healthcare implementation of these technologies is related to emerging ethical and deontological issues regarding the fearsome reduction of doctors\' decision-making autonomy and acting discretion, generally strongly conditioned by cognitive elements concerning the specific clinical case. Moreover, this new operational dimension also modifies the usual allocation system of responsibilities in case of adverse events due to healthcare malpractice, thus probably imposing a redefinition of the established medico-legal assessment criteria of medical professional liability. This article outlines the new challenges arising from AI healthcare integration and the possible ways to overcome them, with a focus on Italian legal framework. In this evolving and transitional context emerges the need to balance the human dimension with the artificial one, without mutual exclusion, for a new concept of medicine \"with\" machines and not \"of\" machines.
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  • 文章类型: Journal Article
    为了诊断和研究目的,在神经肿瘤学中越来越多地使用全基因组测序(WGS),需要重新讨论知情同意程序和管理结构以共享个人健康数据。目前对于如何在该人群中获得WGS的知情同意尚无共识。在这篇叙述性评论中,我们分析了文献中建议的WGS肿瘤学框架的格式和内容,并评估了它们的益处和局限性.我们讨论适用性,具体挑战,以及(复发性)胶质母细胞瘤患者的法律背景。这个人群的特点是罕见的疾病,预后极其有限,以及疾病阶段与认知能力的相关性。由于这对WGS的知情同意程序有影响,我们建议,知情同意书的内容应为(复发性)胶质母细胞瘤患者量身定制.
    Increased use of whole genome sequencing (WGS) in neuro-oncology for diagnostics and research purposes necessitates a renewed conversation about informed consent procedures and governance structures for sharing personal health data. There is currently no consensus on how to obtain informed consent for WGS in this population. In this narrative review, we analyze the formats and contents of frameworks suggested in literature for WGS in oncology and assess their benefits and limitations. We discuss applicability, specific challenges, and legal context for patients with (recurrent) glioblastoma. This population is characterized by the rarity of the disease, extremely limited prognosis, and the correlation of the stage of the disease with cognitive abilities. Since this has implications for the informed consent procedure for WGS, we suggest that the content of informed consent should be tailor-made for (recurrent) glioblastoma patients.
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