Ethical considerations

伦理考虑
  • 文章类型: Journal Article
    背景:癌症治疗和生存的进步依赖于参与研究和获取健康记录。
    方法:本研究在42个社区成员的14个研讨会上探讨了数据访问和共享的偏好,其中大多数是癌症幸存者或照顾者。介绍和讨论了数据访问和共享的各种场景,使用描述性统计数据汇总参与者的偏好。通过对讲习班笔录的专题分析,确定了这些偏好的原因。
    结果:大多数参与者表示,研究人员愿意将他们的自我报告数据和当前的健康记录用于特定的研究项目(86%)。许多人还愿意将他们的自我报告数据和当前(62%)或所有未来(44%)的健康记录与其他研究人员共享,以便在意识到这一点的情况下用于其他研究。同意在癌症研究中访问和共享数据的意愿受到以下因素的影响:(i)数据共享促进医学发现并使未来受癌症影响的人们受益的潜力,(Ii)围绕研究人员的可信度及其数据共享意图的透明度,(iii)对数据共享的所有权和控制水平,和(iv)数据共享中的隐私和保密协议。
    结论:基于这些主题,我们提出了在癌症研究中优化数据访问和共享的实用策略.
    BACKGROUND: Advancements in cancer treatment and survivorship rely on participation in research and access to health records.
    METHODS: This study explored preferences for data access and sharing in 14 workshops with 42 community members, most of whom were a cancer survivor or carer. Various scenarios for data access and sharing were presented and discussed, with participants\' preferences summarized using descriptive statistics. Reasons underlying these preferences were identified through a thematic analysis of workshop transcripts.
    RESULTS: Most participants indicated a willingness for researchers to use their self-report data and current health records for a specific research project (86%). Many were also willing for their self-report data and current (62%) or all future (44%) health records to be shared with other researchers for use in other studies if made aware of this. Willingness to consent to data access and sharing data in cancer research was influenced by: (i) the potential for data sharing to advance medical discoveries and benefit people impacted by cancer in the future, (ii) transparency around researchers\' credibility and their intentions for data sharing, (iii) level of ownership and control over data sharing, and (iv) protocols for privacy and confidentiality in data sharing.
    CONCLUSIONS: Based on these themes, we present practical strategies for optimizing data access and sharing in cancer research.
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  • 文章类型: Journal Article
    一个目标,使用医疗设备进行的生理测量可以通过在视觉迹象出现之前早期检测到问题迹象来降低压疮的发生率。该领域的研究受到临床实践和患者水平混杂因素的影响。
    作者概述了设计一项研究方案的关键考虑因素,以评估预后医疗设备在降低医院压疮发生率方面的有效性和安全性。包括比较器,随机化,样本量,道德和实际问题。
    与方法和道德相关的关键问题与理论协议一起考虑,这可以支持未来的研究人员进行伤口护理试验。
    预期,三臂,多中心,提出了分层整群随机对照试验。建议使用第三臂,因为预计需要移动患者以使用医疗设备,并且重新定位是一种预防策略。至少需要招募33个病房的16200名患者才能达到统计学意义。需要考虑同意或同意方面的道德考虑。
    旨在评估诊断或预后医疗设备在降低二级保健中的压疮发生率方面的有效性的假设研究,在考虑偏见的同时,将需要大样本量,并涉及运营商间和设备间可靠性的风险,用户的异质性和设备结果的模糊临床解释。该领域的强大研究有可能影响或改变与预防二级保健中的压疮有关的政策和实践。
    UNASSIGNED: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders.
    UNASSIGNED: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues.
    UNASSIGNED: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials.
    UNASSIGNED: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered.
    UNASSIGNED: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.
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  • 文章类型: Journal Article
    背景:利用人工智能(AI)和机器学习(ML)的创新工具正在迅速开发用于医学,随着预测中出现的新应用,诊断,以及一系列疾病的治疗,患者群体,和临床程序。成功创新的一个障碍是当前文献中缺乏寻求和分析AI或ML研究人员和医生的观点以支持伦理指导的研究。
    目的:本研究旨在描述,使用定性的方法,AI或ML研究人员和专业接触AI或ML工具的医生在AI和ML在医学中的开发和使用中观察或预期的道德问题景观。
    方法:使用半结构化访谈来促进深入,开放式讨论,并使用有目的的抽样技术来识别和招募参与者。我们对AI和ML研究人员(n=10)和医生(n=11)的有目的样本进行了21次半结构化访谈。我们询问了受访者对与在医学中采用AI和ML有关的道德考虑的看法。我们的研究小组成员对访谈进行了转录和鉴定。数据分析遵循定性内容分析的原则。这种方法,其中转录的数据被分解为描述性单位,这些单位根据其内容进行命名和排序,允许直接从数据集中归纳出现代码。
    结果:值得注意的是,研究人员和医生都表达了对人工智能和机器学习创新在早期发展中如何形成的担忧(即,问题制定阶段)。考虑因素包括评估研究重点和动机,临床需求的清晰度和中心性,研究团队的专业和人口多样性,以及跨学科的知识生成和协作。受访者确定的第一阶段伦理问题在本质上是跨学科的,并邀请了关于如何调整跨学科的优先事项和价值观,并在整个医学AI和ML的开发和实施过程中确保临床价值的问题。相关地,受访者建议跨学科解决这些问题,例如,更多资源来支持开发人员和医生之间的知识生成和协作,与更广泛的利益相关者接触,并努力在广泛的研究和个人团队内部增加研究的多样性。
    结论:这些定性发现有助于阐明AI和ML在医疗保健方面预期或遇到的一些伦理挑战。我们的研究是独一无二的,因为它使用开放式问题允许受访者探索他们的情绪和观点,而不会过度依赖关于AI和ML目前是什么或不是什么的隐含假设。这个分析,然而,不包括其他相关利益相关者团体的观点,如患者,伦理学家,行业研究人员或代表,或医生以外的其他医疗保健专业人员。需要额外的定性和定量研究来重现和建立这些发现。
    BACKGROUND: Innovative tools leveraging artificial intelligence (AI) and machine learning (ML) are rapidly being developed for medicine, with new applications emerging in prediction, diagnosis, and treatment across a range of illnesses, patient populations, and clinical procedures. One barrier for successful innovation is the scarcity of research in the current literature seeking and analyzing the views of AI or ML researchers and physicians to support ethical guidance.
    OBJECTIVE: This study aims to describe, using a qualitative approach, the landscape of ethical issues that AI or ML researchers and physicians with professional exposure to AI or ML tools observe or anticipate in the development and use of AI and ML in medicine.
    METHODS: Semistructured interviews were used to facilitate in-depth, open-ended discussion, and a purposeful sampling technique was used to identify and recruit participants. We conducted 21 semistructured interviews with a purposeful sample of AI and ML researchers (n=10) and physicians (n=11). We asked interviewees about their views regarding ethical considerations related to the adoption of AI and ML in medicine. Interviews were transcribed and deidentified by members of our research team. Data analysis was guided by the principles of qualitative content analysis. This approach, in which transcribed data is broken down into descriptive units that are named and sorted based on their content, allows for the inductive emergence of codes directly from the data set.
    RESULTS: Notably, both researchers and physicians articulated concerns regarding how AI and ML innovations are shaped in their early development (ie, the problem formulation stage). Considerations encompassed the assessment of research priorities and motivations, clarity and centeredness of clinical needs, professional and demographic diversity of research teams, and interdisciplinary knowledge generation and collaboration. Phase-1 ethical issues identified by interviewees were notably interdisciplinary in nature and invited questions regarding how to align priorities and values across disciplines and ensure clinical value throughout the development and implementation of medical AI and ML. Relatedly, interviewees suggested interdisciplinary solutions to these issues, for example, more resources to support knowledge generation and collaboration between developers and physicians, engagement with a broader range of stakeholders, and efforts to increase diversity in research broadly and within individual teams.
    CONCLUSIONS: These qualitative findings help elucidate several ethical challenges anticipated or encountered in AI and ML for health care. Our study is unique in that its use of open-ended questions allowed interviewees to explore their sentiments and perspectives without overreliance on implicit assumptions about what AI and ML currently are or are not. This analysis, however, does not include the perspectives of other relevant stakeholder groups, such as patients, ethicists, industry researchers or representatives, or other health care professionals beyond physicians. Additional qualitative and quantitative research is needed to reproduce and build on these findings.
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  • 文章类型: Journal Article
    背景:将人工智能(AI)集成到医疗保健中引起了重大的伦理问题。在药学实践中,人工智能提供了有希望的进步,但也带来了道德挑战。
    方法:在中东和北非(MENA)地区的国家对501名药学专业人员进行了横断面研究。一份12项在线问卷评估了与在药学实践中采用人工智能相关的道德问题。通过SPSSv.27软件使用适当的统计检验分析了与道德问题相关的人口统计学因素。
    结果:参与者对患者数据隐私表示担忧(58.9%),网络安全威胁(58.9%)潜在的工作位移(62.9%),缺乏法律法规(67.0%)。技术知识和基本AI理解与更高的关注分数相关(p<0.001)。伦理影响包括知情同意的必要性,仁慈,正义,和使用AI的透明度。
    结论:研究结果强调了道德准则的重要性,教育,以及患者在采用人工智能方面的自主权。协作,数据隐私,公平的获取对于在药学实践中负责任地使用人工智能至关重要。
    BACKGROUND: Integrating artificial intelligence (AI) into healthcare has raised significant ethical concerns. In pharmacy practice, AI offers promising advances but also poses ethical challenges.
    METHODS: A cross-sectional study was conducted in countries from the Middle East and North Africa (MENA) region on 501 pharmacy professionals. A 12-item online questionnaire assessed ethical concerns related to the adoption of AI in pharmacy practice. Demographic factors associated with ethical concerns were analyzed via SPSS v.27 software using appropriate statistical tests.
    RESULTS: Participants expressed concerns about patient data privacy (58.9%), cybersecurity threats (58.9%), potential job displacement (62.9%), and lack of legal regulation (67.0%). Tech-savviness and basic AI understanding were correlated with higher concern scores (p < 0.001). Ethical implications include the need for informed consent, beneficence, justice, and transparency in the use of AI.
    CONCLUSIONS: The findings emphasize the importance of ethical guidelines, education, and patient autonomy in adopting AI. Collaboration, data privacy, and equitable access are crucial to the responsible use of AI in pharmacy practice.
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  • 文章类型: Journal Article
    本研究探讨了正畸医生对正畸治疗相关风险的看法,正如希腊和斯洛伐克的正畸医生所描述的。在健康科学中有效沟通风险观点的基础重要性,特别是在促进有效同意和共同决策方面,这项研究解决了文献中发现的差距,这些差距涉及基于人口统计学和文化特征的潜在治疗风险的持续沟通。这项研究确定了正畸治疗期间的15个潜在的关键风险。这些风险包括牙根吸收;咬合的暂时性不良变化;睡眠困难;没有获得理想的结果;牙齿之间黑色三角形的发展;拍摄额外的X射线;言语困难;在运动期间使用保护性夹板;治疗持续时间;访问次数;传染病的传播;和吞咽正畸矫治器。一份问卷,从2022年9月至2022年12月,以电子方式分发给希腊(N1=570)和斯洛伐克(N2=210)的正畸医生,旨在评估风险沟通做法,考虑到社会人口因素,如国家,性别,年龄,和学位相关的变化。共获得168份有效问卷(91份来自斯洛伐克,77份来自希腊),表明在强调和首选同意形式的风险方面存在显著差异。希腊正畸医生更关注所涉及的风险,如复发,根吸收,时间咬合变化,以及所需运动的失败,虽然斯洛伐克的从业者倾向于对睡眠困难更感兴趣,时间咬合变化,并没有取得理想的结果。与希腊团队相比,他们还更频繁地从患者或其父母/监护人那里获得书面或数字同意。男性正畸医生更频繁地讨论特定的风险,包括复发和摘除,而女性更喜欢书面或数字同意。博士培训的正畸医生优先考虑某些风险,表明需要量身定制的方法。这项研究强调了正畸实践中风险评估的动态性,强调其道德和战略层面。调查结果倡导量身定制的风险沟通策略,以识别个人,上下文,和文化因素,并且需要一个正畸知情同意协议,为患者提供量身定制的沟通方法,以提高欧洲正畸的护理标准。对数字工具的依赖反映了增强患者理解的当代趋势,从而支持正畸实践的持续创新。
    This study explores orthodontists\' perspectives on risks associated with orthodontic treatment, as described by Greek and Slovak orthodontists. Informed by the foundational importance of effective communication of risk perspectives in health sciences, particularly in facilitating valid consent and shared decision-making, this research addresses gaps identified in the literature concerning the consistent communication of potential treatment risks based on demographic and cultural characteristics. This study identifies 15 potential critical risks during orthodontic treatment. These risks include root resorption; temporary undesired changes to the occlusion; sleep difficulties; not achieving an ideal result; development of black triangles between teeth; taking additional X-rays; speech difficulties; using a protective splint during sports; duration of treatment; number of visits; transmission of infectious diseases; and swallowing orthodontic appliances. A questionnaire, distributed electronically to orthodontists in Greece (N1 = 570) and Slovakia (N2 = 210) from September 2022 to December 2022, aimed to assess risk communication practices, taking into consideration socio-demographic factors, such as country, gender, age, and academic-degree-related variations. A total of 168 valid questionnaires (91 from Slovakia and 77 from Greece) were obtained, indicating significant disparities in the risks emphasized and preferred forms of consent. The Greek orthodontists focused more on the risks involved, such as relapse, root resorption, temporal occlusal changes, and failure of desired movement, while the Slovak practitioners tended to be more interested in sleeping difficulties, temporal occlusal changes, and not achieving an ideal result. They also obtained written or digital consent from patients or their parents/guardians more frequently than the Greek team. Male orthodontists discussed specific risks more frequently, including relapse and extractions, whereas females preferred written or digital consent. PhD-trained orthodontists prioritized certain risks, indicating the need for tailored approaches. This study underscores the dynamic nature of risk assessment in orthodontic practice, emphasizing its ethical and strategic dimensions. The findings advocate for tailored risk communication strategies that recognize individual, contextual, and cultural factors, and the need for an orthodontic informed consent protocol for a tailored communication approach for patients to elevate the standard of care in European orthodontics. The reliance on digital tools reflects contemporary trends in enhancing patient understanding, thereby supporting ongoing innovation in orthodontic practices.
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  • 文章类型: Journal Article
    人们对一般成年人采用数字技术来支持健康的生活方式知之甚少,特别是当他们被期望承担更大的个人责任来管理他们的健康和福祉的今天。当前的定性研究旨在深入了解新加坡社区成年人采用数字技术以促进健康生活方式的决定因素。
    定性研究设计,用主题框架分析从数据中开发主题。
    通过视频会议平台与参与者进行了面对面或在线的半结构化个人访谈。
    年龄在22至71岁之间的普通人群中有14名女性和16名男性。
    开发了三个主要主题:(1)数字剥夺(2)安全和感知的风险和伤害;(3)文化价值观和驱动力。普通民众对技术的采用是需求驱动的,视个人而定,技术和其他跨文化背景因素。
    我们的发现强调,没有一种解决方案适合所有个人,强调迎合不同群体的挑战,以减少采用数字技术促进健康生活方式的障碍。数字指导和培训,以及社会影响,可以激励人们采用技术。然而,技术问题以及数据安全和隐私问题应该首先得到充分解决。这项研究提供了丰富的跨文化见解,并为政策制定提供了信息,因为它与政府的公共卫生举措保持一致,以促进健康的生活方式。
    Little is known about the general adult population\'s adoption of digital technology to support healthy lifestyle, especially when they are expected to take greater personal responsibility for managing their health and well-being today. The current qualitative study intended to gain an in-depth understanding of determinants of digital technology adoption for healthy lifestyle among community-dwelling adults in Singapore.
    A qualitative study design, with thematic framework analysis was applied to develop themes from the data.
    Semi-structured individual interviews were conducted with participants either face-to-face or online through a videoconferencing platform.
    14 women and 16 men from the general population who were between the ages of 22 and 71 years.
    Three major themes were developed: (1) digitally disempowered (2) safety and perceived risks and harm; (3) cultural values and drives. Adoption of technology among the general population is needs-driven, and contingent on individual, technological and other cross-cultural contextual factors.
    Our findings highlight there is no one solution which fits all individuals, emphasizing the challenges of catering to diverse groups to reduce barriers to adoption of digital technologies for healthy lifestyle. Digital guidance and training, as well as social influences, can motivate technological adoption in the population. However, technical problems as well as data security and privacy concerns should first be adequately addressed. This study provides rich cross-cultural insights and informs policy-making due to its alignment with government public health initiatives to promote healthy lifestyle.
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  • 文章类型: Journal Article
    遗传学和基因组学研究结果的回归一直是全球争论的主题。这样的反馈在伦理上是可取的,以更新参与者的研究结果,特别是那些被认为具有临床意义的研究结果。虽然文献有限,关于返回遗传学和基因组学研究结果的适当实践,在非洲仍在继续辩论。本研究探讨了乌干达基因组学研究人员关于遗传学和基因组学研究结果回归的观点和伦理考虑。
    这是一项采用深度访谈的定性研究。根据乌干达基因组学研究人员的专业知识,有目的地选择了30名参与者。使用全面的主题矩阵,通过沿着研究主题的内容分析来分析数据,找出由叙述产生的共同模式。使用NVivo软件12来支持数据分析。
    遗传学和基因组学研究结果的回归对研究人员来说是普遍可以接受的,一些人表示,他们以前曾将个人或汇总结果返回给参与者和社区。与参与者分享研究结果的主要原因包括他们的临床效用,行动能力和对社会的整体利益。适当返回结果的道德考虑包括需要有效的社区参与,在披露结果之前进行遗传咨询,充分的知情同意,并对其影响进行适当评估,或返回结果的后果。然而,由于缺乏适当的监管框架,返回结果的方法被认为是不标准化的。
    尽管缺乏适当的监管框架,但研究人员通常可以接受遗传和基因组研究结果的回归。遗传学和基因组学研究结果回归的伦理考虑是高度分歧的,因此,需要国家道德准则来适当规范这种做法。
    The return of genetics and genomics research results has been a subject of ongoing global debate. Such feedback is ethically desirable to update participants on research findings particularly those deemed clinically significant. Although there is limited literature, debate continues in African on what constitutes appropriate practice regarding the return of results for genetics and genomics research. This study explored perspectives and ethical considerations of Ugandan genomics researchers regarding the return of genetics and genomics research results.
    This was a qualitative study that employed in-depth interviews. Thirty participants were purposively selected based on their expertise as genomics researchers in Uganda. Data were analysed through content analysis along the main themes of the study using a comprehensive thematic matrix, to identify common patterns arising from the narratives. NVivo software 12 was used to support data analysis.
    The return of genetics and genomics research results was generally acceptable to researchers, and some indicated that they had previously returned individual or aggregate results to participants and communities. The main reasons cited for sharing research results with participants included their clinical utility, actionability and overall benefit to society. Ethical considerations for appropriate return of results included a need for effective community engagement, genetic counselling prior to disclosure of the results, adequate informed consent, and proper assessment of the implications of, or consequences of returning of results. However, the approaches to return of results were perceived as unstandardized due to the lack of appropriate regulatory frameworks.
    The return of genetic and genomic research results is generally acceptable to researchers despite the lack of appropriate regulatory frameworks. Ethical considerations for return of genetics and genomics research results are highly divergent, hence the need for national ethical guidelines to appropriately regulate the practice.
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  • 文章类型: Journal Article
    Adolescence is a period in one\'s lifetime during which sexual maturation occurs. Major changes and increased sexual instinct raise many questions in the minds of adolescents. Receiving wrong education or inappropriate information can affect adolescents\' life and future deeply. Obviously, ethical considerations cannot be ignored in nationwide macro policies and educational programs on such a sensitive issue. In this qualitative study, we attempted to explore the ethical considerations and challenges of sex education for adolescents. The study was conducted between May 2015 and March 2017. Data were collected through semi-structured in-depth interviews with 25 participants, and MAXQDA 11 was used for coding. Six hundred sixty-two codes (662) were extracted and classified into four categories: 1) the potential risks of sex education for adolescents; 2) the advantages of sex education for adolescents, and the approaches; 3) the challenges in the interval between sexual maturation and marriage, and the role of religion; and 4) the measures implemented in Iran. Shame, embarrassment, and some cultural beliefs surrounding the subject of sex education are obstacles to providing adolescents with the necessary information. According to the principles of medical ethics, the main principle in sex education is beneficence, and sometimes infringement of confidentiality has its advantages.
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