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Correction: Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens' Jury for an 'Informed Opt-Out' Approach. 更正:探索在肺癌放疗中使用真实世界数据的同意:公民陪审团对“知情选择退出”方法的决定。
IF 1.6 3区 哲学 Q2 ETHICS Pub Date : 2025-07-26 DOI: 10.1007/s10728-025-00532-3
Arbaz Kapadi, Hannah Turner-Uaandja, Rebecca Holley, Kate Wicks, Leila Hamrang, Brian Turner, Tjeerd van Staa, Catherine Bowden, Annie Keane, Gareth Price, Corinne Faivre-Finn, David French, Caroline Sanders, Søren Holm, Sarah Devaney
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引用次数: 0
Pediatrics 4.0: the Transformative Impacts of the Latest Industrial Revolution on Pediatrics. 儿科学4.0:最新工业革命对儿科学的变革性影响
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-07-21 DOI: 10.1007/s10728-025-00536-z
Derşan Onur, Çağla Özbakır

Industry 4.0 represents the latest phase of industrial evolution, characterized by the seamless integration of cyber-physical systems, the Internet of Things, big data analytics, artificial intelligence, advanced robotics, and cloud computing, enabling smart, adaptive, and interconnected processes where physical, digital, and biological realms converge. In parallel, healthcare has progressed from the traditional, physician-centered model of Healthcare 1.0 by introducing medical devices and digitized records to Healthcare 4.0, which leverages Industry 4.0 technologies to create personalized, data-driven, and patient-centric systems. In this context, we hereby introduce Pediatrics 4.0 as a new paradigm that adapts these innovations to children's unique developmental, physiological, and ethical considerations and aims to improve diagnostic precision, treatment personalization, and continuous monitoring in pediatric populations. Key applications include AI-driven diagnostic and predictive analytics, IoT-enabled remote monitoring, big data-powered epidemiological insights, robotic assistance in surgery and rehabilitation, and 3D printing for patient-specific devices and pharmaceuticals. However, realizing Pediatrics 4.0 requires addressing significant challenges-data privacy and security, algorithmic bias, interoperability and standardization, equitable access, regulatory alignment, the ethical complexities of consent, and long-term technology exposure. Future research should focus on explainable AI, pediatric-specific device design, robust data governance frameworks, dynamic ethical and legal guidelines, interdisciplinary collaboration, and workforce training to ensure these transformative technologies translate into safer, more effective, and more equitable child healthcare.

工业4.0代表了工业发展的最新阶段,其特点是网络物理系统、物联网、大数据分析、人工智能、先进机器人和云计算的无缝集成,实现了物理、数字和生物领域融合的智能、自适应和互联过程。与此同时,通过引入医疗设备和数字化记录,医疗保健已经从传统的以医生为中心的医疗保健1.0模型发展到医疗保健4.0,后者利用工业4.0技术创建个性化的、数据驱动的和以患者为中心的系统。在此背景下,我们在此介绍儿科4.0作为一种新的范式,将这些创新适应儿童独特的发育,生理和伦理考虑,旨在提高儿科人群的诊断准确性,治疗个性化和持续监测。关键应用包括人工智能驱动的诊断和预测分析、支持物联网的远程监控、大数据驱动的流行病学洞察、手术和康复中的机器人辅助,以及针对特定患者的设备和药物的3D打印。然而,实现儿科学4.0需要解决重大挑战——数据隐私和安全、算法偏见、互操作性和标准化、公平获取、监管一致性、同意的伦理复杂性以及长期的技术暴露。未来的研究应侧重于可解释的人工智能、儿科专用设备设计、稳健的数据治理框架、动态的伦理和法律指南、跨学科合作以及劳动力培训,以确保这些变革性技术转化为更安全、更有效和更公平的儿童医疗保健。
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引用次数: 0
Third-Party Consent To Medical Treatment in Malaysia: A Critical Analysis from Ethical and Malaysian Legal Perspectives. 马来西亚的第三方医疗同意:从伦理和马来西亚法律角度的批判性分析。
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-07-10 DOI: 10.1007/s10728-025-00531-4
Mohamad Iqhbal Bin Kunji Mohamad, Aimi Nadia Mohd Yusof, Hazdalila Yais Haji Razali, Julina Azimah Md Noor, Muhammad Aidil Idham Bin Sharom

Third-party consent, while common in medical practice, presents complex ethical dimensions and intricate legal connotations. In Malaysia, the absence of comprehensive legislation governing third-party consent for adults lacking decision-making capacity due to temporary conditions creates profound dilemmas for healthcare professionals. This article critically examines these challenges through a compelling case study of an 18-year-old female with respiratory failure who required immediate invasive intervention but did not receive consent from her mother. Despite medical urgings and a favourable prognosis, the mother's refusal highlights the difficulties healthcare providers face when navigating between their ethical obligations to act in the patient's best interests and the patient's family's wishes. Employing a dual analysis from ethical and Malaysian legal perspectives, the study explores the tensions between universal medical ethics-particularly the principles of autonomy, beneficence, and non-maleficence-and the existing Malaysian legal framework. It reveals contradictions between the Malaysian Medical Council's guidelines, which appear to grant decision-making authority to family members, and English common law principles that emphasise acting in the patient's best interests, especially in emergency situations. This inconsistency generates significant uncertainty for healthcare professionals, potentially compromising patient care and exposing physicians to litigation when acting without explicit consent. Through systematic examination of both emergency and non-emergency scenarios, the article underscores the urgent need for comprehensive legislation in Malaysia to address third-party consent, particularly for patients not covered by the Mental Health Act 2001. It advocates for laws that clearly differentiate between emergency and non-emergency situations, delineate the authority of relatives and legal guardians, and align with international practices and fundamental medical ethics principles. By harmonising legal statutes with ethical imperatives, Malaysia can resolve the contradictions that currently jeopardise patient welfare and physician security. These findings have important implications for healthcare policy development and clinical practice, emphasising the necessity for ethical and legal coherence in medical care in Malaysia.

第三方同意虽然在医疗实践中很常见,但却呈现出复杂的伦理层面和复杂的法律内涵。在马来西亚,由于临时条件而缺乏决策能力的成年人缺乏关于第三方同意的全面立法,这给保健专业人员造成了深刻的困境。本文通过一个引人注目的案例研究,批判性地审视了这些挑战,该案例研究了一名18岁的呼吸衰竭女性,她需要立即进行侵入性干预,但没有得到母亲的同意。尽管有医学上的敦促和良好的预后,这位母亲的拒绝凸显了医疗服务提供者在为患者的最大利益和患者家属的愿望行事的道德义务之间进行导航时所面临的困难。该研究从伦理和马来西亚法律的角度进行了双重分析,探讨了普遍医学伦理之间的紧张关系,特别是自主、慈善和非恶意的原则,以及现有的马来西亚法律框架。它揭示了马来西亚医学委员会(Malaysian Medical Council)的指导方针与英国普通法原则之间的矛盾,前者似乎将决策权授予了家庭成员,而后者强调以病人的最佳利益为出发点,尤其是在紧急情况下。这种不一致给医疗保健专业人员带来了很大的不确定性,可能会损害患者的护理,并使医生在未经明确同意的情况下采取行动时面临诉讼。通过对紧急情况和非紧急情况的系统审查,该条强调马来西亚迫切需要制定全面立法,处理第三方同意问题,特别是2001年《精神卫生法》未涵盖的患者。它倡导制定法律,明确区分紧急情况和非紧急情况,界定亲属和法定监护人的权力,并与国际惯例和基本医疗道德原则保持一致。通过协调法律法规和道德规范,马来西亚可以解决目前危及患者福利和医生安全的矛盾。这些发现对医疗保健政策制定和临床实践具有重要意义,强调了马来西亚医疗保健中道德和法律一致性的必要性。
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引用次数: 0
Ethical Challenges in Research Involving Hospitalized Patients: A Phenomenological Study. 住院病人研究中的伦理挑战:现象学研究。
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-07-10 DOI: 10.1007/s10728-025-00534-1
Moustaq Karim Khan Rony, Dilruba Akther, Umme Rabeya Peu, Md Shafiul Alam, Abu Zafor Md Shaleah, Md Zahirul Alam, Mst Rina Parvin, Ibne Kayesh, Sandra Rumi Madhu, Daifallah M Alrazeeni, Fazila Akter

Hospital-based research plays a crucial role in advancing medical knowledge, but it also presents significant ethical challenges, particularly when involving hospitalized patients. Ethical concerns such as informed consent, patient autonomy, and the power dynamics between healthcare providers and patients are critical to maintaining the integrity of such research. The aim of this research was to explore and analyze the ethical considerations in conducting research involving hospitalized patients. A qualitative phenomenological approach was used to investigate the experiences and perceptions of healthcare professionals involved in clinical or public health research in hospital settings. Semi-structured interviews were conducted with 33 participants from both public and private hospitals in Dhaka, Bangladesh. The data were analyzed using thematic analysis to identify recurring ethical themes. This study identified five key themes: (1) Ethical challenges in hospital-based research, (2) Informed consent and patient vulnerability, (3) Patient autonomy and decision-making in research, (4) Institutional Review Boards (IRBs) and ethical oversight, and (5) Strategies to improve ethical research practices in hospitals. Participants reported concerns about coercion, difficulties in obtaining consent from critically ill patients, conflicts in surrogate decision-making, and delays in IRB approval. The findings also emphasized the importance of ethical training, continuous consent practices, and patient-centered approaches. Ethical research practices in hospital settings require a balance between scientific progress and patient protection. The study emphasizes the need for improved ethical guidelines, better informed consent processes, and ongoing training for healthcare professionals to ensure patient autonomy is respected. The findings also call for streamlined Institutional Review Board (IRB) processes to support timely and ethical research execution.

以医院为基础的研究在推进医学知识方面发挥着至关重要的作用,但它也提出了重大的伦理挑战,特别是在涉及住院患者时。伦理问题,如知情同意、患者自主权以及医疗保健提供者和患者之间的权力动态,对于维护此类研究的完整性至关重要。本研究的目的是探讨和分析进行涉及住院病人的研究的伦理考虑。定性现象学方法用于调查参与医院临床或公共卫生研究的医疗保健专业人员的经验和看法。对来自孟加拉国达卡公立和私立医院的33名参与者进行了半结构化访谈。使用主题分析对数据进行分析,以确定反复出现的伦理主题。本研究确定了五个关键主题:(1)医院研究中的伦理挑战;(2)知情同意和患者脆弱性;(3)研究中的患者自主权和决策;(4)机构审查委员会(irb)和伦理监督;(5)改善医院伦理研究实践的策略。参与者报告了对胁迫、获得危重病人同意的困难、替代决策中的冲突以及IRB批准的延迟的担忧。研究结果还强调了道德培训、持续同意实践和以患者为中心的方法的重要性。医院环境中的伦理研究实践需要在科学进步和患者保护之间取得平衡。该研究强调有必要改进伦理准则,改进知情同意程序,并对医疗保健专业人员进行持续培训,以确保尊重患者的自主权。研究结果还呼吁精简机构审查委员会(IRB)程序,以支持及时和合乎道德的研究执行。
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引用次数: 0
Considering Culturally Sensitive Dementia Care as a Prerequisite for Person-Centered Care: The Turkish Community in Germany as an Example. 将文化敏感性痴呆护理视为以人为本护理的先决条件:以德国土耳其社区为例
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-06-18 DOI: 10.1007/s10728-025-00529-y
Zümrüt Alpinar-Segawa, Sabine Salloch

Culturally diverse societies often struggle with providing appropriate dementia care. Cultural sensitivity is considered an important prerequisite for meeting the needs of persons with dementia. This article discusses culture specific aspects of dementia care by referring to the Turkish community in Germany as an example. Factors are discussed that specifically infringe on the quality of dementia care for migrants. The article defends the claim that good dementia care for migrants can be provided through a person-centered approach which is again based on culturally sensitive approach. We show how culture shapes health phenomena but also argue that a focus on culture may stereotype individuals as belonging to a particular culture, grouping people together irrespective of their heterogeneity. Person-centered care is ideal for recognizing diverse needs and values. It is often seen as being at odds with culturally sensitive care, but this paper suggests a way of reconciling them. We argue that culture does indeed provide a framework to create the necessary foundation for person-centered care. Finally, some criticisms and plausible replies are discussed and practical implications arising from the analysis are presented.

文化多元的社会往往难以提供适当的痴呆症护理。文化敏感性被认为是满足痴呆症患者需求的重要先决条件。本文以德国的土耳其社区为例,讨论了痴呆症护理的文化具体方面。讨论了具体影响移民痴呆症护理质量的因素。文章为这样一种说法辩护,即可以通过以人为本的方法为移民提供良好的痴呆症护理,这种方法再次基于文化敏感的方法。我们展示了文化是如何塑造健康现象的,但也认为,对文化的关注可能会使个人成为属于特定文化的刻板印象,将人们分组在一起,而不管他们的异质性。以人为本的护理是认识多样化需求和价值的理想选择。它通常被视为与文化敏感护理相冲突,但本文提出了一种调和两者的方法。我们认为,文化确实提供了一个框架,为以人为本的护理创造必要的基础。最后,讨论了一些批评和合理的答复,并提出了分析产生的实际意义。
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引用次数: 0
Harm Reduction in Inpatient Hospital Settings: An Ethics (Principlist) Analysis. 减少住院病人的伤害:伦理(原则)分析。
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-06-14 DOI: 10.1007/s10728-025-00530-5
Katherine Birkness, Cheryl Forchuk, Jonathan Serrato, Abraham Rudnick

The opioid epidemic continues to be a prevalent crisis in North America. How best to address this challenge has long been debated. Abstinence is currently the preferred policy within the inpatient hospital setting, however, this is fraught with difficulties such as withdrawal and using substances in secrecy. It can also result in stigma and a lack of knowledge on substance use among health care providers. The concept of harm reduction could provide an ethical approach to supporting people with substance use disorder. Through Principlism and the principles of Autonomy, Beneficence, Justice and Non-Maleficence, this paper suggests that harm reduction practices represent a viable and more ethically sound approach to health care compared to abstinence-based approaches. Harm reduction practices could result in a more equitable health care system that reduces stigma and increases help-seeking behaviour. More empirical research in other jurisdictions or other settings such as long-term care is needed. Future research should address additional theoretical frameworks such as dialogical bioethics, care ethics and the capabilities approach.

阿片类药物流行病仍然是北美普遍存在的危机。如何最好地应对这一挑战一直是人们争论的焦点。目前,在住院医院环境中,禁欲是首选政策,然而,这充满了诸如戒断和秘密使用物质等困难。它还可能导致卫生保健提供者对药物使用的耻辱和缺乏知识。减少伤害的概念可以为支持有物质使用障碍的人提供一种合乎道德的方法。通过原则和自主、仁慈、正义和非恶意原则,本文表明,与基于禁欲的方法相比,减少伤害的做法代表了一种可行的、更合乎道德的卫生保健方法。减少伤害的做法可能导致更公平的卫生保健系统,从而减少污名并增加寻求帮助的行为。需要在其他司法管辖区或其他环境(如长期护理)进行更多的实证研究。未来的研究应探讨更多的理论框架,如对话生物伦理学、护理伦理学和能力方法。
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引用次数: 0
Ethical, Legal and Social Issues in Utilizing In Vitro Gametogenesis (IVG) and Stem Cell-Based Embryo Models (SCBEMs) for Human Reproduction in Singapore. 新加坡利用体外配子发生(IVG)和干细胞胚胎模型(SCBEMs)进行人类生殖的伦理、法律和社会问题。
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-06-12 DOI: 10.1007/s10728-025-00521-6
Alexis Heng Boon Chin, Ido Alon, Timothy Anand Weerasekera, Jean Didier Bosenge-Nguma, Ningyu Sun

Singapore is a small, affluent and technologically advanced city-state located in Southeast Asia. Due to its lack of natural resources, this country relies heavily on its highly educated and skilled workforce to drive its economic engine. However, in recent years, Singapore has been facing a demographic crunch due to its ultra-low fertility rate and rapidly aging population, which poses an existential threat to its survival as a nation-state. The advent of new reproductive technologies such as In Vitro Gametogenesis (IVG) and Stem Cell-Based Embryo Models (SCBEMs) may thus provide novel fertility treatment options for local patients, which may possibly alleviate Singapore's ultra-low birthrate. Nevertheless, these new technology platforms also raise various controversial ethical, legal and social issues. It is anticipated that the application of SCBEMs (also known as synthetic embryos) in human reproduction will likely be banned because these entities are viewed as human clones. Conversely, IVG technology is expected to receive approval in Singapore for a narrow range of applications in human clinical assisted reproduction, as it seeks to recapitulate the natural process of human sexual reproduction and is more aligned with Singapore's family laws and sociocultural values. It is anticipated that IVG will be permitted for the treatments of primary infertility and age-related female infertility, facilitating transgender and intersex parenthood and preventing the transmission of genetic diseases. However, the applications of IVG in posthumous reproduction, mass production of donor gametes, genetic enhancement of offspring, same-sex, solo- and multiplex-parenthood, will likely be banned.

新加坡是一个位于东南亚的小而富裕、科技先进的城市国家。由于缺乏自然资源,这个国家严重依赖其受过高等教育和技术熟练的劳动力来驱动其经济引擎。然而,近年来,由于超低生育率和人口快速老龄化,新加坡面临着人口危机,这对其作为一个民族国家的生存构成了威胁。新的生殖技术的出现,如体外配子发生(IVG)和干细胞胚胎模型(SCBEMs),可能因此为当地患者提供新的生育治疗选择,这可能会缓解新加坡的超低出生率。然而,这些新的技术平台也引发了各种有争议的伦理、法律和社会问题。预计scbem(也称为合成胚胎)在人类生殖中的应用可能会被禁止,因为这些实体被视为人类克隆。相反,IVG技术有望在新加坡获得批准,用于人类临床辅助生殖的小范围应用,因为它旨在重现人类有性生殖的自然过程,并且更符合新加坡的家庭法和社会文化价值观。预计试管婴儿将被允许用于治疗原发性不孕症和与年龄有关的女性不孕症,促进跨性别和双性人生育,并预防遗传疾病的传播。然而,IVG在死后生殖、大量生产供体配子、后代遗传增强、同性、单亲和多重父母中的应用可能会被禁止。
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引用次数: 0
Design and Validation of an Instrument to Evaluate Cognitive-Physiological Repercussions and Coping Strategies in a Pandemic Situation. 大流行情况下认知生理反应和应对策略评估工具的设计与验证。
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-06-10 DOI: 10.1007/s10728-025-00528-z
Noelia Gallego-Ausín, María-Camino Escolar-Llamazares, Sandra Corral-Puente, María-Yolanda González-Alonso, Diego Serrano-Gómez, Andrea-Liliana Ortiz-González, Isabel Serrano-Pintado, María-Ángeles Martínez-Martín

The coronavirus disease (COVID-19) pandemic has significantly affected mental health worldwide, highlighting the need for reliable tools to assess emotional impact (cognitive-psysiological repercusiones) and coping strategies. To validate the psychometric properties of an evaluation instrument with an ad hoc design, called the Evaluation Inventory of Cognitive-Physiological Repercussions and Coping Strategies in a Pandemic Situation (EICPCP), which has two scales: "Cognitive and Physiological repercussions arising from the pandemic due to COVID-19" (RCFPC19-13) and "Coping strategies during the pandemic due to COVID-19" (EAPC19-15). A total of 1,629 participants (students, teachers, and healthcare professionals) from Spain and Colombia completed the instrument. Exploratory and confirmatory factor analyses were conducted to assess their structure and reliability. Both exploratory and confirmatory factor analyses supported the five proposed dimensions: cognitive and physiological impacts on the RCFPC19-13 scale, and adaptation, support, and organization on the EAPC19-15 scale. In addition, satisfactory internal consistency, reliability indices, and temporal stability were obtained for both scales. The EICPCP is a valid and reliable tool for evaluating the cognitive-physiological impact of the pandemic and coping strategies employed. This instrument provides valuable insights for clinical research and psychological interventions in pandemic-related mental-health studies..

冠状病毒病(COVID-19)大流行严重影响了全世界的心理健康,突出表明需要可靠的工具来评估情绪影响(认知-心理反应)和应对策略。验证一种特别设计的评估工具的心理测量学特性,称为大流行情境下认知生理反应和应对策略评估量表(EICPCP),该量表有两个量表:“COVID-19大流行引起的认知和生理反应”(RCFPC19-13)和“COVID-19大流行期间的应对策略”(EAPC19-15)。来自西班牙和哥伦比亚的1,629名参与者(学生、教师和保健专业人员)完成了该工具。通过探索性和验证性因素分析来评估其结构和可靠性。探索性因子分析和验证性因子分析均支持提出的五个维度:认知和生理对RCFPC19-13量表的影响,以及适应、支持和组织对EAPC19-15量表的影响。此外,两种量表均获得了满意的内部一致性、信度指标和时间稳定性。EICPCP是评估流行病的认知生理影响和所采用的应对策略的有效和可靠的工具。该工具为流行病相关心理健康研究中的临床研究和心理干预提供了宝贵的见解。
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引用次数: 0
Relationships Among Cancer Screening Participation, E-Health Literacy, and Healthy Lifestyle Behaviors in a Group of Turkish Women: A Structural Equation Modeling Analysis. 一组土耳其妇女癌症筛查参与、电子健康素养和健康生活方式行为之间的关系:结构方程模型分析
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-06-03 DOI: 10.1007/s10728-025-00525-2
Mine Gökduman Keleş, Eylem Toker

One in five people worldwide is expected to develop cancer during their lifetime. This study aimed to examine the effect of women's E-health literacy levels on their healthy lifestyle behaviors about their cancer screening status, within the scope of preventive cancer healthcare services in Türkiye. This cross-sectional analytical study involved 392 women, and a structural equation model (SEM) was used to identify the causal relationships between variables. Data were collected using the "E-health literacy scale" and the "healthy lifestyle behavior scale". A structural equation model (SEM) was developed to examine the causal relationships among the variables, and the model's fit indices and test values were analyzed and interpreted. Results showed that both E-health literacy and healthy lifestyle behavior scores were significantly higher among women who had undergone cancer screening. Additionally, women who had been screened for breast and cervical cancer demonstrated higher healthy lifestyle behavior scores. The SEM analysis indicated that E-health literacy had a positive effect on healthy lifestyle behaviors. Based on these findings, enhancing women's E-health literacy may promote healthier lifestyle behaviors and encourage more consistent participation in preventive screenings such as cancer screenings.

预计全球五分之一的人在一生中会患上癌症。本研究的目的是检查妇女的电子健康素养水平对其癌症筛查状况的健康生活方式行为的影响,在 rkiye癌症预防保健服务的范围内。这项横断面分析研究涉及392名女性,并使用结构方程模型(SEM)来确定变量之间的因果关系。采用“电子健康素养量表”和“健康生活方式行为量表”收集数据。建立了结构方程模型(SEM)来检验变量之间的因果关系,并对模型的拟合指标和检验值进行了分析和解释。结果显示,在接受过癌症筛查的妇女中,电子健康素养和健康生活方式行为得分均显著较高。此外,接受过乳腺癌和宫颈癌筛查的妇女表现出更高的健康生活方式行为得分。扫描电镜分析显示,电子健康素养对健康生活方式行为有正向影响。根据这些发现,提高妇女的电子健康素养可以促进更健康的生活方式行为,并鼓励更一致地参与癌症筛查等预防性筛查。
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引用次数: 0
The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies' Soft Impacts into Account. 分散临床试验和知情同意的伦理:考虑技术的软影响。
IF 1.8 3区 哲学 Q2 ETHICS Pub Date : 2025-06-01 Epub Date: 2024-05-19 DOI: 10.1007/s10728-024-00483-1
Tessa I van Rijssel, Ghislaine J M W van Thiel, Johannes J M van Delden

Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.

分散式临床试验(DCT)有可能推动临床试验的开展,但也会引发一些伦理问题,包括获得有效的知情同意。关于数字化带来的伦理问题的讨论主要集中在与数据保护、安全性和数据质量等相关的直接风险上。但我们认为,需要从更广的视角来看待 DCT 的伦理问题,以应对 DCT 实践带来的新挑战。数字化通过塑造行为、体验、社会关系和价值观,产生了超越其直接目的的影响。我们研究了知情同意程序中受 DCT 影响的四个要素,同时考虑到技术的这些软影响:(i) 告知参与者并测试其理解程度,(ii) 与责任和负担相关的自由,(iii) 参与者与研究者关系中的信任,以及 (iv) 对隐私概念的影响。我们的分析表明,广阔的视野是优化开展 DCT 的关键。此外,我们还深入分析了 DCT 对知情同意的伦理影响。像 DCT 这样的技术可能会产生深远的影响,而现有的监管框架并没有立即解决这些问题,但认识到这一点非常重要。这些发现可以指导未来的 DCT 实践,在这种新颖的临床试验方法中促进临床研究的重要价值。
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