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Ethical Considerations in Decentralized Clinical Trials
Journal of Bioethical Inquiry ( IF 1.8 ) Pub Date : 2024-03-01 , DOI: 10.1007/s11673-024-10341-3
Barbara E Bierer 1 , Sarah A White 1
Affiliation  

As a consequence of the COVID-19 pandemic, the number of decentralized clinical trials, trials conducted in whole or in part at locations other than traditional clinical trial sites, significantly increased. While these trials have the potential advantage of access, participant centricity, convenience, lower costs, and efficiency, they also raise a number of important ethical and practical concerns. Here we focus on a number of those concerns, including participant safety, privacy and confidentiality, remote consent, digital access and proficiency, and trial oversight. Awareness of these ethical complexities will help foster the development of processes and cooperative solutions to promote safe, ethical trials going forward, optimized to decrease burden and increase access for all participants.



中文翻译:


分散临床试验中的伦理考虑



由于 COVID-19 大流行,分散式临床试验(全部或部分在传统临床试验地点以外的地点进行的试验)的数量显着增加。虽然这些试验具有可及性、以参与者为中心、方便、成本较低和效率高等潜在优势,但它们也引起了一些重要的伦理和实际问题。在这里,我们重点关注其中的一些问题,包括参与者的安全、隐私和保密、远程同意、数字访问和熟练程度以及试验监督。对这些伦理复杂性的认识将有助于促进流程和合作解决方案的开发,以促进安全、伦理试验的进展,并进行优化以减轻负担并增加所有参与者的参与机会。

更新日期:2024-03-01
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