资源匮乏环境下替代试验设计和方法的伦理考量。
Ethics of alternative trial designs and methods in low-resource settings.
机构信息
University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands.
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
出版信息
Trials. 2019 Dec 19;20(Suppl 2):705. doi: 10.1186/s13063-019-3841-2.
Abstract
This editorial introduces articles in this Special Issue, which are based on presentations given at the 2017 meeting of the Global Forum of Bioethics in Research meeting. The main themes presented at the meeting were the use of cluster randomized trials, stepped-wedge cluster randomized trials, and controlled human infection models in research conducted in low-resource settings. The editorial sets out which ethical issues may arise in the context of alternative trial designs and describes the articles in this issue that addresses some or more of the ethical issues, such as justification of the research design, risk-benefit evaluations and consent.
摘要
本社论介绍了本期特刊中的文章，这些文章基于在 2017 年全球研究伦理论坛会议上的演讲。会议提出的主要主题是在资源匮乏环境中开展的研究中使用整群随机试验、逐步楔形整群随机试验和受控人体感染模型。社论阐述了在替代试验设计的背景下可能出现的哪些伦理问题，并描述了本期特刊中涉及部分或更多伦理问题的文章，例如研究设计的合理性、风险-收益评估和知情同意。
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本文引用的文献
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2
Ethical issues in the design and conduct of stepped-wedge cluster randomized trials in low-resource settings.低资源环境下阶梯式整群随机临床试验设计与实施中的伦理问题。
Trials. 2019 Dec 19;20(Suppl 2):703. doi: 10.1186/s13063-019-3842-1.
3
The global forum on bioethics in research meeting, "ethics of alternative clinical trial designs and methods in low- and middle-income country research": emerging themes and outputs.全球研究中的生物伦理学论坛会议，“在低收入和中等收入国家研究中的替代临床试验设计和方法的伦理学”：新兴主题和成果。
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