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Protecting the public from the adverse effects of confused research ethics.

作者信息

Chalmers Iain, Glasziou Paul

机构信息

Centre for Evidence-Based Medicine, Department of Primary Care, University of Oxford, Oxford OX2 6GG, UK.

Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast QLD 4229, Australia.

出版信息

J R Soc Med. 2021 Nov;114(11):507-512. doi: 10.1177/01410768211051720. Epub 2021 Oct 26.

DOI:10.1177/01410768211051720
PMID:34698579
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8649484/
Abstract
摘要

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本文引用的文献

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Improving research ethics review and governance can improve human health.改善研究伦理审查与管理可促进人类健康。
J R Soc Med. 2021 Dec;114(12):556-562. doi: 10.1177/01410768211051711. Epub 2021 Nov 11.
2
'The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back': a survey of views on human research ethics reviews.“一项旨在帮助晚期癌症患者的试验，伦理审批耗时20个月。最后我们不得不把资金退回”：关于人体研究伦理审查的观点调查
J Med Ethics. 2021 Jan 11. doi: 10.1136/medethics-2020-106785.
3
The Magic of Randomization versus the Myth of Real-World Evidence.随机化的魔力与真实世界证据的神话
N Engl J Med. 2020 Feb 13;382(7):674-678. doi: 10.1056/NEJMsb1901642.
4
Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands.免除低风险健康和医学研究的伦理审查：比较澳大利亚、英国、美国和荷兰。
Health Res Policy Syst. 2020 Jan 28;18(1):11. doi: 10.1186/s12961-019-0520-4.
5
When IRBs Say No to Participating in Research about Single IRBs.当机构审查委员会拒绝参与关于单一机构审查委员会的研究时。
Ethics Hum Res. 2020 Jan;42(1):36-40. doi: 10.1002/eahr.500041.
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Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols.新随机试验方案是否考虑了先前类似的试验？当代试验方案的队列研究。
BMJ Open. 2019 Nov 10;9(11):e026661. doi: 10.1136/bmjopen-2018-026661.
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Personalised Medicine Using N-of-1 Trials: Overcoming Barriers to Delivery.使用单病例试验的个性化医疗：克服实施障碍。
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Objecting to experiments that compare two unobjectionable policies or treatments.反对比较两种无可非议的政策或治疗方法的实验。
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Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.研究审批的冰山：在英格兰，一项“低调”的研究为何需要 89 名专业人员来批准，以及我们如何才能做得更好。
BMC Med Ethics. 2019 Jan 25;20(1):7. doi: 10.1186/s12910-018-0339-5.
10
Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation.评估研究浪费 第 1 部分：以钙摄入量和维生素 D 补充研究中检查研究设计、替代终点和临床终点为例。
BMC Med Res Methodol. 2018 Oct 10;18(1):103. doi: 10.1186/s12874-018-0556-0.