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Research approvals iceberg: helping it melt away.
BMC Medical Ethics ( IF 3.0 ) Pub Date : 2019-12-24 , DOI: 10.1186/s12910-019-0434-2
Simon E Kolstoe 1 , David Carpenter 2
Affiliation  

BACKGROUND In their paper "Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better" Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. DISCUSSION As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay's analysis is misleading because it conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network.

中文翻译:

研究批准冰山:帮助它融化。

背景 在他们的论文“研究批准冰山:英国的一项‘低调’研究如何需要 89 名专业人士批准以及我们如何做得更好”中,Petrova 和 Barclay 强调了对英​​国健康研究监管环境的担忧。讨论 作为 NHS 研究伦理委员会的长期主席、研究人员以及研究伦理领域的学者,我们也经常对英国的监管程序感到沮丧。然而,我们认为 Petrova 和 Barclay 的分析具有误导性,因为它将研究伦理与治理和资助流程混为一谈,因此未能充分区分卫生研究机构的国家协调职能、地方研究治理流程以及与研究赞助商和/或研究资助者的互动。或临床研究网络。
更新日期:2020-04-22
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