身处险境？与研究伦理委员会互动的经验。
In the lion's den? Experiences of interaction with research ethics committees.
机构信息
General Practice Education Group, Institute of Public Health, University of Cambridge, Cambridge, UK.
出版信息
J Med Ethics. 2012 Apr;38(4):224-7. doi: 10.1136/medethics-2011-100124. Epub 2011 Nov 2.
Abstract
Research ethics review is an important process, designed to protect participants in medical research. However, it is increasingly criticised for failing to meet its aims. Here, two researchers reflect on their experiences of applying for ethical approval of observational research in clinical settings. They highlight some problems faced by reviewers and researchers and propose a two-stage ethical review process that would alert researchers to the committee's concerns and allow them to give a more considered response.
摘要
研究伦理审查是一个重要的过程，旨在保护医学研究中的参与者。然而，它越来越多地受到批评，未能达到其目的。在这里，两位研究人员反思了他们在临床环境中申请观察性研究伦理批准的经验。他们强调了审查员和研究人员面临的一些问题，并提出了一个两阶段的伦理审查过程，这将提醒研究人员委员会的关注，并使他们能够做出更深思熟虑的回应。
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