Staley Kristina
J Med Ethics. 2013 Dec;39(12):780-2. doi: 10.1136/medethics-2012-100642. Epub 2013 Mar 27.
In practice, the role of lay members of research ethics committees (RECs) often involves checking the accessibility of written materials, checking that the practical needs of participants have been considered and ensuring that a lay summary of the research will be produced. In this brief report, I argue that all these tasks would be more effectively carried out through a process of patient involvement (PI) in research projects prior to ethical review. Involving patients with direct experience of the topic under investigation brings added value beyond the contributions typically made by lay REC members, who are often not patients themselves. This is because PI tailors the design and conduct of research to the specific interests and concerns of the people who will actually take part in a project and make use of its findings. If a project has PI in its early stages, then a similar input from lay REC members could at best result in duplication of effort and at worst create the potential for conflict. The rationale for lay REC membership will therefore need to change from 'contributing a patient perspective' to 'ensuring transparency and public accountability in REC decisions'. This has implications for addressing more strategic questions about lay REC membership, including who is best recruited to the role and how they should be expected to contribute in practice.
在实际操作中,研究伦理委员会(RECs)的非专业成员的职责通常包括检查书面材料的易获取性,检查是否考虑了参与者的实际需求,并确保生成一份研究的非专业摘要。在这份简短的报告中,我认为,在伦理审查之前,通过让患者参与(PI)研究项目的过程,所有这些任务都能更有效地完成。让有正在研究主题直接经验的患者参与,能带来超出非专业伦理委员会成员通常贡献的附加价值,这些成员往往本身并非患者。这是因为患者参与能使研究的设计和实施针对实际将参与项目并利用其研究结果的人群的特定兴趣和关注点进行调整。如果一个项目在早期阶段就有患者参与,那么非专业伦理委员会成员类似的投入最多只会导致工作重复,最坏的情况是可能引发冲突。因此,非专业伦理委员会成员的基本原理需要从“提供患者视角”转变为“确保伦理委员会决策的透明度和公共问责制”。这对于解决关于非专业伦理委员会成员的更具战略性的问题具有影响,包括谁最适合担任这一角色以及在实际中期望他们如何做出贡献。