Clinical governance and research ethics as barriers to UK low-risk population-based health research?
Clinical governance and research ethics as barriers to UK low-risk population-based health research?
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DOI：
10.1186/1471-2458-8-396
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发表时间：
2008-11-28
影响因子：
4.5
通讯作者：
Torrance, Nicola
中科院分区：
文献类型：
--
作者：
van Teijlingen, Edwin R.;Douglas, Flora;Torrance, Nicola
自1964年《赫尔辛基宣言》作为临床研究的实践准则出台以来，人们普遍认为，公共卫生和健康促进研究领域也需要研究治理。最近，一系列因素导致了更严格的官僚程序的发展，管理在英国进行低风险人群为基础的健康研究。我们的论文强调了一个案例研究的应用程序，在英国的医学研究伦理委员会的研究，促进身体活动的医疗保健提供者。这里介绍的案例研究是一个例子，在进行低风险人群为基础的健康研究的挑战。我们的混合方法包括问卷调查和半结构化的采访卫生专业人员（谁都是健康的志愿者）。由于我们的研究不涉及患者或普通人群的参与，因此向相关研究伦理委员会提出的申请应该是一种形式。事实证明并非如此！研究伦理委员会可能会适得其反，它们非但不能保护研究过程中的弱势群体，反而会扼杀低风险的基于人群的健康研究。卫生服务研究中的研究伦理首先是研究人员的责任，我们需要学会再次信任卫生服务研究人员。目前的研究治理监管的负担，以解决所感知的伦理问题是既不适当，也不充分。高级研究人员/学者需要在研究道德领域对学生和初级研究人员进行教育和培训，同时减少导致不道德研究的压力，例如商业资金，政府不适当的干预和出版压力。我们建议，非侵入性的低风险人群为基础的健康研究，如面对面的采访卫生和社会保健专业人员或邮寄问卷调查研究与患者的非敏感话题给予豁免或轻触审查。我们建议，这可以通过两个阶段的道德应用程序来实现。第一阶段从一页或两页的申请大纲开始，伦理委员会可以将其作为批准豁免或要求完整申请的基础。
Since the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research. Recently, a range of factors led to the development of more stringent bureaucratic procedures, governing the conduct of low-risk population-based health research in the United Kingdom. Our paper highlights a case study of the application process to medical research ethics committees in the United Kingdom for a study of the promotion of physical activity by health care providers. The case study presented here is an illustration of the challenges in conducting low-risk population-based health research. Our mixed-methods approach involved a questionnaire survey of and semi-structured interviews with health professionals (who were all healthy volunteers). Since our study does not involve the participation of either patients or the general population, one would expect the application to the relevant research ethics committees to be a formality. This proved not to be the case! Research ethics committees could be counter-productive, rather than protecting the vulnerable in the research process, they can stifle low-risk population-based health research. Research ethics in health services research is first and foremost the responsibility of the researcher(s), and we need to learn to trust health service researchers again. The burden of current research governance regulation to address the perceived ethical problems is neither appropriate nor adequate. Senior researchers/academics need to educate and train students and junior researchers in the area of research ethics, whilst at the same time reducing pressures on them that lead to unethical research, such as commercial funding, inappropriate government interference and the pressure to publish. We propose that non-invasive low-risk population-based health studies such as face-to-face interviews with health and social care professionals or postal questionnaire studies with patients on non-sensitive topics are given a waiver or a light touch review. We suggest that this can be achieved through a two-staged ethics application process. The first stage starts with a one or two-page outline application which ethics committees can use as the basis to grant a waiver or request a full application.
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