卫生部的研究治理框架仍然是多中心研究的一个障碍：一项全国性描述性研究的结果
The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study.
作者信息
Kielmann Tara, Tierney Alison, Porteous Rosemary, Huby Guro, Sheikh Aziz, Pinnock Hilary
机构信息
Division of Community Health Sciences, GP Section, University of Edinburgh, Edinburgh, EH8 9DX, UK.
出版信息
J R Soc Med. 2007 May;100(5):234-8. doi: 10.1177/014107680710000513.
OBJECTIVE
We describe our experience of using the standard application form, designed to streamline applications for multi-centre research, to seek approval from all primary care organizations (PCOs) in England and Wales to undertake a single telephone interview with a health service manager.
DESIGN
We sent applications (n=316), by email to each PCO, or consortium of PCOs, attaching a completed standard application form, the 15 required documents, and the approval we had been granted by the lead NHS organization. We maintained detailed records of the responses to our application, subsequent correspondence, additional paperwork requested, and time spent on the approval process.
SETTING
The UK Research Governance Framework, which regulates all research conducted in health and social care settings.
PARTICIPANTS
All PCOs in England and Wales.
INTERVENTIONS
None.
MAIN OUTCOME MEASURES
Time taken to obtain approval to undertake a telephone interview with a health service manager.
RESULTS
We were unable to establish contact with 13 (4%) PCOs. Six months after submitting our application we had received approval from 259/316 (82%) PCOs and were still awaiting a verdict from 41 (13%). The median time to approval was 56 days (IQR 42-72). Overall, an estimated 318 staff-hours were spent completing supplementary forms, providing additional information and chasing up dormant applications.
CONCLUSIONS
Recent initiatives to 'streamline' research governance approval have failed to address the problems that face researchers undertaking multi-centre studies. There is an urgent need to develop a simpler process that allows low risk research to take place without threatening staff morale and endangering the quality of the research outputs. In the meantime, we advise researchers to allow far greater time than might reasonably be envisioned to obtain research governance approval.
目的
我们介绍了使用标准申请表的经验，该申请表旨在简化多中心研究的申请流程，以寻求英格兰和威尔士所有初级保健组织（PCO）批准对一名卫生服务经理进行单次电话访谈。
设计
我们通过电子邮件向每个PCO或PCO联盟发送申请（n = 316份），附上完整的标准申请表、所需的15份文件以及我们获得的英国国家医疗服务体系（NHS）牵头组织的批准。我们详细记录了对申请的回复、后续通信、要求提供的额外文件以及审批过程所花费的时间。
背景
英国研究治理框架，该框架规范了在卫生和社会护理环境中进行的所有研究。
参与者
英格兰和威尔士的所有PCO。
干预措施
无。
主要观察指标
获得批准对一名卫生服务经理进行电话访谈所需的时间。
结果
我们无法与13个（4%）PCO取得联系。提交申请六个月后，我们收到了259/316个（82%）PCO的批准，仍有41个（13%）在等待裁决。批准的中位时间为56天（四分位间距42 - 72天）。总体而言，估计花费了318个工作人员工时来填写补充表格、提供额外信息并跟进停滞的申请。
结论
最近“简化”研究治理批准的举措未能解决进行多中心研究的研究人员面临的问题。迫切需要制定一个更简单的流程，使低风险研究能够进行，同时不影响工作人员士气并危及研究成果的质量。与此同时，我们建议研究人员预留比合理预期长得多的时间来获得研究治理批准。
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