Abstract Background The governance for introducing innovative surgical procedures/devices differs from the research requirements needed for new drugs. New invasive procedures/devices may be offered to patients outside of research protocols with local organization oversight alone. Such institutional arrangements exist in many countries and written policies provide guidance for their use, but little is known about their scope or standards. Methods One hundred and fifty acute NHS trusts in England and seven health boards in Wales were systematically approached for information about their policies. A modified framework approach was used to analyse when policies considered new procedures/devices to be within local organization remit and/or requiring research ethics committee (REC) approval. Results Of 113 policies obtained, 109 and 34 described when local organization and REC approval was required, respectively. Procedures/devices being used for the first time in the organization (n = 69) or by a clinician (n = 67) were commonly within local remit, and only 36 stated that evidence was required. Others stated limited evidence as a rationale for needing REC approval (n = 13). External guidance categorizing procedures as ‘research only’ was the most common reason for gaining REC approval (n = 15). Procedures/devices with uncertain outcomes (n = 28), requiring additional training (n = 26), and not previously used (n = 6) were within the remit of policies, while others recommended REC application in these situations (n = 5, 2 and 7, respectively). Conclusion This study on NHS policies for surgical innovation shows variability in the introduction of procedures/devices in terms of local oversight and/or need for REC approval. Current NHS standards allow untested innovations to occur without the safety of research oversight and thus a standard approach is urgently needed.

中文翻译：

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医疗保健组织关于外科创新治理的政策建议：NHS 政策审查

摘要 背景引入创新外科手术/设备的管理与新药所需的研究要求不同。新的侵入性手术/设备可能会在研究方案之外仅在当地组织的监督下向患者提供。许多国家都存在这种制度安排，书面政策为其使用提供了指导，但对其范围或标准知之甚少。 方法我们系统地联系了英格兰一百五十家 NHS 信托机构和威尔士七个卫生委员会，以获取有关其政策的信息。使用修改后的框架方法来分析政策何时考虑新程序/设备属于当地组织的职权范围和/或需要研究伦理委员会（REC）批准。 结果在获得的 113 份政策中，109 份和 34 份分别描述了何时需要当地组织和 REC 批准。组织中首次使用的程序/设备 (n = 69) 或由临床医生 (n = 67) 首次使用的程序/设备通常属于当地职权范围，只有 36 人表示需要证据。其他人则表示，需要 REC 批准的理由是证据有限 (n = 13)。将程序归类为“仅限研究”的外部指南是获得 REC 批准的最常见原因 (n = 15)。结果不确定的程序/设备 (n = 28)、需要额外培训 (n = 26) 以及以前未使用过的程序/设备 (n = 6) 属于政策范围，而其他人建议在这些情况下应用 REC (n = 5,分别为 2 和 7）。 结论这项关于 NHS 手术创新政策的研究表明，在当地监督和/或 REC 批准的需要方面，手术/设备的引入存在差异。目前的 NHS 标准允许在没有研究监督安全的情况下进行未经测试的创新，因此迫切需要一种标准方法。