Reflections on the implementation of governance structures for early-stage clinical innovation.

Objectives This paper seeks to further explore the question of how best to monitor and govern innovative clinical procedures in their earliest phase of development. We examine the potential value of proposed governance frameworks, such as the IDEAL model, and examine the functioning of a novel procedures review committee. Methods The paper draws upon 20 qualitative, semi-structured interviews. Nine interviews were conducted with members of a committee that was established as a means of governing innovative procedures within a large National Health Service Foundation Trust hospital in the UK. Eleven interviews were conducted with health providers involved with the development of a variety of novel clinical procedures. Results Prominent themes from the data include the potential willingness of clinicians to engage with regulatory frameworks for innovative procedures, existing ways in which clinicians and others attempt to ensure patient's safety and manage uncertainty in the context of novel procedures, views on the potential benefits and drawbacks of engaging with a review committee for novel procedures, and the pragmatic considerations and potential unintended consequences that are entailed in the implementation of regulatory requirements for the monitoring of innovative procedures. Conclusions The views of committee members and clinical innovators help us to understand the practical issues of implementing governance structures for novel clinical procedures. The data illustrate those factors that must be taken into account if governance is to support innovation rather than act as an inhibiting factor in the development of new clinical procedures. [ABSTRACT FROM AUTHOR]