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Reflections on the implementation of governance structures for early‐stage clinical innovation
Author(s) -
Cowie Luke,
Sandall Jane,
Ehrich Kathryn
Publication year - 2013
Publication title -
journal of evaluation in clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.737
H-Index - 73
eISSN - 1365-2753
pISSN - 1356-1294
DOI - 10.1111/jep.12013
Subject(s) - corporate governance , context (archaeology) , unintended consequences , variety (cybernetics) , medicine , engineering ethics , public relations , process management , business , political science , engineering , computer science , paleontology , finance , artificial intelligence , law , biology
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 N ational H ealth S ervice F oundation T rust 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.