Healthcare organization policy recommendations for the governance of surgical innovation: review of NHS policies

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. Innovative surgery and devices are important to improve patient care. When being offered to patients this requires research or local NHS oversight to ensure transparency and safety monitoring. This study investigated local NHS policies for the oversight of surgical and device innovation in England and Wales. Detailed document analysis revealed a lack of clarity and consistency about what requires 'research approval' and what can be delivered with local NHS oversight. A standardized and clear approach is recommended for the governance of surgical innovation.

Automated summary

The governance for introducing innovative surgical procedures/devices varies from country to country, with unclear standards and lack of consistency observed in NHS policies in England and Wales. A standardized approach is recommended for the oversight of surgical innovation to ensure transparency and safety monitoring.