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

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) approva

SUBMITTER: Cousins S 

PROVIDER: S-EPMC10364689 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature