Ethical considerations
The Oxford University Clinical Trials and Research Governance /Joint
Research Office classified the preliminary patient public involvement
(PPI) activities as ‘pre-research’ not requiring formal regulatory
approvals or research governance (decision on 25.06.2021).
For the clinical pilot, the Medical Research Council and the NHS Health
and Research Authority research decision support tool (7) was used to
determine that this project was not a formal research project as the
HaNC-RC-v2 was a standard tool used in telephone triage of USHNC at the
trust. This was confirmed with the trust’s Associate Medical Director
for Research in March 2022. Trust information governance and data
sharing processes were approved in April 2022 (IG 2021-214).
All patients at the beginning of their telephone consultation were
verbally consented by their clinician to undertake an automated
conversation as part of their consultation.