Adopting human factors in early phase and experimental medicine
research: A nested pilot study observing controlled human infection with
SARS-CoV-2
Abstract
Aim: The influence of human factors on safety in healthcare settings is
well established, with targeted interventions reducing risk and
enhancing team performance. In experimental and early phase clinical
research participant safety is paramount and safeguarded by guidelines,
protocolised care and staff training, however the real-world interaction
and implementation of these risk-mitigating measures has never been
subjected to formal system-based assessment. Methods: Independent
structured observations, systematic review of study documents, and
interviews and focus groups were used to collate data on three key tasks
undertaken in a Clinical Research Facilty (CRF) during a SARS CoV-2
controlled human infection model (CHIM) study. The Systems Engineering
Initiative for Patient Safety (SEIPS) was employed to analyse and
categorise findings, and develop recommendations for safety
interventions. Results: High levels of team functioning and a clear
focus on participant safety were evident throughout the study. Despite
this, latent risks in both study-specific and CRF work systems were
identified in all four SEIPS domains (people, environment, tasks and
tools). 14 actionable recommendations were generated collaboratively.
These included inter-organisation and inter-study standardisation,
optimised checklists for safety critical tasks, and use of simulation
for team training and exploration of work systems. Conclusion: This
pioneering application of human factors techniques to analyse work
systems during the conduct of research in a CRF revealed risks
unidentified by routine review and appraisal, and despite international
guideline adherence. SEIPS may aid categorisation of system problems and
the formulation of recommendations that reduce risk and mitigate
potential harm applicable across a trials portfolio