CONCLUSIONS
It is widely recognised that humans in the workplace create safety far
more than they erode it. Human capacity for recognising problems and
adjusting behaviours and actions in the moment will almost always
prevent an accident rather than cause one. This premise was strongly
supported in our observations of work processes in OxCRF. We observed
the type of attributes and behaviours that support a strong safety
culture in both the leadership teams and staff working in the centre
including: encouraging and valuing diversity of opinion; a constructive
dialogue about risk and an acceptance that just because processes are
running smoothly in the moment, they may not do so reliably in future.
It is this pro-active approach to safety that gave rise to this study in
the first place.
CRFs are operated by NHS Trusts, pharmaceutical companies, contract
research organisations or academic institutions, routinely staffed by a
core team of healthcare professionals supplemented by trial-specific
staff and charged with the delivery of multiple externally-generated
protocols, often concurrently. This environment, especially during
periods of high activity where IMP or interventions with divergent risk
profiles are being evaluated, presents unique challenges where risk is
concerned, and it is therefore vitally important to have robust safety
frameworks in place that can apply across studies. Whilst the tool
traditionally perceived to guarantee this is adherence to guidelines and
regulations (with accompanying documentation), there is real danger
these distract from core, often common sense, measures that involve
consulting with the correct stakeholders with the relevant training,
experience and local knowledge to instigate proportionate and focused
measures to mitigate risk to participants
This is the first time, to our knowledge, that human factors methods
have been explicitly used to analyse work systems in a CRF and protocol
elements of an experimental medicine study to provide recommendations
that improve the safety of clinical research. Our findings support the
further investigation and validation of their value in this context with
a view to routine implementation, not just in retrospect to the
investigation of safety incidents, but proactively to help avert them
Acknowledgements: Author contributions – J.F conceived the
study. H.H and L.M designed and performed the research and analyzed the
data. H.H, J.F and L.M drafted the manuscript which was edited by C.C,
H.McS and D.R and reviewed by all authors. JM, AM and SJ were Trial
Clinicians for the COV-CHIM01 study and took part in the research. RLR
was the Research Matron overseeing all nursing aspects of the COV-CHIM01
study and EH was the Research Nurse.
The Climax donation to the University of Oxford funded the reported
work. The Wellcome Trust funded the COV-CHIM01 study for which the
University of Oxford acted as sponsor.
The authors would like to acknowledge the contribution of the full
COV-CHIM study team, all staff members at the OxCRF and the technical
and administrative team in OxSTaR. We would also like to thank all the
individuals who volunteered to participate in the COV-CHIM01 study,
especially those who agreed to be observed as part of this nested pilot
project.
Conflict of interest statement : RLR and SJ have previously
contributed to intellectual property licensed by Oxford University
Innovation to AstraZeneca. All authors declared no competing interests
for this work
Funding Information: The Climax donation to the University of
Oxford funded the reported work. The Wellcome Trust funded the
COV-CHIM01 study (Wellcome Trust reference: 222305/Z/21/Z) for which
the University of Oxford acted as sponsor.
Data availability statement: The data that support the findings
of this study are available from the corresponding author upon
reasonable request.