Study Limitations
In addition to the limited direct transferability of the specific safety
issues and recommendations identified in this study to other research
programmes and units, there was a limited time frame during which to
undertake observations in OxCRF. We chose to restrict the study to three
core tasks based upon intial consultation and scoping work that
identified not only higher intrinsic complexity (and hence risk), but
also their likely repeated use in future experimental medicine studies
to enhance the applicability of our findings. It is possible that, had
the full range of study activities been examined and a longer period for
observation been permitted, we would have revealed additional latent
safety issues. As with any observational data collection it is possible
that relevant data were missed through distraction, cognitive overload
or were affected by observer bias. This risk was reduced by using two
independent observers experienced in teaching and undertaking
observational research. Data were also collected by both observers
contemporaneously, with comparison of, and agreement on, findings. Due
to the risk of live virus transmission one of the observed tasks had to
be simulated rather than involve enrolled participants, potentially
inducing behavioural artefacts.
Participants gave informed consent to our observations and were offered
the opportunity to comment as they wished. For the purposes of this
pilot work it was not practical to ask for more participant engagement,
however, in future it would be valuable to achieve a more active role
for participants both in study design and delivery.