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.