Rule breaking and normalisation of deviance
Accepted and normalised rule ‘breaking’ is a part of everyday human activity, but it can lead to a shift in the safety culture of a team or unit over time. We observed areas where the guidance provided to researchers and clinical support staff was either not clear, or ‘forced’ the team to bend the rules to achieve protocolised tasks. This was exemplified by variability in the stipulated requirements around the use of PPE and the inaccurate use of the “do not enter” sign during live virus inocuation. Whilst such instances may be dismissed as trivial if not immediately elevating risk to staff or participants, the wider consequences include variability in practice, erosion of trust in trial documentation or procedures (extending beyond the index study) and the development of unapproved (or unacknowledged) workarounds with potentially unintended consequences. Adoption of a systemic approach that actively seeks to pre-identify discrepancies between work as imagined and work as done, and a blame-free culture that enables enforced rule breaking to be openly discussed, should counter these concerns. For instance, the use and acceptance of clear and accurate indicators of risk that are rigidly controlled and adhered to (e.g. an amber light over participants’ rooms and in corridors when live pathogen was present, akin to imaging departments employing ionizing radiation) would cement trust and promote safety.