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.