Background: the framework for clinical and organizational quality improvement (QI) in many health systems is the structure, process and outcome evaluation as described by Donabedian. While there has been global uptake of Donabedian’s model for QI, the role of clinical decision making in ethics associated with QI and implementation of best practice within this framework remains poorly understood and inconsistently implemented, particularly in relation to health consumer engagement. The Standards for QUalitiy Improvement Reporting Excellence (SQUIRE 2.0) suggests ethical aspects should be considered; but does not detail how. Similarly, the Standards for Reporting Implementation Studies (StaRI) checklist item for ethics, does not advise users of the important aspects to consider or how to report them.
Objectives: to raise awareness of the scope for clinician-led, health consumer-engaged pre-screening of ethical requirements in implementation studies and to highlight the inadequacy of current reporting of ethical considerations in implementation studies.
Methods: we reviewed selected literature that addressed clinician-led clinical ethics review methods for implementation and QI studies. We included papers that addressed the following core attributes: use of audit and feedback as the mode of implementation, reference to Donabedian’s structure, process and outcome framework; using evidence to improve the quality of care in healthcare systems. We identified frameworks for clinician-led screening and extracted key characteristics.
Results: five characteristics for clinician-led ethics screening have been identified: a) a clear, common sense ethical framework and rules that are easy to apply in specific cases; b) preserving anonymity and confidentiality of patient and worker information; c) integrating ethical oversight of QI activities into the system of accountability for clinical care; d) linking the intensity of review to the level of additional risk of the activity, compared to the risk inherent in receiving or providing usual care and; e) encouraging evidence-based, consumer-engaged management of organizational change to share best practices and improve the standard of care.
Conclusions: standard localised mechanisms for consistent decision making on when ethics approval should be sought for implementation research (IR) and QI studies remains elusive. Misclassification is likely in projects relying upon current guidance such as SQUIRE 2.0 and StaRI. Clinician-led, consumer-engaged ethics screening is plausible and possible, but mechanisms for integrating healthcare consumer perspectives remain infrequent and are poorly reported.
Patient or healthcare consumer involvement: clinical ethics committees should be structurally inclusive of health consumers in the context of considering IR and QI studies in clinical settings. Consumers are significantly affected by both IR and QI.