Ethical frameworks for quality improvement activities: an analysis of international practice

Abstract

Purpose To examine international approaches to the ethical oversight and regulation of quality improvement and clinical audit in healthcare systems. Data sources We searched grey literature including websites of national research and ethics regulatory bodies and health departments of selected countries. Study selection National guidance documents were included from six countries: Ireland, England, Australia, New Zealand, the United States of America and Canada. Data extraction Data were extracted from 19 documents using an a priori framework developed from the published literature. Results We organised data under five themes: ethical frameworks; guidance on ethical review; consent, vulnerable groups and personal health data. Quality improvement activity tended to be outside the scope of the ethics frameworks in most countries. Only New Zealand had integrated national ethics standards for both research and quality improvement. Across countries, there is consensus that this activity should not be automatically exempted from ethical review, but requires proportionate review or organisational oversight for minimal risk projects. In the majority of countries, there is a lack of guidance on participant consent, use of personal health information and inclusion of vulnerable groups in routine quality improvement. Conclusion Where countries fail to provide specific ethics frameworks for quality improvement, guidance is dispersed across several organisations which may lack legal certainty. Our review demonstrates a need for appropriate oversight and responsive infrastructure for quality improvement underpinned by ethical frameworks that build equivalence with research oversight. It outlines aspects of good practice, especially The New Zealand framework that integrates research and quality improvement ethics.

Quality Improvement and Clinical Audits: What Is the Ethical Oversight?

“…An analysis of international practice regarding QI activities resulted in several countries being compared and explored. 4 The authors of the article conducted an in-depth review at guidance on ethical review, consent, vulnerable groups, and personal health data. The countries reviewed were Ireland, England, Australia, New Zealand, Canada, United States, and the European Union (EU).…”

“…All stated that it did not require ethical review by an IRB or designated committee. 4 However there was no consensus in the literature of what the definition of minimal risk was. In Australia and New Zealand to overcome this lack of general definition a list of criteria is used to determine if a risk higher than minimal exists.…”

“…Canada, England, the EU, and Ireland do not routinely address the ethical considerations around QI and clinical audits. The United States has recently updated its Federal Policy for the Protection of Human Subjects otherwise known as the “Common Rule” to address QI activities in the frequently asked questions section 4 . It is called the Common Rule as it has been adopted by several federal departments and agencies.…”

“…A common rule by all 6 countries was related to QI activity that presented minimal risk. All stated that it did not require ethical review by an IRB or designated committee 4 . However there was no consensus in the literature of what the definition of minimal risk was.…”

Mealtime and patient factors associated with meal completion in hospitalised older patients: An exploratory observation study

“…The ethical requirement for informed consent excluded some of the most vulnerable patients from the study. There is a need for QI ethical frameworks that recognise low-risk projects (Naughton et al, 2020). The sample size was small and data must be interpreted with caution.…”