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

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 organized 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 organizational 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 organizations 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.