Ethical frameworks for quality improvement activities: An analysis of international practice
Loading...
Files
Accepted Version
Date
2020-08-14
Authors
Naughton, Corina
Meehan, Elaine
Lehane, Elaine
Landers, Ciara
Flaherty, Sarah Jane
Lane, Aoife
Landers, Margaret
Kilty, Caroline
Saab, Mohamad M.
Goodwin, John
Journal Title
Journal ISSN
Volume Title
Publisher
Oxford University Press
Published Version
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.
Description
Keywords
Quality improvement , Clinical audit , Ethics , Consent , Personal health data
Citation
Naughton, C., Meehan, E., Lehane, E., Landers, C., Flaherty, S. J, Lane, A., Landers, M., Kilty, C., Saab, M. M., Goodwin, J., Walshe, N., Wills, T., McCarthy, V., Murphy, S., McCarthy, J., Cummins, H., Madden, D. and Hegarty, J. (2020) ‘Ethical frameworks for quality improvement activities: An analysis of international practice’, International Journal for Quality in Health Care, mzaa092. doi: 10.1093/intqhc/mzaa092
Link to publisher’s version
Copyright
© 2020, the Authors. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved. This is a pre-copyedited, author-produced version of an article accepted for publication in the International Journal for Quality in Health Care, following peer review. The version of record [Naughton, C., Meehan, E., Lehane, E., Landers, C., Flaherty, S. J, Lane, A., Landers, M., Kilty, C., Saab, M. M., Goodwin, J., Walshe, N., Wills, T., McCarthy, V., Murphy, S., McCarthy, J., Cummins, H., Madden, D. and Hegarty, J. (2020) ‘Ethical frameworks for quality improvement activities: An analysis of international practice’, International Journal for Quality in Health Care, mzaa092, doi: 10.1093/intqhc/mzaa092] is available online at: https://doi.org/10.1093/intqhc/mzaa092