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.

The SIMPLER Nutrition Pathway for Fragility Fractures: A Quality Improvement Initiative

“…A final challenge is the need to recognize national and international differences in the level of oversight required for quality assurance, improvement, and knowledge translation activities [ 127 ]. Confusion and differences may arise regarding when and where the SIMPLER implementation crosses over from quality improvement to research [ 128 ].…”

The SIMPLER Nutrition Pathway for Fragility Fractures: A Quality Improvement Initiative

“…A final challenge is the need to recognize national and international differences in the level of oversight required for quality assurance, improvement, and knowledge translation activities [ 127 ]. Confusion and differences may arise regarding when and where the SIMPLER implementation crosses over from quality improvement to research [ 128 ].…”

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

“…There is no international consensus and common definitions, which has implications for harmonization of data across countries and for comparing outcomes. The lack of national QI ethics frameworks and best practice guideline is concerning as it presents a “conflict between regulatory systems designed for research and the flexibility required by learning healthcare systems that depend on QI.” 4 From the publication just summarized, it would appear that New Zealand has an approach that could be replicated by other countries.…”

Raising expectations and defining boundaries in quality management scholarship: Strengthening the design, methodology, and reporting of quality-focused work

“…While it is certainly true that many QI and PE projects can be exempted from HREC approval, this would be determined by a project's methodological design rather than the name given to it. 11 For example, QI projects involving randomisation, novel procedures, or excess burden on patients may and often do require ethical review. 12 They are certainly not exempt from a priori internal governance and review, which should be sufficiently sophisticated in procedure to discriminate between what does and does not need referral to a HREC regardless of the methodological design in question or the nomenclature used.…”

The SIMPLER Nutrition Pathway for Fragility Fractures: A Quality Improvement Initiative

“…A final challenge is the need to recognize national and international differences in the level of oversight required for quality assurance, improvement, and knowledge translation activities [ 127 ]. Confusion and differences may arise regarding when and where the SIMPLER implementation crosses over from quality improvement to research [ 128 ].…”

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

“…There is no international consensus and common definitions, which has implications for harmonization of data across countries and for comparing outcomes. The lack of national QI ethics frameworks and best practice guideline is concerning as it presents a “conflict between regulatory systems designed for research and the flexibility required by learning healthcare systems that depend on QI.” 4 From the publication just summarized, it would appear that New Zealand has an approach that could be replicated by other countries.…”

Raising expectations and defining boundaries in quality management scholarship: Strengthening the design, methodology, and reporting of quality-focused work

“…While it is certainly true that many QI and PE projects can be exempted from HREC approval, this would be determined by a project's methodological design rather than the name given to it. 11 For example, QI projects involving randomisation, novel procedures, or excess burden on patients may and often do require ethical review. 12 They are certainly not exempt from a priori internal governance and review, which should be sufficiently sophisticated in procedure to discriminate between what does and does not need referral to a HREC regardless of the methodological design in question or the nomenclature used.…”

The SIMPLER Nutrition Pathway for Fragility Fractures: A Quality Improvement Initiative

“…A final challenge is the need to recognize national and international differences in the level of oversight required for quality assurance, improvement, and knowledge translation activities [ 127 ]. Confusion and differences may arise regarding when and where the SIMPLER implementation crosses over from quality improvement to research [ 128 ].…”

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

“…There is no international consensus and common definitions, which has implications for harmonization of data across countries and for comparing outcomes. The lack of national QI ethics frameworks and best practice guideline is concerning as it presents a “conflict between regulatory systems designed for research and the flexibility required by learning healthcare systems that depend on QI.” 4 From the publication just summarized, it would appear that New Zealand has an approach that could be replicated by other countries.…”

Raising expectations and defining boundaries in quality management scholarship: Strengthening the design, methodology, and reporting of quality-focused work

“…While it is certainly true that many QI and PE projects can be exempted from HREC approval, this would be determined by a project's methodological design rather than the name given to it. 11 For example, QI projects involving randomisation, novel procedures, or excess burden on patients may and often do require ethical review. 12 They are certainly not exempt from a priori internal governance and review, which should be sufficiently sophisticated in procedure to discriminate between what does and does not need referral to a HREC regardless of the methodological design in question or the nomenclature used.…”