This guide, which was updated in October 2025, is intended to help those responsible to review and develop arrangements for the effective ethics oversight of quality improvement and clinical audit activities.
Derived from an extensive search and analysis of published literature on ethics and quality improvement or clinical audit carried out by Healthcare Quality Quest, it describes:
- What’s involved in ethics and how ethical principles may apply
- Why healthcare organisations should provide for ethical oversight
- The difficulty in distinguishing between a research and a QI or clinical audit project as the basis for ethical review.
In summary, this guide states that ethical principles applied to the concept of QI should require every project, clinical audit or service evaluation to meet the following criteria:
- Favourable benefit/risk balance
- Scientifically valid
- Equitable and reflecting priorities
- Value
- Awareness of conflict of obligation to patients.
It also contains a summary of the types of ethical actions for QI, clinical audit and service evaluation, as well as top tips for the successful management of ethical issues.
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