Clinical audit, the case for ethical scrutiny?

Area of Science:

• Healthcare Ethics
• Medical Audit
• Clinical Governance

Background:

• The UK Government's White paper emphasized medical audit development.
• Audit activities have expanded across health professions, often involving patient contact.
• There is a prevalent view that medical audit lacks ethical dimensions.

Purpose of the Study:

• To argue for ethical scrutiny of medical audit activities.
• To highlight the potential overlap between audit and research.
• To propose criteria for when audit requires external ethical review.

Main Methods:

• Literature review and ethical analysis.
• Comparison of ethical frameworks for research and audit.
• Development of criteria for ethical scrutiny of audit.

Main Results:

• Audit activities can be ethically complex and sometimes indistinguishable from research.
• Existing ethical scrutiny mechanisms for research are not always applied to audit.
• Five criteria are proposed for identifying audit activities needing ethical review.

Conclusions:

• Medical audit, particularly when resembling research, necessitates ethical oversight.
• External ethical scrutiny is crucial for patient protection in certain audit contexts.
• Implementing ethical review criteria will enhance patient safety and trust in audit processes.