Quality improvement (QI) is fundamental to maintaining high standards of health care. Significant debate exists concerning the necessity for an ethical approval system for those QI projects that push the boundaries, appearing more similar to research than QI. The authors discuss this issue identifying the core ethical issues in family medicine (FM), drawing upon the fundamental principles of medical ethics, including principles of autonomy, utility, justice and non-maleficence. Recent debate concerning the application of QI ethics boards is discussed with relevance (...) to primary care and issues such as general practitioner (GP) intentions, the impact of QI on patients and the use of confidential patient data and the impact of dissemination. The authors conclude that a system of QI ethical approval leaves many issues unresolved and potentially creates several barriers to implementing QI. To ensure ethical QI work is generated within FM it is essential for GPs to learn about and engage in more ethical reflection so that they can better judge and resolve these issues. (shrink)