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)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...) by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)