• quality improvement
• audit

Most discussions about the ethics of healthcare research focus on the possible harm that could be done to participants. Sometimes such deliberations will highlight tensions between the clinical duty of care to protect the life and health of individual patients to the highest standard and the need to engage in the research that makes improvements in health care possible. Because of the potential risks, patients should not be involved in research unless they have given their informed consent. Equally, they should not be asked to participate unless the project itself has been passed through a process of independent review and its risks assessed. The moral principles for such reviews are summarised in the Declaration of Helsinki. This states, among other things, that consent is only valid if it is based on detailed and appropriate information, that risks should always be proportional to potential benefit, that confidentiality should be protected, and that the interests of individuals should never be compromised solely in order to further the interests of the public.

The ethical review of healthcare research is carried out by research ethics committees (RECs) designed to implement the Helsinki principles. Few now seriously question the moral importance of this work and its centrality for sustaining the trust of research participants. While there may be criticisms of the effectiveness and efficiency of RECs, these …