Why we need ethical oversight of quality improvement projects

The jury is still out on whether ethical oversight is needed for quality improvement projects. Many quality practitioners argue that as long as the quality improvement project is not primarily research, ethical review is unnecessary. In this editorial, I would like to defend the opposite view, that ethical oversight is indeed desirable for most initiatives to improve the quality of health care.Let us redefine the nature of health care. Much of health care would amount to reckless endangerment or even to bodily harm if it were not covered by the tacit covenant between patient and doctor (think of surgery or chemotherapy). Under this covenant, the doctor is allowed to perform potentially dangerous treatments as long as she or he acts solely in the interest of the patient. If the doctor served any master other than the patient’s welfare, his or her actions would be unlawful. This is why strict oversight by an external body is needed when doctors perform research, an activity that aims to produce knowledge for the benefit of society, and not necessarily to help the patient.Clearly, the rule should be: for anything the patient requested you do not need external ethical oversight, for anything else that affects patient care you do. Unfortunately, the rule that is prevalent today has perversely shifted to this: for medical research you need ethical oversight, for anything else you don’t. Several authors have endeavoured to define ‘research’ to delimit the jurisdiction of ethics committees [1–3]. …