All of these activities, whether for pure research, for quality management or for audit, will involve people who are uniquely identifiable as patients of this Trust. This can pose some difficult problems in terms of ethical considerations. There is a conflict between the need to access and incorporate the views of people who use NHS services and the need to protect the confidentiality of those same people who are patients of this Trust. According to this circular, researchers within the NHS will be denied access to patients without such approval of this committee. These guidelines are intended to assist staff, who may wish to involve users in their research, audit or quality initiatives, to decide whether formal ethics approval, chairman s approval or some initial advice, should be sought.
Research is a systematic investigation which aims to increase the sum of knowledge.
It may involve experiments on human subjects, whether patients, patients as volunteers or healthy volunteers. It may involve allocating patients randomly to different treatments. It may involve a completely new treatment or an extra disturbance or work beyond that required for normal clinical management. It usually involves an attempt to test a hypothesis and it may apply strict selection criteria. Conversely, it is good clinical practice to be aware of the results of treatment or any other intervention or the results of no treatment.