Research involving patients. Summary and recommendations of a report of the Royal College of Physicians.

The careful study of disease as it occurs in patients, and the equally careful scrutiny of the effects of treatment, are an indispensable part of the continuing process of improving the efficiency of diagnosis and the effectiveness of treatment. Most patients realise that experience gained from their own case may contribute to their personal benefit or to that of society and, if asked, readily agree to take part in research into their condition. Accordingly, a patient who willingly participates in research has the status of a volunteer similar to that of a healthy person so that some of the questions relating to selection, consent, conduct of research and compensation in the event of injury are similar to those addressed in the College's report on Research in healthy volunteers, published in 1986. It is important to realise, however, that the patient is in a position of at least partial dependence which may affect the degree of voluntariness of collaboration, and also that there is a risk that enthusiasm on the part of the researcher could lead to undue persuasion or incomplete declaration of the facts. Furthermore, the patient's ability to give consent to participate in research may be impaired by illness. For these and other reasons, the College has prepared a separate report addressing the special problems of Research involving patients. A balance has to be struck between the benefits which may flow from properly conducted research, and the risk of infringing the autonomy, or of causing harm to the individual patient.(ABSTRACT TRUNCATED AT 250 WORDS)