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. The report provides guidance for all concerned—including patients, researchers, doctors, nurses and other health workers, sponsors of research, Research Ethics Committees and the institutions in which research takes place. The general public, too, may find this report useful. This report should be read in conjunction with the second edition of the College's Guidelines on the practice of ethics committees in medical research involving human subjects, which is being published at the same time as this report. The Guidelines describe the contribution and working of medical Research Ethics Committees and are designed to assist those committees in their work. Necessarily, many of the issues are common to these two publications, particularly those concerned with consent given by patients to participate in a research study, and the conduct and monitoring of research on human subjects. This report considers all forms of research in patients, whether they involve the study of treatment which may benefit individual patients (therapeutic research) or the acquisition of knowledge which can be of no immediate benefit to the patient (non-therapeutic research). The discussion of medical research in this document includes research involving surgical procedures. It does not include fetal tissue. Particular attention is paid to potentially vulnerable groups of patients such as unborn babies, children, elderly people, patients suffering from mental illness or handicap, and patients in custody. The report also gives consideration to special cases such as research in severely ill or unconscious patients, or research into sudden unexpected events in which it may be difficult to obtain consent for the investigation. Arrangements for compensation in the event of injury occurring as a result of participating in research are also considered, as is the need to protect the patient's confidentiality.