Referral of patients with cancer for participation in randomized clinical trials: ethical considerations.

Physicians with patients with cancer may be faced with two conflicting ethical obligations. One is to contribute to the advancement of scientific knowledge. Among the ways available to respond to this duty is to refer patients for participation in RCTs. The second obligation is to serve the health interests of the individual patient. When these two duties conflict, the latter obligation to the individual takes priority. In the words of the Declaration of Helsinki, "Concern for the interests of the subject (patient) must always prevail over the interests of science and society." Quite often there is no conflict. The patient can pursue his or her health interests most effectively by enrollment in an RCT. In such cases, the referring physician can contribute to the success of the patient's participation in the RCT by explaining what the patient can expect to experience as a patient-subject. It is usually important to explain that referral does not necessarily entail severing the original doctor-patient relationship.