Abstract

KIE: A British surgeon contends that the requirement of informed consent for randomized, controlled clinical trials of alternative therapies would result in a double standard, because physicians are free to conduct informal, unreliable comparisons of different treatments without such a requirement. He asserts that patients' rights are not seriously endangered in trials that are scrutinized by award-granting bodies and local ethics committees to ensure that their aims are to improve quality of care and to increase knowledge. Baum argues that, while informed consent promotes respect for patient autonomy and increases understanding of the illness and treatment, it is chiefly a legalistic device to shift unpleasant physician responsibilities onto the patient and will result in fewer patients entering clinical trials because of negative attitudes induced by uncertainty of treatment and diminished confidence in the physician.