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Informed consent for comparative effectiveness trials.

To the Editor: We reject the argument by Faden et al. (Feb. 20 issue)1 that certain research with randomized assignment of interventions can be conducted without the consent of patients. Whether or not these studies are embedded in the routine processes of medical care, randomization equals research, and such studies are subject to all of the standard requirements for research, including approval by an institutional review board and patient consent. Patients have the right to choose whether to participate after they have been informed about the interventions, risks, and potential benefits and alternatives, irrespective of the risk levels of the interventions. Patients are the ultimate arbiters of what is done to them. Integrated consent, as proposed by Kim and Miller in the same issue of the Journal,2 is fine in theory but difficult in practice. Few studies involve the comparison of agents delivered in the same way with similar side effects. In most research settings, written disclosure of the treatments being compared, including their risks and potential benefits, is necessary. Written documentation of the patient’s agreement to be a research subject remains essential.