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Informed Consent for Comparative Effectiveness Trials
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Journal Article
Informed Consent for Comparative Effectiveness Trials
2014
Overview
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 . . .
Publisher
Massachusetts Medical Society
