Three eminent bioethicists have proposed, in an article published in the New England Journal of Medicine last month, that some comparative effectiveness research should not require informed consent from patients. I do not agree, at least not yet. Drs. Faden, Beauchamp, and Kass have provided a thoughtful justification for their position. However the circumstances in which this new scenario would work does not yet exist.
Let’s be more specific. These authors have been among those advocating what they term a learning healthcare system which blurs the line between clinical care and research but predicates both on a common set of research and clinical ethics principles. Research and medical practice allows the system to learn and implement improvements. They lay down seven ethical principles to guide such a health care system. The first of these principles is to “respect the rights and dignity of patients.” It does not seem to me that you can meaningfully respect the rights and dignity of people and use them in clinical trials, even comparative effectiveness trials, without their permission. The seventh principle, “contribute to the common purpose of improving the quality and value of clinical care and health care systems” seems in some ways laudable but is dubious in the context of respect for rights. The first six principles define obligations of the participants in the health care system. This seventh principle describes an obligation on the patients to “participate in certain types of learning activities that will be integrated with their clinical care.”
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