March 17, 2014 | Posted By John Kaplan, PhD

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.” That is, they are promulgating an obligation on the part of patients to participate in clinical research as research subjects. Moreover they now are advocating that this obligation to participate in these studies could take place without informed consent. It is not conceivable to me that it would be progress to enter a patient into a comparative effectiveness trial of two medications, one in which the patients therapy would be determined by a randomization protocol, without their informed and expressed permission.

I object to this proposal for multiple reasons. First and foremost I feel that we need to respect more that the rights and dignity of the patients. We have to respect the patients themselves and we have to respect them because they are persons. It is much too soon to forget the relatively recent atrocities committed in the name of biomedical research by unscrupulous investigators, many who did not seem to recognize that they were unscrupulous. It may always be too soon. Finally we have to realize that the type of medical care paradigm described by Faden, Beauchamp, and Kass does not yet exist, it is hypothetical.  Perhaps I will feel differently if they ever do exist.  Perhaps not.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.