Consent Required?

May 15, 2014

Berman Institute bioethicists Nancy Kass and Ruth Faden sent shockwaves through the bioethics and healthcare fields earlier this year with their commentary on informed consent, written with Tom Beauchamp, in the New England Journal of Medicine (NEJM).  In brief, the article states that in a mature learning healthcare system, traditional informed consent may not be ethically required for research that compares commonly used treatments. The scholars open by writing:

“Interest in learning health care systems and in comparative-effectiveness research (CER) is exploding. One major question is whether informed consent should always be required for randomized comparative-effectiveness studies, particularly studies conducted in a learning health care system. Our answer to this question is no.”

The February issue of NEJM also contains the opposing view of Scott Y.H. Kim and Franklin G. Miller, who write: “we find the proposal to not disclose to patients the fact of randomization even in low-risk outpatient pragmatic trials (hereafter called the no-consent model) problematic for both ethical and practical reasons.”

Now, NEJM has furthered the public discussion by publishing five letters to the editor on the issue, as well as direct responses from Faden, Kass and Beauchamp addressing their critics. Among them is Ahmed Elsayyad, a sophomore undergraduate student at Johns Hopkins, and the president of the undergraduate bioethics society at the university. Elsayyad writes: “Although policymakers ought to minimize the difficulties researchers and physicians face while conducting their studies, these difficulties are irrelevant to the topic of consent.”

Faden, Kass and Beauchamp respond directly, writing, “Elsayyad rightly says that respecting the dignity of patients should remain fundamental, and it is one of seven core obligations in our Common Purpose Framework. We merely challenge whether written informed consent is always the only or the best mechanism for respecting patients in CER.”

In addition to addressing other letters to the editor regarding their article, Faden, Kass and Beauchamp respond at length to Kim and Miller, starting off by saying that the scholars ‘mischaracterize our view as a “no consent” model.’

As for Elsayyad, Faden and Kass say they appreciate his initiative and publication in NEJM, and hope to hire him as an intern at the Berman Institute this summer.

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Leah Ramsay

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