The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Who Can Consent to Neuroscience Research?

In the fourth series of the presentations from today’s public meeting on neuroscience and related ethical issues, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) addressed questions related to the capacity to consent to neuroscience research.

The Bioethics Commission heard from two experts in the field: Jerry Menikoff, M.D., J.D., the Director of the Office for Human Research Protections at the U.S. Department of Health and Human Services; and Paul S. Appelbaum, M.D., the Elizabeth K. Dollard Professor of Psychiatry, Medicine, & Law, and the Director of the Division of Psychiatry, Law, and Ethics in the Department of Psychiatry at the College of Physicians and Surgeons of Columbia University.

Menikoff focused on the guidance provided by the Office of Human Research Protections about research with those with diminished or diminishing capacity—such as those who have advanced Alzheimer’s disease—and their ability to consent to taking part in neuroscience research.

“Generally, a researcher has to obtain a legally effective informed consent of the subject or the subject’s legally authorized representative,” said Menikoff. However, he went on to explain that while the definition does not sound complicated, its implementation can be.

“If you conclude that they did have the capacity and it’s correct, you’re pretty good,” continued Menikoff. “Once you’ve concluded they do not have the capacity, we are now in the area, as you all know, where the rules are very unclear.”

Appelbaum—who is also a research psychiatrist at the New York State Psychiatric Institute and an affiliated faculty member at Columbia Law School, where he directs Columbia’s Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetic—discussed how to assess decisional capacity in neuroscience research.

“There may be, but is not necessarily going to be, decisional impairment in people with neuropsychiatric illness,” said Appelbaum. “You can screen for incapacity reliably and validly.”

Appelbaum concluded, “Although we very much want to protect incapable subjects from making bad decisions, we need to balance that desire against the real societal interest of having people make their own decisions.”

With today’s discussions, including this session on capacity to consent, the Bioethics Commission is working to address President Obama’s request that it identify core ethical standards to guide neuroscience research and address potential ethical dilemmas arising from the application of neuroscience research.

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About blog.Bioethics.gov

This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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