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11/05/2014

Bioethics Commission Deliberates Consent Capacity

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is devoting the majority of today’s public meeting in Salt Lake City to discussing potential neuroscience-related recommendations that it could offer to President Obama.

This morning, Bioethics Commission Chair Amy Gutmann, Ph.D., noted that three areas have emerged throughout the public meetings at which the Bioethics Commission has discussed ethical issues related to neuroscience. They are cognitive enhancement, consent capacity, and law and neuroscience. A list of Commission meetings relevant to neuroscience can be found here on bioethics.gov.

After spending the second half its morning discussing cognitive enhancement, the Bioethics Commission moved on to discuss consent capacity, specifically research with participants whose capacity is potentially diminished or absent. Many of the conditions that neuroscientists study can affect a person’s capacity to consent to research.

“To generate knowledge about and treatments for these conditions, affected individuals must be included in research – critically, with ethical safeguards in place,” said James W. Wagner, Ph.D., Bioethics Commission Vice Chair. “Several ethical considerations arise. For example, how do we ensure adequate protections for research participants with impaired capacity? What procedures should be in place to assess consent capacity? And how might we address stigma associated with impaired consent capacity?” Wagner asked.

Wagner asked Commission Members Daniel P. Sulmasy, M.D., Ph.D., FACP, and Christine Grady, R.N., Ph.D, to help frame the discussion.

Sulmasy suggested that the Bioethics Commission consider diminished capacity not only in the research setting but in the clinical setting as well. He noted that research on clinical capacity is largely based on clinical exams of patients. Instead of viewing capacity solely as an issue in neuroscience research, it could be treated as a topic of neuroscience research. Such research, he said, could “help us better understand what capacity is from a scientific point of view, how to assess it, and how to assess it again along a very complicated continuum…and, if there are ways, how to improve or restore capacity.”

Grady addressed some of the legal issues around capacity. She observed that capacity is not a static condition; it changes. Therefore researchers need to keep in mind that even after a person with diminished capacity gives consent, there needs to be ongoing capacity assessment as additional decision points arise.

She also noted that, in practice, laws regarding capacity and decision-making are made at the state level, so there is little uniformity. Furthermore, very few state laws explicitly address capacity to make decisions regarding research participation; most are geared toward medical decisions.

Grady also noted that surrogates are frequently viewed as a solution for decision-making issues, but that there is a need for greater clarity around the appointment of legally authorized surrogates to act on behalf of persons with diminished capacity. “Who should be able to serve as a legally authorized representative for the purposes of enrolling people in research?” she said.

The Bioethics Commission will spend its last session today discussing law and neuroscience.

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