By Nicolle K. Strand, JD, M.Bioethics, research analyst at the Presidential Commission for the Study of Bioethical Issues
Earlier this year, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second part of its report on neuroscience and ethics—Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The report examines in depth several controversial topics that bring ethical issues to the fore, including cognitive enhancement, neuroscience and the law, and the ethical conduct of research with participants with impaired capacity for informed consent.
The challenge of impaired consent capacity has been a perennial issue in research ethics for decades yet it is nonetheless well-placed in a report about contemporary neuroscience. Neuroscientists commonly study the very diseases that can cause impairments in decision-making capacity, making informed consent difficult or impossible. These include head trauma, stroke, dementia, schizophrenia, and major depression, among others. Neuroscience research can promote progress towards understanding and alleviating these conditions, but that progress requires the participation of persons affected. Informed consent is a central tenet of research ethics and, in its absence—when working with participants whose capacity is impaired—researchers and IRBs need clear guidelines for whether and how to proceed ethically.
It is vital to find ways whenever possible to ethically and responsibly include individuals with impaired consent capacity in research, but researchers must also vigilantly protect participants from exploitation and abuse. In addition, researchers must guard against and mitigate stigma and harmful assumptions about individuals based on diagnoses or impaired consent capacity.
With all of this in mind, Gray Matters, Vol. 2 explains the long and complex history of national bodies crafting guidance about impaired consent capacity, describes the current regulatory framework to protect participants, and elucidates additional protections that can be employed when consent capacity is impaired or in question. These additional protections include using improved assessment techniques, respecting assent and dissent, engaging independent consent monitors, limiting acceptable levels of risk, requiring legally authorized representatives, honoring research advance directives, and ensuring meaningful stakeholder engagement. The Bioethics Commission made four recommendations in this area, emphasizing responsible inclusion, and calling for clearer requirements for identifying legally authorized representatives to provide permission on behalf of participants when consent capacity is impaired.
As a part of its continued efforts to distribute its findings and recommendations to relevant stakeholders, the Bioethics Commission has developed educational materials to accompany its reports. Included among the Gray Matters educational material is a primer for researchers on neuroscience and consent capacity. Researchers can use the primer to aid ethical decision making and ensure that they have considered and implemented appropriate safeguards. All of the Bioethics Commission’s materials are free and available at http://bioethics.gov/education.