On March 26 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second volume of its two-volume report on neuroscience and ethics, Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). In Gray Matters, Vol. 2, the Bioethics Commission recognized the challenging tension between the need for rigorous research on debilitating neurological diseases and psychiatric conditions, and the need to protect research participants who might be vulnerable because of impaired consent capacity.
To make discoveries about the brain and related neurological disorders that will benefit society, neuroscientists need to conduct research. Well-established ethical guidelines generally require that participants give their fully informed consent before enrolling in research. This might not be possible, however, if an individual cannot give consent because of an impaired capacity to do so. In such cases, U.S. regulations allow a legally authorized representative (LAR) to give permission for participation.
In Gray Matters, Vol. 2 the Bioethics Commission makes four recommendations regarding research involving human participants whose consent capacity might be absent, impaired, fluctuating, or in question. In its sixth recommendation, the Bioethics Commission called for the responsible inclusion of participants with impaired consent capacity. Specifically the Commission recommended that:
Researchers should responsibly include individuals with impaired consent capacity who stand to benefit from neuroscience research. Participation, with ethical safeguards in place, can ensure progress aimed at understanding and ameliorating neurological disorders and psychiatric conditions.
The Bioethics Commission acknowledged the need for additional safeguards to ensure that participants with impaired consent capacity are adequately protected. Numerous national panels over the last four decades have attempted to establish uniform guidelines and safeguards to ensure ethical research with adults who have impaired consent capacity. Despite these efforts no federal regulations specifically address research with this population.
Protections might include robust initial and ongoing assessment of consent capacity; methods to improve informed consent processes to accommodate participants’ needs, for example, including audiovisual means and paced verbal instructions; methods to respect participant assent and dissent when consent capacity is partial or in question; and clear parameters and procedures for obtaining the permission of an LAR when a participant lacks consent capacity. In addition, use of research advance directives (a set of written instructions articulated by an individual to appoint a proxy and direct their involvement in future research) and stakeholder engagement can provide protection.
Neuroscience research is a principal means of promoting progress and benefiting populations affected by neurological disorders and psychiatric conditions, including those associated with impaired consent capacity. Substantial progress in understanding many of these disorders has been possible because of the advances in research, yet more needs to be done. The Bioethics Commission’s recommendations are intended to promote vital neuroscience research while protecting those with impaired consent capacity.
Gray Matters, Vol. 2 and all other Bioethics Commission reports are available at Bioethics.gov.