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.
Neuroscience research offers promise to find ways to prevent, treat, and cure neurological disorders, psychiatric conditions, and brain and nervous system injuries that inflict great individual and societal burden. Clinical research involving affected individuals is necessary to achieve this worthy goal. However, some potential research participants might have impaired capacity to provide fully informed consent before enrolling in research—an important ethical tenet in the protection of research participants. The Common Rule (the federal policy that governs research supported by 18 federal departments and agencies) requires permission from a legally authorized representative (LAR) if research participants cannot provide their voluntary informed consent. However, federal regulations and state laws lack clarity about who can legally serve as an LAR when a prospective research participant lacks consent capacity. This uncertainty can stall important research.
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 ninth recommendation, the Bioethics Commission called for the establishment of clear requirements for identifying LARs for research participation. The Commission recommended that:
State legislatures and federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.
Current laws for designating an LAR to facilitate decisions about medical care vary by state. For example, they differ in describing how LARs should make decisions on behalf of patients in the clinical context and who can serve as an LAR. Very few of these state laws address decisions about enrollment in research.
Within the current legal and regulatory framework, uncertainty and lack of clarity remain regarding ethically acceptable research involving participants with potentially impaired consent capacity. Using an LAR is one important way to facilitate inclusion of participants with impaired consent capacity in research, ensuring the just distribution of the benefits that might accrue to those affected by the disorder under study. Using an LAR also can help protect participants from exploitation, because loved ones or caregivers who have been designated as LARs are often the best proxy for representing participant interests. Federal regulatory bodies could endorse an existing list of who can serve as an LAR—for example, the Secretary’s Advisory Committee on Human Research Protections’ (SACHRP) recommended list—and explicitly permit researchers and institutional review boards to rely on that list. Alternatively, state legislatures that have not already done so could draft their own priority lists for LARs for research, eliminating the need to rely on lists included in laws pertaining to medical treatment. The Bioethics Commission acknowledged that clarity in identifying LARs will promote the ethical conduct of vital research by helping researchers and IRBs remain accountable to a clear set of ethical and legal standards for enrolling participants with impaired consent capacity in research.
Gray Matters, Vol. 2 and all other Bioethics Commission reports are available at Bioethics.gov.