Dbs Research In The Decisionally Incapacitated

Individuals with severe psychiatric illness or head trauma, who may become candidates for enrollment in DBS clinical trials, may lack decision-making capacity. When these individuals are unable to engage in the informed-consent process, they are considered a vulnerable population and in need of special protections. While surrogates are generally allowed to consent to therapeutic procedures, their authority is more constrained when permission is sought for enrollment in a clinical trial unless they have been authorized through an advance directive for prospective research.

The National Bioethics Advisory Commission (NBAC), in its 1998 report, Research Involving Persons with Mental

Disorders That May Affect Decisionmaking Capacity, proposed guidelines to regulate the conduct of research on individuals who are unable to provide consent. While the NBAC recommendations were never enacted into law, they do point to the ethical complexity of neuromodulation research in several cases: when subjects lack decision-making capacity, when the research has yet to demonstrate the prospect of direct medical benefit, and when the research poses more than minimal risk.

BALANCING THE PROTECTION OF HUMAN SUBJECTS WITH ACCESS TO RESEARCH. When considering the balance between the protection of human subjects and access to neuromodulation research, it is important to ask whether current ethical norms deprive decisionally incapacitated individuals of interventions that have the potential to promote self-determination by restoring cognitive function (Fins, 2000). While the ethical principles of respect for persons, beneficence, and justice require that decisionally incapacitated subjects are protected from harm, these principles can also be invoked to affirm a fiduciary obligation to promote well-designed and potentially valuable research for this historically underserved population (Fins and Miller; Fins and Schiff). This justice claim becomes especially compelling as developments in neuromodulation demonstrate growing clinical potential (Fins, 2003).

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