Advance directives for subjects of research who have fluctuating cognitive impairments due to psychotic disorders (such as schizophrenia).

Current and coincident biomedical advances make this an opportune time to encourage research with subjects who have fluctuating cognitive impairments due to disorders like schizophrenia. Effecting research with a heterogeneous population who may have impaired decision-making capacity that diminishes their autonomy, while honoring their liberty and safeguarding their wellbeing, entails a rigorous moral charge. Federal regulations and guidelines in regard to research involving this population are insufficient and make for additional obstacles. Use of research advance directives that allow for the appointment of surrogate decision-makers and delineate safeguards for the research subjects may afford protection both for subjects and researchers.