KIE: The New York Supreme Court for New York County determined that a state regulation allowing substituted consent to research on mentally ill individuals by a spouse, parent, adult child or sibling, guardian, or authorized committee did not apply to nonfederally funded research. The court was asked by a group of involuntary state mental patients to decide on the validity of state regulations concerning participation in potentially high risk experimentation without consent. The patients, who were incapable of giving informed consent, claimed that their right to refuse treatment based on autonomy, privacy, due process, and equal protection was violated by provisions allowing substituted consent by third party decision makers. The court interpreted federal regulations on research and state regulations on public health and mental health as they applied to both federally funded and nonfederally funded, possibly therapeutic and nontherapeutic, research using non-FDA approved psychotropic drugs that could cause stroke, heart attack, convulsions, hallucinations, or death. The court found first, that the state mental health regulations covered the care, treatment, and rehabilitation of the mentally ill generally; second, that the state public health regulations specifically governed research on human subjects; and third, that the federal regulations controlled federally funded research unless state or local law provides additional protection. But in this case the state public health regulations did not apply to the federally funded research due to an exemption by the state legislature, but did apply to the nonfederally funded research, because not all the federal requirements had been met. The state mental health regulation on substituted consent was enacted without authority and thus was found to be invalid.