HHS halted all research that involved human subjects at a New York City psychiatric hospital as the agency investigates a drug trial participant's suicide, The New York Times reported Aug. 10.
The agency's Office for Human Research Protections is reviewing safety protocols at New York State Psychiatric Institute and "has restricted its ability to conduct HHS-supported human subject research." In mid-June — before the federal order — the hospital voluntarily paused all of its studies with human subjects.
It's rare for a federal agency to suspend research across an organization, according to the Times. The institute has halted 417 studies.
A study participant in a drug trial, which was testing Parkinson's disease therapy levodopa for depression and reduced mobility in older people, died by suicide, according to a report on clinicaltrials.gov under the "serious adverse events" section. Another subject was hospitalized because of an infection. Both were part of the placebo group.
The study was paused in January and discontinued in May, and the lead author resigned from the hospital June 1, according to the Times.
A spokesperson told the Times the hospital's "top priority is the health and safety of individuals engaged in our award-winning research programs," and the institute "worked to assist federal agencies in their audit and has subsequently restructured and strengthened its research compliance and monitoring programs across the institution."
Three scientific journals have run retractions on methodological errors in the study. One of the identified issues was a failure in the trial's protocol. Study participants were supposed to stop taking their antidepressants for 28 days before starting the new, investigative treatment, but this was not followed for eight subjects.