Federal regulators have halted research involving human subjects at the New York State Psychiatric Institute, an affiliate of Columbia University, as they investigate safety protocols following the suicide of a research participant. The U.S. Department of Health and Human Services’ Office of Human Research Protections is conducting the investigation and has restricted the institute’s ability to conduct government-supported human subject research. The decision to suspend research is unusual and suggests that safety protocol violations may have occurred throughout the institute. The institute has voluntarily paused all studies involving human subjects and is currently reviewing its research compliance and monitoring programs.
The investigation began after the death of a participant in a study led by Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University. Dr. Rutherford was testing the drug levodopa as a potential treatment for depression and reduced mobility in older individuals. Dr. Rutherford resigned from the institute on June 1 and is no longer a faculty member at Columbia University. The institute has not confirmed the reported suicide, citing health privacy laws.
The institute is prioritizing the health and safety of individuals involved in its research programs. It is working with federal agencies to conduct an audit and has restructured and strengthened its research compliance and monitoring programs. Additionally, the institute is seeking federal approval for a new research safety plan to resume federally funded studies and is conducting a safety review of non-federally funded research.
The trial of levodopa for late-life depression, which began in 2018 and received funding from the National Institute of Mental Health, aimed to recruit adults over the age of 60 suffering from mild to moderate depression and a slowed gait. The trial was temporarily suspended in 2022 and terminated in 2023. Three scientific journals have retracted articles from Dr. Rutherford’s laboratory due to methodological errors.
The regulator’s decision to halt research across the institute is rare. In the past, research enrollment has been suspended at other institutions following critical incidents, such as the 2004 suicide of a patient enrolled in a clinical trial at the University of Minnesota and the death of a volunteer at Johns Hopkins University in 2001.
The investigation into the New York State Psychiatric Institute is ongoing, and the institute is working closely with regulatory agencies to address any concerns and ensure the safety of its research participants. If you or someone you know is struggling with thoughts of suicide, please seek help from a helpline or visit resources for support.