Federal Regulators Suspend Human Subject Research at New York State Psychiatric Institute

Investigation of Safety Protocols Prompted by Participant Suicide

Federal Research Suspending Research

Federal regulators have halted research on human subjects at the New York State Psychiatric Institute, an esteemed research center affiliated with Columbia University. The investigation is focused on safety protocols at the institute following the suicide of a research participant. The U.S. Department of Health and Human Services’ Office of Human Research Protections is leading the investigation, which has led to restrictions on the institute’s ability to conduct research supported by the department.

Institute Temporarily Paused Studies

Approximately two weeks before the federal order, the institute voluntarily paused all studies involving ongoing interactions with human subjects. This decision affected 417 studies, 198 of which are still ongoing, with 124 receiving federal funding.

Potential Violations of Safety Protocols

The suspension of research is uncommon and suggests that regulators are concerned about potential safety protocol violations across the institute. The institute is currently conducting almost 500 studies with a combined budget of $86 million.

Triggered by Suicide of Research Participant

The investigation was prompted by the suicide of a participant in a study led by Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University. The study aimed to test the drug levodopa for its efficacy in treating depression and reduced mobility in older individuals with Parkinson’s disease.

Resignation of Dr. Rutherford

Dr. Rutherford resigned from his position at the institute and is no longer a faculty member of Columbia’s psychiatry department. The institute’s director of communications, Carla Cantor, confirmed his resignation. Dr. Rutherford has not responded to requests for comment.

Inquiry and Restructuring

The institute has been working with federal agencies to assist in the investigation and has since restructured and strengthened its research compliance and monitoring programs. It is currently seeking federal approval for a new research safety plan to resume federally funded studies. Additionally, a safety review of non-federally funded human research studies is underway, set to be completed next month.

Collaboration with NIH

The National Institutes of Health (NIH) is closely collaborating with the Office of Human Research Protections on the investigation. However, they are unable to discuss matters under review.

Concerns Over Study Conduct and Results

Controversial Clinical Trial

The trial led by Dr. Rutherford, testing the drug levodopa for late-life depression, began in 2018 and received $736,579 in funding from the National Institute of Mental Health. The trial aimed to recruit adults over 60 with mild to moderate depression and reduced mobility. However, the trial faced challenges in recruitment and had relaxed criteria for enrollment.

Results and Retractions

The trial reported promising results that were subsequently published in scientific journals, highlighting the potential benefits of levodopa for depression treatment. However, this year, retractions were issued for several articles from Dr. Rutherford’s laboratory due to methodological errors. One specific flaw identified was the inclusion of subjects who had recently stopped taking antidepressants, contrary to the study’s protocol.

Prolific Researcher and Controversial Practices

Dr. Rutherford, a prolific researcher who received numerous grants for his work, has been criticized for his laboratory’s lack of rigor. Emily Roberts, a former research assistant who managed the clinical trial’s first year, expressed disillusionment with the research practices of the institute and chose to leave the field as a result.

Rare Instances of Research Halts

Universities and Institutes Facing Research Suspension

Halting research across an entire institution is a rare occurrence. In the past, the University of Minnesota suspended enrollment in psychiatric drug trials after a patient’s suicide raised concerns about the study’s protocol. Johns Hopkins University also faced suspension of federally financed medical research following the death of a volunteer in a clinical trial.

Resources for Suicide Prevention

Seeking Help

If you or someone you know is struggling with thoughts of suicide, please reach out to the National Suicide Prevention Lifeline at 1-800-273-8255 (TALK) or visit SpeakingOfSuicide.com/resources for additional resources.