The US Department of Health and Human Services has suspended research studies involving human subjects at a psychiatric institute affiliated with Columbia University after the suicide of a research participant, according to research documents.
A spokesperson for HHS told CNN on Thursday the agency's Office for Human Research Protections was investigating the psychiatric institute "and has restricted its ability to conduct HHS-supported human subject research."
"The Office for Human Research Protections (OHRP) is committed to protecting the rights, welfare, and well-being of people participating in research conducted by or supported by HHS. OHRP takes very seriously the protection of people who volunteer for research studies and has procedures to ensure that those protections are in place," the HHS spokesperson said in a statement to CNN.
The New York State Psychiatric Institute, which is affiliated with Columbia University, said it voluntarily paused all research studies involving human subjects in early June.
The investigation began after reports that a participant in a study testing a Parkinson's drug for late-life depression died by suicide while enrolled in the study, according to a research document held by the US National Library of Medicine. The patient was part of a group of participants receiving a placebo rather than the medication, according to research documents.
When asked about the patient's reported suicide, the psychiatric institute said it is unable to "provide specific details about any individual involved in a research study."
The study was led by Dr. Bret R. Rutherford, who was an associate professor of psychiatry at Columbia University. It was funded by the National Institute of Mental Health. Rutherford's research has received about $15 million in funding from NIMH since 2010, according to the US National Institutes of Health database.
According to New York State Psychiatric Institute, Rutherford resigned from his position there effective June 1, and he is no longer a Columbia faculty member. CNN has attempted to contact Rutherford for comment.
Rutherford began testing the central nervous system drug Levodopa as a medical treatment for late-life depression in 2018, according to documents on clinicaltrials.gov.
The central hypothesis of the institute's study is that Levodopa could help alleviate late-life depression "by enhancing dopamine functioning in the brain and improving cognitive and motor slowing," according to the study's Protocol Summary Form.
For the eight-week trial, Rutherford aimed to recruit 90 adults ages 60 or older who had depressive disorder, decreased processing speed or decreased gait speed, as outlined in the Protocol Summary Form. In total, 51 participants were enrolled, according to documents on the trial.
Of the 51 participants, 20 subjects were found to be ineligible or did not continue in the study after enrolling, and the remaining 31 were divided into two groups, one of which received daily doses of Levodopa while the other was administered placebo doses, as indicated in documents regarding the study.
About two weeks after the New York State Psychiatric Institute's pause, HHS restricted funding for research involving human subjects at the institute, according to a statement. The review is expected to be completed next month, according to an institute spokesperson.
A representative from the NIH, Amanda Fine, said the agency is in close collaboration with the Office for Human Research Protections, which is currently investigating. Fine said the NIH is unable to comment on matters currently under review.
Editor's Note: If you or a loved one have contemplated suicide, call The 988 Suicide and Crisis Lifeline, formerly known as the National Suicide Prevention Lifeline, to connect with a trained counselor.
