Human subject research at the New York State Psychiatric Institute, connected with Columbia University and one of the country’s oldest research centres, has been paused until the results of an investigation of the institute’s safety measures after the suicide of a study participant.
On Wednesday, Kate Migliaccio-Grabill, a spokesperson for the United States Department of Health and Human Services, confirmed that the agency’s Office for Human Research Protections was conducting an investigation into the psychiatric institute.
About two weeks before the federal injunction, on June 12, the institution “voluntarily paused all studies that included ongoing interactions with human subjects,” according to Carla Cantor, the organisation’s head of communications. There were a total of 417 studies impacted by the ruling, with 198 maintaining active enrollment. 124 of them are supported by the federal government.
Research has been suspended, which is rare for the U.S. regulatory agency, suggesting that there may have been widespread breaches of safety rules throughout the organisation. According to the institute’s website, there are around 500 active investigations with a total budget of $86 million.
An investigation was launched when a participant in a research conducted by Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University, committed himself while using the Parkinson’s disease medicine levodopa to address depression and mobility issues in the elderly.
According to Ms. Cantor, Dr. Rutherford resigned from the institution on June 1 and is no longer a member of the psychiatry department at Columbia University. Dr. Rutherford ignored messages left at his home and workplace seeking comment.
Ms. Cantor, when asked about the alleged suicide, declined to acknowledge that a death had happened during a clinical experiment, citing health privacy rules as the reason the institute could not share any information about research participants.
She revealed that the state’s Office of Mental Health, which runs the institution, had submitted a revised research safety plan to the federal government for approval so that federally sponsored studies may continue. Additionally, it is next month that it will finish its safety evaluation of privately sponsored human research trials.
An external audit of all federally sponsored research was sought by the NIH after the first audit of the Rutherford facility, she added.
Amanda Fine, an N.I.H. spokesperson, said the organisation is cooperating fully with the Office of Human Research Protections, which is conducting an investigation. She stated N.I.H. policy prohibits them from commenting on investigations.
Spectrum, a news site devoted to autism studies, had already reported on the subject’s suicide. However, the U.S. agency’s decision to demand a wider stop to additional investigations was not previously made public.
Starting in 2018, with $736,579 from the National Institute of Mental Health, a study with levodopa for late-life depression sought to enrol 90 persons over the age of 60 who had mild to moderate depression and a slower gait.
Records submitted to government monitoring authorities show that the team started with 61 members but lost 20 due to attrition or eligibility issues. The remaining 31 were randomly split into two groups, one receiving levodopa and the other receiving a placebo.
Researchers reported the suicide death of a participant in the placebo arm of the study on the website clinicaltrials.gov under the title “serious adverse events.”
Dr. Rutherford and his co-authors published many publications based on the research, noting that the administration of levodopa, which elevates dopamine levels, improved mobility, processing speed, and the absence of depressive symptoms.
Johns Hopkins University was forced to halt almost all federally funded medical research involving human beings in 2001 when a volunteer died after inhaling an unauthorised asthma medication, per an order from the Office for Human Research Protections.
Human subject research at the University of Oklahoma was briefly halted in 2000 after an inquiry revealed that patients had been injected with a vaccine created by untrained laboratory staff.
