Research Participant Suicide
A research participant died during a study on depression. An FDA audit found many serious errors and sent a warning letter and the study was put on hold.
On March 26, 2024, the FDA sent a warning letter to a psychiatrist clinical investigator. He was informed "of objectionable conditions observed during the U.S. Food and Drug Administration inspection conducted at your clinical site between December 19, 2022, and January 10, 2023." The warning letter had a long history.
The story was reported in the New York Times on August 10, 2023:
Federal regulators have suspended research on human subjects at the Columbia-affiliated New York State Psychiatric Institute, one of the country’s oldest research centers, as they investigate safety protocols across the institute after the suicide of a research participant....
It is unusual for the U.S. regulatory office to suspend research, and this suggests that investigators are concerned that potential violations of safety protocols occurred more broadly within the institute. Almost 500 studies, with combined budgets totaling $86 million, are underway at the institute, according to its website.
The inquiry followed the death by suicide of a person enrolled in a study led by Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University who was testing a drug for Parkinson’s disease, levodopa, as a treatment for depression and reduced mobility in older people.
As a former Institutional Review Board Chair, this triggered thoughts I'd like to share on:
- Unethical Protocols & IRB Role
- Meticulously Follow the Protocol
- Clinical Investigator Responsibility is 100%
- Sponsor Responsibility
- Clinical Research Coordinator Responsibility
- Institutional Responsibility
- Deaths in Medical Research
