A psychiatry researcher who received a warning letter from the U.S. Food and Drug Administration earlier this year committed research misconduct, another federal watchdog found.
Bret Rutherford, formerly a research psychiatrist at the New York State Psychiatric Institute and Columbia University, “engaged in research misconduct by recklessly falsely reporting that all human research subjects met the inclusion/exclusion criteria for late-life depression studies,” according to a case summary from the U.S. Office of Research Integrity (ORI) published today.
As The Transmitter previously reported, a suicide that occurred during one of Rutherford’s trials in 2021 was followed by a suspension of his research a few months later. The U.S. Office of Human Research Protections subsequently halted all federally funded research involving human participants at the institute in June 2023 and launched a review of its research practices.
The ORI’s findings detail how in five published papers, Rutherford reported that 45 research participants were eligible for clinical studies, when in fact they were taking antidepressants or other medications that should have excluded them from participation. Rutherford also included 15 participants who took medications during a 28-day washout period before the trial when they were not supposed to be taking the medications, and he reported full washout periods for 8 participants who underwent shorter periods.
The false reporting affected “the reported clinical research methods and results” of the five articles, the ORI’s finding stated. Three of the articles have been retracted, and the other two have been corrected. The Transmitter previously reported on the corrections and two of the retractions, which reference protocol violations in a clinical trial of whether levodopa, a drug for Parkinson’s disease, could help older adults with depression.
The third retraction, of a paper about a levodopa trial published in Neuropsychopharmacology, appeared in March. The retraction notice stated that the authors had retracted the article “because they have found deviations from the approved protocols supplying data for this analysis.”
Rutherford agreed to a three-year ban on U.S. government funding, effective 27 September 2024, followed by a three-year period of supervision for any research conducted with funding from the U.S. Public Health Service, which includes the National Institutes of Health.
Rutherford did not respond to The Transmitter’s request for comment.
This article is a collaboration between The Transmitter and Retraction Watch, a nonprofit news outlet that covers research misconduct and related issues. Ivan Oransky, editor-in-chief of The Transmitter, is the volunteer co-founder of Retraction Watch.
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