A former research psychiatrist at Columbia University, Bret Rutherford, has been found to have committed research misconduct, according to the U.S. Office of Research Integrity (ORI). The investigation revealed that Rutherford recklessly and falsely reported that human research subjects met the inclusion/exclusion criteria for late-life depression studies, compromising the integrity of multiple clinical trials and published papers.
Details of the Misconduct
The ORI's findings indicate that Rutherford reported 45 research participants as eligible for clinical studies when they were, in fact, taking antidepressants or other medications that should have excluded them. Furthermore, 15 participants took medications during the 28-day washout period, and eight participants had shorter washout periods than reported. These discrepancies significantly affected the reported clinical research methods and results of five articles.
Impact on Published Research
The false reporting led to the retraction of three articles and the correction of two others. These articles included studies on the use of levodopa, a drug typically used for Parkinson's disease, as a potential treatment for depression in older adults. The retractions and corrections highlight protocol violations and deviations from approved methodologies.
Consequences and Penalties
As a result of these findings, Rutherford has agreed to a three-year ban on receiving U.S. government funding, effective September 27, 2024. Following this ban, he will be subject to a three-year period of supervision for any research conducted with funding from the U.S. Public Health Service, including the National Institutes of Health.
Background and Context
This misconduct came to light following a suicide that occurred during one of Rutherford’s trials in 2021, which led to a suspension of his research. The U.S. Office of Human Research Protections subsequently halted all federally funded research involving human participants at the New York State Psychiatric Institute in June 2023 and initiated a review of its research practices. The FDA had also issued a warning letter earlier in the year regarding objectionable conditions at the institute.
Specific Retractions
One notable retraction was a paper published in Neuropsychopharmacology concerning a levodopa trial. The retraction notice stated that the authors retracted the article due to deviations from the approved protocols supplying data for the analysis. This incident underscores the critical importance of adhering to research protocols and maintaining data integrity in clinical trials.
