Dr. Bret Rutherford, a research psychiatrist formerly at the New York State Psychiatric Institute and Columbia University, falsely reported that all human research subjects met the inclusion/exclusion criteria for late-life depression studies when they did not.  

As a result, the Office for Human Research Protections (OHRP) began an investigation, and the Office of Research Integrity ultimately took action. The FDA also issued a warning letter citing serious non-compliance. Dr. Rutherford’s studies were suspended, his publications were retracted, and he agreed to a three-year ban on U.S. government funding followed by a supervised research period.

The New York State Psychiatric Institute’s IRB also came under scrutiny during this investigation. Listen to a brief podcast episode or read further in links below for more details about this case.

References 

1. Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial. The Transmitter: Neuroscience News and Perspectives. July 31, 2023. Accessed November 14, 2024. https://www.thetransmitter.org/ethics/exclusive-shake-up-at-top-psychiatric-institute-following-suicide-in-clinical-trial/

2. FDA describes ‘objectionable conditions’ at New York State Psychiatric Institute. The Transmitter: Neuroscience News and Perspectives. April 2, 2024. Accessed November 14, 2024. https://www.thetransmitter.org/ethics/fda-describes-objectionable-conditions-at-new-york-state-psychiatric-institute/

3. Former Columbia University psychiatrist committed research misconduct, says federal watchdog. The Transmitter: Neuroscience News and Perspectives. October 8, 2024. Accessed November 14, 2024. https://www.thetransmitter.org/ethics/former-columbia-university-psychiatrist-committed-research-misconduct-says-federal-watchdog/

4. Research C for DE and. New York State Psychiatric Institute IRB - 670989 - 03/21/2024. FDA. March 26, 2024. Accessed November 14, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-york-state-psychiatric-institute-irb-670989-03212024

Show notes

Sources regarding reporting adverse events

• https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-adverse-event-and-unanticipated-problem-reporting-policy

• Adverse Event Reporting to IRBs - Improving Human Subject Protection, Guidance Clinical Investigators, Sponsors, and IRBs

• \https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adverse-event-reporting-irbs-improving-human-subject-protection

UVA IRB sources

• https://hrpp.research.virginia.edu/teams/irb-hsr/researcher-guide-irb-hsr/serious-adverse-events 

• https://hrpp.research.virginia.edu/investigator-responsibilities-selection-subjects

Rutherford et al. Papers:

• Effects of L-DOPA Monotherapy on Psychomotor Speed and [¹¹C]Raclopride Binding in High Risk Older Adults With Depression. Biol. Psychiatry 2019 Aug 1;86(3):221-229. doi: 10.1016/j.biopsych.2019.04.007 (hereafter referred to as "Biol. Psychiatry<> 2019”). Retraction in: Biol. Psychiatry 2023 Feb 15;93(4):382. doi: 10.1016/j.biopsych.2022.12.007. 

• Neuroanatomical predictors of L-DOPA response in older adults with psychomotor slowing and depression: A pilot study. J. Affect. Disord. 2020 Mar 15;265:439-444. doi: 10.1016/j.jad.2020.01.066 (hereafter referred to as “J. Affect. Disord. 2020”). Retraction in: J. Affect. Disord 2023 Jun 1;330:369. doi: 10.1016/j.jad2023.03.021. 

• Association between neuromelanin-sensitive MRI signal and psychomotor slowing in late-life depression.  Neuropsychopharmacology 2021 Jun;46(7):1233-1239. doi: 10.1038/s41386-020- 00860-z (hereafter referred to as “Neuropsychopharmacology 2021”). Retraction in: Neuropsychopharmacology 2024 Jun;49(7):1202. doi: 10.1038/s41386-024-01851-0.

• Slowed Processing Speed Disrupts Patient Expectancy in Late Life Depression. Am. J. Geriatr. Psychiatry 2021 Ju1;29(7):619-630. doi: 10.1016/j.jagp.2020.11.001 (hereafter referred to as “Am. J. Geriatr. Psychiatry 2021a”). Erratum in: Am. J. Geriatr. Psychiatry 2023 Jan;31(1):78-79. doi: 10.1016/j.jagp.2022.09.006.

• Association of White Matter Integrity With Executive Function and Antidepressant Treatment Outcome in Patients With Late-Life Depression. Am. J. Geriatr. Psychiatry 2021 Dec;29(12):1188-1198. doi: 10.1016/j.jagp.2021.01.004 (hereafter referred to as “Am. J. Geriatr. Psychiatry 2021b”). Erratum in: Am. J. Geriatr. Psychiatry 2023 Jan;31(1):76-77. doi: 10.1016/j.jagp.2022.09.007.