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###### Department of Health and Human Services

###### Office of the Secretary

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

Notice.

# SUMMARY:

Findings of research misconduct have been made against Bret Rutherford, M.D. (Respondent), who was formerly a Research Psychiatrist, New York State Psychiatric Institute (NYSPI). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH102293 and R61/R33 MH110029. The administrative actions, including debarment for a period of three (3) years followed by supervision for a period of three (3) years, were implemented beginning on September 27, 2024, and are detailed below.

# FOR FURTHER INFORMATION CONTACT:

 Sheila Garrity, JD, MPH, MBA, Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 240, Rockville, MD 20852, (240) 453-8200.

# SUPPLEMENTARY INFORMATION:

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

*Bret Rutherford, M.D., New York State Psychiatric Institute (NYSPI):*                     Based on the report of an investigation conducted by NYSPI and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Bret Rutherford (Respondent), former Research Psychiatrist, NYSPI, engaged in research misconduct in research supported by PHS funds, specifically, NIMH, NIH, grants R01 MH102293 and R61/R33 MH110029.                

                    ORI found that Respondent engaged in research misconduct by recklessly falsely reporting that all human research subjects met the inclusion/exclusion criteria for late-life depression studies in five (5) published papers, thus affecting the reported clinical research methods and results including demographics,                           ( print page 83025)                        gait speed, Positron Emission Tomography (PET) scan brain activities, depression scores, Magnetic Resonance Imaging (MRI) brain volumes, neuromelanin MRI contrast values, cognition tests, diffusion brain imaging data, and other neurocognitive assessments and conclusions in five (5) published papers:                
    - Effects of L-DOPA Monotherapy on Psychomotor Speed and [ 11                     C]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.jad.2023.03.021.                
    - 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.                

Specifically, ORI found that Respondent recklessly:
    - falsely reported that all subjects met the studies' inclusion/exclusion criteria by not having taken exclusionary medications at time of study enrollment for as many as forty-five (45) subjects, by reporting eligibility of subjects who had taken exclusionary medications during a 28-day washout period prior to enrollment for as many as fifteen (15) subjects and by reporting full medication washout periods for as many as eight (8) subjects who received shorter washout periods than 28-days. Specifically, in:

                    —                    *Biol. Psychiatry*                     2019, the Methods and Materials section falsely reported that all subjects met the protocol's inclusion/exclusion criteria when the medication status of fifteen (15) of the forty-seven (47) subjects failed to meet the exclusion criteria of current treatment or treatment within the last 4 weeks with psychotropic or other medications known to affect dopamine                

                    —                    *J. Affect. Disord.*                     2020, the Methods and Materials and Results sections falsely reported that all subjects met the protocol's inclusion/exclusion criteria when the medication status of a subset of subjects failed to meet the exclusion criteria of within the past 4 weeks treatment with psychotropic or other medications known to affect dopamine                

                    —                    *Neuropsychopharmacology*                     2021, the Methods and Materials and Results section falsely reported that all subjects met the protocol's inclusion/exclusion criteria when the medication status of a subset of subjects failed to meet the exclusion criteria of being treated within the past 4 weeks with psychotropic or other medications known to affect dopamine                

                    —                    *Am. J. Geriatr. Psychiatry*                     2021a, the Method and Results sections falsely reported that all subjects met the protocol's inclusion/exclusion criteria when the medication status of thirty (30) of the one hundred eight (108) subjects failed to meet the exclusion criteria of current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers                

                    —                    *Am. J. Geriatr. Psychiatry*                     2021b, the Methods and Results sections falsely reported that all subjects met the protocol's inclusion/exclusion criteria when the medication status of eighteen (18) of the seventy-one (71) subjects failed to meet the exclusion criteria of current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers                
    - falsely reported the research methods in Biol. Psychiatry                      2019,                      J. Affect. Disord.                      2020,                      Neuropsychopharmacology                      2021,                      Am. J. Geriatr. Psychiatry                      2021a, and                      Am. J. Geriatr. Psychiatry                      2021b by omitting the medication taper administered to as many as forty (40) subjects after study enrollment                

Respondent entered into a Voluntary Exclusion Agreement (Agreement) and voluntarily agreed to the following:

(1) Respondent will exclude himself voluntarily for a period of three (3) years beginning on September 27, 2024 (the “Exclusion Period”) from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement or procurement transactions referred to as “covered transactions” in 2 CFR parts 180 and 376 (collectively the “Debarment Regulations”). At the conclusion of the Exclusion Period, Respondent agrees to have his research supervised for a period of three (3) years (the “Supervision Period”). During the Supervision Period, prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity in PHS-supported research, Respondent will submit a plan for supervision of Respondent's duties to ORI for approval. The supervision plan must be designed to ensure the integrity of Respondent's research. Respondent will not participate in any PHS-supported research until such a supervision plan is approved by ORI. Respondent will comply with the agreed-upon supervision plan.

(2) During the Exclusion Period, Respondent will not apply for, permit his name to be used on an application for, receive, or be supported by funds of the United States Government and its agencies made available through contracts, subcontracts, or covered transactions.

(3) During the Supervision Period, the requirements for Respondent's supervision plan are as follows:

i. A committee of 2-3 senior faculty members at the institution including Respondent's supervisor or collaborators, will provide oversight and guidance. The committee will review primary data from Respondent's laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals, setting forth the committee meeting dates and Respondent's compliance with appropriate research standards and confirming the integrity of Respondent's research.

                    ii. The committee will conduct an advance review of each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved. The review will include a discussion with Respondent of the primary data represented in those documents and will include a certification to ORI that the data                           ( print page 83026)                        presented in the proposed application, report, manuscript, or abstract are supported by the research record.                

(4) During the Supervision Period, Respondent will ensure that any institution employing him submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI and the PHS funding agency that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract.

(5) If no supervision plan is provided to ORI, Respondent will provide certification to ORI at the conclusion of the Supervision Period that his participation was not proposed on a research project for which an application for PHS support was submitted and that he has not participated in any capacity in PHS-supported research.

(6) During the Exclusion and Supervision Periods, Respondent will exclude himself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee.

Dated: October 8, 2024.

Sheila Garrity,

Director, Office of Research Integrity, Office of the Assistant Secretary for Health.

[FR Doc. 2024-23689 Filed 10-11-24; 8:45 am]

BILLING CODE 4150-31-P