[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83024-83026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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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,

[[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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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

    <bullet> 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

[[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