Notice2024-23689
Findings of Research Misconduct
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 15, 2024
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 199 (Tuesday, October 15, 2024)</title>
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[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83024-83026]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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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
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