Findings of Research Misconduct, 83024-83026 [2024-23689]
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Specifically, the Division: (1) provides
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provided they are consistent with this
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This reorganization is effective upon
date of signature.
(Authority: 44 U.S.C. 3101)
Carole Johnson,
Administrator.
[FR Doc. 2024–23783 Filed 10–11–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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,
SUMMARY:
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Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
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 [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.jad.2023.03.021.
• Association between neuromelaninsensitive 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
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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
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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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Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
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 PHSsupported 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]
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National Institutes of Health
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National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Sleep Disorders Research
Advisory Board.
The meeting will be held as a virtual
meeting and will be open to the public
as indicated below. Individuals who
plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
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https://nih.zoomgov.com/webinar/
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Name of Committee: Sleep Disorders
Research Advisory Board.
Date: December 5, 2024.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: The purpose of this meeting is to
update the Advisory Board and public
stakeholders on the research agenda across
NIH for the upcoming fiscal year, and the
activities of professional societies.
Address: National Institutes of Health,
National Heart, Lung, and Blood Institute,
6701 Rockledge Drive, Bethesda, MD 20892,
Virtual Meeting.
Contact Person: Marishka Brown, Ph.D.,
SDRAB Executive Secretary, Director,
National Center on Sleep Disorders Research,
National Institutes of Health, National Heart,
Lung, and Blood Institute, 6705 Rockledge
Drive, Suite 407B Bethesda, Maryland
20814–7952, 301–435–0199.
Email: ncsdr@nih.gov.
Any member of the public interested in
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meeting. Interested individuals and
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record. In addition, any interested person
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committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nhlbi.nih.gov/about/advisory-and-peerreview-committees/sleep-disorders-research,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: October 9, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–23742 Filed 10–11–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
National Heart, Lung, and Blood
Institute; Cancellation of Meeting
Notice is hereby given of the
cancellation of the National Heart, Lung,
and Blood Advisory Council, October
29, 2024, 8 a.m. to October 29, 2024, 5
p.m., National Institutes of Health,
Building 31, 31 Center Drive, Bethesda,
MD, 20892 which was published in the
Federal Register on September 30, 2024,
89 FR 79933.
The meeting is cancelled.
Dated: October 9, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–23752 Filed 10–11–24; 8:45 am]
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Federal Advisory Committee Act, as
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following meetings.
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel
Pathway to Independence Awards (K99/R00).
Date: November 13, 2024.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Meeting Format: Virtual Meeting.
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
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443–9734, millerda@mail.nih.gov.
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]]>Agencies
[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
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,
[[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
[[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
