[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69034-69035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25031]


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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 Romina 
Mizrahi, M.D., Ph.D. (Respondent), who was a Clinician Scientist, 
Positron Emission Tomography Centre, Centre for Addiction and Mental 
Health (CAMH), and an Associate Professor, Department of Psychology, 
University of Toronto (UT). Respondent engaged in research misconduct 
in research reported in a grant application submitted for U.S. Public 
Health Service (PHS) funds, specifically National Institute of Mental 
Health (NIMH), National Institutes of Health (NIH), grant application 
R01 MH118495-01. The administrative actions, including supervision for 
a period of one (1) year, were implemented beginning on November 3, 
2022, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting 
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:
    Romina Mizrahi, M.D., Ph.D., Centre for Addiction and Mental Health 
and University of Toronto: Based on the report of an investigation 
conducted by CAMH and analysis conducted by ORI in its oversight 
review, ORI found that Dr. Romina Mizrahi, former Clinician Scientist, 
Positron Emission Tomography Centre, CAMH, and an Associate Professor, 
Department of Psychology, UT, engaged in research misconduct in 
research reported in a grant application submitted for PHS funds, 
specifically NIMH, NIH, grant application R01 MH118495-01.
    ORI found that Respondent engaged in research misconduct by 
intentionally, knowingly, or recklessly falsifying data in the 
following grant application:
     R01 MH118495-01, ``Imaging nociceptin receptors in 
clinical high risk

[[Page 69035]]

and first episode psychosis,'' submitted to NIMH, NIH, on February 2, 
2018.
    Specifically, ORI finds that Respondent knowingly, intentionally, 
or recklessly falsified the Positron Emission Tomography (PET) data of 
the binding of radiopharmaceutical [\11\C]NOP-1A (NOP) in brain regions 
between the patient group and healthy volunteer (HV) group. Respondent 
selectively included one (1) and excluded three (3) participants with 
their PET data in the HV group and selectively excluded four (4) 
participants with their PET data in the patient group, to falsely state 
that the NOP binding in the patient group was statistically higher than 
that in the HV group in Figure 3, right panel, and the corresponding 
text in grant application R01 MH118495-01.
    Dr. Mizrahi entered into a Voluntary Settlement Agreement 
(Agreement) and voluntarily agreed to the following:
    (1) Respondent will have her research supervised for a period of 
one (1) year beginning on November 3, 2022 (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) The requirements for Respondent's supervision plan are as 
follows:
    i. A committee of 2-3 senior faculty members at the institution who 
are familiar with Respondent's field of research, but not including 
Respondent's supervisor or collaborators, will provide oversight and 
guidance for a period of one (1) year from the effective date of the 
Agreement. 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 
presented in the proposed application, report, manuscript, or abstract 
are supported by the research record.
    (3) During the Supervision Period, Respondent will ensure that any 
institution employing her 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 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 and not plagiarized 
in the application, report, manuscript, or abstract.
    (4) If no supervision plan is provided to ORI, Respondent will 
provide certification to ORI at the conclusion of the Supervision 
Period that her participation was not proposed on a research project 
for which an application for PHS support was submitted and that she has 
not participated in any capacity in PHS-supported research.
    (5) During the Supervision Period, Respondent will exclude herself 
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: November 14, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2022-25031 Filed 11-16-22; 8:45 am]
BILLING CODE 4150-31-P