2022-25031. Findings of Research Misconduct

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

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, [phone].

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 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.