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###### Department of Health and Human Services

###### Office of the Secretary

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

Notice.

# SUMMARY:

Findings of research misconduct have been made against Charles A. Downs (Respondent), former Adjunct Assistant Professor, Arizona Health Sciences Center, University of Arizona (UA). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Center for Advancing Translation Sciences (NCATS), National Institutes of Health (NIH), grant UL1 TR000454. The administrative actions, including supervision for a period of four (4) years, were implemented beginning on November 18, 2020, and are detailed below.

# FOR FURTHER INFORMATION CONTACT:

Elisabeth A. Handley, 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:

*Charles A. Downs, University of Arizona:*                     Based on the report of an investigation conducted by UA and analysis conducted by ORI in its oversight review, ORI found that Respondent, former Adjunct Assistant Professor, Arizona Health Sciences Center, UA, engaged in research misconduct in research supported by PHS funds, specifically NCATS, NIH, grant UL1 TR000454.                

Respondent neither admits nor denies ORI's findings of research misconduct. Respondent and ORI desire to close this matter without further expense of time and other resources and thus have entered into a Voluntary Settlement Agreement (Agreement).

ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/or fabricating data included in the following six (6) grant applications submitted for PHS funds:
    - R01 NR016242-01, submitted to the National Institute of Nursing Research (NINR), NIH
    - R01 NR016242-01A1, submitted to NINR, NIH
    - R01 NR016957-01, submitted to NINR, NIH
    R01 NR016957-01A1, submitted to NINR, NIH      ( print page 80123)    
    - R01 HL142576-01, submitted to National Heart, Lung, and Blood Institute (NHLBI), NIH
    - R01 NR016957-02, submitted to NINR, NIH

ORI found that Respondent knowingly, intentionally, or recklessly falsified and/or fabricated histological images and bar graphs of fluorescent signal data for the production of reactive oxygen species (ROS) in rat lung tissue slices and isolated alveolar type-2 cells by reusing and relabeling previously published figures to represent results from different experiments in twelve (12) figures and related text included in six (6) grant applications. Specifically, Respondent falsified data in:
    - Figures 4 and 5 in R01 NR016242-01
    - Figures 2 and 3 in R01 NR016242-01A1
    - Figures 3A and 3B in R01 NR016957-01
    - Figures 3A and 3B in R01 NR016957-01A1
    - Figures 3A and 3B in R01 HL142576-01
    - Figures 3A and 3B in R01 NR016957-02

Respondent entered into an Agreement and agreed to the following:

(1) Respondent agreed to have his research supervised for a period of four (4) years beginning on November 18, 2020. Respondent agrees that 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 on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval. The supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution. Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI. Respondent agrees to maintain responsibility for compliance 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 four (4) years 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 any PHS grant applications (including supplements, resubmissions, etc.), manuscripts reporting PHS-funded research submitted for publication, and abstracts. 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/publication are supported by the research record.

(3) Respondent agreed that for a period of four (4) years beginning on November 18, 2020, any institution employing him shall submit, in conjunction with each application of 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 in the application, report, manuscript, or abstract.

(4) If no supervisory plan is provided to ORI, Respondent agreed to provide certification to ORI at the conclusion of the supervision period that he has not engaged in, applied for, or had his name included on any application, proposal, or other request for PHS funds without prior notification to ORI.

(5) Respondent agreed to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of four (4) years, beginning on November 9, 2020.

Dated: December 8, 2020.

Elisabeth A. Handley,

Director, Office of Research Integrity, Office of the Assistant Secretary for Health.

[FR Doc. 2020-27309 Filed 12-10-20; 8:45 am]

BILLING CODE 4150-31-P