[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80122-80123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27309]


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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 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:

<bullet> R01 NR016242-01, submitted to the National Institute of 
Nursing Research (NINR), NIH
<bullet> R01 NR016242-01A1, submitted to NINR, NIH
<bullet> R01 NR016957-01, submitted to NINR, NIH
<bullet> R01 NR016957-01A1, submitted to NINR, NIH

[[Page 80123]]

<bullet> R01 HL142576-01, submitted to National Heart, Lung, and Blood 
Institute (NHLBI), NIH
<bullet> 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:

<bullet> Figures 4 and 5 in R01 NR016242-01
<bullet> Figures 2 and 3 in R01 NR016242-01A1
<bullet> Figures 3A and 3B in R01 NR016957-01
<bullet> Figures 3A and 3B in R01 NR016957-01A1
<bullet> Figures 3A and 3B in R01 HL142576-01
<bullet> 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