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

###### Office of the Secretary

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

Notice.

# SUMMARY:

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

*James P. Warne, Ph.D., University of California San Francisco:*                         Based on an assessment conducted by the University of California San Francisco (UCSF), the Respondent's admission, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. James P. Warne, former Senior Scientist, Diabetes Center, UCSF School of Medicine, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants DK080427, DK007161, and DK063720.                    

ORI found that Respondent engaged in research misconduct by falsifying data that were included in the following two (2) publications and two (2) grant applications:
      -  Cell Metabolism                          14:791-803, 2011 (hereafter referred to as the “                         Cell Metabolism                          paper”)                    
      -  Journal of Neuroscience                          33(29):11972-85, 2013 (hereafter referred to as the “                         Journal of Neuroscience                          paper”)                    
      - R01 DK080427-06A1 submitted to NIDDK, NIH
      - R01 AA022665-01A1 submitted to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIH

ORI found that Respondent falsified data and related text by altering the experimental data to support the experimental hypothesis. Specifically:

1. Respondent fabricated graphs purported to represent the results of ten (10) different ELISA experiments measuring norephinephrin (NE) or leptin levels in wild-type mice, in AGRP knockout mice, or in AGRP RNAi mice and controls that had received brain infusions of alpha-MPT, a tyrosine hydroxylase inhibitor or vehicle and leptin or AGRP in the following figures:
      ( print page 74093)    
Figures 2D/E, 3G, and 7C in the*Cell Metabolism*                     paper                

Figures 6B/C/E, Figure 8C, and Figure 9H in the*Journal of Neuroscience*                     paper; Figures 6B/C/E of the                     *Journal of Neuroscience*                     paper also were included as Figures 5A/C/B in grant application DK080427-06A1, and Figure 8C of the                     *Journal of Neuroscience*                     paper also was included as Figure 8C in grant application DK080427-06A1                

2. Respondent fabricated graphs purported to represent the results of six (6) different quantitative polymerase chain reaction (Q-PCR) experiments measuring mRNA levels in mouse liver from wild-type or AGRP RNAi mice and controls that had received brain infusions of alpha-MPT, a tyrosine hydroxylase inhibitor or vehicle and leptin, AGRP knockout mice injected with ethanol, or wild-type mice injected with ethanol and caffeine in the following figures:

Figure 2F in the*Cell Metabolism*                     paper                

Figures 5A, 6F, and 9A in the*Journal of Neuroscience*                     paper; Figure 5A of the                     *Journal of Neuroscience*                     paper also was included as Figure 4A in grant application DK080427-06A1, and Figure 6F of the                     *Journal of Neuroscience*                     paper also was included as Figure 7A in grant application DK080427-06A1                

Dr. Warne has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed:

(1) to have his research supervised for a period of three (3) years, beginning on November 18, 2014; Respondent agrees that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the 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 his 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) that for a period of three (3) years, beginning on November 18, 2014, any institution employing him shall submit, 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 in the application, report, manuscript, or abstract;

(3) 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 three (3) years, beginning on November 18, 2014; and

(4) that as a condition of the Agreement, the senior authors will request retraction or correction of the following papers:

*Cell Metabolism*                     14:791-803, 2011                

*Journal of Neuroscience*                     33(29):11972-85, 2013                

# FOR FURTHER INFORMATION CONTACT:

Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.

Donald Wright,

Acting Director, Office of Research Integrity.

[FR Doc. 2014-29337 Filed 12-12-14; 8:45 am]

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