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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) and the Assistant Secretary for Health have taken final action in the following case:

*Nagendra S. Ningaraj, PhD, Vanderbilt University School of Medicine:*                         Based on the reports of an investigation conducted by Vanderbilt University School of Medicine (VUSM) and additional analysis by the Division of Investigative Oversight (DIO), ORI, in its oversight review, found that Nagendra S. Ningaraj, PhD, former Associate Professor of Neurological Surgery and Cancer Biology, VUSM, engaged in scientific misconduct by falsifying MALDI-MS images and mass spectral tracings and associated text in Figure 21 reported in National Cancer Institute (NCI), National Institutes of Health (NIH), grant application 1 U54 CA119421-01 and by falsifying MALDI-MS images in a presentation during the American Association for Cancer Research (AACR) meeting held on April 16-20, 2005, which cited support from NCI, NIH, grants R25 CA92943 and P50 CA098131.                    

Specifically, ORI found that:

1. Respondent reversed the images for the control and minoxidil-treated brains in Figure 21 of the 1 U54 CA119421-01 grant application, claiming that minoxidil increased delivery of Gleevec to the tumor. Respondent also reversed the same images in a presentation during the AACR meeting in April 2005.

2. In Figure 21 of the 1 U54 CA119421-01 grant application, Respondent reported mass spectral tracings as having been obtained from brain tumors in Gleevec-treated mice that had been pretreated with minoxidil, while in fact they were pretreated with another potassium channel opener, NS1619, and Respondent falsely stated the minoxidil pretreatment caused an 8-fold increase in Gleevec delivery to brain tumors (compared to non-minoxidil pretreated tumors).

                        3. Respondent further falsified Figure 21 of the 1 U54 CA119421-01 grant application by juxtaposing the reversed MALDI-MS images (obtained with mioxidil) with the mass spectral tracings (obtained with NS1619) in the same figure and by failing to report that the images and spectra in the figure were actually obtained in totally different experiments, performed on different dates and with different K+                         agonist pretreatments.                    

Dr. Ningaraj has entered into a Voluntary Settlement Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on August 31, 2009:

(1) To be prohibited 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;

(2) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or which uses him in any capacity on PHS-supported research or that submits a report of PHS-funded research on which he is involved must submit a plan for supervision of his duties to the funding agency for approval no later than a month before the scheduled funding; the supervisory plan must be designed to ensure the scientific integrity of his research contribution; a copy of the supervisory plan also must be submitted to ORI by the institution; Respondent agrees that he will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI; and

(3) Respondent will ensure that any institution employing him submits, in conjunction with each application for PHS funds or any report, manuscript, or abstract of PHS-funded research in which he is involved, a certification that the data provided by him are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report. Respondent must ensure that the institution send the certification to ORI. The certification shall be submitted no later than one month before funding and concurrently with any report, manuscript, or abstract.

# FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8800.

John Dahlberg,

Director, Division of Investigative Oversight, Office of Research Integrity.

[FR Doc. E9-23046 Filed 9-23-09; 8:45 am]

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