[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46438-46439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18990]


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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: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Mepur H. Ravindranath, Ph.D., John Wayne Cancer Institute: Based on 
the report of an investigation conducted by the John Wayne Cancer 
Institute (JWCI) and additional analysis conducted by ORI in its 
oversight review, ORI found that Dr. Mepur H. Ravindranath, former 
Director of the Laboratory of Glycoimmunotheraphy, JWCI, engaged in 
research misconduct in research supported by National Cancer Institute 
(NCI), National Institutes of Health (NIH), awards R21 CA107316 and R03 
CA107831.
    ORI found that the Respondent engaged in research misconduct by 
falsifying results reported for research supported by U.S. Public 
Health Service (PHS) grants R21 CA107316 and R03 CA107831, in progress 
reports for those grants and in two publications in scientific 
journals.
    It is expressly understood that by entering into a Voluntary 
Settlement Agreement (Agreement), Respondent is not admitting to any of 
the allegations made against him by JWCI and/or ORI, or any of their 
respective agents, employees, associates, or related persons, including 
but not limited to the findings made by ORI listed in the Agreement. 
Respondent agreed to enter into the Agreement and not to contest the 
findings contained therein solely because contesting the findings would 
cause Respondent undue financial hardship and stress, and Respondent 
wished to seek finality.

Specifically

    1. Respondent falsified the number of subjects accrued in the 
double-blind study reported in the paper Ravindranath, M.H., 
Muthugounder, S., Presser, N., Ye, X., Brosman, S., & Morton, D.L. 
``Endogenous immune response to gangliosides in patients with confined 
prostate cancer.'' Int. J. Cancer 166:368-377, 2005 (subsequently 
referred to as the ``IJC paper) and later reviewed in Ravindranath, 
M.H. Yesowitch, P., Sumobay, C., & Morton, D.L. ``Glycoimmunomics of 
human cancer: Current concepts and future perspectives.'' Future 
Oncology 3(2):201-214, 2007 (subsequently referred to as the ``Future 
Oncology paper''), by reporting data of 7 of 63 patients with serial 
bleeds taken at different points in time and reporting that the values 
from the 7 patients were for different patients. This same reporting 
data of individual patients with serial bleeds taken at different 
points in time and reporting that those values were for different 
patients was presented in the CA107316 and CA107831 final reports.
    2. The methodology used for the Tables of ANOVA results comparing 
Log Titers of IgM antibodies for the different subject groups in the 
IJC and Future Oncology papers and the CA107316 and CA107831 final 
reports is incorrect and false, since the papers and reports fail to 
state that the results are not for a simple ANOVA but include various 
degrees of repeated measures on the variables.
    3. In Table 1 of the CA107831 Final Report, Respondent reported 
mean log titer values for GM1b for healthy, BHP, and T3/4 CaP patients. 
These values exactly matched with values published for a different 
ganglioside, GM1, for healthy, BHP, and T3/4 CaP patients, earlier in 
the IJC (Table II) and Future Oncology publications. The only exception 
was the log titer value for T1/2 CaP patients for GM1b (n = 20), which 
matched with the earlier published mean log titer value for GT1b (6.22 
 1.40; n = 36). ORI finds the pairwise-difference in the 
log titer values of GM1b between the T1/2 CaP and healthy patients, 
claimed to be significant (p<0.01), to therefore be incorrect and 
false. Respondent contends otherwise.
    4. Because Respondent included serial bleed values from individual 
patients in Table 1 of the IJC paper, the summary data for anti-
ganglioside antibody values, and the statistical analyses derived from 
them in Tables II and III of the IJC paper, Tables 1 and 2 of the 
Future Oncology paper, published Tables A and B of the CA107316 final 
report, and Tables 1 and 2B of the CA107831 final report are incorrect 
and false. The inclusion of serial bleeds from

[[Page 46439]]

individual patients in Table 1 of the IJC paper and their inappropriate 
impact on the antibody values reported in Table II of the IJC paper 
were reported in detail by Respondent to the Managing Editor in IJC in 
email communications dated September 24 and 29, 2008.
    Dr. Ravindranath has entered into a Voluntary Settlement Agreement 
and has voluntarily agreed for a period of three (3) years, beginning 
on July 2, 2012:
    (1) To have any PHS-supported research supervised; Respondent 
agreed that prior to the submission of an application for 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 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 agreed that 
he shall not participate in any PHS-supported research until such a 
supervision plan is submitted to and approved by ORI; Respondent agreed 
to maintain responsibility for compliance with the agreed upon 
supervision plan;
    (2) That 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, that the 
data, procedures, and methodology are accurately reported in the 
application, report, manuscript, or abstract, and that the text in such 
submissions is his own or properly cites the source of copied language 
and ideas; and
    (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 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. 2012-18990 Filed 8-2-12; 8:45 am]
BILLING CODE 4150-31-P