[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46438-46439]
From the Federal Register Online via the Government Printing 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]
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