[Federal Register Volume 74, Number 128 (Tuesday, July 7, 2009)]
[Notices]
[Pages 32167-32168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Scientific 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) and the Assistant Secretary for Health have taken final action in 
the following case:
    Juan Luis R. Contreras, M.D., University of Alabama at Birmingham: 
Based on a finding of scientific misconduct made by the University of 
Alabama at Birmingham (UAB) on January 24, 2008, a report of the UAB 
Investigation Committee, dated November 21, 2007, and analysis 
conducted by ORI during its oversight review, and further discussion 
between UAB and ORI to clarify UAB's investigative findings and 
decision with respect to the requirements of 42 CFR Parts 50 and 93, 
the U.S. Public Health Service (PHS) found that Dr. Juan Luis R. 
Contreras, Assistant Professor, Department of Surgery--Transplantation, 
UAB, engaged in scientific misconduct in research supported by National 
Institute of Allergy and Infectious Diseases (NIAID), National 
Institutes of Health (NIH), grants R01 AI22293, R01 AI39793, and

[[Page 32168]]

U19 AI056542, National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), NIH, grant U19 DK57958, and NIH/Novartis Cooperative 
Research and Development Agreement 96-MH-01/NIHITC-0697.
    PHS found that Respondent engaged in scientific misconduct by 
falsifying in seven publications reports of research results in NIH-
supported experiments with non-human primate (NHP) renal allograft 
recipients.
    Specifically, PHS found that Respondent engaged in scientific 
misconduct by falsely reporting in five publications \1\ that at least 
32 specific non-human primates in a renal allo-transplantation study 
had received bilateral nephrectomies, while in fact an intrinsic kidney 
was left in place in each animal, and generally, in two additional 
publications \2\ by reporting that all long term surviving non-human 
primate renal allograft recipients had received bilateral nephrectomies 
of their native kidneys.
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    \1\ Hutchings, A., Wu, J., Asiedu, C., Hubbard, W., Eckhoff, D., 
Contreras, J., Thomas, F.T., Neville, D., & Thomas, J.M. ``The 
immune decision toward allograft tolerance in non-human primates 
requires early inhibition of innate immunity and induction of immune 
regulation.'' Transpl Immunol. 11(3-4):335-344, July-September 2003. 
(Retraction required by UAB.)
    Thomas, J.M., Eckhoff, D.E., Contreras, J.L., Lobashevsky, A.L., 
Hubbard, W.J., Moore, J.K., Cook, W.J., Thomas, F.T., & Neville, 
D.M. Jr. ``Durable donor-specific T and B cell tolerance in rhesus 
macaques induced with peritransplantation anti-CD3 immunotoxin and 
deoxyspergualin: Absence of chronic allograft nephropathy.'' 
Transplantation 69(12):2497-2503, June 27, 2000. (Retracted.)
    Thomas, J.M., Contreras, J.L., Jiang, X.L., Eckhoff, D.E., Wang, 
P.X., Hubbard, W.J., Lobashevsky, A.L., Wang, W., Asiedu, C., 
Stavrou, S., Cook, W.J., Robbin, M.L., Thomas, F.T., & Neville, D.M. 
Jr. ``Peritransplant tolerance induction in macaques: Early events 
reflecting the unique synergy between immunotoxin and 
deoxyspergualin.'' Transplantation 68(11):1660-1673, December 15, 
1999. (Retracted.)
    Contreras, J.L., Eckhoff, D.E., Cartner, S., Frenette, L., 
Thomas, F.T., Robbin, M.L., Neville, D.M. Jr., & Thomas, J.M. 
``Tolerability and side effects of anti-CD3-immunotoxin in 
preclinical testing in kidney and pancreatic islet transplant 
recipients.'' Transplantation 68(2):215-219, July 27, 1999. 
(Retracted.)
    Contreras, J.L., Wang, P.X., Eckhoff, D.E., Lobashevsky, A.L., 
Asiedu, C., Frenette, L., Robbin, M.L., Hubbard, W.J., Cartner, S., 
Nadler, S., Cook, W.J., Sharff, J., Shiloach, J., Thomas, F.T., 
Neville, D.M. Jr., & Thomas, J.M. ``Peritransplant tolerance 
induction with anti-CD3-immunotoxin: A matter of proinflammatory 
cytokine control.'' Transplantation 65(9):1159-1169, May 15, 1998. 
(Retracted.)
    \2\ Hubbard, W.J., Eckhoff, D., Contreras, J.L., Thomas, F.T., 
Hutchings, A., & Thomas, J.M. ``STEALTH on the preclinical path to 
tolerance.'' Graft 5(6):322-330, 2002. (Retraction required by UAB--
Journal has ceased publication.)
    Hubbard, W.J., Contreras, J.V., Eckhoff, D.E., Thomas, F.T., 
Neville, D.M., & Thomas, J.M. ``Immunotoxins and tolerance induction 
in primates.'' Current Opinion in Organ Transplantation 5:29-34, 
2000. (Partially retracted.)
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    The objective of the research was to test the effectiveness of 
different immunomodulating agents, administered around the time of 
renal transplantation in non-human primates, in preventing rejection of 
the transplanted kidney. To determine whether or not the transplanted 
kidney was functioning (able to sustain life) after the 
immunomodulating therapy, the animals were to have both of their native 
kidneys removed at or shortly after the time of transplant, so that 
their survival would depend solely on the viability of the transplanted 
kidney. Failure to remove both native kidneys rendered it impossible to 
assess the effectiveness of the immunomodulating treatment.
    Both Dr. Contreras and PHS are desirous of concluding this matter 
without further expense of time and other resources, and the parties 
have entered into a Voluntary Exclusion Agreement to settle the matter. 
Dr. Contreras accepted responsibility for the reporting described 
above, but denied that he intentionally committed scientific 
misconduct. The settlement is not an admission of liability on the part 
of the Respondent.
    Dr. Contreras has entered into a Voluntary Exclusion Agreement in 
which he has voluntarily agreed, for a period of three (3) years, 
beginning on June 17, 2009:
    (1) To exclude himself voluntarily from any contracting or 
subcontracting with any agency of the United States Government and from 
eligibility or involvement in nonprocurement programs of the United 
States Government referred to as ``covered transactions'' and defined 
by 2 CFR Parts 180 and 376; and
    (2) To exclude himself 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. E9-15909 Filed 7-6-09; 8:45 am]
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