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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:

*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                               ( print 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.                    

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.

# Footnotes

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.)                        
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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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[FR Doc. E9-15909 Filed 7-6-09; 8:45 am]

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