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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:

Michael E. Ganz, M.D., Case Western Reserve University: Based on the report of an investigation conducted by Case Western Reserve University (CWRU Report) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Dr. Ganz, Associate Professor of Medicine, CWRU, engaged in scientific misconduct by falsification and fabrication of research in grant application R01 DK058674-01A2, “The role of protein kinase C and shuttling proteins in diabetic kidney disease,” submitted to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH).

Specifically, PHS found that Dr. Ganz engaged in scientific misconduct by:

(1) Falsifying Figure 16 in NIH grant application R01 DK058674-01A2 by claiming that photomicrographs of glomeruli were from a streptozotocin model of induced diabetes in rat, while the photomicrographs were actually from tissue of human or other primate origin;

(2) Falsifying Figure 16 of this NIH grant application by claiming that six photomicrographs all represented glomeruli from different animals, whereas they actually were from only three different glomeruli, with each glomerulus being shown in two images with different orientations and/or magnifications; and

(3) Falsifying and fabricating documents, purportedly showing the source of the falsified Figure 16 in the NIH grant application, which the Start Printed Page 124Respondent provided to the CWRU inquiry committee.

The research was significant because it was designed to develop a therapy to prevent the progressive glomerular hypertrophy and matrix deposition that occur with the renal disease associated with diabetes in animals and humans.

Dr. Ganz has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed for a period of five (5) years, beginning on December 18, 2002:

(1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government referred to as “covered transactions” as defined in 45 CFR part 76 (Debarment Regulations); 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.

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FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700, Rockville, MD 20852, (301) 443-5330.

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