Notice Number: NOT-OD-06-042
Release Date: February 24, 2006
Department of Health and Human Services (DHHS), (http://www.hhs.gov/)
Notice is hereby given that the Deputy Assistant Secretary for the Office of Acquisition Management and Policy of the Department of Health and Human Services (HHS) has taken final agency action in the following case:
Paul H. Kornak, Stratton VA Medical Center, Albany, New York: Upon recommendations from the Office of Research Integrity (ORI), Acting Assistant Secretary for Health for the Department of Health and Human Services (HHS), the Office of Research Oversight (ORO), and the Under Secretary for Health, Department of Veterans Affairs (VA), that were based on the criminal convictions of making and using a materially false statement, in violation of 18 U.S.C. 1001(a)(3); mail fraud, in violation of 18 U.S.C. 1341 and 1346; and criminally negligent homicide, in violation of 18 U.S.C. 13 and New York Penal Law Sec. 125.10, the HHS debarring official has permanently debarred Mr. Paul Kornak, former research coordinator at the Stratton VA Medical Center. This action is taken pursuant to the HHS government-wide nonprocurement debarment and suspension regulation at 45 CFR part 76. As such, Mr. Kornak is excluded for life from participating in any and all Federal agency transactions, both procurement and nonprocurement, as set forth in part 76.
Of the 48 criminal charges contained in his Indictment, Paul Kornak pled guilty to the three criminal charges listed above. See United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). In addition to the 71-month term of imprisonment imposed, Mr. Kornak was directed to pay restitution to two pharmaceutical companies and the VA in the amount of approximately $639,000.
As part of his guilty plea, Mr. Kornak admitted to the following facts:
Based on the criminal conviction and the facts admitted to above, HHS and VA believe that a debarment period longer than the standard length of debarment is warranted in this case. Mr. Kornak admitted to a dishonest handling of the research records and demonstrated a complete disregard for the well-being of vulnerable human subjects under his care. In pleading guilty to criminally negligent homicide, Mr. Kornak admitted that a reasonable person would have perceived a substantial and unjustifiable risk of death if an ineligible subject were enrolled in the cancer study in question and that his failure to perceive such a risk in enrolling the ineligible subject constituted a gross deviation from the standard of care.
Moreover, a longer debarment period is warranted in this case because of an established pattern of misconduct and criminal behavior on the part of Mr. Kornak. As stated above, Mr. Kornak has a prior conviction of mail fraud. In addition, the Office of Personnel Management excluded Mr. Kornak from all Federal nonprocurement transactions for an indefinite period, effective July 22, 1993. Nonetheless, beginning in 1999, Mr. Kornak actively participated in federally sponsored research protocols in violation of the imposed exclusion.
A lifetime debarment of Mr. Kornak is necessary to protect the public interest overall. Given the scope of his criminal conviction, his longstanding pattern of criminal behavior, and his total disregard for the safety and well-being of human subjects, Mr. Kornak's responsibility to engage in transactions with the Federal Government cannot be assured at any time in the future.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative Oversight
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Health Science Specialist
Office of Research Oversight
Veteran's Health Administration, VA
811 Vermont Ave., NW. (10R), Suite 574
Washington, DC 20420
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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