Notice Number: NOT-OD-12-046

Key Dates
Release Date: February 7, 2012

Issued by
Department of Health and Human Services (DHHS)

Purpose

SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Calleen S. Zach, Creighton University: Based on evidence obtained from Creighton University (CU) and additional evidence gathered by the Office of Research Integrity (ORI) during its oversight review, ORI found that Ms. Calleen S. Zach, former Research Assistant and Data Base Manager, CU, engaged in research misconduct in research funded by National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grant R01 HD046991.

Specifically, ORI found that the Respondent provided falsified subject enrollment numbers in an application to NIH for continued funding of R01 HD046991 in 2008, a no-cost, one-year extension request for R01 HD046991 (April 8, 2009, letter to NICHD, NIH), and an application for additional funding of R01 HD046991 (June 30, 2009, to NICHD, NIH). In addition, she knowingly and intentionally provided falsified subject enrollment numbers in reports to the CU Institutional Review Board (IRB) in 2008 and 2009.

ORI concluded that Respondent's knowing and intentional falsification of data constitutes research misconduct as defined by 42 CFR 93.103. In addition, ORI found that Respondent's intentionally deceptive behavior, including false statements made to the CU institutional officials, forgery of petty cash receipts, and theft of NIH research grant funds establish a lack of trustworthiness and present responsibility to be a steward of Federal funds. 2 CFR 180.125, 180.800(d), 376.10.

The following administrative actions have been implemented for a period of five (5) years, beginning on January 23, 2012:

(1) Ms. Zach is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government, referred to as ``covered transactions' as defined in 2 CFR 180.200, 376.10; and

(2) Ms. Zach is prohibited from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

Inquiries

FOR FURTHER INFORMATION CONTACT:

Director
Division of Investigative Oversight
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
(240) 453-8800