Findings of Scientific Misconduct

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case:

Vickie L. Hanneken, R.N., Decatur Memorial Hospital: Based on the report of an investigation conducted by Decatur Memorial Hospital (DMH) and additional analysis conducted by the Office of Research Integrity in its oversight review, the U.S. Public Health Service (PHS) found that Vickie L. Hanneken, R.N., former Clinical Research Associate, DMH, engaged in scientific misconduct in research that was part of a Southwest Oncology Group prostate cancer prevention clinical trial supported by a National Cancer Institute (NCI), National Institutes of Health (NIH), cooperative agreement U10 CA45807 under the Central Illinois Clinical Community Oncology Program.

PHS found that the Respondent engaged in scientific misconduct by falsifying or fabricating data in the clinical/study records of 35 participants in the Selenium and Vitamin E Cancer Prevention Trial (SELECT) at Decatur Memorial Hospital, with a total of 60 separate acts, which included:

• Falsification of the laboratory reports on PSA concentration for 12 participants;
• Fabrication of the laboratory reports on PSA concentration for 2 participants;
• Falsification of the physician's and nurse's records for 10 participants;
• Fabrication of the nurse's records for 2 participants;
• Falsification of data on patients' history and physical forms for 21 participants; and
• Entry of falsified data into the SWOG computerized data base for 13 participants.

Ms. Hanneken has entered into a Voluntary Exclusion Agreement (Agreement ) in which she has voluntarily agreed for a period of three (3) years, beginning on March 15, 2004:

(1) To exclude herself 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 as defined in the debarment regulations at 45 CFR Part 76; and

(2) To exclude herself 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, (301) 443-5330.