FINDINGS OF SCIENTIFIC MISCONDUCT
RELEASE DATE: April 5, 2004
NOTICE: NOT-OD-04-038
Department of Health and Human Services (DHHS)
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:
1. falsification of the laboratory reports on PSA concentration for 12
participants;
2. fabrication of the laboratory reports on PSA concentration for 2
participants;
3. falsification of the physician’s and nurse’s records for 10
participants;
4. fabrication of the nurse’s records for 2 participants;
5. falsification of data on patients history and physical forms for
21 participants; and
6. 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 C.F.R. 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.
INQUIRIES
For further information contact:
Director
Division of Investigative Oversight
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Telephone: 301-443-5330
Weekly TOC for this Announcement
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