[Federal Register Volume 69, Number 61 (Tuesday, March 30, 2004)]
[Notices]
[Pages 16541-16542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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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

[[Page 16542]]

     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.

Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 04-7041 Filed 3-29-04; 8:45 am]
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