[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41357-41358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy08-87]
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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 Assistant Secretary for Health have taken final action in
the following case:
J. Keith Hampton, St. Luke's Hospital: Based on the report of an
investigation conducted by St. Luke's Hospital (SLH) in Chesterfield,
MO, and additional analysis conducted by the Office of Research
Integrity (ORI) during its oversight review, the U.S. Public Health
Service (PHS) found that J. Keith Hampton, MSN, APRN, former Clinical
Research Associate, SLH, engaged in scientific misconduct in research
supported by National Cancer Institute (NCI), National Institutes of
Health (NIH), awards U10 CA69651, U10 CA12027, and U10 CA33601.
PHS found that Mr. Hampton engaged in scientific misconduct by
falsifying and fabricating data that were reported to the National
Surgical Adjuvant Breast & Bowel Project (NSABP) and Cancer and
Leukemia Group B (CALGB) cooperative research groups.
Specifically, PHS found that:
1. For protocol CALGB 90206, Respondent:
(a) Falsified a patient's CT scan reports and registration forms
and reported the falsified CT scan reports and registration worksheet
to CALGB,
(b) Falsified a patient's performance status records (giving 80%
performance status) and registration forms and reported the falsified
performance status report and registration form to CALGB.
2. For protocol NSABP B-35, Respondent:
(a) Falsified eligibility data related to hematology and chemistry
assays and to the performance of a pelvic exam on one patient's
registration form and reported the falsified registration forms to the
National Cancer Institute Cancer Trial Support Unit (CTSU),
(b) Falsified pelvic exam eligibility on a second patient's
registration form and reported the falsified registration form to the
CTSU,
(c) Falsified hematology and chemistry assay eligibility on a third
patient's registration form and reported the falsified registration
form to the CTSU.
3. For protocol NSABP B-36, Respondent falsified a patient's
multigated acquisition test (MUGA--a test of heart function) records,
cardiac function, and registration forms, certified the patient's
eligibility, and reported the falsified MUGA test, cardiac function,
and registration forms to the CTSU.
4. For protocol NSABP B-38, Respondent falsified hematology,
chemistry, and MUGA eligibility for a patient on the registration form
and reported the falsified registration form to the CTSU.
5. For protocol NSABP C-08, Respondent:
(a) Falsified urine protein/creatinine ratio eligibility for one
patient on the registration form and reported the falsified
registration form to the CTSU,
(b) Falsified urine protein/creatinine ratio eligibility for a
second patient on the registration form and reported the falsified
registration form to the CTSU,
(c) Falsified claims of the urine protein/creatinine ratio and
PT(INR) eligibility for a third patient on the registration form and
reported the falsified registration form to the CTSU.
6. For protocol NSABP R-04, Respondent falsified a patient's
colonoscopy report and eligibility at registration and reported the
falsified colonoscopy report and registration form to the CTSU.
Mr. Hampton has entered into a Voluntary Exclusion Agreement
(Agreement) in which he has voluntarily agreed for a period of three
(3) years, beginning on June 17, 2008:
(1) To exclude himself 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
referred to as ``covered transactions'' pursuant to HHS' Implementation
(2 CFR part 376 et seq.) of OMB Guidelines to Agencies on
Governmentwide Debarment and Suspension (2 CFR part 180); and
(2) To exclude himself 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 or
contractor to PHS.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity,
[[Page 41358]]
1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8800.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E8-16357 Filed 7-17-08; 8:45 am]
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