Notice Number: NOT-OD-08-096
Key Dates
Release Date: July 23, 2008
Issued by
Department of Health and Human Services
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.
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
and Human Services (HHS)
