E8-1024. 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 Assistant Secretary for Health have taken final action in the following case:

Scott E. Monte, Huntington Memorial Hospital: Based on the findings of an investigation conducted by Huntington Memorial Hospital (HMH) and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Scott E. Monte, L.V.N., former Clinical Research Associate, HMH, engaged in scientific misconduct by knowingly and intentionally falsifying and fabricating clinical research records in HMH cancer prevention and treatment protocols supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards U10 CA69651, U10 CA12027, U10 CA32012, and U10 CA86004.

Specifically, Mr. Monte knowingly and intentionally:

(1) Entered falsified and fabricated laboratory data or physical examination results on five (5) research protocol case report forms (CRFs);

(2) Falsified a gynecological examination report in a physician's progress note and entered the falsified document in the patient's research chart; and

(3) Fabricated progress notes for four patients and a case report form for one of these patients.

ORI has implemented the following administrative actions for a period of three (3) years, beginning on January 7, 2008:

(1) Dr. Monte is debarred 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 pursuant to HHS' implementation of the OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR Part 376; and

(2) Dr. Monte is prohibited 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, [phone].

Chris B. Pascal,

Director, Office of Research Integrity.