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:

Michael Shishov, M.D., Brigham and Women's Hospital, Inc. (BWH): Based on the report of an investigation conducted by Brigham and Women's Hospital, Inc. (BWH Report), the respondent's admission, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that the respondent, a former laboratory technician in the Intensive Physiological Monitoring Unit of the BWH General Clinical Research Center, engaged in scientific misconduct in a program of sleep disorder research supported by the National Institutes of Health (NIH) under National Center for Research Resources (NCRR), NIH, grant M01 RR02635.

Specifically, PHS found, and the respondent admitted, that on numerous occasions between May and August 1995, he registered on the Termiflex-computer terminal, as well as writing in hand on blood draw sheets and laboratory logs, the times that he claimed he drew blood samples from human subjects in investigational sleep research. These times differed from the actual times when the samples were collected. The accurate assessment of the endogenous circadian phase and amplitude of the measured variables, including the timing and amount of blood cortisol, was essential for the studies. However, PHS acknowledges certain mitigating circumstances: (a) That occasionally during this time, the respondent may have been responsible for more protocol procedures than he could reasonably be expected to perform; and (b) that the BWH Report notes that he was respectful and honest during the investigation and that he has participated conscientiously in a program of professional ethics counseling. Therefore, PHS accepts the administrative actions previously imposed by BWH and performed by the respondent: (1) Attending an ORI conference on research misconduct; and (2) participating in ethics counseling over a three-year period.

Dr. Shishov has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed 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 for a period of three (3) years, beginning on July 2, 2002.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700, Rockville, MD 20852, (301) 443-5330.