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###### Department of Health and Human Services

###### Office of the Secretary

# 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:

*Robert B. Fogel, M.D., Harvard Medical School and Brigham and Women's Hospital:*                     Based on information that the Respondent volunteered to his former mentor on November 7, 2006, and detailed in a written admission on September 19, 2007, and ORI's review of Joint Inquiry and Investigation reports by Harvard Medical School (HMS) and the Brigham and Women's Hospital (BWH), the U.S. Public Health Service (PHS) found that Dr. Robert B. Fogel, former Assistant Professor of Medicine and Associate Physician at HMS, and former Co-Director of the Fellowship in Sleep Medicine at BWH, engaged in scientific misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), awards P50 HL60292, R01 HL48531, K23 HL04400, and F32 HL10246, and National Center for Research Resources (NCRR), NIH, award M01 RR02635.                

                    PHS found that Respondent engaged in scientific misconduct by falsifying and fabricating baseline data from a study of sleep apnea in severely obese patients published in the following paper: Fogel, R.B., Malhotra, A., Dalagiorgou, G., Robinson, M.K., Jakab, M., Kikinis, R., Pittman, S.D., and White, D.P. “Anatomic and physiologic predictors of apnea severity in morbidly obese subjects.”                     *Sleep*                     2:150-155, 2003 (hereafter referred to as the “                    *Sleep*                     paper”); and in a preliminary abstract reporting on this work.                

                    Specifically, PHS found that for the data reported in the                     *Sleep*                     paper, the Respondent:                
      - Changed/falsified roughly half of the physiologic data
      - Fabricated roughly 20% of the anatomic data that were supposedly obtained from Computed Tomography (CT) images
      - Changed/falsified 50 to 80 percent of the other anatomic data
      - Changed/falsified roughly 40 to 50 percent of the sleep data so that those data would better conform to his hypothesis.

                    Respondent also published some of the falsified and fabricated data in an abstract in                     *Sleep*                     24, Abstract Supplement A7, 2001.                

Dr. Fogel has entered into a Voluntary Settlement Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on March 16, 2009:

(1) 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;

                    (2) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution; a copy of the supervisory plan must also be submitted to ORI by                           ( print page 14991)                        the institution; the Respondent agrees that he will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI; and                

(3) To ensure that any institution employing him submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS-funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report. The Respondent must ensure that the institution sends the certification to ORI.

# FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8800.

John Dahlberg,

Director, Division of Investigative Oversight, Office of Research Integrity.

[FR Doc. E9-7411 Filed 4-1-09; 8:45 am]

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