[Federal Register Volume 74, Number 62 (Thursday, April 2, 2009)]
[Notices]
[Pages 14990-14991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7411]


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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:
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:
    <bullet> Changed/falsified roughly half of the physiologic data
    <bullet> Fabricated roughly 20% of the anatomic data that were 
supposedly obtained from Computed Tomography (CT) images
    <bullet> Changed/falsified 50 to 80 percent of the other anatomic 
data
    <bullet> 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

[[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]
BILLING CODE 4150-31-P