[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Page 15127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05921]



[[Page 15127]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research 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) has taken final action in the following case:
    Parag Patel, D.O., Advocate Health Care Network d/b/a Advocate 
Health Care: Based on an investigation conducted by Advocate Health 
Care Network d/b/a Advocate Health Care (Advocate Health Care) and 
additional analysis conducted by ORI in its oversight review, ORI and 
Advocate Health Care found that Dr. Parag Patel, Cardiologist, 
Department of Medicine, Advocate Health and Hospitals Corporation d/b/a 
Advocate Lutheran General Hospital, Park Ridge, Illinois, engaged in 
research misconduct in research supported by National Heart, Lung, and 
Blood Institute (NHLBI), National Institutes of Health (NIH), grant U01 
HL089458.
    ORI and Advocate Health Care found that the Respondent engaged in 
research misconduct by directing or intimidating fellows and others to 
influence left ventricular ejection fraction (LVEF) scores of <= 35% 
and requesting attending physicians to reassess scores of LVEF to be 
reported as <= 35% for research subjects after being diagnosed with 
acute myocardial infarction, thereby causing and being responsible for 
falsification of research records. These falsifications made subjects 
eligible for enrollment into the ``Vest Prevention of Early Sudden 
Death Trial'' (VEST) when they otherwise may not have been eligible.
    The Respondent, Advocate Health Care, and the U.S. Department of 
Health and Human Services (HHS) want to conclude this matter without 
further expenditure of time or other resources and have entered into a 
Voluntary Settlement Agreement (Agreement) to resolve this matter. 
Respondent neither admits nor denies ORI's and Advocate Health Care's 
findings of research misconduct. This settlement does not constitute an 
admission of liability on the part of the Respondent.
    Dr. Patel has voluntarily agreed for a period of two (2) years, 
beginning on February 21, 2014:
    (1) To have any U.S. Public Health Service (PHS)-supported research 
in which he is involved be supervised; Respondent agreed that prior to 
the submission of an application for PHS support for a research project 
on which the Respondent's participation is proposed and prior to 
Respondent's participation in any capacity on PHS-supported research, 
Respondent shall ensure that a plan for supervision of Respondent's 
duties is submitted to ORI for approval; the supervision plan must be 
designed to ensure the scientific integrity of Respondent's research 
contribution as outlined below; Respondent agreed that he shall not 
participate in any PHS-supported research until such a supervision plan 
is submitted to and approved by ORI; Respondent agreed to maintain 
responsibility for compliance with the agreed-upon supervision plan;
    (2) That the requirements for Respondent's supervision plan are as 
follows:
     A committee of two to three qualified physicians at the 
institution's discretion, who are familiar with Respondent's field of 
research, but not including Respondent's supervisor or collaborators, 
will provide oversight and guidance; the committee will review primary 
data from Respondent's participation in PHS-supported research on a 
quarterly basis and submit a report to ORI at six (6) month intervals 
setting forth the committee's meeting dates, Respondent's compliance 
with appropriate research standards, and confirming the integrity of 
Respondent's research contribution; and
     The committee will conduct an advance review of any PHS 
grant applications (including supplements, resubmissions, etc.), 
manuscripts reporting PHS-funded research submitted for publication, 
and abstracts; the review will include a discussion with Respondent of 
the primary data represented in those documents and will include a 
certification to ORI that the data presented in the proposed 
application/publication are supported by the research record;
    (3) That any institution employing him shall submit, in conjunction 
with each application for PHS funds, or report, manuscript, or abstract 
involving PHS-supported research in which Respondent is involved, a 
certification to ORI that the data provided by Respondent are based on 
actual experiments or are otherwise legitimately derived and that the 
data, procedures, and methodology are accurately reported in the 
application, report, manuscript, or abstract; and
    (4) To exclude himself voluntarily 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:
Acting Director, Office of Research Integrity, 1101 Wootton Parkway, 
Suite 750, Rockville, MD 20852, (240) 453-8800.

Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2014-05921 Filed 3-17-14; 8:45 am]
BILLING CODE 4150-31-P