Office of the Secretary April 27, 2011 – Federal Register Recent Federal Regulation Documents

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Young Adult
Document Number: 2011-10241
Type: Rule
Date: 2011-04-27
Agency: Department of Defense, Office of the Secretary
This interim final rule implements Section 702 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). It establishes the TRICARE Young Adult (TYA) program to provide an extended medical coverage opportunity to most unmarried children under the age of 26 of uniformed services sponsors. The TRICARE Young Adult program is a premium-based program.
Findings of Research Misconduct
Document Number: 2011-10157
Type: Notice
Date: 2011-04-27
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Junghee J. Shin, PhD, New York Medical College: Based on the report of an investigation conducted by New York Medical College (NYMC) and additional analysis by the Office of Research Integrity (ORI) in its oversight review, the U.S. Public Health Service (PHS) found that Junghee J. Shin, PhD, former graduate student, NYMC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI048856 and R01 AI043063. PHS found that the Respondent engaged in research misconduct by falsifying data in Figure 4 of a manuscript submitted to the journal Infection and Immunity (Shin, J.J., Godfrey, H.P., & Cabello, F.C. ``Expression and localization of BmpC in Borrelia burgdorferi after growth under various environmental conditions.'' Submitted to Infection and Immunity; hereafter referred to as the ``manuscript'') and Figure 5 of a paper published in Infection and Immunity (Shin, J.J. Bryksin, A.V., Godfrey, H.P., & Cabello, F.C. ``Localization of BmpA on the exposed outer membrane of Borrelia burgdorferi by monospecific anti- recombinant BmpA rabbit antibodies.'' Infection and Immunity 72(4):2280-2287, April 2004; hereafter referred to as the ``paper.'' Retracted in: Infection and Immunity 76(10):4792, October 2008). Specifically, NYMC and ORI found that: Dr. Shin falsified microscopic immunofluorescence blank images in Figure 4 of the manuscript (top row, 1st, 2nd, 4th, and 5th panels, and bottom row, 1st panel) and Figure 5 of the paper (top row, 1st and 5th panels, lower 1st panel) by using one blank image from an unknown experiment to falsely represent the preimmunization control conditions (intact cells and methanol fixation) as well as the negative staining of anti-BmpC and anti-FlaB in Figure 4 and anti-FlaB in Figure 5 on intact cells. Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different portions of a green-red pair of microscopic immunofluorescence images (1230036.tif and 1230037.tif) because unfixed cells staining positive for BmpA in the top row, 4th panel, of Figure 5 were the same unfixed cells purportedly positive for OspA in the top row, 3rd panel, of Figure 4. Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different photo cropping from a single microscopic immunofluorescence image (1230039.tif) to represent fixed cells positive for BmpA and labeled with anti-FlaB in the lower row, 5th panel, of Figure 5 and to also represent fixed cells positive for BmpC and stained with anti-FlaB in the lower row, 5th panel, of Figure 4. Dr. Shin has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on April 5, 2011: (1) 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 her in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of her duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of her research contribution; Respondent agrees that she will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; and (2) to exclude herself voluntarily from service 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.
Findings of Research Misconduct
Document Number: 2011-10150
Type: Notice
Date: 2011-04-27
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Vipul Bhrigu, PhD, University of Michigan Medical School: Based on the findings of an investigation by the University of Michigan Medical School (UMMS) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, ORI found that Vipul Bhrigu, PhD, former postdoctoral fellow, Department of Internal Medicine, UMMS, engaged in research misconduct in research funded by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA098730-05. Specifically, ORI found that the Respondent knowingly and intentionally tampered with research materials related to five (5) immunoprecipitation/Western blot experiments and switched the labels on four (4) cell culture dishes for cells used in the same type of experiments to cause false results to be reported in the research record. ORI also found that the Respondent tampered with laboratory research materials by adding ethanol to his colleague's cell culture media, with the deliberate intent to effectuate the death of growing cells, which caused false results to be reported in the research record. ORI has concluded that these acts seriously deviated from those that are commonly accepted within the scientific community for proposing, conducting, and/or reporting research. ORI found that the Respondent's intentional tampering of his colleague's laboratory research constitutes research misconduct as defined by 42 CFR part 93. ORI determined that the Respondent engaged in a pattern of dishonest conduct through the commission of multiple acts of data falsification. ORI also determined that the subterfuge in which he freely engaged for several months constitutes an aggravating factor. The Respondent attempted to mislead the University of Michigan (UM) police by initially denying involvement in the tampering and refusing to accept responsibility for this misconduct. The Respondent eventually made an admission only after the UM police informed him that his actions in the laboratory had been videotaped. This dishonest conduct established the Respondent's lack of present responsibility to be a steward of Federal funds (2 CFR 376 et seq.; 42 CFR 93.408). The following administrative actions have been implemented for a period of three (3) years, beginning on April 7, 2011: (1) Dr. Bhrigu is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government, referred to as ``covered transactions,'' pursuant to HHS' Implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR 376 et seq.); and (2) Dr. Bhrigu is prohibited from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
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