Office of the Secretary December 28, 2012 – Federal Register Recent Federal Regulation Documents

Findings of Research Misconduct
Document Number: 2012-31287
Type: Notice
Date: 2012-12-28
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: Shuang-Qing Zhang, Ph.D., Texas Tech University Health Sciences Center: Based on the report of an investigation conducted by the Texas Tech University Health Sciences Center (TTUHSC) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Shuang- Qing Zhang, former Postdoctoral Researcher, Department of Pharmaceutical Sciences, TTUHSC, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM069869. ORI found that Respondent engaged in research misconduct by the falsification and fabrication of plagiarized data that were included in the publication: Zhang, S.Q. & Mehavr, R. ``Determination of dextra- methylprednisolone conjugate with glycine linker in rat plasma and liver by high-performance liquid chromatography and its application in pharmacokinetics.'' Biomed. Chromatogr. 24(4):351-357, 2010 (hereafter the ``BC 2010 article''). Specifically, ORI found that the Respondent: Falsified Figures 2(c) and 3(c) of the BC 2010 article by misrepresenting HPLC data that he had plagiarized, originally generated prior to the Respondent's arrival in the laboratory by a former postdoctoral researcher; in Figure 2(c), the Respondent claimed that the HPLC chromatogram was of a ``plasma sample obtained 12 h after intravenous injection of DMP to rats at a single dose of 5 mg/kg,'' while the actual chromatogram was of a calibration test of 1 [mu]g/ml of DMP added to rat plasma, and similarly in Figure 3(c), the Respondent claimed that the HPLC chromatogram was of a ``liver homogenate obtained 3 h after intravenous dose of DMP at a dose of 5 mg/kg,'' while the actual chromatogram was of a calibration test of 2 [mu]g/ml DMP added to rat liver homogenate. Falsified and fabricated Figure 4 of the BC 2010 article; in the top panel, the Respondent reported the measurement of DMP concentrations in plasma samples of three rats after a single injection of 5 mg/kg DMP while the actual data that he had plagiarized, originally generated prior to the Respondent's arrival in the laboratory by a former postdoctoral researcher, was from a single rat. In the bottom panel, the Respondent reported the measurement of DMP concentrations in liver samples obtained from three rats at 1, 30, 90, 180, 300, and 720 minutes after a single injection of 5 mg/kg DMP, requiring a total of 18 rats, while the actual data that he had plagiarized, originally generated prior to the Respondent's arrival in the laboratory by a former postdoctoral researcher, was from plasma samples from a single rat, and the error bars for both panels were fabricated. Dr. Zhang has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) To have his research supervised for a period of three (3) years; Respondent voluntarily agrees that within sixty (60) days of the effective date of the Agreement, 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 research to ORI for approval; Respondent agrees that he will not participate in any PHS-supported research after sixty (60) days from the effective date of the Agreement until an appropriate supervision plan is submitted to ORI; the supervision plan must be designed to ensure the scientific integrity of the Respondent's research contribution; and (2) 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 a period of three (3) years, beginning on December 4, 2012.
Notice of Interest Rate on Overdue Debts
Document Number: 2012-31284
Type: Notice
Date: 2012-12-28
Agency: Department of Health and Human Services, Office of the Secretary
Findings of Research Misconduct
Document Number: 2012-31275
Type: Notice
Date: 2012-12-28
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: Martin Biosse-Duplan, D.D.S., Ph.D., Harvard School of Dental Medicine: Based on the report of an investigation conducted by the Harvard School of Medicine (HSM) and Harvard School of Dental Medicine (HSDM), the admission of the Respondent, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Martin Biosse-Duplan, former Research Fellow, Department of Oral Medicine, Infection, and Immunity, HSDM, engaged in research misconduct in research supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), grant R01 AR054450. ORI found that the Respondent engaged in research misconduct involving one (1) laboratory presentation and two (2) published abstracts: Boisse-Duplan, M., Stephens, S., Lai, F.P.L., Oelkers, M., Kitamura, D., Rottner, K., Horne, W., & Baron, R. ``The Association Between the Microtubule Plus End Protein EB1 and Cortactin Controls Podosomes and Bone Resorption.'' J Bone Min Res 26:Supl.1, pS215. Boisse-Duplan, M., Stephens, S., Lai, F.P.L., Oelkers, M., Rottner, K., Horne, W., & Baron, R. ``In Osteoclasts, Dynamic Microtubules and their Associated Protein EB1 Control Podosomes and Bone Resorption through Cortactin.'' Bone 48:Suppl. 2, pS97. As a result of HSM's and HSDM's investigation, the data were not presented at the meetings and the experiments reported in the abstracts are being redone. Specifically, ORI finds that Respondent: Falsified Powerpoint slides and spreadsheets for histomorphometric and microCT results by using the values of HS1 knockout (KO) mice and their controls to represent the CathepsinK cre- Cortactin KO mice and their controls; Dr. Biosse-Duplan also switched two sets of numbers between the HS1 KO mice and their controls to falsely demonstrate a difference in bone density when there was none. The numerical data were presented at a lab meeting, and false text was included in two submitted meeting abstracts published in Bone 48:Suppl 2, pS97 and J Bone and Mineral Research 25:Suppl 1, pS215. Both the Respondent and 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. Dr. Boisse-Duplan has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) That if within two (2) years from the effective date of the Agreement Respondent does receive or apply for PHS support, Respondent agrees to have his research supervised for a period of two (2) years beginning on the date of his employment in a research position in which he receives or applies for PHS support and to notify his employer(s)/ institution(s) of the terms of this supervision; Respondent agrees 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; Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) That if within two (2) years from the effective date of the Agreement, Respondent does receive or apply for PHS support, Respondent agrees 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 (3) 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 a period of two (2) years, beginning on December 4, 2012.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2012-31196
Type: Notice
Date: 2012-12-28
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
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