Department of Health and Human Services November 4, 2008 – Federal Register Recent Federal Regulation Documents

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 8:30 a.m. to 5 p.m. on December 15, 2008, and from 8:30 a.m. to 3:30 p.m. on December 16, 2008, at the Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

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: Jusan Yang, M.S., M.D., University of Iowa: Based on the report of an investigation conducted by the University of Iowa (UI) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, this settlement resolves proposed U.S. Public Health Service (PHS) findings that Dr. Jusan Yang, former Assistant Research Scientist, UI, engaged in scientific misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL48058. PHS finds the Respondent engaged in scientific misconduct by falsifying and fabricating data that were reported in a scientific manuscript intended for publication entitled ``Increased renin transcription after inhibition of NF-YA with RNAi reveals through regulation of Ea element and Ear2'' and at two professional scientific meetings. Specifically, PHS found that: 1. Respondent falsified Figure 1 in the manuscript that purports to show the effectiveness of four plasmids targeting different parts of the NF-Y coding sequence in inhibiting NF-Y expression by (1) Claiming in Figure 1A that the loading control bands were obtained by reprobing a Western blot with antibody to GAPDH when he used a prominent background (nonspecific) band from the blot probed with antibody to NF- YA, (2) inappropriately enhancing and manipulating the NF-YA band in Figure 1A claiming decreased expression of NF-YA in cultures transfected with 2 of the 4 constructs, and (3) falsely claiming in Figure 1B that the quantitative data for NF-YA expression obtained by scanning Western blot films were based on an n of 4 and that the expression of NF-YA in cultures treated with two constructs was statistically significantly lower than the control. Versions of the same falsified blot and histogram also were reported in several of the Respondent's public presentations. 2. Respondent falsified Figures 4, 5, 6, and 8 in the manuscript by claiming in the figure legends that 4 independent repetitions contributed to each figure's results when the actual numbers of repetitions were n=3 for Figure 4, n=1 for Figure 5, n=3 for Figure 6, and n=2 for Figure 8; in Figure 5, error bars based on the Student's t test further falsely claim that n was >2. He further falsified Figures 6 and 8 by reporting smaller standard errors of the mean than were obtained from the actual data, thereby giving an enhanced impression of rigor for the reported experiments. Respondent reported Figures 5, 6, and 8 (without legends) at the American Heart Association Council for High Blood Pressure meeting in September 2003, and he reported Figures 5 and 8 at the Experimental Biology meeting in April 2004. Respondent stated that he does not intend to apply for or engage in PHS-supported research. However, if such a circumstance were to arise, Respondent agreed for a period of five (5) years, beginning on October 14, 2008: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS funded research in which he 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; Respondent agreed to ensure that a copy of the supervisory plan is also submitted to ORI by the institution; Respondent agreed that he will not participate in any PHS- supported research until such a supervision plan is approved by ORI; (2) That any institution employing the Respondent submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS funded research in which he 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 also sends a copy of the certification to ORI; and (3) 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.