Archive for October, 2011

Findings of Research Misconduct

Notice is hereby given that ORI has taken final action in the following case:

Based on an inquiry conducted and written admission obtained by the University of Pittsburgh and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Marija Manojlovic, former graduate student, Department of Chemistry, engaged in research misconduct in research supported by P50GM067082, P01CA078039, U54MH074411, and R01AI033506.

ORI found that the Respondent engaged in research misconduct by falsifying and fabricating the synthesis and spectral data that were included in one poster presentation and in one pre-submission draft of a paper to be submitted for publication.

Specifically, ORI found that the Respondent knowingly falsified and fabricated the synthesis and characterization, largely in the form of manipulated 1H- and 13C-NMR spectral data, for 5 intermediate steps and the final product, 9-desmethylpleurotin, and presented these false results in a poster, “Efforts Towards the Total Synthesis of Pleurotin,’ presented at the 2011 National Organic Symposium, and in a manuscript, “Total Synthesis of 9-desmethylpleurotin,’ prepared for submission to Angewandte Chemie International Edition.

Ms. Manojlovic has voluntarily agreed for a period of 3 years, beginning on September 26, 2011:

(1) To have her US PHS-supported research supervised; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS-supported research, she shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she 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 any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which she 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 herself 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.

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SMRB Meeting October 26

Remember our friends at the SMRB? The folks charged to advise the NIH Director on the use of organizational authorities? The Federal Register (and finally, today, so does their main Website) announced their meeting next on October 26th, which is open to the public and can be viewed via Webcast.

Let’s see. Since their last meeting in Feb, the Director has directed the planned dismantling and redistribution of NCRR programs, which in fact remained at NCRR under the CR … and would be permanently kept at NCRR according to the House draft (which also increases NIH funding) of the Labor, HHS, and Education appropriations bill … whereas the Senate version eliminates NCRR, establishes NCATS, and cuts the NIH appropriation.

The agenda for next Wednesday’s SMRB meeting is as follows:

    9:00 AM Opening Remarks, Norman Augustin
    9:15 AM Status of NIH Today and Looking to the Future, Francis Collins
    9:45 AM Advancing Translational Sciences, Kathy Hudson
    10:15 AM Discussion
    10:45 AM Substance Use, Abuse, & Addiction Research, Lawrence Tabak
    10:50 AM Discussion
    11:00 AM Public Comments
    11:30 AM NIH Clinical Center, Stephen Katz
    12:00 PM Discussion
    12:30 PM Public Comments
    12:45 PM Lunch (nothing served via Webcast)
    1:30 PM SBIR & STTR Programs at NIH, Sally Rockey
    2:00 PM Charge to the SMRB, Francis Collins
    2:10 PM Discussion
    2:45 PM Next Steps, Norman Augustine
    3:00 PM Adjournment

To sign up to make a public comment at the meeting, send your name and affiliation to Lyric Jorgenson, PhD by October 25, 2011 (you can submit a written comment to the same address).

We will see what advice on executing organizational authority comes forth next …

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If You Ruled the NIH, How Would You Fund the Most Research Possible?

Sally Rockey invites the extramural community to chime in on what the NIH should do to best manage its dwindling funds. She points us to a nice set of slides that lay out how various scenarios would impact the number of awards and success rate (includes links to data tables). In fact, there are cool interactive slides that let you turn the knob on award distribution by size ($250K vs $1M) and the number of RPG awards per PI to see how the number of additional awards, the success rate, and the average award size are affected. You can also see the percentage of funded PIs by their total RPG award dollars (e.g., 12% of NIH-funded PIs receive $1M+ in RPG support, comprising 40% of the NIH RPG budget).

The scenarios covered in the NIH slides lay out the impact of:

  • Reducing or limiting size of awards
  • Limiting number of awards held by an PI
  • Limiting the amount of funds an PI can hold
  • Limiting salaries of PIs

Comments thus far expand the discussion to renegotiating a lower and uniform indirect cost (F&A) rate (this would need to be done at a federal rather than NIH level, though); funding departments directly & uniformly (they redistribute the dollars as they see fit); and limiting the number of 100%-grant funded PIs (soft-money positions).

You can post comments at Rock Talk or send your thoughts to the electronic suggestion box.

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Findings of Research Misconduct (x2)

Busy month for ORI …

Notice is hereby given that ORI has taken final action in the following case:

Based on an inquiry conducted by Duke , admissions by the Respondent, and additional analysis conducted by ORI, ORI and Duke found that Shamarendra Sanyal, PhD, former postdoctoral scholar, engaged in research misconduct by falsifying data in a grant application submitted to NHLBI). Specifically, ORI found that the Respondent falsified Figure 2C of grant application R01HL107901, “Store-operated calcium entry in airway inflammation,’ by altering the gain settings in the instrument used to measure store-operated current (SOC) densities in a whole cell patch clamp experiment comparing Stim 1+/- mouse airway cells and wild type mouse airway cells. Respondent also falsified the calcium response data in Figure 5A (right panel) of the grant application referenced above by adding ATP as a reagent to the mouse airway epithelial cells to sharpen the results purported to be caused by PGN without disclosing that ATP had been added and without disclosing that ATP was not added to the control sample. The questioned research was not submitted for publication.

Dr. Sanyal has entered into a Voluntary Settlement Agreement with ORI and Duke. The administrative actions are required for 2 years beginning on the date of Dr. Sanyal’s employment in a research position in which he receives or applies for PHS support on or after the effective date of the Agreement (September 16, 2011); however, if he has not obtained employment in a research position in which he receives or applies for PHS support within 3 years of the effective date of the Agreement, the administrative actions set forth below will no longer apply. Dr. Sanyal has voluntarily agreed:

(1) To have his research supervised as described below and to notify his employer(s)/institutions(s) of the terms of this supervision; Respondent agrees to ensure that prior to the submission of an application for PHS support for a research project on which Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS supported research, the institution employing him will submit a plan for supervision of Respondent’s duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that he will not participate in any PHS supported research from the effective date of this Agreement until a plan for supervision is submitted to and approved by ORI; Respondent agrees to be responsible for maintaining compliance with the agreed upon plan for supervision;

(2) that any institution employing him must submit, in conjunction with each application for PHS funds, or report, manuscript, or contract 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 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.

Notice is hereby given that ORI has taken final action in the following case:

Based on an investigation conducted by the University of Michigan Medical School (UMMS) and a preliminary analysis conducted by ORI, ORI found that Nicola Solomon, PhD, former postdoctoral scholar, Department of Human Genetics, UMMS, engaged in research misconduct in research supported by grants R37HD030428 and R01HD034283.

Specifically, the Respondent did not perform DNA sequencing on 202 cDNA clones of homeobox genes to confirm their identity and integrity. Through multiple revision of the manuscript, the Respondent did not discuss this with the corresponding author or question and correct the corresponding author’s addition of text indicating that the clones had been fully sequenced and were full length or longer (as indicated in Table 3) when compared to NCBI Mus musculus Unigene. This text supported the use of the Cap-Trapper technique to produce full length clones for the discovery of new genes without polymerase chain reaction (PCR).

Both the Respondent and the US PHS are desirous of concluding this matter without further expenditure of time and other resources and have entered into a Voluntary Settlement Agreement to resolve this matter. This settlement is not an admission of liability on the part of the Respondent. Respondent and ORI agreed to settle this matter as follows:

(1) Respondent agreed that for a period of 2 years beginning on September 16, 2011, prior to the submission of an application for PHS support for a research project on which her participation is proposed in a research capacity, and prior to her participation in this capacity on PHS-supported research, Respondent shall ensure that a plan for supervising her duties is submitted to ORI for approval; the supervision must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agreed that she shall not participate as a researcher 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; and

(2) Respondent agreed to exclude herself 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 2 years, beginning on September 16, 2011.

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Findings of Research Misconduct

Notice is hereby given that ORI has taken final action in the following case:

Based on the letters from the Research Integrity Officer at the University of Pittsburgh, ORI’s oversight review, and an admission by the Respondent, ORI found that Scott Weber, EdD, MSN, former Assistant Professor, Health and Community Systems, School of Nursing, engaged in research misconduct by (1) plagiarizing text and falsifying data from two publications and (2) including significant portions of that plagiarized text in two grant applications (L30NR010444 and R03HD062761).

ORI found that the Respondent engaged in research misconduct by plagiarizing text, falsifying data and references, and fabricating data from two publications (Mufson, L., Dorta, K.P., Wickramaratne, P., Nomura, Y., Olfson, M., Weissman, M.M. “A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents.’ Arch Gen Psychiatry 61(6):577-84, 2004 June; and Cho, M.J., MoĊ›cicki, E.K., Narrow, W.E., Rae, D.S., Locke, B.Z., Regier, D.A. “Concordance between two measures of depression in the Hispanic Health and Nutrition Examination Survey.’ Soc Psychiatry Psychiatr Epidemiol. 28(4):156-63, 1993) in two journal article submissions. Specifically, ORI found that the Respondent plagiarized more than 90% of the text from Mufson et al. 2004 in a manuscript entitled “A randomized effectiveness trial of psychiatric-mental health nurse practitioner-administered interpersonal psychotherapy for sexual minority adolescents with depression in primary care clinics’ submitted to the Journal of the American Academy of Nurse Practitioners. Furthermore, the Respondent plagiarized approximately 66% of the text from Cho et al. 1993 in a manuscript entitled “Assessing the diagnostic predictive power of a screening tool for depression: Concordance between the CES-D and DIS in the Parent Identity Survey’ submitted to the Journal of GLBT Family Studies.

In both manuscripts, the Respondent falsified and fabricated tables and figures by using all or nearly all of the data in tables and graphs from the plagiarized articles while altering numbers and changing text to represent data as if from another subject population; he also copied most of the original bibliographic references but falsified 35% of the copied references from JAANP and 25% of the copied references from JGMS, by changing volume numbers and/or publication years, apparently to hinder detection of the plagiarism. The data fabrication occurred when the Respondent altered or added values to Table 2 in each manuscript describing the demographic characteristics of the study population that was never studied.

ORI also finds that the Respondent engaged in research misconduct by plagiarizing text from Cho et al. 1993 in two NIH grant applications (L30NR010444 and R03 HD06276) by copying substantial word-for-word portions of the text describing the test instrument to be used in the proposed study without citing the Cho et al. 1993 paper.

Dr. Weber has voluntarily agreed for a period of 3 years, beginning on September 7, 2011:

(1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as “covered transactions’ pursuant to HHS’ Implementation (2 CFR part 376 et seq.) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the “Debarment Regulations’); and

(2) 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.

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