Archive for April, 2011

Findings of Research Misconduct x2

My least favorite scenario for my least favorite type of post … as reported last year in Nature and again on Nature’s Great Beyond blog

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

Based on the findings of an investigation by UMich and additional analysis conducted by ORI, ORI found that Vipul Bhrigu, PhD, former postdoctoral fellow, Department of Internal Medicine, engaged in research misconduct in research funded by R01CA098730-05.

Specifically, ORI found that the Respondent knowingly and intentionally tampered with research materials related to 5 immunoprecipitation/Western blot experiments and switched the labels on 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 UMich 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 UMich 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 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 [[Page 23600]] 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. PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

And …

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

Based on the report of an investigation conducted by New York Medical College (NYMC) and additional analysis by ORI, the U.S. PHS found that Junghee J. Shin, PhD, former graduate student, NYMC, engaged in research misconduct in research supported by 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 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.

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CSR Gets its Own Council

As of March 31st and as recently announced, CSR has its own Advisory Council, the CSRAC, whose chartered mission is to “advise the Director … concerning matters of policy and practice pertaining to monitoring of, coordination of, and evaluation of peer review at CSR.” The CSRAC will be “keenly focused on enhancing CSR’s operations.” Notice there is no mention of approving applications for funding. Study sections still do not fund grants.

The CSRAC replaces the PRAC (Peer Review Advisory Committee), which was established in 2005 to provide “technical and scientific advice and recommendations to the NIH Director, the Deputy Director for Extramural Research, and the Director of CSR on matters relating broadly to review procedures and policies for the evaluation of scientific and technical merit of applications for grants and awards.” PRAC held its last meeting on Feb 1, 2010, when it discussed peer review pilot projects, study section realignments, the ESI initiative, and electronic submissions.

Some PRAC members will continue on the CSRAC (Garret Fitzgerald, Penn; Heidi Hamm, Vanderbilt; Peter MacLeish, Morehouse; Andrew Murray, Harvard), and two CSRAC members come from the ACD Working Group on Peer Review (which was active during the Enhancing Peer Review initiative): co-Chair Keith Yamamoto (UCSF) and Bruce Alberts (UCSF and editor-in-chief of Science).

Of course, continuous review of peer review occurs at OER, where you can also learn more about peer review policies and practices. CSR itself offers resources for applicants and for reviewers.

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Collins to Honor NCRR as the NIH’s “Healthiest” IC on Take a Hike Day!

It’s true …

The Office of Research Services is proud to announce that the NCRR is the winner of the 2010 NIH President’s Challenge.

The NCRR bested two-time defending champion, NIDCD, with the highest average point total per employee. …

Thus, the NCRR is now the “Healthiest” Institute/Center at NIH!

… Dr. Collins awards the trophy to NCRR at the 4th annual Take a Hike Day on Thursday May 11, 2011 at 11:30 AM on the steps of Building 1.

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“Project not congruent with program objectives”

Having never heard of an application being labeled as such, I thought I would pull this comment out from NIH Paylines and Resources for broader dissemination and consideration:

Colleague got rejection email from NCI (NI/ESI) with 14% – “project not congruent with program objectives” – yikes.

Well then. Thank you for accepting primary assignment. Thank you for wasting the time and effort of the applicant and the SRG. Thank you for discouraging this ESI/NI. With Varmus’s new approach to cherry-picking awards above the 10th percentile (for ESI/NI), I can understand a 14th percentile being passed up if it fell in an area already well funded or outside a current high-priority topic of investigation or in the pile of a PO with lesser lobbying skills (or too many exceptional applications) etc. … and perhaps this was the intended meaning … but the statement as worded suggests the research focus was beyond the scope of the program that accepted the application, and it is certainly not useful in conveying to the PI how he/she could make 14th percentile science more relevant to program. I think Enhancing Peer Review needs to go back to school on this one, especially if such categories of rejection are likely to become more commonplace in a time of dwindling budgets.

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Limping Toward FY11 Appropriations

With ~5.5 months left in the fiscal year, we now know how much the NIH et al. will have in the piggy bank. Here is text from the final appropriations bill for FY11 related to the NIH (available at Thomas as H.R. 1473):

TITLE I–GENERAL PROVISIONS

Sec. 1101. (a) Such amounts as may be necessary, at the level specified in subsection (c) and under the authority and conditions provided in applicable appropriations Acts for fiscal year 2010, for projects or activities (including the costs of direct loans and loan guarantees) that are not otherwise specifically provided for, and for which appropriations, funds, or other authority were made available in the following appropriations Acts:

(1) The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111-80).
(2) The Energy and Water Development and Related Agencies Appropriations Act, 2010 (Public Law 111-85).
(3) The Department of Homeland Security Appropriations Act, 2010 (Public Law 111-83).
(4) The Department of the Interior, Environment, and Related Agencies Appropriations Act, 2010 (division A of Public Law 111-88).
(5) The Legislative Branch Appropriations Act, 2010 (division A of Public Law 111-68).
(6) The Consolidated Appropriations Act, 2010 (Public Law 111-117).
(7) Section 102(c) (except the last proviso relating to waiver of fees) of chapter 1 of title I of the Supplemental Appropriations Act, 2010 (Public Law 111-212) that addresses guaranteed loans in the rural housing insurance fund.

Sec. 1812. Notwithstanding section 1101, the level for `Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases’ shall be $4,818,275,000, and the requirement under `National Institute of Allergy and Infectious Diseases’ in division D of Public Law 111-117 for a transfer from Biodefense Countermeasures funds shall not apply.

Sec. 1813. The amount provided by section 1101 for `Department of Health and Human Services, National Institutes of Health’ is reduced by $210,000,000, through a pro rata reduction in all of the Institutes, Centers, and Office of the Director accounts within `Department of Health and Human Services, National Institutes of Health’ based on the total funding provided.

Sec. 1814. Notwithstanding section 1101, the level for `Department of Health and Human Services, National Institutes of Health, Buildings and Facilities’ shall be $50,000,000.

And at the NSF:

Sec. 1317. Notwithstanding section 1101, the level for `National Science Foundation, Research and Related Activities’ shall be $5,575,025,000 {$5,617,920,000 in Public Law 111-117}.
Sec. 1318. Notwithstanding section 1101, the level for `National Science Foundation, Education and Human Resources’ shall be $862,760,000 {$872,760,000 in Public Law 111-117}.

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