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NCI Publishes FY11 Funding Data (R01s, R21s)

05.4.12 by Michelle Kienholz

NCI has joined NIGMS in releasing some of its FY11 funding data, which break down applications and awards by percentile and PI status (established, new, ESI). They introduce the charts and table with a concise statement about “the zone”:

Beginning in FY 2011, NCI adopted a new approach to the selection of grant applications for funding that sets a zone within which nearly all applications are selected for funding. In both 2011 and 2012, that zone extended to the 7^th percentile. Beyond that point, all applications are considered, resulting in a final success rate of 15% in 2011.

And they are sufficiently stouthearted to accept comments.

| Posted in NIH Advice, Payline, Research News | No Comments »

Findings of Research Misconduct

04.19.12 by Michelle Kienholz

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

Based on the report of an investigation conducted by Oregon Health Sciences University and additional analysis conducted by ORI in its oversight review, ORI found that Peter J. Francis, MD, PhD, Associate Professor, Casey Eye Institute, OHSU, engaged in research misconduct in research reported in two grant applications, R01 EY021214-01 and resubmitted as R01 EY021214-01A1.

Specifically, ORI finds that the Respondent fabricated results of a pilot experiment in which he claimed to have injected retinal pigment epithelial (RPE) cells obtained from Rhesus monkey embryonic stem cells (ECS) into a strain of rats (RCS) that develops retinal degeneration.

Respondent claimed that after the injection of ECS-derived RPE cells 21 days postnatal, the rats were tested at day 60 postnatal for optomotor acuity, and that the retinal histology of eyes receiving ECS-derived RPE cells, compared to mock-injected controls, showed enhanced photoreceptor preservation and no adverse effects. Respondent admitted that this experiment had not been conducted either by the time the original grant application had been submitted or by the time the later R01 EY021214-01A1 application was submitted.

Dr. Francis has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of 2 years, beginning on March 29, 2012:

(1) To have his research supervised; Respondent agrees to ensure that prior to the submission of an application for US 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, the institution employing him must 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 shall not participate in any PHS-supported research after 60 days from the effective date of this Agreement 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 this supervisory plan provided by any institution employing him shall provide assurance that each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent was involved was based on actual experiments or was otherwise legitimately derived, that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions was his own or properly cited the source of copied language and ideas; 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.

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Standardized Process for JIT Requests & Electronic Submission

04.2.12 by Michelle Kienholz

I should leave the country more often. Last Friday, the NIH released a notice indicating that to:

reduce application confusion and to minimize requests from NIH staff for JIT submissions, NIH is revising its business processes so applicants will have better information on when JIT submissions are required …

Hallelujah.

Specifically:

Beginning April 20, 2012, applications receiving an impact score of 40 or less will receive a standard notice and request for submitting JIT information … Notices will be sent via e-mail from NIH eRA Commons to the PI 2 weeks after release of the impact score …

They make it clear that this threshold is not intended to reflect the payline of any IC and that they will “review the JIT notification trigger level to determine if additional adjustments are needed to improve the process.” I assume PIs with applications scoring above 40 to be funded by exception will be asked by their PO to submit JIT via the live link available for all applications on eRA Commons, which the notice also takes care to explain does reflect likelihood of funding or any genuine need for JIT submission:

For all applications, the eRA Commons JIT link will be opened and available for submission of JIT information within 24 hours after the impact score has been released. … Since the JIT link will be available for all applications, applicants should not rely on this as an indicator of the need to submit JIT information; instead they should rely on the JIT notification described above and any specific requests from NIH staff.

My thanks to OER for this simple but very helpful adjustment to this process.

As a reminder, JIT information is needed “at least 60 days before the applicant’s proposed project period start date (or sooner if requested by the IC)” and includes:

Current Other Support: Provide active support information for all individuals designated in an application as senior/key personnel—those devoting measurable effort to a project. Other support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes or gifts are excluded. Sample format pages are available (Word or PDF), however, there is no specific form provided to report on “Current Other Support.” Effort devoted to projects must be measured in person-months.
For all senior/key personnel, provide details on how you would adjust any budgetary, scientific, or effort overlap if this application is funded.
For Career Development Award applications, information on all active support for the candidate, sponsor(s), co-sponsor(s), and Senior/Key Personnel may be requested by the awarding component prior to award.

Certifications:

IACUC Approval Date: If the proposed project involves research using live vertebrate animals, the verification date of IACUC approval along with any IACUC-imposed changes must be submitted. Pending or out-of-date approvals are not acceptable.
IRB Approval Date: If the proposed project involves human subjects research, the certification date of IRB review and approval must be submitted. Pending or out-of-date approvals are not acceptable.
Human Subjects Education: If the proposed project involves human subjects research, certification that any person identified as senior/key personnel involved in human subjects research has completed an education program in the protection of human subjects must be submitted.
Human Embryonic Stem Cells (hESCs): If the proposed project involves hESCs and the applicant did not identify an hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line(s) may be submitted as an “Other Upload” file.
Other Information Requested by the Awarding IC: Additional JIT information (i.e., revised budgets, changes to the human subjects, or vertebrate animal sections of the application) may be requested by ICs on a case-by-case basis. These should be submitted as an “Other Upload” file.

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Findings of Research Misconduct

03.2.12 by Michelle Kienholz

As reported earlier in the week by Retraction Watch when the Federal Register notice came out, we have a case involving something more than a reseach coordinator, grad student, or postdoc …

Based on the report of an investigation conducted by SUNY Upstate Medical University and additional analysis conducted by ORI in its oversight review, ORI found that Michael W. Miller, PhD, former Professor and Chair, Department of Neuroscience and Physiology, SUNY UMU, engaged in research misconduct by falsifying and/or fabricating data that were included in grant applications R01AA07568-18, R01AA07568-18A1, R01AA006916-25, and P50AA017823-01 and in the following:

Miller, M.W., Hu, H. “Lability of neuronal lineage decisions is revealed by acute exposures to ethanol.’ Dev. Neurosci. 31(1-2):50-7, 2009 (“Dev. Neurosci. 2009′)

A prepared manuscript submitted to PNAS for publication.

As a result of its investigation, SUNY UMU recommended that Dev. Neurosci. 2009 and J. Neurochem. 2007 be retracted. Both publications have now been retracted:

Dev. Neurosci. 2009 was retracted online on January 19, 2012, at: http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=323471&Ausgabe=0&ProduktNr=224107&filename=323471.pdf.

J. Neurochem. 2007 was retracted online on January 23, 2012, at: http://onlinelibrary.wiley.com/doi/10.1111/j.1471-4159.2012.07662.x/full.

Specifically, ORI finds that the Respondent:

Falsified Figure 5 in NIH grant application R01 AA07568-18A1 by altering the bar graphs to make the experimental results appear valid and consistent with his hypothesis that ethanol exposure in-utero alters the transition of cells from Pax 6 expression to Tbr2 expression, which is critical to normal brain development. Specifically:

a. In the VZ/SZ panel (upper row, right), Dr. Miller decreased the values by 50% for the bar graphs representing control and treated mice for “Tbr2,’ “both,’ and “both/Ki-67,’ to falsely report an equivalent frequency of Tbr2 expressing cells in the right and left panels; this result was required for the experiment to appear valid;

b. In the MGE panel (lower row, right), Dr. Miller altered the bar graphs representing control and treated mice for “Ki-67,’ “Pax6,’ and “both’ to falsely report that ethanol increased the frequency of K-67+ cells and to report an equivalent frequency of Pax expressing cells in the right and left panels.

Fabricated bar graphs in Supplemental Figure 2 in a manuscript submitted to PNAS and text in the manuscript also appearing in the grant application AA00616-25 to support the hypothesis that ethanol exposure during postnatal weeks 1 and 2 causes specific neuronal cell death in layers II/III and V of the cortex. Specifically, Dr. Miller:

a. Fabricated bar graphs in Supplemental Figure 2 and related text in the PNAS manuscript to show that in select layers of the cortex, ethanol induced neuronal death occurred in post-natal day 10 (P10) mice;

b. Included fabricated text in the PNAS manuscript and the grant application citing results of experiments using 15-25-day-old mice treated with ethanol during the second postnatal week, when these mice were never generated.

Falsified Figure 6 in a manuscript submitted to PNAS by altering data points for the labeling index of caspase3 and TUNEL in cortex layers II/III and V after exposure to ethanol in postnatal day 7 (P7) mice, such that the two assays confirmed each other. The same data were also included as Figure 4 in NIH grant application R01 AA06916 and as Figure 7 in a poster presentation at the 2009 Research Society on Alcoholism.

Falsified the figure legends and/or text in a published paper and multiple grant applications to support the primary hypothesis of the published paper that gestational alcohol exposure had an effect on brain development by affecting the way neurons differentiate and migrate into the cortex, rather than by changes to cell growth or death. Specifically, Dr. Miller falsely reported the number of animals (n) that were used in figure legends and/or text in the following:

Figures 2 and 5, Dev. Neurosci. 2009, also included as Figures 3 and 4, respectively, in R01 AA07568-18;

Figure 4 and Table 2 in P50 AA017823-01

Falsified Figures 4 and 6 in J. Neurochem. 2007 by altering bar graphs to increase the significance of the effect of ethanol exposure and/or withdrawal on NGF or trkA protein expression, thereby conforming with the paper’s hypothesis that ethanol exposure and withdrawal affect the normal NGF/trkA circuits in cortical layer V. Specifically, Dr. Miller:

a. Increased the value of the ethanol treated NGF expression in Figure 4 and decreased the value of withdrawal NFG to alter the difference between the two from approximately 2.2% to 11.6%, thereby falsely reporting significance where there was none;

b. In Figure 6:

(a) Increased the value of withdrawal trkA data by approximately 70% to falsely report significance with relation to the ethanol treated value and increase significance with relation to the control;

(b) Increased the value of the ethanol treated phospho-trkA data by approximately 100% to increase the significance with relation to the control;

(c)Falsely reported the results for Figure 6 as showing a nearly doubled ratio of p-trkA to total trkA after ethanol exposure when there was no increase at all.

Dr. Miller has entered into a Voluntary Exclusion Agreement. Dr. Miller neither admits nor denies committing research misconduct but accepts ORI has found evidence of research misconduct as set forth above. Dr. Miller has voluntarily agreed:

(1) To exclude himself voluntarily 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’) for a period of one (1) year, beginning on February 6, 2012;

(2) To have his research supervised for a period of two (2) years immediately following the one (1) year period of exclusion; Respondent agrees that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent’s participation is proposed and prior to the 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 as outlined below; 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; the requirements for Respondent’s supervision plan are as follows:

A committee of 2-3 senior faculty members at the institution who are familiar with Respondent’s field of research, but not including Respondent’s supervisor or collaborators, will provide oversight and guidance for two (2) years immediately following the period of exclusion; the committee will review primary data from Respondent’s laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates, Respondent’s compliance with appropriate research standards, and confirming the integrity of Respondent’s research; and

The committee will conduct an advance review of any PHS grant applications (including supplements, resubmissions, etc.), manuscripts reporting PHS-funded research submitted for publication, and abstracts; the review will include a discussion with Respondent of the primary data represented in those documents and include a certification to ORI that the data presented in the proposed application/publication is supported by the research record;

(3) That any institution employing him during the two (2) years during which the supervisory plan is in effect 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

(4) 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 for a period of three (3) years, beginning on February 6, 2012.

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FY13 Budget Discussions Begin

02.15.12 by Michelle Kienholz

The President’s FY13 budget proposal, which Republicans in Congress declared dead on arrival, should generally be of concern to those in biomedical research. The HHS Budget in Brief report euphemistically starts the section on the NIH budget (p 34) with:

The FY 2013 Budget requests $30.9 billion for the NIH, the same level as in FY 2012, reflecting the Administration’s priority to invest in innovative biomedical and behavioral research that spurs economic growth while advancing medical science.

Hmmm. Unless we are projected to have 0% inflation, this translates into a decrease, leaving some head-scratching about actual level of priority given here. Of course, the NIH budget hasn’t kept up with the pace of inflation for the last decade, so why start now.

The flat line does not extend across all ICs either. Only NINDS, NIAMS, NINR, and FIC remain unchanged from FY12 funding levels. NIGMS gives up the bonus $ appropriated to the IDeA program last year with a $48M drop, and the OD (Office of Director) loses $28M (from the National Children’s Study), with perhaps some of this going to NCATS, a clear winner in this budget proposal ($64M, of which $40M will go to CAN, the Cures Acceleration Network). Most other IC increases/decreases are in the $1-3M range, with a few exceptions: NIAID gains $10M, NEI loses $9M, and the NLM bumps up $8M.

Although the budget proposal shows RPG $ going down by $26M ($23M of this shifts to intramural & management budgets), the number of competing awards (Type 1/Type 2) will go up by 672, offset by the removal of 777 noncompeting renewals from the books. Guess not all these folks are among the happy competing renewal crowd. The allocation for research centers drops by $64M and for research training by $2M (but a 2% stipend increase for pre/postdocs). R&D contracts would see a $108M boost.

Just over half (53.3%) of the NIH budget goes to support extramural RPGs, and the NIH is squeezing each grant awarded harder to come up with enough cash to fund more applications, mainly by controlling average award size (target of $431M for FY13). The OER gave us a peak into what fiscal policies might be implemented to make dwindling dollars go farther (Sally Rockey just added a post about the belt-tightening measures in relation to the FY13 budget). A lower salary cap is already in place, shifting some of this burden to the awardee institutions. For all you basic science assistant professors, this doesn’t sound like much of a burden, but clinician scientists will have a harder sell asking to do research (net loss to their department) rather than see patients (net gain), particularly if academic medical centers must also absorb significant cuts in Medicare indirect medical education payments. As per fiscal policy in FY12, no inflationary increases will given to awardees. The budgets of all noncompeting renewals will be reduced by 1% below their FY12 budget. New for FY13 (regardless of what appropriation finally passes, no doubt in mid 2014) will be NIH-wide scrutiny of PIs receiving more than $1.5M in total costs annually prior to making additional awards (you may recall the Nature piece on the 22 big hitters or may have seen the recent story on “grandee grantees“, plus its informative comment by Jeremy Berg); some ICs have already done this, such as NIMH and NIGMS.

For those of you with more basic research interests, the NSF was the biggest science winner in the Administration’s budget blueprint, with a $340M increase that translates into 5.2% increase in research funding at the 6 science directorates and a 5.8% increase in the education directorate. FASEB spells out the 3% increase to the Biological Sciences Directorate:

BIO plans to focus on 5 Grand Challenges including “genomes to phenomes;” synthetic biology; neurosystems; Earth, climate, and biosphere; and biological diversity. Assistant Director John Wingfield, PhD also expressed a desire to increase collaboration, broaden participation, and improve public outreach.

Of course, it is hardly all over but the shoutin’. The shoutin’ hasn’t even begun …

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National Institute of Substance Use and Addiction Disorders

02.8.12 by Michelle Kienholz

Notice was given today that the NIH is seeking input on the strategic plan for the new Institute to be created through the merger of NIDA and NIAAA (recommended by the SMRB in September 2010 and written up as a report - before NCATS was ever discussed). You have until May 11th to submit an response electronically on the development of a strategic plan for this new Institute, which will be included in the FY14 budget. There will also be public meetings in 2012, details of which will be released on the NIH Feedback Page.

You are asked to consider and comment on the “potential scientific opportunities and public health needs that are not sufficiently addressed within the existing NIH structure”:

Developing a compendium of the pharmacokinetic and pharmacodynamic interactions between alcohol and the therapeutics used to treat general medical and psychiatric conditions (e.g., hypertension, diabetes, epilepsy, depression);
Encouraging research on the generation of novel metabolites resulting from the in situ interaction of alcohol with opiates, stimulants, hallucinogens, or inhalants (e.g., the production of cocaethylene when alcohol and cocaine are co-ingested) and their pharmacokinetic and pharmacodynamic properties and toxicity;
Understanding the mechanisms by which alcohol and other drugs of abuse increase risk for certain diseases (e.g. cancers), particularly when used in combination;
Developing strategies to enhance stakeholder interest in developing medications to treat various addictions, including nicotine and alcohol;
Engaging the medical community in prevention and treatment of drug addiction and alcoholism;
Encouraging patient recognition and utilization of effective substance abuse treatments;
Alleviating the translational bottleneck for treatments to move from the bench to the bedside to the community;
Improving prevention efforts by developing a better understanding of the patterns and trajectories of drugs of abuse and their influence on brain development;
Designing clinical trials that accurately reflect real-world conditions (e.g., greater inclusion of polydrug users);
Encouraging research to elucidate the impact of using one substance (e.g., alcohol) on likelihood of relapse to other substances (e.g., other drugs);
Targeting efforts to prevent substance abuse in adolescents and young-adults;
Understanding the implications of policy changes on substance use patterns and trajectories, especially in youth; and,
Furthering knowledge of tobacco use and addiction, including co-morbidity with other addiction and psychiatric disorders.

Specifically …

To ensure a thorough and comprehensive exploration of the scientific opportunities that could potentially be included in the Scientific Strategic Plan for substance use, abuse, and addiction research at NIH, responses are being sought from addiction research experts and stakeholders, including treatment and prevention specialists, investigators, patient advocates, and policy specialists, as well as from the general public.

Responders should note that the NIH is not seeking input on the SMRB recommendation to establish a new Institute focusing on addiction-related research and public health initiatives. Rather, the agency is seeking input on the scientific opportunities and public health needs that should be included in the Scientific Strategic Plan. Input is sought on the areas described above, as well as any other areas that NIH might consider.

For any of the areas identified above and any other specific areas you believe are worthy of consideration by NIH, please identify the critical issues(s) and effect(s) on the public, on scientists, or both. Please identify and explain which of the issues you identified are, in your opinion, the most important for NIH to address and why.

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Findings of Research Misconduct

02.7.12 by Michelle Kienholz

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

Based on evidence obtained from Creighton University and additional evidence gathered by ORI during its oversight review, ORI found that Ms. Calleen S. Zach, former Research Assistant and Data Base Manager, engaged in research misconduct in research funded by grant R01HD046991.

Specifically, ORI found that the Respondent provided falsified subject enrollment numbers in an application to NIH for continued funding of R01HD046991 in 2008, a no-cost, one-year extension request for R01HD046991 (April 8, 2009, letter to NICHD) and an application for additional funding of R01HD046991 (June 30, 2009, to NICHD). In addition, she knowingly and intentionally provided falsified subject enrollment numbers in reports to the CU IRB in 2008 and 2009.

ORI concluded that Respondent’s knowing and intentional falsification of data constitutes research misconduct as defined by 42 CFR 93.103. In addition, ORI found that Respondent’s intentionally deceptive behavior, including false statements made to the CU institutional officials, forgery of petty cash receipts, and theft of NIH research grant funds establish a lack of trustworthiness and present responsibility to be a steward of Federal funds. 2 CFR 180.125, 180.800(d), 376.10.

The following administrative actions have been implemented for a period of 5 years, beginning on January 23, 2012:

(1) Ms. Zach 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’ as defined in 2 CFR 180.200, 376.10; and

(2) Ms. Zach 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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FY 11 Success Rates & Other Stats from the NIH

01.17.12 by Michelle Kienholz

Sally Rockey posted the latest NIH success rate numbers (& other applicant data) today …

Overall success rates for research project grants fell compared to 2010.	18%
Success rates for new investigators were equal to established investigators submitting new applications.	15%
The representation of women NIH investigators remained the same as in 2010.	29%
Women’s success rates were equal to men for new applications.	15%
Our commitment to supporting the individual investigator remains strong, with R01s and R37s representing a significant percentage of all research grants.	60%
The average size of R01-equivalent grants increased slightly compared to 2010.	$408,594
The average size of a center grant fell by 6% compared to 2010.	$1,863,037
Number of institutional training grant applications continued to decline, from a peak in 2005.	686

Sally also notes that the success rate (which is not the same thing as a payline or percentile) dropped from 20% to 18% due in part to an 8% increase in the number of applications received (49,592). In addition, fewer applications were funded in FY11 (8,765) than during any of FYs in the decade prior … the same number were funded in FY00 (though that year, the success rate was 32%).

Update: Sally explains the decline in success rate (more applications, less $ appropriated, increasing award size).

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Findings of Research Misconduct x 3

01.10.12 by Michelle Kienholz

Three notices from ORI, the first particularly instructive in terms of guiding ethical behavior (holding the facility director responsible for oversight) …

Notice is hereby given that ORI has taken final action in the following case: Based on an inquiry conducted and written admission obtained by Kansas University and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Gerald Lushington, PhD, Director of the K-INBRE Bioinformatics Core Facility and Director of the Molecular Graphics and Modeling Lab, engaged in research misconduct in research supported by P20RR016475. Specifically, ORI found that Respondent engaged in research misconduct by approving publication of 3 articles and 1 abstract he knew contained significant amounts of plagiarized text without attribution or citation from other writers’ published papers. The specific published documents as well as the relevant source documents are:

Visvanathan, M., Adagarla, B., Lushington, G., Sittampalam, S., Proceedings of the 2009 International Joint Conference on Bioinformatics, Systems, Biology and Intelligent Computing, 2009, 494-497. Greater than half of the total text was obtained from
(1) Yang, C.-S., Chuang, L.-Y., Ke, C.-H., Yang, C.-H., International Journal of Computer Science, International Association of Engineers, August 2008 35(3),
(2) Goffard, N. and Weiller, G., Nucleic Acids Research, 2007, 35L:W176-W181, and
(3) Chuang, L.-Y., Yang, C.-H., Tu, C.-J., Yang, C.-H., Proceedings of the Joint Conference on Information Sciences, Atlantis Press, October 2006.

Retracted: Retracted administratively by IEEE on Jan 5, 2011 http://ieeexplore.ieee.org/xpl/freeabs_all.jsp?arnumber=5260432
Vijayan, A.; Skariah, B. E., Nair, B.; Lushington, G., Subramanian, S., Visvanathan, M., Proceedings of the IEEE International Conference on Bioinformatics and Biomedicine Workshop, 2009, BIBMW2009, 267-271.
Approximately 15% of the text was plagiarized from Goffard, N. and Weiller, G., Nucleic Acids Research, 2007, 35L:W176-W181.

Retracted: Retracted administratively by IEEE on Jan 5, 2011 http://www.computer.org/portal/web/csdl/doi/10.1109/BIBMW.2009.5332106
Visvanathan, M., Netzer, M., Seger, M., Adagarla, B. S., Baumgartner, C., Sittampalam, S., Lushington, G., International Journal of Computational Biology and Drug Design, 2009, 2,236-251.
A complete paragraph of the text was plagiarized from Goffard, N. and Weiller, G., Nucleic Acids Research, 2007, 35L:W176-W181.
Adagarla, B., Lushington, G., Visvanathan, M., ISMB International Conference, January 2009; the entire abstract for this poster was obtained by plagiarizing text from Pihur, V., Datta, S., Datta S., Genomics, 2003, 92:400-403.

Dr. Lushington has entered into a Voluntary Settlement Agreement for a period of 2 years, beginning on December 6, 2011:

(2) that this annual summary, provided by any institution employing him, shall provide assurance that each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent was involved, was based on actual experiments or was otherwise legitimately derived, that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions was his own or properly cited the source of copied language and ideas; 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 inquiry conducted and written admission obtained by Kansas University and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Mahesh Visvanathan, PhD, Research Assistant Professor in the K-INBRE Bioinformatics Core Facility, engaged in research misconduct in research supported by P20RR016475. Specifically, ORI found that Respondent engaged in research misconduct by intentionally and knowingly plagiarizing large amounts of text from other writers’ published papers without attribution or citation in the following 3 papers and 1 abstract. (see list above)

Dr. Visvanathan has entered into a Voluntary Settlement Agreement for a period of 2 years, beginning on December 20, 2011:

(2) That this annual summary, provided by any institution employing him, shall provide assurance that each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent was involved, was based on actual experiments or was otherwise legitimately derived, that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions was his own or properly cited the source of copied language and ideas; 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 the report of an investigation conducted by SUNY, Upstate Medical University and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Jennifer Jamieson, former graduate student, Department of Cell and Developmental Biology, engaged in research misconduct in research supported by R01GM047607-18A1 and R01HL70244-05. ORI found that Respondent engaged in research misconduct by falsifying data that were included in grant application R01 GM047607-18A1, in a manuscript submitted for publication to the Journal of Cell Biology, and in several interdepartmental data presentations. Specifically, ORI found that:

Respondent falsified Figure 3I in a manuscript submitted for publication to the Journal of Cell Biology by falsely labeling a Western blot to indicate levels of expression for various Vav2 mutants, when the experimental data were taken from a completely unrelated experiment.

Respondent falsified Figure 6A in an interdepartmental laboratory presentation by falsifying Western blot data to falsely depict Paxillin and Hic-5 expression and phosphorylation levels after siRNA treatment.

Respondent falsified Figure 5 from grant application R01GM047607-18A1 by falsifying Western blot data to support the hypothesis that co-transfection of PKL plus RhoA GEF Vav2 induces RhoA activation and signaling upon plating on fibronectin.

Ms. Jamieson has entered into a Voluntary Settlement Agreement. Ms Jamieson neither admits nor denies ORI’s finding of scientific misconduct nor any particular finding of fact asserted in support of that finding. The settlement is not an admission of liability on the part of the Respondent. Ms. Jamieson has voluntarily agreed for a period of 3 years, beginning on December 20, 2011:

(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 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 were 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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NCRR is Dead, Long Live NCATS … Oops

12.19.11 by Michelle Kienholz

NCRR is not quite dead yet … but on Saturday, Collins jumped the gun in trumpeting this “signal moment for NIH”:

From: Exec Sec1 (NIH/OD)
To: NIH-STAFF@LIST.NIH.GOV
Sent: Sat Dec 17 18:56:52 2011
Subject: Message from the NIH Director – Changes at NIH

To: All NIH Staff
From: Director, NIH
Date: December 17, 2011
Subject: Changes at NIH

The omnibus appropriations bill for FY2012 passed by Congress and signed into law by President Obama today includes provisions that formally establish the National Center for Advancing Translational Sciences (NCATS) as a new component of the NIH. This is an important step forward in our efforts to speed the delivery of new drugs, diagnostics, and medical devices to patients. It was just over a year ago that the Scientific Management Review Board recommended the establishment of this new component of NIH, and the achievement of this complex outcome in this time frame is a testimony to the remarkable diligence of many dedicated individuals, both within and outside of NIH, who have worked together to achieve this goal.

This is a signal moment for NIH. I want to take this opportunity to recognize the rich history of the National Center for Research Resources (NCRR) and pay tribute to the important contributions of its dedicated employees and grantees. Over more than two decades, NCRR has established and administered a remarkably diverse portfolio of research programs, most recently including the re-invention of our nation’s academic clinical research network in the form of the Clinical and Translational Sciences Awards (CTSAs). I am grateful to Acting Director Dr. Louise Ramm and all of the dedicated staff of NCRR, for their devotion to the cause of excellence in NIH research. Although NCRR is now disbanded, its scientific legacy will live on. As former NCRR employees and their programs transition into new homes within NCATS and other Institutes and Centers, please welcome them with open arms and embrace their wealth of expertise and experience.

Change is never easy; however, it often opens doors to unexpected opportunities for personal growth and scientific collaboration. So, even as we look back at the many accomplishments of NCRR, let us also look ahead to NCATS and realizing its vision of transforming translational research.

In this vein of change, I am pleased to designate Thomas Insel, M.D., as the Acting Director of NCATS and Kathy L. Hudson, Ph.D., as Acting Deputy Director of NCATS. Drs. Insel and Hudson will lead the many activities of bringing the Center into being and getting its programs underway, while we conduct a nationwide search for the first NCATS Director. Drs. Insel and Hudson have already been deeply involved in establishing the Center and are natural choices to implement our plans for NCATS. Both of them will continue to serve in their current roles, at NIMH and in the Director’s Office respectively, while serving in these Acting leadership positions.

I very much appreciate Tom’s and Kathy’s willingness to take on these exciting but challenging additional roles, and I know I can count on all of you to join me in giving them as much support as possible.

Francis S. Collins, M.D., Ph.D.

***

From: “Exec Sec1 (NIH/OD)” <EXECSEC1@od.nih.gov>
Date: December 17, 2011 7:59:57 PM EST
To: “NIH-STAFF@LIST.NIH.GOV” <NIH-STAFF@LIST.NIH.GOV>
Subject: Message from the NIH Director — Correction: Please disregard the previous message.
Reply-To: “Exec Sec1 (NIH/OD)” <EXECSEC1@od.nih.gov>

To: All NIH Staff
From: Director, NIH
Date: December 17, 2011
Subject: Correction: Please disregard the previous message.

The President signed a Continuing Resolution until December 23, so nothing is finalized until we have a signed bill. We apologize for any confusion.

Francis S. Collins, M.D., Ph.D.

I hope he was not suggesting we disregard the polite praise for NCRR … which, according to the NIH Almanac, has been serving the biomedical research community quite well for closer to five decades (though only formally as NCRR since 1990).

The FY12 appropriations bill Conference Report includes its own assessment of the process by which NCRR was replaced by NCATS:

The conference agreement includes language to eliminate the NCRR and create the National Center for Advancing Translational Sciences (NCATS).

NCATS will study steps in the therapeutics development and implementation process, consult with experts in academia and the biotechnology and pharmaceutical industries to identify bottlenecks in the processes that are amenable to re-engineering, and develop new technologies and innovative methods for streamlining the processes. In order to evaluate these innovations and new approaches, NCATS will undertake targeted therapeutics development and implementation projects. In all of these efforts, the conferees expect that NCATS will complement, not compete with, the efforts of the private sector.

While the conferees welcome the creation of NCATS, they were disappointed by the way the administration requested it. The President’s proposed budget for fiscal year 2012 included a vague description of NCATS but did not formally request funding for the restructuring or provide any details about which components of NIH would be consolidated into the new Center. The failure to do so caused unnecessary uncertainty about the proposal and contributed to the impression that it was being rushed. The conferees are also aware of concerns that the NIH process for evaluating the merits of the NCATS reorganization did not comply with the NIH Reform Act of 2006 with respect to the role of the Scientific Management Review Board (SMRB).

The decision to create NCATS might have been rushed?