Archive for June, 2009

Findings of Research Misconduct

Notice is hereby given that the ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on reports submitted by MetroHealth System’s inquiry and investigation committees, the Respondent’s own repeated admissions, and additional analysis conducted by ORI during its oversight review, the US PHS found that Ms. Jennifer Wanchick, former Research Assistant, MetroHealth System (an affiliated hospital of Case Western Reserve University), engaged in research misconduct in research supported by grant P60MD002265.

Specifically, by her own admission, Ms. Wanchick engaged in research misconduct by fabricating information in the electronic database purportedly collected from 150 individuals about their willingness to sign up to be an organ donor at the time they obtained a driver’s license. Ms. Wanchick also admitted to fabricating the information on several survey instruments. The study at issue was entitled “Community Based Intervention to Enhance Signing of Organ Donor Cards.’

ORI acknowledges Ms. Wanchick’s cooperation and assistance in completing its oversight review and resolution of this matter.

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Fewer Research Universities?

Update: In addition to the comment below from the AAU that provides clarification provided regarding the article in The Chronicle described in this post, I will add that Mr. Berdahl’s commentary on this issue can be read in The Chronicle, and Stan Katz apologizes for misinterpreting Berdahl’s comments, also in The Chronicle. Stan also poses some questions of his own, such as “Shouldn’t we also be asking the more complex question of whether research universities are (or are not) developing the broad range of human resources required by a vibrant democracy?”

Today The Chronicle of Higher Education reports a suggestion from the Association of American Universities that the US “may need “fewer but better” when it comes to top research universities.” The Chronicle reports AAU has taken its concern to the National Academies (Science, Engineering, IOM, NRC):

The association isn’t making any specific recommendations regarding such a reduction and instead has asked the National Academies to study the question. It also hasn’t said how deeply the number of American research universities would be reduced, though Mr. Berdahl [AAU president] suggested federal spending decisions could play a role.

Berdahl sent a letter to Senator Lamar Alexander in February asking, “How many research universities does the United States realistically require in order to maintain its agenda of innovation and advanced training?”

This in turn led to the press release earlier this week (distributed by AAMC & I’m sure other groups) by Senators Barbara Mikulski (D-MD) and Lamar Alexander (R-TN), joined by Representatives Bart Gordon (D-TN) and Ralph Hall (R-TX), in which they ask the National Academies to come up with “the top ten actions that Congress, state governments, research universities, and others could take to assure the ability of the American research university to maintain the excellence in research and doctoral education needed to help the United States compete, prosper, and achieve national goals for health, energy, the environment, and security in the global community of the 21st century?”

Sounds like AAU thinks the answer is more money to fewer institutions. The NIH’s CTSA and other major Roadmap programs are distinguishing to a certain extent the haves from the have nots. Consider too that of the 20K+ Challenge Grants submitted, ~7% came from 5 institutions, which comprised less than a quarter of one percent of applying institutions. Not that they’ll all get funded of course.

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Lobbying for the NIH FY10 Budget

Research Means Hope (also on Facebook), a coalition seeking sustained growth in NIH funding and other federal support for biomedical research, has developed a nice Web portal for communicating your concern over the NIH FY10 budget appropriation with your Congressional delegation. In addition to formatting both electronic and print letters to your House and Senate representatives, the Web form provides a canned letter body, suggests factoids for customizing your letter, and encourages you to add personal anecdotes. I’m sure your favorite professional society likewise has such a form letter available as well.

Of course, just in time for this process, a new report in PNAS whose “analysis shows consistent non-linear temporal correlations of funding to mortality rates across diseases” and, as summarized by Nature News, suggests that the past 50 years of NIH funding have “helped to avert up to 1.35 million deaths per year from four chronic diseases: cardiovascular disease, stroke, cancer and diabetes.”

Now, given the nature of the paper, the funding citation for this work is, unfortunately, incorrect. The PNAS footnote refers to simply AG01159 –31 (no mechanism prefix), which RePORTER identifies as R01AG011595 (Blood Pressure, Cognitive Function & MRI in Older Adults), which seems to have limped along after only 6 years of funding on no-cost extensions from 1994 until 2003 under the direction of Iris Goldstein at UCLA. However, slipping in an extra “0″ after the IC abbreviation returns the correct long-standing award to the lead author, Kenneth Manton: R01AG001159, Demographic Study of Multiple Causes of Death (funded through March 31, 2009 with a supplement last year and no doubt a pending competitive renewal (no A1s or A2s in the entire history – impressive).

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Searching-Browsing ARRA Awards from NIH

In case you were not aware, you can browse NIH ARRA-funded awards by state (notice the nice distribution of push pins) or you can search RePORTER (think enhanced CRISP) using the swanky new query form, which includes a check box to “show only projects supported by NIH Recovery Act funds.” Each list of projects by state (scroll down below map) can be sorted by PI or organization name (click on the appropriate column heading) to find those of most interest.

<I’ll pause a moment while feverish fingers check out the success of rivals.>

Notice upon searching RePORTER that you will be given tabs that list award description (abstract), details (including $ amounts), results (publications), history (renewals, supplements – interesting for long-standing awards especially), and subprojects. I’ll add that the new query portal layout and functionality is a very welcome improvement over the CRISP query page.

You can also view an interactive graph to monitor how much of the ARRA monies have been committed to FOAs.

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ARRA Success Stories

Update: Happy ending stories already coming online, such as one PI receiving two R21s and another receiving a P01 … I guess they certainly do have something to cheer about.

As more and more of you become stimulated by ARRA funding, you might consider whether you have a “success story” to share with your funding IC. NIAID has created an ARRA Success Stories Website, and I assume at least some – if not all – other ICs will follow suit. NIAID will eventually have a Web-form through which you can submit your anecdotes, but in the meantime, please send niaidarraimpact@mail.nih.gov the following information:

  • Grant number, project title, PI name
  • How ARRA funding has helped you (1,000 words or fewer)

Another NIAID page suggests what you might report:

Share your successes, both big and small, with us and your community. For example, your personal stories can illustrate how the funds enabled you to keep your lab intact, hire a promising young scientist, expand your research, or advance science.

Maybe even salvage a tenure application. Good luck to you all in getting your sliver (à la mode, of course) of the stimulus pie!

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So, with the new scoring procedure, is an 80 good news?

No.

Update: Emaderton3′s comment below includes this formula for converting the new impact score into the former priority score: [5 * (new impact score - 10)] + 100 = old priority score

e.g., [5 * (80 - 10)] + 100 = 450

An impact score of 80 at the 59th percentile means either the study section discussed all proposals, or someone took an interest in your otherwise triage-destined application and advocated for its discussion.

The new scoring range is from 10-90, with impact scores under 20 most likely to be funded … perhaps under 25 since ARRA has relieved the system of some of the backlog of potentially fundable applications. Percentiles issued in this round reflect only the current study section in which the application was reviewed (assuming the study section had 25 or more applications under review … if fewer than 25, then pooled with either all CSR or all IC applications, as appropriate to the review group’s affiliation).

You can find details on the scoring procedure and interpretation as well as reviewer guidelines by mechanism at the Enhancing Peer Review Website.

I’m guessing NIAID will be the first to update their paylines accordingly, and I’ll post updates as the ICs provide them here in the main blog and on the NIH Paylines & Resources page.

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12 h per RC1 Review???

What is Toni Scarpa smoking? He recently told The Chronicle of Higher Education that

The numbers [of RC1s] are causing concern for the present, as each application requires an average of three reviewers working 12 hours apiece, Dr. Scarpa told agency representatives.

Everyone out there who is spending 12 hours reviewing their Challenge Grants, raise your hand. Based on conversations I’ve had with investigators here at BICO (& warmer environs elsewhere) in a wide range of disciplines, they uniformly find these proposals, shall we say, unchallenging, to be kind. I’m sure Comrade PhysioProf can provide the appropriate color commentary. The minimal time needed to assess these is a good thing given that I also know of faculty who just last week unexpectedly found as many as 5 RC1 applications sitting in their eRA Commons account with reviews due June 12. Twelve hours per application? Ooooooh yaaaaaa.

And this apparently is after the NIH removed about 8% of applications that were deemed to be unresponsive/noncompliant … I think noncompliant with the laws of science more than the FOA policies. Many are apparently recycled ideas that weren’t funded the first time as R01s/R21s etc., so novelty will not be a common term used in the truncated summary statements (unless to point out the distinct lack of). It could be that the most novel proposals achieve this distinction due to their basis in woo.

Anyone experiencing review nirvana out there?

But, Toni is most grateful:

“Our scientists and their staff are unsung heroes, managing twice as many applications in a very compressed time with great professionalism and excellence,” said CSR Director Dr. Toni Scarpa. “The response by the scientific community also has been tremendous. The help is particularly gratifying because it shows the value and respect that scientists have for NIH peer review.”

I am glad Toni decided to issue a press release about the number of applications (nearly 21K) and reviewers (18K+) involved. The sheer numbers will hopefully serve as a wake up call that the NIH base appropriation needs to be restored and maintained in a responsible manner – not in irregular spikes guaranteed to stimulate irrational exuberance followed by a musical chairs, survival of the fittest (& richest) scramble for the crumbs that remain after the feast.

Indeed, The Chronicle article concludes:

Mr. Obama’s proposal, if approved by Congress, would set the agency’s baseline budget 4.7% higher than its final budget under President George W. Bush in 2008. But the biology federation said the increase proposed by Mr. Obama for the NIH in fiscal 2010 is only 1.45% higher than the fiscal 2009 level, excluding the stimulus money, raising questions about the federal government’s commitment to sustain biomedical research.

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Job Stimulation – and Study by the NSF

A brief observation. This morning, the Washington Post sent out a news alert that “Obama promises more than 600,000 stimulus jobs” this summer. As if we needed another reminder as to a key review criteria for applications for ARRA funding.

Perhaps this would be a good time to remind you that in the NSF Dear Colleage letter that appeared and then disappeared and then reappeared, the Science of Science & Innovation Policy (SciSIP) Program is accepting 2-5 page proposals for RAPID funding that address the outcome of ARRA, such as:

  • What was the contribution of the science investment to the creation and retention of jobs?
  • What was the contribution of the science investment to science and technology industries?
  • What scientific or technological advances were achieved?
  • What was the impact on the scientific workforce?

In keeping with the Presidential focus on openness and transparency in government, proposals might also examine and evaluate different approaches to building appropriate platforms for tracking and assessing science investments across the federal government as well as ways to visually convey the information to policy makers and the American public.

Edward Tufte, your country needs you.

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ARRA-Funded Human Immunology Profiling Research Groups

NIAID has released its own ARRA funding opportunity with some unique twists (e.g., 5 years of funding, with only the first year covered by ARRA): Protection of Human Health by Immunology and Vaccines (U01, U19).

LOI due: Sept 15
Application due: Oct 15 (full-length applications – not the 12-p jobs sought by most ARRA FOAs)

For U01 applications, requested annual total costs may not exceed $1.5M in year 1 and $1.3M in years 2-5. For U19 applications, requested annual total costs may not exceed $4.5M in year 1 and $4.0M in years 2-5. NIAID anticipates that 6-10 awards will be made for fiscal year 2010.

NOTE: Recovery Act funds will only support the first budget year of the award, and MUST be completely spent by the end of the first budget year, including spending all Infrastructure and Opportunities Funds allocated to support projects and pilot projects. Award recipients must be prepared to initiate their proposed studies upon issuance of the award. Carryover of unobligated funds from the first to subsequent budget years of the award will NOT be allowed. Any unspent first year funds will be returned. Applicants are encouraged to include in their first year budgets any large, one-time costs to support activities that will be carried out during the project period of the award. Examples of such costs include equipment, large peptide or antibody microarrays, microarray analyses, and small molecule libraries.

All applications are required to use bioinformatic, multiplex, and/or systems biology approaches to establish human immune system profiles using samples from well-characterized cohorts obtained (1) after infection, (2) prior to and following challenge with specific vaccines, or (3) prior to and following treatment with an immune adjuvant that targets a known innate immune receptor(s). It is the goal of this initiative to determine how immune profiles are perturbed and eventually return to a new homeostatic state after antigenic challenge. Each Awardee will establish a research infrastructure to collect, characterize and store human samples, and support the complex statistical analysis and informatics needs of the proposed research. All applications are required to include experimental approaches to measure some aspect(s) of the human transcriptome and/or proteome.

Scientific/Research Contacts:

Dr. Matthew J. Fenton
Division of Allergy, Immunology and Transplantation
Telephone: (301) 496-8973
Email: fentonm@niaid.nih.gov

Dr. Helen R. Quill
Division of Allergy, Immunology and Transplantation
Telephone: (301) 435-4416
Email: hquill@niaid.nih.gov

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ARRA Business Funding Opps at NIH

Hmm. Two new business-oriented ARRA funding opps. Hopefully not bridges to nowhere … woo-woo.

Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3)

LOI due: August 3, 2009
Application Due: September 1, 2009

U.S.-owned, for-profit enterprise/commercial organization doing a majority of its business in the United States may apply for RC3 funding. The requested budget is limited to $1 million total costs per year for a maximum of 3 years (up to 10 awards are anticipated).

The RC3 application Research Plan component is limited to a total of 13 pages, including 1 page for the Specific Aims and 12 pages for Research Design and Methods.

The BRDG-SPAN pilot program encourages projects representing, for example, the following:

  • a novel, “first in class” therapy
  • a material improvement over existing technologies
  • a potential substantial reduction in cost over existing technologies/products
  • U.S. alternative to foreign suppliers
  • a product for unmet, under-addressed medical needs (e.g., technologies to produce solid medication dosage forms for children, and therapeutic devices appropriate for children in terms of size and functionality)
  • a significant and demonstrable potential U.S. and/or global markets

Participating ICs list their own program officer and grant administrator contacts.

Small Business Catalyst Awards for Accelerating Innovative Research (R43)

LOI due: August 3, 2009
Application Due: September 1, 2009

Only United States small business concerns are eligible to submit SBIR applications. Budget requests are limited to $200,000 total costs for a maximum project period of 1 year (20-25 awards are anticipated).

The Research Plan is limited to a total of 7 pages, including 1 page for the Specific Aims and 6 pages for Research Design and Methods.

In accord with the funding priority of this initiative to attract applicants without a history of SBIR/STTR support from NIH, the focus of the projects solicited by this FOA is on early stage technology development. High-risk, high reward R&D that is unlikely to be undertaken by ongoing academic efforts or within industrial firms is strongly encouraged.

Again, participating ICs have designated their own program officer and grant administrator contacts.

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