Archive for February, 2010

Joint NIH-FDA Leadership Council Announced

February 26, 2010 at 8:17 pm · Filed under NIH Advice, Research News

The NIH and FDA announced “a new collaboration on regulatory and translational science to … help speed the translation of research into medical products and therapies.”

Oh, you know this is going to be good, starting with their description of the two, um, partners in this collaboration:

The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.

And, indeed, the NIH is just the partner to make it happen, according to Francis Collins:

“This collaboration … will use the NIH’s breadth of experience as a leader in biomedical sciences, to help make the regulatory review process at the FDA as seamless as possible.”

Hmm. Somehow I missed that improving the FDA’s regulatory review process was a major priority in biomedical research, though clearly the FDA does need help in that department. But wait, there’s more …

As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council [chaired by NIH Director and FDA Commissioner plus 6 members from each agency] will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process.

I have not yet had time to view the entire hour-long videocast of this announcement, so I didn’t hear how much the NIH budget would be increased to absorb this additional effort (which will clearly need more than $6.75M to succeed).

However, this new emphasis on regulatory science does explain the latest unusual RFA issued from the Office of the Director (supported with $6M from the NIH Common Fund and $650K from the FDA), Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01), which offers up to $675K in direct costs per year for 2010, 2011, and 2012. The RFA describes 5 broad areas of research to be supported … by 2-3 awards.

More big applied science, one hopes not at the expense of the most basic biomedical research needed to fill the translational pipeline with science to “shape into treatments.”

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PLoS Tobacco Ban

February 24, 2010 at 6:10 pm · Filed under Biomedical Research Ethics, Research News, Tobacco "Research"

PLoS Medicine has joined PLoS Biology and PLoS ONE in not accepting “papers where support, in whole or in part, for the study or the researchers comes from a tobacco company.”

Long-time readers of the blog will know that I say, Bravo! I particularly appreciate their rationale:

First, tobacco is indisputably bad for health. … Tobacco interests in research cannot have a health aim—if they did, tobacco companies would be better off shutting down business—and therefore health research sponsored by tobacco companies is essentially advertising.

Second, we remain concerned about the industry’s long-standing attempts to distort the science of and deflect attention away from the harmful effects of smoking. … we do not wish to provide a forum for companies’ attempts to manipulate the science on tobacco’s harms.

They acknowledge this policy will have minimal impact on submissions as PLoS Medicine has not received any manuscripts involving tobacco support and PLoS ONE only two. However, they note that

the business model used to support our open access publishing (the research funder covers publication costs, unless the author requests a waiver) means we would essentially be accepting money from the tobacco industry by publishing their papers. This is unacceptable to the editorial team of PLoS Medicine.

Again, I applaud PLoS for another commendable contribution to the scientific community.

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Reviews of New NIH Review System

February 23, 2010 at 5:11 pm · Filed under Grantsmanship, NIH Advice, Research News

Thanks to Jef Akst at The Scientist for his post earlier today entitled NIH Reviewers Praise New Rules (& SaG for the alert). Thanks too to those who in turn have commentend on the piece. I tend to agree with both sets of contributors – the 3 grant reviewers in the main article and the various commenters who have come along since.

Recognizing the learning curve associated with adopting a new system and inherent challenges in assessing significance and impact, reviewers felt that “changes to the reviewing guidelines have actually increased the validity and utility of the reviews.” Specifically:

For example, in the new system scoring is limited to whole numbers (1 through 9), whereas before, a reviewer could give a proposal a priority score anywhere from 1 to 5 in increments of tenths. But such a fine scale was counterproductive, Wiley noted. “[Y]ou cannot possibly discriminate grants on that kind of level,” he said, adding that the process was effectively “a crapshoot after you pick the top 25%.”

Another benefit of the new system is that reviewers are now required to justify their scores by listing strengths and weaknesses for each subcriterion…

Other changes to the review process specifically aim to cut down on the amount of time the process takes. … The template now provided by the NIH gives bullet points where reviewers are to write a couple of sentences summarizing the strengths and weakness of each category, limiting them to just half a page.

Finally, rather than reviewing the grant proposals in random order, the study section starts with the highest scored applications (based on preliminary scores) and works their way down the list. In addition to cutting the total number of grants the study section will review orally — low-ranked applications with no chance of getting funded won’t even be discussed — it also helps the reviewers to “recalibrate” their scores, Wiley said, by providing an excellent standard against which the others can be judged. “It was a very clever idea,” he said. “I found this has been very, very helpful.”

Of course, those fast, easy, bulleted comments are not without their shortcomings, as many commenters noted (e.g.):

The comments are vague and provide little meaningful guideline for improvement. Of course, that is not the primary goal-to be helpful. I think this is mainly a mechanism to more efficiently winnow down the stack of applications in this time of tight paylines.

The new format makes the critique more diffuclt to decipher and the applicant will have a hard time to get a handle on how to revise the application to get a better score.

Plus a reflection on the preliminary score-driven discussion order:

The new review order is truely a clever idea that helps to calibrate the scores and make the whole process more consistent. I delibrately avoid the wording “fairer” because I also see the downside of this new order. The more contentious and contraversial applications are more likely being discussed near the lunch breaks or late in the day and people tend to get really tired by that point. The debate on those contraversial grants may not be as vigorous as it used to be.

I dunno. Looking at summary statements coming out of this brave new world, I’m pretty happy with the way things are going, vague bullets and all. I especially like the ability (or perhaps increased tendency) of reviewers to comment directly on the advisability of resubmission. And I’m happy with the way SROs are preparing the Resume & Summary of Discussion paragraphs as well. I like the short applications. I like the reviews. The paylines, not so much.

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2009 International Science & Engineering Visualization Challenge

February 19, 2010 at 12:33 pm · Filed under Biomedical Writing/Editing, NSF Info, Research News

Woohoo! One of my favorite events of the year … the announcement of the NSF & Science International Science & Engineering Visualization Challenge winners.

The NSF maintains a nice Website for this annual competition, and this issue of Science covers the 2009 highlights. Categories include Illustration, Photography, non-interactive media, and interactive media.

Enjoy!

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Nature Journal Editors are Well-Meaning and Insightful

February 18, 2010 at 3:01 pm · Filed under Biomedical Writing/Editing, Research News

Or maybe, in light of today’s editorial, Nature’s Choices, inciteful. The editors:

offer an explanation of how we pick research papers for publication in Nature, focusing on a number of false impressions that we have become aware of in and beyond the research community.

Myths addressed include gaming impact factor, kowtowing to big names, using only a small clique of reviewers per discipline, and allowing a single spiteful reviewer to derail a submission. And, indeed, they do not at all mind admitting outright that:

… there were several occasions last year when all the referees were underwhelmed by a paper, yet we published it on the basis of our own estimation of its worth.

Hmm. Refreshing honesty, but one wonders the long-term outcome of these papers and whether reveiwers whose recommendations were ignored (particularly if there was consensus, unbeknownst to them, among the reviewers against publication) were inclined to accept more Nature manuscripts for review, having had their time, effort, and expertise discounted by an editor’s prerogative. The editorial explains that decisions on which papers to publish are made

on the basis of criteria such as the paper’s depth of mechanistic insight, or its value as a data resource or in enabling applications of an innovative technique.

Well, at least no tarot cards seem to be involved. In the end, they conclude:

Myths about journals will continue to proliferate. We can only attempt to ensure that the processes characterized above remain as robust and objective as possible, in our perpetual quest to deliver to our readers the best science that we can muster.

Perhaps continue with the transparency as part of your “attempt to ensure … as possible”? Perhaps remind readers of how you “become aware of” false impressions and channels through which concerns can be raised, such as your thoughtful but undersubscribed Peer-to-Peer blog?

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Cool NSF Solicitation … even if it is “transformative”

February 14, 2010 at 9:47 pm · Filed under Funding Opportunities, NSF Info, Research News

I don’t recall prior NSF solicitations with a subtitle or tag line …

Innovations in Biological Imaging and Visualization (IBIV)
An Ideas Lab activity to stimulate transformative approaches to biological image analysis and data visualization

Preliminary proposals due April 12, 2010 … invited full proposals due July 15, 2010 … 2-10 awards will be made ($5M set aside)

What’s so interesting?

The goal of this activity is to identify opportunities for investment to advance the state-of-the-art in biological image analysis, data visualization, archiving, and dissemination. Participants selected through an open application process will engage in an intensive five-day residential workshop (May 24-28, 2010) to generate project ideas through an innovative, real-time review process. Members of the biological research community, computational theorists and engineers, mathematicians, imaging specialists from other fields, educators involved in training the next generation of researchers, and a range of other specialists (artists, illustrators, etc.) are all strongly encouraged to participate.

[Program Description section rewrites the last sentence above to read:] Participation from molecular and cell biologists, biophysicists, ecologists, evolutionary and population biologists, computational theorists and engineers, mathematicians, imaging specialists from other fields, educators involved in training the next generation of researchers, and a range of other specialists (artists, illustrators, etc.) is strongly encouraged.

The Program Description also lays out some of the potential challenges to be addressed at the Ideas Lab workshop:

Potential applications of biological image capture and analysis are diverse, but offer many scientific and educational benefits:

  • Automated feature recognition in complex biological images
  • Enhanced algorithms for filtering data from images with low signal-to-noise profiles
  • High throughput image or video capture and analysis for quantification or classification of subject matter
  • Improved multidimensional spatial registration and object tracking in sequential series or overlapping images
  • Validated analysis of heterogeneous data submitted by “citizen scientists”
  • Enhanced representation and visualization of multi-dimensional datasets for dissemination of scientific findings

A myriad of challenges and barriers must be overcome for biological image analysis to reach its full potential. Advances in the applications listed above, or in one of many other areas, could have profound impacts on the biological research community, and other scientific disciplines.

The narrative for the preliminary proposal due in April is exactly 2 pages in length. The first half of page one is should describe your professional background, with the other half of the page covering the special expertise you bring to biological image analysis & visualization … plus 50 words or less describing “an imaging challenge you think should be addressed at the Ideas Lab.”

Page two includes responses of no more than 100 words to the following questions:

  • What is your personal experience with working in teams?
  • How would you describe your ability to explain your research to non-experts?
  • The Ideas Lab environment is especially suited to individuals who are willing to step outside their particular area of interest or expertise, who are positively driven, who enjoy creative activity, who can think innovatively and who can settle in easily in the company of strangers. Please describe an experience you have had in a comparable environment.
  • What would you personally and professionally gain from participating in this Ideas Lab event?

No appendices or supplementary material … no project summary … no references or budget etc.

Have fun. Have transformative ideas.

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Cures Acceleration Network Resurfaces

February 4, 2010 at 6:31 pm · Filed under NIH Advice, Research News

As I noted last spring, NIH Stimulus Patron Arlen Specter introduced the concept of the Cures Acceleration Network (CAN) as part of the NIH Reauthorization Bill of 2009. Last year, this intiative was to be housed outside the NIH (and DHHS), governed by Presidential appointees, and launched at an initial budget of $1B per program area to pay out $15M grant awards.

Nature Medicine now reports on Specter’s slipping the CAN into health care reform legislation with a $500M price tag (but no appropriated funds) and operating within the NIH. Some of the details are the same otherwise.

The network would be overseen by the NIH director, with advice from a board of 24 experts drawn from academia, venture capital firms, government agencies and disease advocacy groups. It would disburse individual grants of up to $15 million per year to speed potential therapies from bench to bedside. Awardees with access to private funds would be required to match every three government dollars with one private dollar. Key to CAN’s functioning would be early and close coordination with the Food and Drug Administration to ensure that a drug’s development meets regulatory requirements.

Still no word on who appoints the 24-member expert board … and no guarantee that Congress will up the NIH appropriation by $500M to absorb CAN. And, of course, no guarantee that Specter’s amendment will survive the conference committee process in its current form (though this initiative would be popular and his now Democratic vote is critical) … or that the legislation itself will survive in any form.

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Findings of Misconduct in Science

February 2, 2010 at 6:20 pm · Filed under Biomedical Research Ethics, Research News

Notice is hereby given that on January 7, 2010, the DHHS Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of ORI in the following case:

James Gary Linn, PhD, former Professor, School of Nursing, Tennessee State University (TSU) committed misconduct in science and research misconduct in research supported by S06GM008092 and G12RR03033. Specifically, ORI found:

  • The Respondent knowingly and intentionally falsified and/ or fabricated the data and results of a study in which he purportedly tested the effects of an intervention to reduce sexual risk behaviors in high risk, impaired populations of homeless men with mental illness by reporting false values for variables in Tables 2-5 of Cellular and Molecular Biology 49(7):1167-1175, 2003. In that published article, he falsified the values in Tables 2-5 by altering the values that he had obtained from another author’s manuscript.
  • The Respondent provided a CD ROM disc to TSU’s Institutional Research Investigation Committee (RIC) that he claimed contained files supporting his analyses for the article in question but that contained fabricated and/or falsified data.
  • The Respondent submitted falsified summary data to the TSU RIC during the TSU investigation and to ORI.

ORI issued a charge letter enumerating the above findings of misconduct in science and proposing HHS administrative actions. Dr. Linn subsequently requested a hearing before an Administrative Law Judge of the Departmental Appeals Board to dispute these findings. However, on November 30, 2009, Dr. Linn withdrew his request for a hearing. On December 18, 2009, the Judge accepted Dr. Linn’s withdrawal and dismissed his request for a hearing.

For 3 years, beginning January 7, 2010, Dr. Linn is debarred from any contracting or subcontracting with any agency of the US Government and from eligibility or involvement in nonprocurement programs and from serving in any advisory capacity to PHS.

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FY11 Budget Take 1

February 2, 2010 at 4:52 am · Filed under NIH Advice, NSF Info, Research News

Quick post with some links to nice Science Insider overviews of Obama’s budget request for the NIH ($32.1B, with 3% increase from FY10) and NSF ($7.4B, with 8% increase from FY10). The NIH news sounds good until you get to:

The pot of money for new and competing extramural grants will fall 0.3% to roughly $4 billion, and the number of these grants will drop by 199 to 9052. And demand for grants could soar because of the many scientists who received temporary, 2-year funding through the $8.2 billion for extramural research that NIH received in the Recovery Act.

Indeed, Collins expects success rates—the chances that a submitted application will be funded—to slide in 2011.

The Chronicle of Higher Education has a great table showing the increase from FY10 to FY11 for individual ICs at the NIH and Directorates at NSF (keep scrolling down past the DoEd listings to “In Other Federal Agencies”). Nature likewise has a summary of who got what (including more detail on NSF).

You can also check out the 114-p Budget in Brief for a summary of all HHS budget components.

Maybe Congress will pass appropriation bills by this time next year … or maybe not.

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