Archive for June, 2010

NIH Guide 2.0 – Enhanced FOAs

Yesterday I attended a last-minute session at which NIH folks presented potential new changes to the way FOAs are released, the idea being that shorter, simpler applications deserve shorter, simpler funding announcements.

The question to you all: what data are most important in an FOA (especially in the Part 1. Overview Information) – that is, what would you not want to see disappear from this section (e.g. key dates, number of applications allowed, etc.) … and what aspects of FOAs do you feel need to be changed (e.g., details on eRA registration, page limitations, submission requirements, etc.)?

At the end of the session, one brave volunteer gave an e-mail address to which comments/suggestions could be sent … or you could add them here in response to this post.

And now … off the grid for a few days. Try not to trash the place while I’m gone …

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NIH Regional Grants Seminar

Writedit is in Portland for the NIH Regional Grants Seminar (& I recommend everyone attend one of these or at least view the online presentations) – limited Web access and will be off the grid for a few days after. Have fun.

But … a few tidbits already. Later this afternoon, I’ll learn about plans to shorten/streamline/”enhance” the writing of FOAs. More on that later.

At one talk, an SRO shared a good rule of thumb for differentiating Impact from Significance: Significance is the hypothetical benefit to science/technology/clinical practice *if* the aims are achieved … Impact is the real-world impact, taking into account why the investigators & environment will really make this cool study work & shift a paradigmm or two.

Also, for resubmissions, SROs really want the reviewers to look at the A1 as a “new” application (reviewers don’t see old application in any case) evaluated based on its own merit – not in relation to how much it improved from the prior submission or whether all the reviewer critiques were met. Not news – but clearly laid out today.

And Sally Rockey (head of OER) confirmed that the NIH is rigorously sniffing out “new” applications that are not new. Rigorously (investing time & personnel needed). Please remember that just changing PAs does not make the application new (changing mechanisms, resubmission after failing at an RFA do qualify as new). She also noted that so far, there has only been a 10% bump in applications submitted. The next big jump will likely be in 2012, when everyone who had ARRA funding and asked for no-cost extensions comes back to the trough for more ….

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Collins on NIH Budget, Investigator-Initiated Research, Basic Science, etc.

In the published version of his interview with Science, Francis Collins had some rather grim news for NIH-supported investigators, particularly those in the basic sciences:

Q: Regarding the budget and grant funding, you’ve said that you expect very low success rates in 2011, 15%. What’s this going to mean?

F.C.: We don’t know what the budget will end up being. Obviously, the signs are not particularly good that the Congress will do better than the president’s budget [a 3.2% increase]. Some noises might even indicate that they’ll do worse.

We will undoubtedly have to look at draconian things like downward negotiations, which means cutting the budgets of approved grants in order to try to free up dollars to fund more grants. We are trying to protect certain parts of the enterprise. Postdoc training slots, for instance. But I’m sorry, I can’t come up with a magic solution here that is going to reduce all of the pain.

Q: Some researchers are worried that your emphasis on translational research and big goals will mean cutting back on investigator-initiated grants.

F.C.: I don’t think they should be very worried. Everybody’s going to be stressed, so it will be tempting if your grant didn’t get funded to look around for some reason other than the fact that it was a tough year budgetarily. The amount of additional funds that might go into focusing on translation are going to be maybe 1% or thereabouts of the overall NIH effort. That shouldn’t have a very big effect.

Q: Does that mean 1% less for investigator-initiated research?

F.C.: I would argue that if NIH simply said we’re going to keep doing what we’ve been doing all along, we’re not in a very good position then to ask the Administration or the Congress to give us more resources.

The translational goals get a lot of traction with the Congress, with the public. They should. I mean, we’re the National Institutes of Health. We are supposed to be coming up with ways to prevent and treat disease.

I was a bit taken aback by that last answer, but in the complete transcript of his almost hour-long interview with Science staffers Jocelyn Kaiser, Eliot Marshall, and Laura Zahn, Collins’ full sentiments become more clear. The full question was:

so we wanted to talk about the budget and the stimulus cliff which you’ve been talking about on the Hill lately. You’ve said that you expect very low success rates, 15%. What’s this going to mean? Is it going to shut labs down? We’ve heard plenty of people talking about posdocs being out of work. What’s it going to mean if that’s what you get?

Collins first notes that success rates depend on a lot of things, including “the budget you actually have to spend.” And then …

Yesterday’s primary result was a big disappointment, I think to many people. {clearly the interview was held on May 19th, the day after our primary election here in BICO- writedit} We were hoping to see Senator [Arlen] Spector [(D-PA)] reelected because he’s been such a strong champion for medical research, as you all know. And I am personally grieving at that outcome because of what it may mean for medical research in the congressional appropriation process. And because Senator Specter as a human being has been remarkably devoted to making the case for the importance of this kind of work. And he’s a courageous cancer survivor himself.

And the real pisser is what has happened in the aftermath of Sestak’s win … but don’t get me started.

Collins adds

So we don’t know what the budget will end up being. Obviously the signs are not particularly good that Congress will do better than the president’s budget. Some noises even indicate they’ll do worse with all the other pressures upon them from education needs and so on.

The other question we don’t know the answer to is what will be the number of grant submissions in FY’11. I will tell you, there were some concerns that we would see a huge deluge already in the January submissions because even though they would be submitted in January 2010 because of the cycle time, they wouldn’t be funded until early ’11. And many people were wondering if all those Challenge Grant applications, those 20,000 that came in during the stimulus and only 800 of those got funded, are the other 19,200 going to come back? … {but} We didn’t see a particularly big bump.

Well, a 13% increase in applications received since Oct 2009 (even with some ARRA applications still coming in) isn’t nothing …

We will undoubtedly have to look at draconian things like downward negotiations, which means cutting the budgets of approved grants in order to free up dollars to approve more grants.

Undoubtedly.

When asked whether the NIH would be “facing more flat funding”, Collin states the obvious:

Our system is every year is a brand new year and you’re very much at the mercy of what’s happening with the economy and the political system. And we have to roll with that and do the best we can. … It will obligate all of us who are science managers … to look really hard at whether there are less productive areas of sicence that we can’t continue to push forward just because we always have.

And then we get to the full answer to the “Does that mean 1% less for investigator initiated research?”, which is quite a bit longer and a bit more encouraging – for those in basic research – than the printed excerpt:

… When you no doubt listened to the hearings in the House and the Senate, a lot of interest about translation, about the Cures Acceleration Network and whether it’s going to get appropriated and not just authorized. And I think that puts us in a pretty good position to say, we really are at a critical juncture as far as moving basic science forward discoveries into the clinic in ways that we couldn’t have 5 or 6 years ago.

All that being said, I totally want to protect the basic science foundation of everything we do because that is our future. And I would certainly say to any R01 investigator who’s worried about this that the vast majority of the discoveries that are going to matter are going to come from those hypothesis-driven investigator-initiated efforts.

… But I also want to inspire those individuals who may have thought of themselves as lifelong basic scientists to think translationally if the opportunity arises and not to feel that’s off limits. And that’s not for everybody but I can certainly point to a few basic scientists who found that pretty exhilarating. Why do people go into biomedical research? Curiosity, sure, it’s fascinating, it’s intellectually stimulating, it’s not very profitable if you’re in the academic sector. But also because you have a dream that you’re going to do something, that you’re going to discover something that wasn’t known before and you’re going to help somebody. And if we in this effort to emphasize translation are going to give a few more basic scientists a chance to see that part of their dream become a little more real, I don’t think that’s bad as long as we’re not seen as putting down the basic science part of their careers and many others like them. We can’t do that.

However, the funding emphasis will remain on translational and applied research – accelerating cures … on cue, it seems. And the more pure basic science, seeking to serendipitously discover mechanism … the way things work? I worry that these sorts of projects will be lost as “less productive” … harder to explain to Congress.

But then, in moving on to talk about drug discovery, a question comes up about the new regulatory science initiative between NIH and FDA, which will be paid for out of the NIH Common Fund. Eliot Marshall asks, “They [FDA] do have a research program, right?” To which Collins replies:

Very, very limited and they certainly have not had anything like this. And so we – most of this is actually funded by the NIH since their budget is so tight, so we volunteered because it seems like a great idea that will cover most of our costs. We put out an RFA and we got 59 letters of intent. I’ve read all of those and they’re really interesting. In fact, we’re going to be challenged when the review goes through, we may not have enough money to fund the best stuff and have to go scrabbling around to fund more.

Having read the RFA, I’m impressed they got 59 letters of intent (all read by the NIH Director – not something you think about when jotting off these formalities). I wonder how many applications came in and how much more than the budgeted $6M will go toward this rather unusual RFA … and those to follow as part of the larger “regulatory science” initiative.

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Broader Impact of the America COMPETES Reauthorization Act of 2010

As nicely summarized by Jeffrey Mervis in ScienceInsider, the America COMPETES Reauthorization Act of 2010 (H.R.5116) has passed the House on its third attempt. The Senate still needs to take up the measure, and then any differences would need to be reconciled. While this bill authorizes $84 billion for research, education, and other programs over the next 5 years at the NSF (which gets $40B), the Department of Energy, and the National Institute of Standards and Technology, another less welcome bit of NSF authorization is include. Namely, the new Broader Impact review criteria:

SEC. 214. BROADER IMPACTS REVIEW CRITERION.

(a) Goals- The Foundation shall apply a Broader Impacts Review Criterion to achieve the following goals:

    (1) Increased economic competitiveness of the United States.

    (2) Development of a globally competitive STEM workforce.

    (3) Increased participation of women and underrepresented minorities in STEM.

    (4) Increased partnerships between academia and industry.

    (5) Improved pre-K-12 STEM education and teacher development.

    (6) Improved undergraduate STEM education.

    (7) Increased public scientific literacy.

    (8) Increased national security.

(b) Policy- Not later than 6 months after the date of enactment of this Act, the Director shall develop and implement a policy for the Broader Impacts Review Criterion that–

    (1) provides for educating professional staff at the Foundation, merit review panels, and applicants for Foundation research grants on the policy developed under this subsection;

    (2) clarifies that the activities of grant recipients undertaken to satisfy the Broader Impacts Review Criterion shall–

      (A) to the extent practicable employ proven strategies and models and draw on existing programs and activities; and

      (B) when novel approaches are justified, build on the most current research results;

    (3) allows for some portion of funds allocated to broader impacts under a research grant to be used for assessment and evaluation of the broader impacts activity;

    (4) encourages institutions of higher education and other nonprofit education or research organizations to develop and provide, either as individual institutions or in partnerships thereof, appropriate training and programs to assist Foundation-funded principal investigators at their institutions in achieving the goals of the Broader Impacts Review Criterion as described in subsection (a); and

    (5) requires principal investigators applying for Foundation research grants to provide evidence of institutional support for the portion of the investigator’s proposal designed to satisfy the Broader Impacts Review Criterion, including evidence of relevant training, programs, and other institutional resources available to the investigator from either their home institution or organization or another institution or organization with relevant expertise.

Actually, the new first and eighth goals are not far off from the NSF’s original intent: “The National Science Foundation (NSF) is an independent federal agency created by Congress in 1950 ‘to promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense…’ ” Who knew?

Nature’s Corie Lok recently took a look at the NSF’s broader impact requirement, which began in 1997 (and started to be enforced in 2002), though this was based on prior NSF criteria. Even so …

Many NSF-funded researchers find the foundation’s definition of broader impacts to be, perhaps unsurprisingly, broad, and frustratingly vague. …

Because it lacks conceptual clarity, the broader-impacts requirement often leaves researchers unsure about what to include in their proposals, and leads to inconsistencies in how reviewers evaluate applications. …

To make matters worse, the NSF has made little attempt to systematically track how its broader-impacts requirements are being met, or how much grant money is being spent in the process. Nor does it have a system in place to evaluate the effectiveness of the various projects.

Indeed, how does one track the impact of individual NSF-funded investigators on achieving the new first and eighth goals (increased economic competitiveness and national security)? It seems, at least, help may be on the way:

In March, the NSF’s oversight body, the National Science Board, launched a task force to examine how broader impacts can be improved. Chaired by Alan Leshner, chief executive of the American Association for the Advancement of Science in Washington DC, the task force is not expected to make its recommendations until 2011.

Perhaps the task force will concur with suggestions that remove the burden of broader impacts from individual investigators:

Yet such ideas lead to a more fundamental question. Is having every principal investigator working individually on broader impacts — for which many are inexperienced and untrained — the most efficient way of achieving the maximum effect?

Some scholars say no. In a paper published last year, Warren Burggren, a biologist and dean of the College of Arts and Sciences at the University of North Texas in Denton, writes that the job of implementing broader impacts should fall to the researcher’s institution, not to the researcher him or herself. The institution, be it college, department or centre, would pool a portion of the NSF grants obtained by its members and hire the professionals needed to broaden impacts effectively. Scientists should still be involved, but the coordination would happen at the institutional level. “I think it will be more efficient, because you’ve got people doing what they’re trained for,” says Burggren.

Another idea, suggested by Barry Bozeman, a science-policy expert at the University of Georgia in Athens, is for the NSF to create specific research programmes with strong broader-impact goals around areas in which the effects are important and obvious, such as climate change. Bozeman says that the NSF is already following this strategy with awards that, for example, promote the recruitment and retention of women in academic science.

Imagine that … having everyone concentrate on doing what they’re trained to do … talk about making America competitive in science again.

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