General Thoughts on the NIH

I've been tagged by Hope for Pandora (who was tagged by DrugMonkey, who was tagged by Writedit) in a blog meme regarding the NIH's request for feedback on its peer review system. I'm not huge into these blog memes, so I'm not going to pass this along to seven others, but I will share a few thoughts.

Being only in the second year of my Ph.D. (and studying overseas), I haven't applied for an NIH grant before, so I'm not intimately familiar with the NIH's peer review system and can't offer much in the way of constructive criticism there. I can, however, speak generally about some of the major issues facing the NIH from my perspective, and some of these will be related to the areas in which the NIH is currently soliciting feedback.

Noting that the most significant hurdle facing the NIH is a general dearth of funding shouldn't be news to anyone, especially anyone at the NIH. This is the root of most of the problems currently plaguing the agency, though, so it cannot be emphasized enough. In short, the situation is dire. There are too many grant applicants and not enough grant dollars to go around. See this post for more details. NIH R01research grant application success rates have plummeted since 2001, due to both increasing numbers of applicants and decreasing funds. The onus here is on Congress and President Bush, neither of which has done anything significant to address this issue.

Due to these financial constraints, the NIH now has to much more carefully manage its once healthier budget. In 2003, NIH Director Elias Zerhouni laid out the new NIH Roadmap, a set of goals for the NIH to help it more rapidly and cohesively advance biomedical research in the US. In theory, such a project is a great idea, as biomedical research today suffers to an extent from an overload of disconnected research findings. Operating under the current budget constraints, though, means that dedicating more resources to a set of chosen goals will take away much needed resources form other areas. The Roadmap goals focus too much on translational medical research and not enough on basic research. The NIH has an outstanding reputation for its support of basic research, and that should be its primary focus. The NIH, of course, also has a duty to translational research, but this is an area where industry can contribute as well. If it has to pick and choose, the NIH should focus more on the areas where its strengths lie and where it has a more unique ability to make a difference.

Along these same lines, the nation as a whole has been devoting enormous resources post-9/11 to biodefense at the expense of other areas. I won't argue that anthrax isn't a little sexier than cell motility, on the surface at least, but despite the hype, biodefense and bioterrorism are still niche areas and shouldn't be given precedence over other more relevant lines of research.

Young investigators are hit hardest by tightening budgets, as remaining grants are more likely to go to more established investigators. Fortunately, the NIH has an extensive New Investigators Program (including the Pathway to Independence award and special consideration for R01 grants) to counteract this. As budget constraints grow, these programs should be protected and expanded at a higher priority than the general pool. Otherwise, young scientists will be squeezed out completely.

The final point I'll raise in unrelated to these others. As the largest supporter of biomedical research in the US, the NIH has a special obligation to make sure that its (taxpayer funded!) research is published in the public domain. Since May 2005, the NIH has had an optional open access program that revolves around PubMed Central. Specifically, the NIH "requests and strongly encourages all investigators to make their NIH-funded peer-reviewed, author's final manuscript available to other researchers and the public through the NIH National Library of Medicine's (NLM) PubMed Central (PMC) immediately after the final date of journal publication." This, however, hasn't gone so smoothly, and as I noted before, pervasive misunderstandings of the policy, noncompliance, and a general lack of participation have been observed. These problems seem to stem largely from the fact that providing an open access copy of research articles is not mandatory. A bill was introduced last year (S. 2695, the Federal Research Public Access Act of 2006) to require free public access to most government-funded research (including research funded by the NIH), but it did not progress through the Senate. Mandatory public access should be the policy for any publications stemming from NIH grants, whether or not it requires an act of Congress.

Here are the original instructions from Hope for Pandora:

The NIH is seeking comments regarding NIH’s support of the biomedical and behavioral research, including peer review, with the goal of examining the current system to optimize its efficiency and effectiveness. The NIH is especially interested in creative suggestions, even if they involve radical changes to the current approach. Responses will be accepted until August 17, 2007 online or via e-mail ( I hope that all of you reading this - whether you are a grant recipient, a student or a taxpayer - will offer advice to Uncle Sam.

I made this post as part of a pyramid meme initiated by Writedit and sent to me by DrugMonkey, both individuals who know more about the nitty-gritty of NIH grants than myself. If you blog and want to tag yourself to write about this, here are 4 rules:

1. Include in your post the links to the NIH RFI and the comments page.

2. Include the list of six topics the NIH wants information about.

  1. Challenges of NIH System of Research Support
    Please describe any specific challenges presented by NIH’s support of biomedical and behavioral research such as the current array of grant mechanisms, number of grants awarded per investigator, and the duration of grants.
  2. Challenges of NIH Peer Review Process
    Please describe any specific challenges presented by the current peer review process at NIH.
  3. Solutions to Challenges
    Please concisely describe specific approaches or concepts that would address any of the above challenges, even if it involves a radical change to the current approach.
  4. Core Values of NIH Peer Review Process
    Please describe the core values of NIH peer review that must be maintained or enhanced.
  5. Peer Review Criteria and Scoring
    Are the appropriate criteria and scoring procedures being used by NIH to evaluate applications during peer review? If not, are there changes in either that you would recommend?
  6. Career Pathways
    Is the current peer review process for investigators at specific stages in their career appropriate? If not, what changes would you recommend?

3. Comment on one or more of these issues.

4. Decide who the next seven vectors will be for this meme.

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NIH R01research grant application success rates have plummeted since 2001, due to both increasing numbers of applicants and decreasing funds.

Actually, that's not quite true. If I recall correctly, grant success rates didn't start to plunge until after 2003, which is the fiscal year in which the five year doubling of the NIH budget was completed. (The doubling occurred between FY 1998 and 2003). At the NCI, at least, as of around 2004, the payline was at or even above the 20th percentile (meaning over 20% of applications were funded), which was quite high. Around the time I got my first R01, the paylines started plunging precipitously. I distinctly remember this because in late 2004, I got a score on my R01 that was easily fundable--in the prior year. However, the payline fell by 4 points in one year (an almost unprecedented plunge) for FY 2005, and I sweated it out. I did get my R01, but it went from being a slam dunk to just slipping in under the wire in the course of a few months. For FY 2006 and 2007, the payline fell even further. At the NCI, at least, it is around the 12th percentile now.

A worse problem is that price being paid to maintain even this anemic payline. One way the NCI is keeping paylines from plunging into the single digits is by slashing new grants. Two years ago, my R01 grant was slashed by 23%. My colleague, whose newly awarded R01 grant I am a co-investigator for, had his budget slashed by 30%. Worse, it's not just new grants. The NCI is shaving 2-3% off of existing grants every year. The salaries my grants support go up around 4% every year, and there is nothing I can do about it. The end result, I don't know if I can afford to replace a technician who resigned, and, if I do, my supply budget will be squeezed into near nonexistence by the fifth and final year of my grant.

Thanks for that, Orac, and that's definitely frightening. Although it's unrelated to what's going on at the NIH, we're having pretty significant budget woes in the Oxford biochemistry department right now, and virtually all departmentally funded technical staff positions have been dissolved.

In regards to the comment about declines starting in 2001, that refers specifically to Type-1 grants. The decline in success rates of Type-2 grants began later, and the real plunge, for both, started, as you mentioned, after 2003.

I see that you caught Coturnix's relay of the new NIH funded research public access policy.

With regard to the young investigator programs, I have heard several NIH officials (once at a Keystone meeting and once during a campus visit) vehemently defend the young investigator targeting that the NIH does to improve chances at independence. One thing that I do not understand about the clinical fellowship research training system (which seems to me designed for MD's who do not have any research experience) is how it can be claimed as an effective way to establish independence. The medical resident fellows that I see are more like cogs in someone else's system. The PI's like the system because it gets the work done, most fellows like it because they usually get a paper and can check the 'research experience' box on their CVs, but young scientists interested in translational research on a path to independence, the kangaroo-type grants are much more attractive. I think the NIH lumps them both together, which does not seem accurate to me.

I've always been a little skeptical of research programs targeted specifically toward M.D.s. For example, in one of my friend's labs here in Oxford, they recently took on a German medical student who needed to do a one year research project as part of his medical degree. In accepting the student, though, the lab had to guarantee the student x first author publications and y total publications (something like x = 1 and y = 3). That's in one year! That's a hell of a deal, and certainly no PI would commit to that for a student's first year in a Ph.D. program.