Journal of the National Cancer Institute Advance Access originally published online on June 12, 2007
JNCI Journal of the National Cancer Institute 2007 99(12):917-919; doi:10.1093/jnci/djm034
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© Oxford University Press 2007.
NEWS |
Budget, Review Initiatives Change Playing Field at NIH
Heading into a fifth straight year of flat budget allocations from Congress, the National Institutes of Health finds itself searching for new ways to stretch investigator-initiated grant dollars just to maintain its current grant portfolio. After 5 years of budget expansion from 1998 to 2003 that doubled the NIH budget, the current fiscal belt-tightening has seemed particularly severe and has many wondering about the future of federally funded biomedical research.
Given the fiscal realities, the NIH is reviewing the way it gives out grants and intends to make changes to address some of these constraints. The center for Scientific Review (CSR), which oversees NIH's peer-review process, has held several open houses to get the research community's input on structural changes that will make reviews more efficient. An open house focusing on "disease-based" review groups, including cancer research, is scheduled for June 29 (see http://cms.csr.nih.gov/aboutcsr/openhouses.htm).
But there are many challenges to overcome. Much of the problem stems from a period of dramatic NIH expansion and subsequent belt-tightening, which has had an unintended consequence that is only beginning to be felt. The number of investigator-initiated R01 grant proposals submitted each year rose from what had been a relatively steady 22,000 per year for the previous 10 years to more than 28,000 from 2003 to 2006. At the same time, Congress has essentially capped funding at about $28 billion. The government's own biomedical research inflation index has averaged just under 4% annually during that time, meaning that NIH finances have slipped back to 2003 levels just when the number of new investigators and new proposals has skyrocketed. The result for individual investigators has been a severe cutback in the number of funded R01 grants, with some study sections reporting less than 10% of applications funded.
"As a reviewer, it is difficult knowing that at this time most grants—90%–95%—will fail and that failed grants can close labs and cost people jobs," said Catherine Kunst, Ph.D., interim director of the Eleanor Roosevelt Institute at the University of Denver and a reviewer in the cell death in neurodegeneration study section. "It is even more difficult knowing that even if an investigator makes all of your desired corrections, the resubmitted grant, while technically flawless, may not meet the necessary significance threshold to bump it into a scoring range that is fundable at this time."
Morale within the scientific community has slipped to the point that research institutions are banding together to make their voices heard in Congress. On March 19, a group of scientists and university administrators testified that federal investment in NIH would go to naught if funding continues at its current level. Simultaneously, the group issued a report with the ominous title Within our Grasp—or Slipping Away, documenting the desperation being felt by many investigators.
"The effects are being felt by both principal investigators and young researchers trying to enter the field. Investigators are forced to spend excessive time writing multiple grants—time that could be better spent doing the hard work of laboratory discovery," the report states. Researchers say they have abandoned some of their most productive collaborations and innovative work, since projects seen as risky are less likely to be funded. Certain NIH components, such as the National Cancer Institute, can fund only 11% of research project grant applications "and must, therefore, reject many grants of exceptional quality."
For its part, NIH is struggling to keep up with the number of new grant applications and the burden of having to find reviewers for so many new grant applicants. To alleviate the strain, the CSR has undertaken several initiatives designed to streamline the process and relieve the burden on reviewers and applicants alike. CSR is responsible for organizing the peer review groups, called integrated review groups, or IRGs, that evaluate nearly all investigator-initiated grant applications.
Among the changes CSR is flirting with is replacing the time-honored tradition of face-to-face peer-review meetings with electronic discussion and scoring on secure NIH servers for some review groups, although it acknowledges that the move has met with some resistance.
"I think there is a qualitative difference between these videoconferences or teleconferences and actually being face to face with people," said Bruce Chabner, M.D., professor of medicine at Harvard Medical School, clinical director of Massachusetts General Hospital, and member of NCI's National Cancer Advisory Board. "I really don't think that's a good idea. There's so much money at stake and these are such important grants that I'm just not sure I agree with that."
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Nonetheless, CSR director Toni Scarpa, M.D., Ph.D., said that by the end of 2007 10% of all IRGs will meet by teleconference or on the Internet. Deciding which format best suits its members will be left up to the individual study sections, but many are beginning to adopt at least some remote meetings into their schedules. For example, Scarpa said a new study section in structural biology will meet for the first time in person but will then convert to using the electronic platform.
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"A lot of people are skeptical," Scarpa said. "But the majority of people who have tried it have been converted."
Asking for Input
Scarpa said that NIH is responsive to concerns about changes to IRGs and their component study sections and is currently soliciting input from the scientific community on the alignment of IRGs. Now is the time to take a critical look at whether emerging areas of research are adequately covered by current study sections, he added, saying that it has been 7 years since the NIH panel on scientific boundaries for review reorganized the study sections.
About 200 scientists attended the first such meeting, focusing on neuroscience, on March 2. Participants expressed concern that emerging fields are not always well represented or well received in study section review and that clinical and translational research continue to lag behind basic research in the review process.
Scarpa responded to the concern about clinical sciences by citing an analysis done by Michael Martin, Ph.D., director of the division of physiology and pathology review group at NIH. Martin's research shows that much of the disparity between clinical research and basic research grant success is because only half as many clinical grantees submit competitive renewals, which are funded at a much greater rate than new grant applications.
"It could be that clinical investigators don't have protected time for research and therefore don't have anything to show at the end of the grant period. It could be that for some clinical research, you do it and you are finished," Scarpa said. "So we haven't solved the problem, but we can say it is not a problem with review."
Speeding the Process
At the same time, NIH has been converting from an entirely paper-based grant submission process to an entirely electronic one. The February deadline for R01 proposal submission was the first with a mandated electronic submission. The deadline came and went with few complaints from investigators. But this is only the first in a series of CSR initiatives designed to speed grant review.
Beginning in June, CSR will pilot an automated grant referral system designed to use data mining to assign proposals to appropriate review groups from information provided in cover letters. Currently, grants are assigned to IRGs by human reviewers who read each cover letter and make review group assignments. Scarpa said that he anticipates making automated IRG assignments will save a month or more in the review process.
Also, NIH piloted an initiative in 2006 that made reviewer summaries of proposals available to new investigators within 10 days of their grants’ being reviewed. Previously, review scores and summary statements had taken weeks to months to make their way back to applicants. The goal of the expedited review is to assist new investigators whose proposals require modification to make those changes and resubmit their proposals within one grant cycle—rather than stretching the process out for 2 years.
The expedited review process is expected to help reduce the strain on new investigators who may not have the financial resources to wait through a 2-year resubmission process. And although many scientists remain concerned about the fate of new investigators, Scarpa said that it is a misconception that new investigators don't fare as well in the grant review process.
"If you compare apples to apples, a new investigator writing a new grant application compared to a senior investigator writing a new grant application, they don't do that poorly—just slightly below the senior investigator," Scarpa said. "They are not really that handicapped. It just looks that way because competitive renewals of senior investigators do much better, two to three times better, in peer review."
In February 2006, 40 study sections piloted the program for new investigators submitting R01 applications. Of the 820 new investigators who received expedited feedback on their grants, 107 (13%) resubmitted their application in time for the next review cycle. This group did better than expected in the review process, with 62% receiving scores within the fundable top 10th percentile.
CSR considered the pilot a success, and it will be expanded in 2007, with 22 other study sections providing expedited reviews in February. By November, all 182 study sections will let new investigators applying for an R01 grant submit a revised proposal within the span of one grant cycle.
Lightening the Load
In what may be its most controversial proposal, NIH is considering shortening and restructuring the behemoth research plan required for R01 grant applications. At 25 pages, it is more than 60% longer than National Science Foundation grant applications and more than twice as long as many private foundation grant applications. A pan-NIH application committee is examining the issue and recently solicited comments from the scientific community through a 90-day request for information. More than 5,000 people responded, and they overwhelmingly favored shortening the application, by a three to one ratio.
"We have a mandate, but we will proceed very carefully," Scarpa said. "Because that is a major cultural change in the way you write and review the R01 grant. ... I expect a decision coming shortly, probably a pilot project. But nothing has been finalized."
Meanwhile, Congress passed a 7.5%, or $952 million, increase for NIH in the 2007 continuing budget resolution, but the appropriation process for fiscal 2008 has just begun. Even if no increase is possible in the fiscal 2008 budget, the Within Our Grasp report states that Congress should aim to at least eventually outpace inflation. Otherwise, the momentum generated by earlier Congressional investments in NIH could be lost.
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