What Does the NIH FY12 Appropriations Report Actually Say?

Why should we follow the Appropriations process? Aside from the obvious reason—to know how big the pot of extramural money will be next year and to understand the government’s commitment (or lack thereof) to science funding—there is another important reason: If you know the language worked into Appropriations testimony you can strategically design your research and incorporate key language and ideas into your NIH proposal in order to improve your odds of funding. (In these competitive funding times, every little advantage helps.) So without further ado, here are some key concepts from the NIH FY12 Appropriation report:

NIH has requested $31.987B for FY12. In the cover letter for the report from the Office of the Budget, Francis Collins states: “The requested funding will enhance NIH’s ability to support research that prolongs life, reduces disability, and strengthens the economy. NIH-funded research contributes to economic growth, produces well-paying jobs, and helps to keep the United States competitive on the global stage.” He continues: “For the FY 2012 budget request, NIH has identified one major area of extraordinary opportunity and three other themes that are exceptionally ripe for investment and integral to improving the health of the American people.” The one major area of opportunity of course is the proposed highly-controversial National Center For Advancing Translational Science (NCAT), which Collins refers to as “a new paradigm for turning lab discoveries into cures and treatments through targeted investments in translational science and medicine.” The three themes that NIH has deemed “instrumental in paving the way for more rapid scientific advances across all areas of human health and disease, including global applications”:

 1) Technologies to Accelerate DiscoveryThis area focuses on genes and the environment (I guess we will see more of those FOAs), and directly lists advanced technologies such as DNA sequencing, microarray technology, nanotechnology, new imaging modalities, and computational biology.

2) Enhancing the Evidence Base For Health Care Decisions. Language here includes “comparative effectiveness” and “personalized medicine.” He also cites the new HMO Research Network, which “will bring together HMOs caring for more than13 million patients for the purpose of accelerating research in the high priority areas of epidemiological studies, clinical trials, and electronic-health-record-enabled health care delivery.”

3) New Investigators, New Ideas. Here Collins mentions two programs: “the NIH Director’s New Innovator Award, which supports new investigators with potentially high-impact projects, and the Early Independence Award, which enables our most talented young scientists to move directly from a doctoral degree to an independent research career.”

If you write NIH grants, I strongly encourage you to spend some time with the full Appropriations report put out by the NIH Office of the Budget. (click here)

The Administration requested $31.829B for NIH FY12. Here are highlights that the Administration pulled from the NIH report (and therefore deem important):

*The FY12 budget proposes to support a total of 9,158 competing Research Project Grants (RPGs), a reduction of 228 from FY10. In total, NIH projects it will support 36,582 RPGs (competing and non-competing) in FY12, an increase of 43 grants from 2010.

*The budget also proposes a 4 percent increase in stipends under the Ruth L. Kirschstein National Research Service Award (NRSA) program. The goal is to “improve NIH’s ability to attract high-quality research investigators to the field of biomedical research.” This will result in an increase in NRSA funding of $19 million over FY10, for a total of $794 million.

*The Cures Acceleration Network would receive $100 million in FY12; it is included in the budget of the Office of the Director.

*As in previous years, $300 million is transferred out of the budget of the National Institute of Allergy and Infectious Diseases (NIAID) for the Global Fund to Fight HIV/AIDS, Malaria, and TB.

*Although the budget narrative specifically mentions implementation of the National Center for Advancing Translational Sciences (NCATS), the National Center for Research Resources (NCRR) remains a line item in the FY12 budget.

*At a briefing of NIH advocates, NIH Director Francis Collins said that within the next month, the agency expects to file a budget amendment detailing the movement of NCRR programs into NCATS or other NIH institutes and centers.

*The National Children’s Study would receive $194 million, the same level as FY10; the Common Fund would receive $557 million, an increase of $13 million.

*NIH intramural research would increase by $50 million, to a total of $3.382 billion, which is approximately a 1.4 percent increase.

*NIH estimates it will be able to save more than $15 million in administrative costs in FY12. The agency plans to do so through such means as using technology to save study section travel costs by holding virtual peer review sessions.

To illustrate the achievements of NIH, Dr. Collins used two particularly compelling examples at the budget briefing:

*A 21-year-old diagnosed today with HIV/AIDS has a life expectancy of 70 years, thanks to the anti-retroviral         therapy made possible by NIH funding.

*Gains in life expectancy supported by NIH-funded research result in $3.2 trillion in annual savings.

NIH identified in its FY12 budget justification priority areas and initiatives related to the following diseases: autism; cancer; Alzheimer’s disease; type 1 diabetes; and HIV/AIDS.

Some scientific program areas of accomplishment or special emphasis provided by NIH include: bioinformatics and computational biology; National Technology Center for Networks and Pathways programs; epigenomics; genotype-tissue expression; global health; Gulf oil spill long-term follow-up; health economics; high-risk, high-reward investigator initiated research; the HMO research collaboratory; the human microbe project; and nanomedicine.

Design Your Translational Research Project With Patients In Mind

When designing a translational research project, be sure to target the end-user or end-market right from the first basic science experiments. This suggestion seems obvious. Yet time and again I see draft proposals that don’t accomplish this task, or pink sheets that complain a project misses the mark. Here are examples of how to achieve this goal from proposals I have worked on over the past few months:

*Enlist a physician as a consultant. Not a physician-scientist, but an M.D. who regularly treats the patient population you hope will benefit from your work. I recently worked on a polymer science grant that sought to create better cardiac stents—the Program Officer wisely suggested that a physician be added as consultant, given that the PIs were bench scientists. If you already have a physician on the proposal, make sure s/he emphasizes in the personal statement of the biosketch that s/he regularly sees the intended audience for the work being performed. Which leads me to the next point:

*Make sure you know what the patients want and need. According to one of my clients, researchers once thought that what quadriplegics wanted most was the ability to walk, therefore lots of money was devoted to that subject area. But when these patients are surveyed, it turns out that what they miss the most is the use of their hands. Before you design a bench project whose ultimate goal is to ease human suffering, make sure you know from what the patient suffers. If you can’t easily ascertain the main quality of life issues for that patient population, at least determine national healthcare costs that would be alleviated if your research findings informed clinical approaches.

*Keep the cost down. You could design the niftiest gizmo in the world that accomplishes precisely what you (and the patient population) want it to do. But if it is cost-prohibitive to produce, it will never see the light of day. Assure reviewers right from the design phase of your project that cost will be at the forefront of your mind as you proceed through your research. Whenever possible, point out where your device could interface with existing technology (ex- Bluetooth, cell phones, PCs). I work on a lot of NIH proposals where folks are trying to develop some sort of device, anything from activity monitors to robotic surgery gadgets. If you don’t confront the issue of cost from the very first design (yes, even in an R21) then you are almost certain to see that comment on your pink sheets.

*Bring on board a collaborator who has experience with regulatory approval. If you hope to move toward marketing a product, assure reviewers that someone on your team has some clue how to navigate the labyrinthine FDA approval process. If you have no such person, find one.

*Your goal is to help patients, not market a product. Remember that when writing an NIH proposal, you are asking for taxpayer dollars to fund your research, and therefore your work ought to benefit taxpayers. I am working on a diabetes grant for a for-profit company right now, and one suggestion I made was to state that the end goal is to help patients, not market their product. Perhaps it seems like a subtle language shift, but it will play better at review.

I could probably come up with other suggestions but I have finished my coffee and huevos rancheros and need to get back to work. So here’s the take-home message: Assure reviewers that from the very first experiment, your translational research project is aimed directly at the clinical end-users. More-than-the-usual concern prevails on the NIH campus right now that promising bench science is lying fallow, never being developed to the point where it will benefit patients (who, after all, paid for the research through their tax dollars). If you are on the bench side of the bench-to-bedside equation, make sure reviewers know that you are keenly aware of the clinical target and that you are not just a smart person in a white lab coat incapable of thinking beyond your cool idea.