Medical Writing, Editing & Grantsmanship

For the next couple of years, almost 2% of the NIH budget ($486 million in President’s 2008 & 2009 budgets) will be devoted to NIH Roadmap Initiatives, which receive 5-10 years of “incubator space” to … incubate, I guess. Maybe do some pre-emptive transformations while they’re at it.

NIAID is leading the Inflammation Working Group, and they are right on the ball seeking public input about Inflammation as a Common Mechanism of Disease. In addition to the various e-mails for providing feedback on specific topics, NIAID asks you to contact Dr. Chuck Hackett at 301/496-8973 or chackett@niaid.nih.gov.

During the next few months, NIH will plan new Roadmap initiatives with input from the Council of Councils and the Council of Public Representatives. This spring, IC directors will give these plans a final review, after which (summer-fall) the Great Zerhouni will select the which initiatives are converted to RFAs with advice from the Advisory Committee to the Director.

Maybe a good idea will even make it past all these councils & committees.

NIAID sent out a little notice today that included survey data about specific complaints federally funded PIs have about the administrative burden of managing a grant award. The study’s shocking conclusions include:

Looking at stats about the respondents, these seem to be solid R01-type folks not hard up for NGAs. Average direct-cost (ie, no indirect or F&A costs included) funding among respondents was $434,753 … median direct-cost funding was $213,000. More than half were full professors, with only 22% at the Asst Prof level. In other words, these are people who should have some access to administrative assistance at the division/dept level.

Listed below in descending order are the top research-related burdens as reported by the majority of faculty surveyed:

1. Grant progress-report submissions
2. Personnel hiring
3. Project-revenue management
4. Equipment and supply purchases
5. IRB protocols and training
6. Training personnel and students
7. Personnel evaluations

Project revenue management? On the other hand, they report very little burden related to managing conflict of interest issues. Hmm. And much to the dismay, no doubt, of their parent institution, they spend almost no time on IP protection or patent applications.

In spite of all the griping, almost 92% would still choose an academic research career if they had it to do over again. Wonder why the other 8% are still in the game, especially if they have a couple of R01s on their plate.

These data come from the Faculty Administrative Burden Report, which comes from the Federal Demonstration Project or FDP.

Curious about this FDP creature, I discovered the following disturbing sentence:

“Begun as an experiment in 1986 between five federal agencies (National Science Foundation, National Institutes of Health, Office of Naval Research, Department of Energy, and US Department of Agriculture) and the Florida State University System and the University of Miami to test and evaluate a grant mechanism utilizing a standardized and simplified set of terms and conditions across all participating agencies, the FDP has evolved into an organization of 10 federal agencies and more that 90 research institutions dedicated to finding efficient and effective ways to support research by maximizing resources available for research and minimizing administrative costs.”

Somehow, I suspect the length, complexity, and thesis of this sentence offers good insight on how much (or little) to expect from this … project.

My *favorite* new factoid from the NIH … the oldest “new investigator” to date received his first R01 last year at age … 82. You go, guy!

On the other hand, a nobel laureate was triaged.

At the other end of the scale, confirmation at how extremely competitive the kangaroo (K99/R00) awards are and will remain. They are essentially reserved for the absolute best & brightest of the postdocs, those who clearly & overwhelmingly demonstrate their ability to quickly & successfully achieve independent grant funding.

Also learned that historical data show about 60% of K award recipients go on to receive additional NIH funding … though generally not until the 8th year from the start of their K award (ie, after K support ends). Here is the graph showing K Awardee Outcome from Dr. Khachaturian’s presentation.

Lots of good intel on the multiple PI option, including the fact that the contact PI cannot take the grant with him/her if he/she changes institutions. This is critical knowledge in an era of aggressively recruiting funded investigators … any grant award with multiple PIs ain’t walking. The PI’s share might follow him/her if scientifically appropriate, but not the award. The multiple PI option is also the reason for the cessation of NIH ranking tables - though apparently the NIH has been looking for an excuse to discontinue these for years. Wonder how many Universities will claim to be 5th in NIH funding next year …

Well, more details to follow on specific topics, but - whoa. This is by far the largest of these seminars ever held - more than 900 people from all over the US (no-brainer for the folks from Alaska) & the world (including South Africa, UK, Canda, Puerto Rico, etc.). Clearly everyone is desperate for that pearl of wisdom that will nudge their grant score within the payline.

My chats with NIH officials have been pleasant, though no big surprises or hot gossip. Yet. No inside scoop on the CSR open houses (reviewing study section make-up etc.), though I did learn the process will be glacial since the NIH peer review process is written into public law. I also learned that the NIH does not plan to issue any more ranking tables (in terms of where institutions rank with regard to total NIH $ & awards). A relief to some institutions, others will download the data & create their own to show their position in the top 10.

Had a very engaging lunch with Chris Pascal, Director of ORI. Not sure how to interpret the fact that no one else opted to join the table labeled “Research Integrity.” Talking with folks from OER and CSR winds up with the inevitable advice to “talk with the program officer.” My usual rote speech about spending time on the cover letter, the specific aims, the organization, the addressing IC programmatic priorities … yep, all are still very important to success. Asked about data & model organism sharing plans - use the examples given online and “talk with the program officer.” A Deputy Director told me they will go so far as to request feedback on a resubmission (esp the Introduction) from prior reviewers who can’t or are not scheduled to attend the study section meeting that discusses the A1 or A2 in question.

No one here from the magical kingdom of OPASI or even NCRR that I can see. When asked about the post-Zerhouni longevity of Roadmap items, the NIH folks are holding their cards close to the vest. Lots of Bob Dylan lines being tossed around in presentations though.

I look around and see scores (hundreds) of investigators hanging on every word said, feverishly taking notes. My heart goes out to all of them, and I wish I could help each one pull together a competitive submission. They are getting good advice here, which is freely available to everyone through the presentations online at the Seminar Website.

This week in Science, you might appreciate brief examination of the NIH budgets past & present and the overwhelmed peer review system.

One key tidbit includes the rather dramatic jump in awards for A2 (third & final) R01 submissions owing to the dismal chances of success the first time in: “Across NIH, the success rate (the number of funded grants divided by applications) in 2006 jumped from 8% for first-time R01 applications to 28% for second submissions and to 47% for third attempts. In 1998, in contrast, the difference between first and third application success rates was smaller: 21% and 41%.”

That 8% first-time submission success rate breaks down to 7% for established PIs and 9% for new investigators.

And of course, the results are predictable: “NIH officials say they’re hearing from many scientists who … can’t keep their labs running. “I get phone calls from people saying, ‘I’m letting my people go, what do I do now?’ ” says Michael Oberdorfer, a program director at the National Eye Institute. ‘I feel like I’m doing a lot of social work.’”

Of course, when the budget was doubling, research institutions celebrated by planning new buildings and went shopping for investigators to fill them. So not suprisingly … “In 1998, fewer than 20,000 scientists sought research grants from the agency; in 2006, that number was more than 33,000, and according to NIH forecasts, the number of applicants is expected to top 35,000 in 2007. The number of applications has grown at an even faster clip, as scientists, concerned about their chance of getting funded, are submitting proposals more frequently.” Sounds like something we’ve discussed before …

In other cheery news, “77% of the research budget [is] tied up in ongoing projects, including grants that last several years” … so not a lot of leeway for taking on new projects. So don’t discover anything paradigm-shifting just yet!

According to the Great Zerhouni, the “NIH will support, at a minimum, 1500 First-Time Investigators on competing R01 awards in FY 2007.” Not too shabby I guess.

And the NIH … or at least the Great Zerhouni … is tracking poll numbers: “According to a nationwide Harris Poll of 2,337 U.S. adults surveyed online by Harris Interactive(R) between January 11 and 18, 2007, 63% of the public claims it knows what NIH does and 75% of those individuals think we are doing a good job. The trend data show that NIH has experienced a 12% increase in favorability since 2000.”

Oh, and the NIH brand apparently has a motto: transforming health and medicine through discovery.

Makes sense given the “NIH Core Strategic Vision”:

• Transform medicine and health from a Curative to a Preemptive paradigm
• Support basic research to identify the earliest molecular stages of disease in complex biological systems
• Accelerate translation of findings from the bench to the bedside to the community
• Provide the evidence and knowledge base to allow for a rational transformation of our healthcare system

A pre-emptive paradigm, eh?

So - I keep harping on how wonderful program officers/officials are at the NIH and how you need to become best friends with one. But if you don’t already have a, shall we say, committed & long-term relationship with anyone in Bethesda/Rockville (et al.), how do you find the “one”? Not through e-Harmony … but through the various IC (institute & center) sites themselves. Each includes a list of program officials (with contact info) broken down by branch and/or area of interest. You can read these personals to see who looks like a good match.

For example, at NICHD, you would check out the overview of extramural research first. Then you would click on the Center or Branch/Division that likely covers your research area (& there could be more than one - polygamous relationships allowed!). As a hypothetical, suppose your area of work falls under the Reproductive Sciences Branch. You will find lists of program areas in the center column of the site, with a compilation of relevant reports, funding opportunitiess, links, etc. on the far right column (global site navigation aids on the left). You could then check the more detailed description and lead program official for a program area, such as Reproductive Genetics/Epigenetics … or maybe you are looking to see which institutions are members of a specific consortium or network or center grant program. Even better, you can look at the grant awards funded (title, #, PI, location) in a given year and see which program officer manages which funded project. Very enlightening.

Other ICs handle this differently. At NINDS, you would select Program Areas from the Funding & Research section of the Website and then click on the “Funding Announcements and General Information link for a matching research interest, such as Neurodegeneration (tell me about it). Here, you get the current & archived funding announcements, all relevant reports & conferences, and then finally at the very bottom (keep scrolling), the list of program officers. Clicking on individual names gives their scientific training and research interests as well as their portfolio coverage.

Of course, with something like neurodegeneration, you would do well to check for like-minded program officers at NIA (Neuroscience & Neuropsychology), NIEHS (neurodegeneration falls under Cellular, Organ, & Systems Pathobiology), NINR (Neuroscience program - possibly also Long-Term Care), NIMH (Divisions of Neuroscience and Adult Translational Research), and probably several more.

So go forth & explore the potential matches awaiting you throughout the ICs of the NIH. Could be the most rewarding effort you’ll make to find that special someone with similar interests & values who likewise wants to make you one of “their” PIs.

The Great Zerhouni got an earful from Science readers this week regarding his Nov 2006 Policy Forum commentary on the paradox of tighter paylines in the post-doubling period, particularly with regard to the foundation mechanism, the R01.

Dr. Werner from the Rockefeller University offers some real analysis: “As of the end of fiscal year 2005, the R01-equivalent represented 12% less of the overall grant budget relative to 1998, the year the NIH budget began to double. During this same period, there has been an increase in the total number of awarded grants, but these increases did not include a sustained increase in the total number of R01-equivalents awarded. … Moreover, the number of new investigator R01-equivalent grants has remained essentially unchanged since 1981, including the doubling period 1998-2003.”

Dr. Avantaggiati of Georgetown University further notes (with supporting data analysis of her own): “On the contrary, the success rate of true investigator-initiated grants has decreased dramatically, while NIH continues to promote multiple special programs through the R01 award mechanism. Consequently, if an appropriate balance between NIH-solicited-and investigator-initiated proposals is lost, the scientific community risks disenfranchisement of its role in guiding scientific directions. … [and on funding levels]… The anemic budgets awarded by NIH hamper everyone’s ability to realistically perform research. Hence, the vicious cycle: less money is awarded per single grant, and fewer grants are available per single investigator, which begs for more grant writing efforts. This further saturates the system by increasing the load of submissions and negatively impacting upon success rates. Zerhouni does not explain how his proposals solve this ill-fated Catch-22.”

Well, the big splash this week is the publication in Science of the genomic sequence for the rhesus macaque monkey (Macaca mulatta). This excellent online collection site includes links to the relevant articles (all free access - this is too important to reserve for subscribers) as well as some great posters (interactive & printable) and teacher resources.

The National Human Genome Research Institute’s Office of Population Genomics supports the application of genomic knowledge to health by promoting multidisciplinary research in epidemiology and genomics, by applying genomic technologies to existing population and clinical studies, and by developing new population resources for investigation of genetic and environmental contributions to complex diseases. The Office provides a home for the Genes, Environment and Health Initiative and the Genetic Association Information Network. Led by Jeff Struewing, MD, MS, the Office has an interesting RFA on Genome-Wide Studies in Biorepositories with Electronic Medical Record Data that could really bring a whole new perspective to clinical research … ie, using routine clinical data and biospecimens to answer the big questions. One of my current challenges and a fascinating proposal to work on indeed.