In the course of collecting evidence to justify why my current employer hauled my ass up here & paid my salary for the last 6 months, I came across a file I prepared shortly after arriving and before getting this blog off the ground. Last Nov, an NCI program officer who was previously a faculty member here came back to address a packed audience of young investigators on strategies for succeeding in the NIH shell game. Her advice works just dandy for seasoned PIs as well.
She spent a bit of time on what remains a controversial issue at the NIH, but her stance was clear: new PIs should concentrate on crafting and submitting a very competitive R01 rather than divert their effort to R21 or R03 proposals. Neither of the latter are renewable, and neither are appropriate “starter” grants on the road to independence. The R21 is appropriate if the work is truly exploratory – but not if the work is just a 2-year R01. The R03 is appropriate if the new investigator has no internal sources of pilot data collection funding … but she indicated that study sections & program officers prefer to see the home department/school picking up the tab for pilot data collection if the new PI is truly promising. That is, the NIH wants to see some institutional commitment & co-investment in this process. [I will add that responding to a specific RFA or PA with an appropriate proposal for the mechanism is another matter as well ... just be sure the proposed research is responsive to the stated objectives and the mechanism.]
In the category of putting out a strong new PI R01, she also recommended that you include letters of support from your mentor, division/dept chair, outside collaborators, etc. who could vouch that you are ready to launch your independent career. These are not like the formal K award letters but short, specific, clearly sincere recommendations to the IC and study section that awarding the grant would be a good investment. A senior study section member in the audience confirmed this – but added that the letters must clearly demonstrate that the mentor (or whoever) has read the R01 and helped refine the narrative … a glowing letter of support appended to an unfundable narrative backfires for both the new investigator and the mentor. [As a reviewer of internal pilot funding applications, I can attest to the frustration of a ridiculously immature proposal paired with a bubbling mentor letter - makes everyone look bad.]
When resubmitting (A1 or A2), she reminded the audience they could certainly ask the SRA to not reassign a specific reviewer (by number on the last summary statement). Those cover letters I keep telling you to write are confidential documents only read by the referral officer and the SRA (scientific review administrator – the NIH staff person assigned to each study section). She said usually one-two of the original reviewers re-reviews amended applications, with one-two new reviewers. The SRA can look at your last summary statement and concur (or not) with your request that Critique #2 (e.g.) was way off base. In fact, SRAs will ask an outlier study section member to leave the room during your review since the SRA now considers that reviewer to have a conflict of interest (based on the tone-content of the initial review in comparison with the other reviews & the application itself).
And she emphasized there is life after an unfunded A2 submission – not to get discouraged, not to give up, not to let your career/life be defined by this … especially with the budget in the toilet and submissions at an all-time high. She immediately explained why you cannot submit a disguised A3 (fourth attempt) submission … that the referral officers check the recent submission history of every application coming in, and if they see a recently unfunded A2, they search your current application for matching word strings and other tell-tale signs of illegal fourth submissions. She said at least 50% of the aims must be new and that often the mechanism can be changed (apply for piece of a failed R01 as an R21 if exploratory or R03 if pilot data are needed). Alternatively, given that 3 cycles have passed, use data accumulated over the years to expand an R21 into an R01 or develop a truly new R01, again taking the time needed to prepare a really polished and readable application.
Okay, Drugmonkey, let the commentary begin …