NIH and Resubmissions

Q.Dear GrantDoctor,

The National Institutes of Health (NIH) has a pilot program that allows new investigators (in a few study sections) to resubmit R01 applications in time for the next review cycle. But in order to make the deadlines, we've only got about a month to revise and resubmit. Should I participate in this program, or wait for the following deadline 3 months later?

Thanks,

Jeff

A.Dear Jeff,

In response to the recommendations of an internal committee, last December, NIH announced a pilot program designed to make it possible for new investigators who were not funded in a particular round to resubmit in time for the very next review cycle. The way things normally work this isn't possible, since applications for the next round are due before applicants receive the decision from the current round.

Here's how it works. In 40 study sections, reviewers are given only 4 weeks, instead of the usual 6, to turn in their reviews of proposals from new investigators. Study sections meet earlier and internal review procedures are accelerated. The result: New investigators who submitted on 1 February were notified on 20 June. Participating new investigators got a 20-day extension on the deadline for resubmission--from 1 July to 20 July--which gives them a month to revise and resubmit.

When NIH announced the pilot program, they made no commitment beyond the 1 February 2006 due date. But the program was continued through the 1 June date (new proposals are due one month earlier than resubmissions) and, although no official announcement has been made, "it would be safe to say that CSR [NIH's Center for Scientific Review] expects the pilot will continue in the original listed study sections" through the 1 October submission date, according to CSR press officer Donald Luckett.

After October, it's anyone's guess whether the program will continue, be expanded, or go away. A report is expected--from the Trans-NIH Committee on Shortening the Review Cycle--this fall. At that point NIH will decide whether to cancel the program or broaden it to include all study sections. If it works out really well, the program might be expanded, eventually, to include all R01 applications, not just those from new investigators.

Should you take advantage of the opportunity? It really depends. NIH makes it clear that rapid resubmission is not for everyone. New investigators should "consider this option carefully," an NIH staffer wrote in CSR'sPeer Review Notes. "They only will have about one month to revise, and we do not recommend that investigators who need to make substantial revisions take this option. We will thus advise them to discuss their situations with NIH program staff and their mentors and to weigh options carefully."

I've heard from one scientific review officer involved in the pilot program, and her take is largely negative. Having an R01 proposal rejected is an emotional business. It isn't a good idea to respond to reviewers´ comments when you're still feeling their sting and taking them personally. A month isn't enough time to cool off.

And once you've cooled off, you don't have much time to get the work done. If all you need to do is alter the text (or add data you've already collected) 30 days is probably enough time to do a pretty good job. But if new work in the lab is involved, or serious re-visioning of the work, the schedule is likely to be too tight.

Finally, that good idea at the heart of your proposal can only be presented 3 times; NIH rules say that after the third attempt--the first submission and two amendments--you have to start fresh with a new--or radically altered--idea. You need to present your very best work each time; you can't afford to burn a resubmission in your haste to move things along.

Still, there are some great (potential) advantages to the accelerated schedule. For new investigators at institutions where R01 grants are the coin of the realm--research universities and academic medical centers--time is money. Tenure decisions come in the seventh year, typically; by then you need to be well funded and widely published to have a strong dossier. The accelerated schedule means that if you were so inclined, you could submit the same proposal 3 times in a single calendar year--something that would take 2 years at a minimum within the status-quo system. Even if the proposal is rejected all 3 times, that still gives you time to develop and pursue new, fresh ideas. And here's one major advantage, in my view: Even the best review processes have a large stochastic element, so the more often you play, the more likely you are to win. As long as you consistently submit high quality proposals and play the game well, more submissions may translate into more frequent success.

But the most interesting aspect of this exercise may be that it is likely to tighten up the entire review process. Follow-up reviews are supposed to be tied to the original review, but often they aren't. Even when investigators do an excellent job addressing reviewers' concerns (as expressed in the original review), reviewers sometimes come up with a whole new batch of criticisms. It happens. But if the follow-up meeting happens earlier--just 4 months after the first meeting--the scoring of the amended proposal is likely to be tied more closely to the original review. That can only help new investigators.

This new program is not without risks, but I think it's a good idea. Success isn't certain, but in the effort to get funding to young scientists earlier in their careers, bold measures are called for. NIH is merely offering new investigators an additional option. It's up to them to manage the risks and make it pay.

A related note: NIH has just started posting summary statements (NIH's official document showing the outcome of initial peer review, which includes a short synopsis prepared by a scientific review administrator using peer-reviewer critiques) on its Web site forallnew investigators applying for R01s--not only those in the 40 "pilot" study sections--within a week of the study-section meeting, cutting 3 weeks off the previous notification time.

Be Well,

The GrantDoctor

Q.Hello,

I am currently a graduate student who just completed my third year of my Ph.D. with a focus on infectious diseases (primarily HIV/AIDS) and an interest in health disparities. After some soul searching and feeling the need to be more involved in the trenches, I decided to pursue a clinical career as well, and thus will be starting medical school this year--next week to be precise. So now I am an M.D./Ph.D. dual-degree student with 5 years ahead to complete both degrees. The good news is that I am able to work on the two degrees concurrently; the not-so-good-news is that although I have some need-based financial support, these five letters are costly. My university has an NIH-sponsored Medical Scientist Training Program [MSTP] but I'm not part of it, since my research is in an area not supported by the grant. Because of this situation and because my professional trajectory does not seem to pair up well with financially lucrative future, I would like to explore any and all funding opportunities out there for someone in my situation. I am Hispanic and come from an economically disadvantaged background. I would appreciate any help you may be able to lend.

Thank you,

Jose

A.Dear Jose,

Let's start with the obvious: as an M.D./Ph.D. student, you qualify for an NIH predoctoral National Research Service Awards (NRSA)--including an NIH Predoctoral Fellowship Awards for Minority Students . "Support is NOT available for individuals enrolled in medical or other professional schools," reads the program announcement, "UNLESS they are also enrolled in a combined professional doctorate/Ph.D. degree program in biomedical, behavioral, or health services research." The NRSA won't pay all your expenses--tuition, fees, etc., are reimbursed only up to 60% of the total (beyond $3000)--but maybe you can get your institution to cover the balance. The graduate-student stipend for 2006 is $20,772.

Speaking of your institution: your university is a participant in NIH's Medical Scientist Training Program (MSTP), NIH's primary mechanism for supporting M.D./Ph.D. training. You're not a part of that program, so you can't get funding from NIH through that grant. But that NIH grant pays onlypartof the cost of educating participating M.D./Ph.D. students; the MSTP institution must provide the balance of support from other sources, and it might be possible for you to draw on these other funding sources--if your institution wants to make it possible and their policies allow it.

There are a few private-sector sources of funding for M.D./Ph.D. student support, but they tend to be disease-specific and I'm not aware of any that fund work in HIV/AIDS, or health disparities, or any of the areas you're interested in.

Beyond that, your best bet is to wait until you're finished with your degrees and participate in one of NIH's loan-repayment programs. You probably qualify in two categories, one for disadvantaged students and one focusing on health-disparities research . These programs can repay up to $35,000 of your education debt for each year of biomedical research you do after the completion of your degrees--plus taxes.

Be Well,

The GrantDoctor

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