Implications for Grantees of no more “Two Strikes You’re Out”

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Ding, dong the evil resubmission policy is dead. What are the implications in terms of your grantsmanship strategy and writing?

The original intent of the ill-fated, much-hated “Two Strikes You’re Out” policy was to reduce the time from first submission to award. According to the statistics and metrics put out by NIH, it was achieving that goal. With the policy change that went into effect last month, grantees still submit an A0 (new application) and an A1 (first resubmission), with no A2 (second resubmission) available. But if they fail at both the A0 and A1, they no longer need to shelve the application forever. They can now submit the application again as an A0 to any IC or study section they choose, and the reviewers will be given no information about earlier versions or summary statements. I have yet to find a grantee who is unhappy about the change of policy. ESI and New Investigator grantees in particular have expressed relief that they will have multiple attempts to “get it right” (the incorrect assumption being that study sections are static entities and that each review will be similar to previous reviews in terms of expectations and criticisms.)

Yet, it seems to me that this resubmission policy will lead to even longer lengths of time from first submission to award than were seen when people were allowed three submissions total. In essence, the very problem that “Two Strikes You’re Out” sought to fix will be made worse than it was prior to the “Two Strikes” policy. Here is my tongue-in-cheek mathematical representation of the new resubmission policy:

(A0, A1) ∞

To my mind, this policy equates not only to longer times to award than ever before, but also to an unprecedented number of NIH submissions going forward. In recent years, the total aggregate number of R01 submissions has been fairly steady at about 28 or 29 thousand per year. I expect we will see a dramatic increase in that number in FY14 and into FY15, as all those shelved, failed submissions go back into circulation. At some point that number will decrease a bit to a steady state that is still significantly higher than 29 thousand applications per year.

Love or hate the new policy (and while I recognize that “Two Strikes” was flawed, I am firmly in the latter camp), how should you fold this information into your approach to grantsmanship?

1. Consider deferring your June 5 A0 to the Oct deadline. I suspect that everyone and his brother will be dusting off an old, unfunded application and submitting an A0 for June 5. I suspect that that will equate to a gigantic number of submissions for this cycle, and my suspicions appear to be supported by the sheer volume of A0s on which I have been contracted to work. (I haven’t seen a crushing number of applications like this since the stimulus money.)

2. Give yourself more time to upload to the grants.gov portal with any R01 deadline going forward, but particularly for the June 5 deadline. As you know, applications must be uploaded and time stamped. When traffic at the portal is heavy, there are delays in your ability to upload. Many grantees have told me they missed a deadline because they waited too long and could not upload due to traffic at the portal, or not enough time to correct error messages received. This problem will be exacerbated by the increased application volume from now on.

3. Format your application with greater care than ever. A sharp increase in submissions will likely mean that reviewers will be even more overworked than ever, and the increased time/cost of reviewing all these extra applications may mean that CSR will step up its experiments with virtual peer review. How should this affect your writing? Use lots of unique identifiers throughout the application (numbering system with multiple subheadings) to help orient reviewers who are exhausted and/or not meeting face to face while discussing your application. Make judicious use of formatting to highlight key words and phrases so that reviewers can skim and quickly grasp your main points.

4. Understand that the time from first submission to funding may be very, very long. Plan your work accordingly. Your career strategy must be able to accommodate long review times at NIH. Your career cannot come to a standstill while you wait years to find out if you will receive NIH funding. Understand that you cannot have the same science in review at two NIH ICs simultaneously. However, you can and should submit the same science to different federal agencies simultaneously (ex- NIH and HRSA, AHRQ, DoD, PCORI, NSF, etc). And of course you can blanket the private foundation landscape with the same project. (Should you receive funding from multiple entities— may you have such a problem—this conundrum can generally be worked out in consultation with the program officers.)

5. The standard for quality of a submission is likely to be raised, so you will need to write stronger applications than ever before. Historically, it seemed that if reviewers knew you had a resubmission available to you, they expected you to use it to hone and polish the submission. Because reviewers know you have endless resubmissions available, I wonder if they might raise the bar for quality of the application. They may want you to resubmit until they feel it is just right (which is a moving target, given that your original reviewer(s) may have rotated off the study section before you resubmit.) In addition, a sharp increase in the number of submissions will likely mean that competition will be stiffer, so the quality of the submission will need to be even higher to stand out from the larger crowd. Grantees will need to write their applications more thoughtfully than ever, taking extra time and care.

6. Institutions also will need to step up their game if they want to stay ahead of the competition. If your institution does not do so already, now is the time to implement Chalk Talks and Red Team Reviews (i.e., mock study sections) if you want to help your grantees succeed with the policy change. And of course, hire your grantees a professional grant writer for a few thousand dollars to improve the quality of their R01. It will improve their grantsmanship not just on this submission but on all submissions going forward, and if it helps land even one award it will have paid for itself by many orders of magnitude in the indirects received.

7. Write every submission as if it were your only shot at funding. I am afraid that less savvy grantees may think that they should jump into the game and submit an application that may not represent their best effort. After all, what harm is there in doing so if they can just keep submitting? And wouldn’t it be helpful to have multiple summary statements to hone one’s grantsmanship? Keep in mind that if you are submitting to the same study section repeatedly, they may not formally be given previous submissions and summary statements. But if you have some of the same reviewers, they will remember your past submissions, and it may color their impressions of the current submission. I liken it to a jury who hears testimony and is then instructed by a judge to ignore it in their deliberations. We know from the social psychology literature that despite our best efforts, it is not feasible to act as if we do not know something. If your assigned reviewers still serve on the study section, they may recognize your A0 as something they read in the past, and may recall their reaction to the previous submissions. Reviewers, like jurors, are human. Therefore, I maintain that grantees should write every submission as if it were their only one.

Can you think of other ways you will need to alter your approach to NIH applications because of the new resubmission policy? Do you like or dislike the new policy?

Grantwriting Workshops Offered by Meg Bouvier Medical Writing

On May 8-9, The Arizona Biomedical Research Commission (ABRC) will be hosting a series of workshops on NIH grant submissions, at which I will be the featured presenter. For details and registration information, click here.

Workshops are often a cost-effective way to educate a larger group of faculty on the NIH grant process. In Phoenix next week, I will be kicking off my presentations with a popular 3 ½ hour R01 workshop, which includes a workbook that contains exercises and samples of funded grant applications. After, I will be conducting a series of one-hour breakout groups on topics including NIH submission strategies, resubmissions, mistakes commonly made by applicants, the review process, and how to choose an appropriate funding mechanism (R01, R21, or R03). Each time I present to a group, I work with the client to customize the presentations to address the needs of a particular group of attendees.

The workshops have proved quite popular with departments and institutions and can be taken for CME credit. I draw upon my experience working each year with dozens of NIH submissions and summary statements. My experience as both a bench scientist and staff writer at NIH also informs my approach to NIH grantsmanship and trainings.

Please contact us to discuss a workshop that will fit your needs and budget, and for a sampling of workshop formats and topics.

The State of Despair Among Many NIH Grantees

I am on a flight returning from a trip to Washington DC. I was visiting friends and former colleagues from my days at NIH. Several of my friends are now running research labs at medical centers, one of whom has served on several study sections. Another former colleague has gone on to become a Program Officer at NIH. One person does public health education at NIH, and another is running a successful freelance business. Each of them was interested in discussing the state of NIH grantwriting, especially given that the preliminary summary statements from the previous grant cycle have just become available on eCommons. We are all disturbed by the pervasive feeling of despair that I hear among NIH grantees.

One concern I hear repeatedly from both grantees and NIH program staff is concern about the quality of the review process on study sections. There are those who feel that regardless of the quality of the proposal, the best scores tend to go to the big-name labs who already are flush with funding. (I have heard it suggested by more than one person that reviews would work better if proposals were submitted anonymously.) Some feel that while New and Early Stage Investigators are given better opportunities to obtain funding, mid-career researchers are left in the cold because of the tendency to dole out money for the big-name labs. Another concern I often hear is that there are “cliques” within a given field, and the power to award great scores rests in the hands of the “in group” in a study section, while those outside the clique remain unscored and unfunded. I sometimes hear grantees and even program staff at NIH complain that the Summary Statements are illogical or contradictory– or worse, unintelligent. (When I see Summary Statements that are illogical or contradictory, often it is because the grant was confusing. Poor writing is not always the cause of such reviewer responses. But you can decrease your odds of a confused or ill-informed reviewer by writing more clearly and concisely.)

Almost certainly, there is some element of truth to each of these concerns. But I hate to see such talk discourage promising researchers from entering or remaining in the field. One could speculate endlessly about how to game the system when it comes to NIH grantsmanship. I think a great deal of such speculation is wasted energy. I hear a lot of stories from people in the field about what has gone wrong with their career, their proposals, the myriad ways in which they have been screwed. Being a proposal writer is a bit like being a bartender at times. And I see grantees making a lot of poor choices that are directly within their control to change. Here are some suggestions based on the mistakes I see:

When it comes to interacting with your colleagues, do your level best not to make enemies. Areas of biomedical research expertise have become so narrow and esoteric that you cannot afford to antagonize anyone in the handful of researchers in your field. That said, given the level of desperation over the current funding climate, you probably also should play your cards close to the vest. Be careful with whom you discuss your ideas. Your draft Aims may be best discussed at departmental chalk talks, where you can elicit great feedback while also divulging your ideas to a larger group who may serve as witnesses later on that the ideas were indeed yours. (Yes, I hear lots of talk of researchers stealing each other’s ideas.) Be assertive. It pays to ask for everything and anything you need, as the worst you will hear is no. I have a client who requested funds for proposal writing support from everyone—her Chair, the Dean, anyone who would listen. She got a little money from each source that, together with a little money from her start-up, helped pay for help on a K01 and a Robert Wood Johnson proposal (she landed both.) Her colleagues have whined about the help she has gotten, and why haven’t they been offered such help? (The answer: They never asked.) More examples: If you have done the work, insist on being first or last author on the manuscript. Conversely, if you are not the PI on a grant, do not do all the work. You will get no recognition. Above all, behave with integrity– even when your colleagues do not.

I have a great deal of respect for researchers who remain in the trenches of biomedical research, continuing to apply for grants even in the current funding climate. Such work is much more difficult than what I do. Increasingly, medical research facilities are shifting toward the elimination of tenure while demanding that their faculty rely 100% on soft money. It is not for the faint of heart.

But if you choose to remain, you must work to develop an extraordinarily thick skin. Proposal writing is an iterative process. With each submission, you use the Summary Statements to hone your grantsmanship. You work to find a great Program Officer in an institute that is a good fit for your work, and then you work with the PO to figure out how to tailor your research to fit the funding priorities and interests of the institute. If you are suspect of the quality of your study section, shift your focus and request a different one. There is little use in dwelling on your fears (real or not) about the inequities and injustices in the review process, at least not while you are putting together a proposal submission. Your energy is best spent on improving your proposal and your grantsmanship on that submission, to the best of your ability.