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

By Bouvier Grant Group

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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?

Author:
Dr. Meg Bouvier

Margaret Bouvier received her PhD in 1995 in Biomedical Sciences from the Mount Sinai School of Medicine. After an NINDS post-doctoral fellowship, she worked as a staff writer for long-standing NIH Director Dr. Francis Collins in the Office of Press, Policy, and Communications for the Human Genome Project and NHGRI. Since 2007, Meg has specialized in editing and advising on NIH submissions, and began offering virtual courses in 2015. She's recently worked with more than 40% of the nation's highest-performing hospitals*, four of the top 10 cancer hospitals, three of the top five medical schools for research, and 14 NCI-designated cancer centers. Her experience at NIH as both a bench scientist and staff writer greatly informs her approach to NIH grantwriting. She has helped clients land over half a billion in federal funding. Bouvier Grant Group is a woman-owned small business.

*Our clients include 9 of the top 22 hospitals as recognized by the 2023/24 US News & World Report honor roll

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