The End of Two Strikes You’re Out: Good or Bad News for Grant Applicants?

Yesterday, NIH and AHRQ announced that they had changed its resubmission policy. While a given application is still allowed only one resubmission, if you are unsuccessful on the A1, you can then submit the application again as an A0 without having to substantially redesign the content and scope of the project. This “new submission” will be reviewed without any association to the previous attempts. There will be no Introduction to the Revised Application, no explanation of how you addressed the reviewers’ concerns. Even if reviewers have seen the application in prior review cycles, they will be instructed to review it as new. (However, reviewers are human, and one wonders if this is realistic. It’s like asking a juror to ignore evidence they just heard, and we know from social psychologists that that doesn’t actually work.) Of course, the idea is that an applicant will use previous reviewer comments to strengthen the application, thereby improving their odds of funding.

Click here to read the full notice

In 2009, as part of their Enhancing Peer Review project, NIH eliminated the A2 in what has been dubbed by unhappy researchers as the “Two Strikes You’re Out” policy. NIH eliminated the A2 because meritorious research was most likely funded on the A2, which meant quite a delay to funding. The resubmission policy did indeed result in an increase in the number of awards made on A0 applications (although most funded applications are successful on the A1). About the “Two Strikes You’re Out” policy, Deputy Director Dr. Sally Rockey states: “…we heard increasing concerns from the community about the impact of the policy on new investigators because finding new research directions can be quite difficult during this phase of their career. Also, established investigators voiced concern about the need to redirect the research focus of productive labs in order to submit future NIH applications.” For one of many discussions on Dr. Rockey’s blog about the decision to sunset the A2 submission, click here.

In theory, it would appear that one could submit the same idea endlessly until one finds the best way to sell it to reviewers. The policy will no doubt appeal to many researchers, because it is now up to a researcher to decide when it is time to abandon a given project. If one waits long enough, one could submit to the same study section after most of the members have turned over, thereby having a new set of reviewers to weigh in on the project. One risk I see is that sometimes a PI is so blindly enamored with their idea that they have difficulty hearing that the reviewers are trying to tell them that the idea is simply not fundable in any form; i.e., no amount of tinkering with the writing or the details will fix it. A PI could waste a lot of time if they cannot see when it is time to abandon an unfundable project.

Judging from the comments on some of the NIH blogs (for examples, click here), many reviewers are thrilled to have more submission attempts, while others are dismayed that this marks a return to a huge number of submissions and long delays to funding. What do you think?

Reviewers of NIH Grant Submissions May Pay A Heavy Price When Their Own Submissions Are Reviewed

Grant scores are being posted right now. I was at a policy meeting last week with one of my grant clients and we waited with baited breath to see her scores. Although she has had a great deal of success on past NIH submissions, she was worried about this one, and with good reason. She recently agreed to serve as a reviewer on an NIH study section, but quickly realized that it meant that the resubmission of her own R01 competing renewal could no longer be reviewed in the most appropriate study section. Instead, it was assigned to a Special Emphasis Panel, or SEP. My client studied the list of reviewers on the SEP and learned that there was no one on the panel with the expertise needed to review her submission. She informed her SRO of this problem, but was told to sit tight and wait and see how the review went.

My client is considered an eminence in her field. She chairs a nationally-ranked academic department in her area, has landed numerous R01s, a U01, ARRA funding, and more. On her R01 competing renewal she scored in the 20th percentile, but the problems identified by the reviewers were certainly fixable and she resubmitted with hope, if not confidence. Then she accepted the position on the study section and the resubmission went to the (underqualified) SEP. The results of the resubmission were posted: Unscored.

It is hardly the first time I have heard such a story, it is just the most recent. It is considered an honor to be invited to serve on a study section. Many, like my client, choose to do so despite the time and effort involved because they feel they should give back for the many years of funding they have received from NIH. But the inadvertent result may be that the reviewer’s own submissions must be reviewed elsewhere, often on a panel that lacks the necessary expertise. As a result, my client and others have decided to terminate their service on study sections, which has the result of denying other NIH grantees reviews from those deemed the most qualified to provide them.

The current policy creates a situation where reviewers of a study section may be unable to get a fair review of their own grant applications at the most appropriate study section, thereby essentially penalizing them for service to NIH.

When discussing this problem last week in Washington with an NIH program officer, I was told to contact my local congressman. The PO felt that if we wanted to effect change to this NIH policy, the only approach was to inform a congressman that his constituents were not receiving millions in federal funding due to this policy. I plan to do so, and urge you all to do the same.

NIH Grantwriting Circles of Hell

T.S. Eliot says that “April is the cruellest month”, but if you work on NIH grant applications for a living, April’s got nothing on May. For those of us whose professional lives largely revolve around the NIH grant cycles, May is the month leading up to all those dreaded deadlines in June. Forget Eliot, this feels more like Dante’s Inferno:

First Circle: LIMBO. This is where the guiltless damned reside. Sounds about right. It is when a client sends you a dreadful first draft of their Research Strategy and you read and re-read it, and think, “I don’t even know where to begin.”

Second Circle: LUST. Where your appetite sways your reason, and you are consumed with fantasies of eight- and nine-figure grant awards.

Third Circle: GLUTTONY. You are at your computer at 2am. For the ten thousandth time this month, you do a global find-and-replace to change “data is” to “data are”.  With red-rimmed eyes, you decide to crack open your fifteenth bag of peanut M&Ms. Large bags of potato chips wait nearby.

Fourth Circle: GREED. When you lose your ability to understand why any other person’s grant applications should ever be funded.

Fifth Circle: ANGER. May is not the month to spend time looking at funding statistics on the NIH Reporter website.

Sixth Circle: HERESY. You start to believe that other federal funding agencies, such as Department of Defense or NSF, are evil or satanic because you believe their funding levels are better than those at NIH. You generally find yourself in this circle of hell after a conversation with a grantwriting colleague who has recently landing a DoD or NSF grant.

Seventh Circle: VIOLENCE.

Outer Ring: You fantasize about sabotaging the portal.

Middle Ring: You fantasize about being transformed into a gnarled thorny bush and being fed upon by Harpies, because anything would be better than spending one more minute creatively formatting to meet a page limit.

Outer Ring: You shake your fist at God and rue the day you ever applied to a biomedical research graduate program.

Eighth Circle: FRAUD. You tell your client their R01 will not be competitive with so little preliminary data. They miraculously return two weeks later with seven more figures. You say nothing.

Ninth Circle: TREACHERY. You recall the client who first talked you into trying your hand at grantwriting and remember how he recommended you to all his research colleagues. At the time you were grateful for his having launched this lucrative segment of your business portfolio, but you now recognize it for the act of treachery that it truly was. You recall the day he kissed you on the cheek at a department-wide meeting in front of the faculty, and kick yourself for having missed the symbolism.

The Centre of Hell: SATAN. Satan is portrayed by Dante as ignorant and full of hate—i.e., a Study Section. He has three faces: one represents basic science, one clinical science, and one translational science. He is waist-deep in applications, entrapped and weeping tears from his six eyes as he shouts, “You have given poor consideration to alternative hypotheses! You have not run the appropriate controls! Your ideas are not innovative! Your diffuse study design has dampened our enthusiasm for your project! You did not cite me in your references!” The icy winds of bureaucracy ensure his continued imprisonment in the Pooks Hill Marriot. Each of his mouths chews on an unscored grantee, as he rakes his hideous claws over the applications, reducing them to shreds. And just when you cannot stand one more moment…

You reach COB June 5. And your phone starts ringing for help on the Cycle III apps…