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?

Sequester Cuts to the NIH Budget Look Increasingly Likely

Guest Blog by Luke Bouvier, PhD

The day of reckoning is fast approaching as concerns the sweeping federal budget cuts known as “sequestration,” scheduled to go into effect on March 1.  Originally slated for January 1, 2013, the cuts were mandated by the Budget Control Act of 2011, which was enacted as part of that year’s fight over the increase in the federal debt ceiling.  In the hope that a long-term budget deal would make the automatic cuts unnecessary, their implementation was postponed by the New Year’s Day deal that averted the so-called “fiscal cliff,” but most observers now agree that there is little appetite for a political compromise that could avoid them once again.  On January 24, incoming chair of the Senate Budget Committee Senator Patty Murray (D-WA) released a memo outlining the history of the budget deals reached over the past two years as well as the current state of affairs.  The details are messy, but the consequences for the NIH are clear:  a cut of approximately 5.1% to the current year’s budget, or $1.57 billion, which would be all the more severe in that it would have to be squeezed into the remaining seven months of the fiscal year.

In an interview with Politico last month, NIH Director Francis Collins called the impending cuts “a profound and devastating blow” to medical research, adding that “there’s no sort of lever you can pull and all of a sudden everything will be fine” in the face of a cut of that magnitude.  Collins noted that over the past ten years, the NIH budget has been essentially flat, which means that inflation has whittled away about 20% of its value.  The looming cuts would greatly exacerbate that trend, at a time when cancer research is “just exploding with potential,” Collins said.  “We could go faster and faster; … it’s an incredibly exciting science, but it will go slower.”

Nature reported last week that scientists are already cutting back expenditures in anticipation of the cuts.  Senior officials at the science agencies are under White House orders not to discuss specific plans for implementing the cuts, but the Office of Management and Budget has directed them to minimize the impact of the cuts on their core missions and to give priority to concerns over life, safety, or health.  Nature reports that the cuts to the NIH budget would be spread over all of its 27 institutes and centers, with only its Clinical Center spared in order to avoid putting patients’ lives in danger.  Directors would have some discretion in apportioning the cuts, as long as the total adds up to 5.1%.  Given the uncertainty, the NIH has been paying only 90% of the promised amounts for previously awarded grants; if the sequester goes into effect, the final 10% of these grants would almost certainly suffer a significant cut, leaving principal investigators with difficult spending decisions to make.

As if sequestration weren’t enough, looming right behind it is another impending budget crisis, as the current fiscal year’s Continuing Resolution expires on March 27.  If no budget deal is reached by then, a government shut-down is a real possibility.  And following along close behind that deadline is the expiration of the debt ceiling suspension on May 19, which could lead to a US government default on its payment obligations in the absence of congressional action.

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.