Two recent posts discuss the topic of stabilizing NIH funding within a PI's career, triggered by a blog post from Mike Lauer and Francis Collins. In the latter, the two NIH honchos claim to be losing sleep over the uncertainty of funding in the NIH extramural granting system, specifically in application to those PIs who received funding as an ESI and are now trying to secure the next round of funding.
One key part of this, in my view, is how they (the NIH) and we (extramural researchers, particularly those reviewing applications for the NIH) think about the proper review of Renewal (formerly known as competing continuation) applications. I'm reposting some thoughts I had on this topic for your consideration.
This post originally appeared Jan 28, 2016.
In the NIH extramural grant funding world the maximum duration for a project is 5 years. It is possible at the end of a 5 year interval of support to apply to continue that project for another interval. The application for the next interval is competitively reviewed alongside of new project proposals in the relevant study sections, in general.
The NIH Success Rate data shows that RPG success rates were 16.8% in 2013 and 18.1% in 2014. Comparable rates for competing continuation RPG applications were 35% in 2013 and 39% in 2014. So you can see why this is important.
I visited these themes before in a prior post. I think I covered most of the issues but in a slightly different way.
Today I want to try to get you folks to talk about prescriptives. How should a competing continuation / renewal NIH grant application be reviewed?
Now in my experience, the continuation application hinges on past-productivity in a way that a new application does not. Reviewers are explicitly considering the work that has been conducted under the support of the prior award. The application is supposed to include a list of publications that have resulted from the prior award. The application is supposed to detail a Progress Report that overviews what has been accomplished. So today I will be focusing on review mostly as it pertains to productivity. For reference, Berg's old post on the number of papers per grant dollar is here and shows an average output of 6 papers (IQR about 4-11) per $250K full modular award*.
Quoted bits are from my prior post.
Did you knock our socks off? This could be amazing ELEVENTY type findings, GlamourPub record (whether “expected” for your lab or not), unbelievably revolutionary advances, etc. If you have a record of this, nobody is going to think twice about what your Aims may have been. Probably won’t even give a hoot whether your work is a close match to the funding IC, for that matter.
We should probably separate these for discussion because after all, how often is a panel going to recognize a Nobel Prize type of publication has been supported by the award in the past 5 years? So maybe we should consider Glamour publications and amazing advances as two different scenarios. Are these going to push any renewal application over the hurdle for you even if the remaining items below are lacking? Does GlamMag substitute for direct attention to the experiments that were proposed or the Aims that guided the plan? In the extreme case, should we care if the work bears very little on the mission of the IC that has funded it?
Were you productive? Even if you didn’t WOW the world, if you’ve pumped out a respectable number of papers that have some discernible impact on a scientific field, you are in good shape. The more, the merrier. If you look “fabulously productive” and have contributed all kinds of interesting new science on the strength of your award(s), this is going to go down like gangbusters with the review panels. At this level of accomplishment you’d probably be safest at least be doing stuff that is vaguely in line with the IC that has funded your work.
Assuming that Glam may not be in the control of most PIs but that pedestrian, workaday scientific output is, should this be a major credit for the continuation application? We don't necessarily have to turn this into a LPU sausage-slicing discussion. Let's assume a quality of paper commensurate with the kind of work that most PIs with competitive applications in that particular study section publish. Meets the subfield standard. How important should raw productivity be?
Were you productive in addressing your overall goals? This is an important distinction from the Specific Aims. It is not necessary, in my view, that you hew closely to Aims first dreamed up 7 years prior to the conclusion of the actual study. But if you have moderate, or disappointing, productivity it is probably next most-helpful that you have published work related to the overall theme of the project. What was the big idea? What was mentioned in the first three sentences of your Specific Aims page? If you have published work related to this broad picture, that’s good.
This one is tricky. The reviewers do not have the prior grant application in front of them. They have the prior Summary Statement and the Abstract as published on RePORTER. It is a decent bet the prior Aims can be determined but broader themes may or may not come across. So for the most part if the applicant expects the reviewers to see that productivity has aligned with overarching programmatic goals, she has to tell them what those were. Presumably in the Progress Report part of the continuation application. How would you approach this as a reviewer? If the project wasn't overwhelmingly productive, didn't obviously address all of the Aims but at least generated some solid work along the general themes. Are you going to be satisfied? Or are you going to downgrade the failure to address each Aim? What if the project had to can an entire Aim or two? Would it matter? Is getting "stuck" in a single Aim a death knell when it comes time to review the next interval of support? As a related question if the same exact Aim has returned with the argument of "We didn't get to this in the past five years but it is still a good idea"? Neutral? Negative? AYFK?
Did you address your original Specific Aims? ...this can be a big obsession of certain reviewers. Not saying it isn’t a good idea to have papers that you can connect clearly to your prior Aims. ... A grant is not a contract. It is quite natural in the course of actual science that you will change your approaches and priorities for experiments. Maybe you’ve been beaten to the punch. Maybe your ongoing studies tell you that your original predictions were bad and you need to go in a whole new direction. Maybe the field as a whole has moved on. ... You might want to squeeze a drop out of a dry well to meet the “addressed Aims” criterion but maybe that money, effort and time would be better spent on a new direction which will lead to three pubs instead of one?
My original formulation of this isn't quite right for today's discussion. The last part is actually more relevant to the preceding point. For today, expand this to a continuation application that shows that the prior work essentially covers exactly what the application proposed. With data either published or included as ready-to-submit Preliminary Data in the renewal. Maybe this was accomplished with only a few papers in pedestrian journals (Lord knows just about every one of my manuscript reviews these days gets at least one critique that to calls for anywhere from 2 to 5 Specific Aims worth of data) so we're not talking about Glam or fabulous productivity. But should addressing all of the Aims and most if not all of the proposed experiments be enough? Is this a credit to a competing continuation application?
It will be unsurprising to you that by this point of my career, I've had competing continuation applications to which just about all of these scenarios apply, save Glam. We've had projects where we absolutely nailed everything we proposed to do. We've had projects get distracted/sidelined off onto a subsection of the proposal that nevertheless generated about the same number and quality of publications that would have otherwise resulted. We've had low productivity intervals of support that addressed all the Aims and ones that merely covered a subset of key themes. We've had projects with reasonably high productivity that have....wandered....from the specifics of the awarded proposal due to things that are happening in the subfield (including getting scooped). We've never been completely blanked on a project with zero related publications to my recollection, but we've had some very low productivity ones (albeit with excellent excuses).
I doubt we've ever had a perfect storm of sky-high productivity, all Aims addressed and the overarching themes satisfied. Certainly I have the review comments to suggest this**.
I have also been present during review panel discussions of continuation applications where reviewers have argued bitterly over the various productivity attributes of a prior interval of support. The "hugely productive" arguments are frequently over an application from a PI who has more than one award and tends to acknowledge more than one of them on each paper. This can also involve debates about so called "real scientific progress" versus papers published. This can be the Aims, the overall theme or just about the sneer of "they don't really do any interesting science".
I have for sure heard from people who are obsessed during review with whether each proposed experiment has been conducted (this was back in the days when summary statements could be fairly exhaustive and revealed what was in the prior application to a broader extent). More generally from reviewers who want to match publications up to the scope of the general scientific terrain described by the prior application.
I've also seen arguments about suggested controls or key additional experiments which were mentioned in the summary statement of the prior review, never addressed in the resulting publications and may still be a criticism of the renewal application.
Final question: Since the reviewers of the competing continuation see the prior summary statement, they see the score and percentile. Does this affect you as a reviewer? Should it? Especially if in your view this particular application should never have been funded at that score and is a likely a Programmatic pickup? Do you start steaming under the collar about special ESI paylines or bluehair/graybeard insider PO backslapping?
DISCLAMER: A per usual, I may have competing continuation applications under current or near-future review by NIH study sections. I am an interested party in how they are reviewed.
*This probably speaks to my point about how multi-award PIs attribute more than one grant on each paper. My experience has not been that people in my field view 5 papers published per interval of support (and remember the renewal application is submitted with the final year of funded support yet to go, if the project is to continue uninterrupted) as expected value. It is certainly not viewed as the kind of fabulous productivity that of course would justify continuing the project. It is more in line with the bare minimum***. Berg's data are per-grant-dollar of course and are not exactly the same as per-grant. But it is a close estimate. This blog post estimates "between 0.6 and 5 published papers per $100k in funding." which is one to 12 per year of a full-modular NIH R01. Big range and that high number seems nigh on impossible to me without other funding (like free trainee labor or data parasitism).
**and also a pronounced lack of success renewing projects to go with it.
***I do not personally agree. At the point of submitting a competing continuation in year 4 a brand new research program (whether b/c noob PI or very new lab direction) may have really only been rocking for 2 years. And large integrated projects like a big human subjects effort may not even have enrolled all the subjects yet. Breeding, longitudinal development studies, etc - there are many models that can all take a long time to get to the point of publishing data. These considerations play....let us say variably, with reviewers. IME.