NIH policy on A2 as A0 that I didn’t really appreciate.

The NOT-OD-18-197 this week seeks to summarize policy on the submission of revised grant applications that has been spread across multiple prior notices. Part of this deals with the evolved compromise where applicants are only allowed to submit a single formal revision (the -xxA1 version) but are not prohibited from submitting a new (-01, aka another A0 version) one with identical content, Aims, etc.

Addendum A emphasizes rules for compliance with Requirements for New Applications. The first one is easy. You are not allowed an extra Introduction page. Sure. That is what distinguishes the A1, the extra sheet for replying.

After that it gets into the weeds. Honestly I would have thought this stuff all completely legal and might have tried using it, if the necessity ever came up.

The following content is NOT allowed anywhere in a New A0 Application or its associated components (e.g., the appendix, letters of support, other attachments):

Introduction page(s) to respond to critiques from a previous review
Mention of previous overall or criterion scores or percentile
Mention of comments made by previous reviewers
Mention of how the application or project has been modified since its last submission
Marks in the application to indicate where the application has been modified since its last submission
Progress Report

I think I might be most tempted to include prior review outcome? Not really sure and I’ve never done this to my recollection. Mention of prior comments? I mean I think I’ve seen this before in grants. maybe? Some sort of comment about prior review that did not mean the revision series.

Obviously you can accomplish most of this stuff within the letter of the law by not making explicit mention or marking of revision or of prior comments. You just address the criticisms and if necessary say something about “one might criticize this for…but we have proposed….”.

The Progress Report prohibition is a real head scratcher. The Progress Report is included as a formal requirement with a competing continuation (renewal in modern parlance) application. But it has to fit within the page limits, unlike either an Introduction or a List of Publications Resulting (also an obligation of renewals apps) which gets you extra pages.

But the vast majority of NIH R01s include a report on the progress made so far. This is what is known as Preliminary Data! In the 25 page days, I tended to put Preliminary Data in a subsection with a header. Many other applications that I reviewed did something similar. It might as well have been called the Progress Report. Now, I sort of spread Preliminary Data around the proposal but there is a degree to which the Significance and Innovation sections do more or less form a report on progress to date.

There are at least two scenarios where grant writing behavior that I’ve seen might run afoul of this rule.

There is a style of grant writer that loves to place the proposal in the context of their long, ongoing research program. “We discovered… so now we want to explore….”. or “Our lab focuses on the connectivity of the Physio-Whimple nucleus and so now we are going to examine…”. The point being that their style almost inevitably requires a narrative that is drawn from the lab as a whole rather than any specific prior interval of funding. But it still reads like a Progress Report.

The second scenario is a tactical one in which a PI is nearing the end of a project and chooses to continue work on the topic area with a new proposal rather than a renewal application. Maybe there is a really big jump in Aims. Maybe it hasn’t been productive on the previously proposed Aims. Maybe they just can’t trust the timing and surety of the NIH renewal proposal process and need to get a jump on the submission date. Given that this new proposal will have some connection to the ongoing work under a prior award, the PI may worry that the review panel will balk at overlap. Or at anticipated overlap because they might assume the PI will also be submitting a renewal application for that existing funding. In the old days you could get 2 or 3 R01 more or less on the same topic (dopamine and stimulant self-administration, anyone?) but I think review panels are unkeen on that these days. They are alert to signs of multiple awards on too-closely-related topics. IME anyway. So the PI might try to navigate the lack of overlap and/or assure the reviewers that there is not going to be a renewal of the other one in some sort of modestly subtle way. This could take the form of a Progress Report. “We made the following progress under our existing R01 but now it is too far from the original Aims and so we are proposing this as a new project..” is something I could totally imagine writing.

But as we know, what makes sense to me for NIH grant applications is entirely beside the point. The NOT clarifies the rules. Adhere to them.