NIH All About Grants Podcast � Post-Submission Policy

August 24, 2023

David Kosub: You've gone through the process and submitted your application to NIH, but it hasn't been reviewed yet. There's a time between those two things happening, and you have something else that you think you want to put into your application. But what exactly is NIH's policy on submitting post submission materials? My name is David Kosub, and this is NIH's All About Grants.

Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.

David Kosub: All right, welcome to the show. I'm glad to say that we have with us Dr. Stephanie Constant. She is NIH's review policy officer and is going to tell us everything we wanted to know about the NIH's post submission policy. Welcome to the show, Stephanie.

Dr. Stephanie Constant: Thank you, David. Nice to be here.

David Kosub: Absolutely. So, you know, I'll just jump right in. What is the overarching goal of this policy? Why does it exist?

Dr. Stephanie Constant: So post submission materials are there to provide applicants with an opportunity to share some unforeseen events. This is the time between submitting their application and the time that it gets reviewed. And so there are several examples of unforeseen events. For example, a change in PI, that could be changes or loss in personnel. And this is a time for applicants to be able to share this with reviewers and provide new bio sketches. There could be incidences where an applicant has received a new award and may need to revise the budget pages for the application under review. We also want to hear about professional promotions. Another one that, I think, a lot of applicants are not aware of is that if they want to submit a video as part of their application, they can't do this at the time of submission. Videos can only come in as part of post submission material. Another one, which, I think, is probably the most common one that we see is applicants providing news of an article that's been accepted for publication. We don't want to hear about that you've submitted a paper for publication, only if it's been accepted. And so again, this is a way for reviewers to see the progress has been made and the applicant and the team's being productive.

David Kosub: So what about, like, any additional new data?

Dr. Stephanie Constant: So additional new data is only allowed under very specific circumstances. There's actually a new policy notice that was published recently, which outlines what are types of applications will be able to provide additional preliminary data as part of post submission materials. These are new applications type one applications only, and the only activity codes for which they are allowed are the R01, R21 and R03.

David Kosub: Sounds like there's lots of different unforeseen events that might be, you know, able to be submitted, you know, after one's application. I guess, on the flip side, what can't?

Dr. Stephanie Constant: So essentially, anything that's not listed in the post submission material notice is not allowed. So one example that we often hear about is, "Can I submit pre-prints?" So pre-prints are a little different than a regular publication because they're not peer reviewed. And so pre-prints is an example of materials that we do not allow. They are allowed for the initial application, they're allowed for progress reports. But we don't consider them to be an unforeseen event because they can be submitted at any time. There's no time dependence or waiting for reviewers to review the article in question. So we don't consider that to be something that's unforeseen because the applicant has more control over when those get submitted and published.

David Kosub: So think about it being unforeseen and not being able to be controlled, makes sense.

Dr. Stephanie Constant: Exactly.

David Kosub: So let's just say I have something, I have some unforeseen events that I want to report. And, you know, can I do it at any time? What's the process there?

Dr. Stephanie Constant: So you can, the deadline is 30 calendar days before the review meeting. So you can submit these additional materials at any time in between submitting the application and the review meeting. However, we strongly recommend that you wait because applicants can only submit one package of post submission materials. And if you submit it very soon after you've submitted your original application, you may find several weeks down the line that you have more that you'd like to include, and only one package is accepted. So we suggest that you wait for the SRO to reach out and say, "You know, this is the timeline for submitting your post submission materials. These are the instructions." Just hold off until you get that message from the SRO or Scientific Review Officer. That way you don't miss out on being able to include as much as you can as part of these extra materials.

David Kosub: So, one and done it sounds like.

Dr. Stephanie Constant: Right.

David Kosub: You know, more on the logistics side, more questions. You know, who's submitting these post submission materials and where are they submitting them?

Dr. Stephanie Constant: Yeah, so again the SRO will provide instructions when they reach out to applicants but it is the applicants that submit these materials. They come in as a single PDF file via email. However, what's important is that there has to be concurrence from the authorized organization representative, so that's the AOR. And this can be in the form of a cover letter that's included with the materials or sometimes the AORs themselves submit it on behalf of the applicants. But this is important because we need to know that the institutional officials are aware that additional materials was submitted from an applicant.

David Kosub: And these additional materials, you know, when it comes to the review side of the house are reviewers taking these materials into account when they're, you know, assessing, you know, the merit of an application?

Dr. Stephanie Constant: Yes, these materials must be taken into account and the SROs remind reviewers that these materials are there. They remind them where to find them. And even during review meetings, if they're not raised by a reviewer, an SRO may prompt reviewers to make sure that they have actually taken these, or at least seen the materials and looked them over.

David Kosub: So it sounds like the SRO a Scientific Review Officer, you know, provides the instructions. And it sounds like they could be a good sounding board, a good resource for applicants to communicate with on these policies. Can you talk more about that?

Dr. Stephanie Constant: Yes, absolutely. The SRO is your resource. And that can be even for submitting the original application. They can provide you with help and guidance. You know, what attachments are needed, help submitting if there's some technical issues. But yes, the SRO is your friend. Pease reach out to them if you have any questions at all about anything to do with your application including post submission materials.

David Kosub: You have a friend in your SRO. Well, Stephanie, this has been great to hear more about the post submission policy here at NIH. Before we go, I always like to leave the opportunity for our guests to, you know, talk more, anything they want to say about this policy that they may not have said already. Or, you know, reiterate something else, you know, would you like to add anything?

Dr. Stephanie Constant: So, you know, take advantage of this. I think, a lot of applicants don't. They feel that maybe this is, you know, the information isn't going to be useful, reviewers aren't going to be reading it. It's an extra burden for reviewers or even the SRO, but that's really not the case. You want to have the best application that you can, and new things may have happened. And, I think, that can help and help inform reviewers of, you know, how you're doing. But also the other thing I stress, please, please look at the notice and look at it very carefully. Again, it lists all the things that are allowable and, you know, it has all the right instructions that you need to follow. So please be sure to look at that carefully.

David Kosub: Wonderful. Thank you, Stephanie. And I echo that sentiment. This has been a great opportunity to learn more about this policy and hear from you. You know, for those interested, also feel free and check out the NIH grants page on post submission policies. There's a lot of information there, including the guide notice that we've been talking about. Also check out Center for Scientific Review, they have some good resources as well. This has been David Kosub with NIH's All About Grants. Thank you.

Dr. Stephanie Constant: Thank you.