NIH All About Grants Podcast � Administrative Withdrawal of Applications

June 21, 2024

Kosub� >> So you can finally exhale. After months of working on that application, you've done everything to get it submitted. You had your Office of Sponsored Research sign off on it and it was actually submitted. But oh wait. Oh no, it looks like NIH has withdrawn the application. But why? Why would they do that? Well, join us for this episode of the NIH All About Grants podcast to learn more about the administrative withdrawal process.

Announcer >> From the National Institutes of Health in Bethesda, Maryland. This is all about grants.

Kosub >> All right. Well, welcome to the show. My name is David Kosub, and I'm with the NIH's Office of Extramural Research. And I'm glad to say that we have with us doctor Ray Jacobson. He is the acting director of the Division of Receipt and Referral within the NIH center for Scientific Review. And he's going to be telling us everything we ever wanted to know about the administrative withdrawal process. Welcome to the show, Ray. So why does this process actually exist? What's the overarching reason?

Jacobson >> well, first of all, let me say, David, thank you for having me. It's a pleasure to be here and maybe explain some of what happens inside of the division of receipt and referral. Uh, so people understand what happens to the grant after they send it to NIH. And what we hope is that they go forward to review, and people get to hear about the exciting science that you're doing in your laboratory. But sometimes that doesn't happen. Um, one of the charges that the division of receipt and referral has is to look at applications to make sure that all the required elements are there so that when it goes to review, actually, the reviewers are able to assess the science and have all the necessary information to be able to do that. Um, sometimes if there's essential components missing, things get withdrawn because it, it wouldn't be allowable for review or there's unallowable material maybe that were included. Um, there's a variety of reasons that could lead to a withdrawal. Um, and I'm happy to, to talk about those things today.

Kosub >> Well, let's jump right into that. So that you mentioned a couple of out there of why we might withdrawal an application. Can you talk about that more?

Jacobson >> Sure. So, um, as I said, there's a variety of different kinds of things that might lead to withdrawals. Uh, you know, for example, uh, we have some programs that look at, uh, productivity of an investigator, and they need to know what level of support the investigators have. And so to be able to measure it, different investigators in a fair way. They look at productivity in terms of, um, their other support. And so the actually those funding announcements, those NOFO ask that the applicant submit an attachment that outlines all of the different types of support that they have from NIH, but also from other institutions, so that when the review panels are looking at those, that they are able to have a level playing field and be able to assess people, uh, and essentially calibrate productivity versus support. So, for example, if that document, that attachment wasn't included with the grant, um, it's a required element. So they actually the funding IC says that that document needs to be there. And if it's not there, it can't go and be considered by the review panel or for funding. And so in that case, if it was missing, that application would, uh, there would be no choice but to withdraw it. That being said, if you submit your grant early, you know, sometimes there's things we can do about that, but I think we'll get to that later.

Kosub >> Yeah, definitely plan to talk more about that. Um, before we jump to that part. Like, how often do we administratively withdrawal an application? Is it a frequent occurrence?

Jacobson >> I think by and large, most of the applications that we receive go forward. You know, I think right now this morning I was we had a staff meeting for the Division of Receipt referral this morning. So I met with all of the assistant and associate directors in the group. Uh, currently, um, the NIH R01 applications are arriving, and I think I asked them how many there were in the queue this morning. And I think there were about 2500 applications that had arrived. And so we have 10 or 11 staff that look through those applications. Um, and out of those 2500, there may be a handful, you know, 5 to 10, maybe less than that, even depending on, you know, there's some random element to it in terms of how many things are missing. But it's not not a large number. But if you're the person whose application is withdrawn, it's it's a very large number, right? It's your application. And so, you know, ideally we'd like to move everything we can forward to review. And that's, that's certainly our intent if it's possible. But sometimes we can't because there are parts that are required that aren't there or there's things that are included that aren't allowed.

Kosub >> Yeah, I could definitely see that being stressful if you're one of those one, one of those few applicants out there. Um, so and before we go even further, just one more clarification. So like, how is this different from when an applicant themselves withdrawals an application, how is what's the difference between them doing it and us doing it.

Jacobson >> So if an applicant withdraws their application, the signing official from the institution will contact the division of Receipt and Referral and they'll ask to have the application withdrawn from consideration. And that could happen for a variety of reasons. For example, there may be a previous version of that application that was submitted that scored well. And they the Funding Institute has made a decision to go ahead and award that application. And so the applicant institution, after receiving an award notification from NIH, usually would decide to withdraw the one that was going to go forward to review. And so they'll reach out to us and ask us to withdraw. And that's that's a simple process. Um, can be done, I think, through the ERA Commons account, when we withdraw something, we actually look at the applications quite carefully. And there's actually a discussion frequently, you know, if it's a if it's a tricky, complicated question about whether this is something that rises to the level of withdrawal to be a discussion among staff. Um, and then, um, if there's a decision that the application needs to be withdrawn, uh, one of the staff members actually individually crafts a letter that explains the circumstances, um, and why the application was withdrawn in, in a good level of detail, uh, and also outlines any possible next steps. Um, and they have their contact information. So if there are questions about the action, uh, actually the, the investigator and the applicant, the applicant investigator can reach out to the doctor staff to, to get further clarification. So frequently after something is withdrawn, there's, there's a dialog between the applicants and, and the particular staff member who was handling their case.

Kosub >> Well. Definitely like to hear that there's a dialog that's going on. And you're kind of touched on this. I'm hoping to learn a little bit more about like what we need to do to explain, like how we explain to the to the applicant in that in that letter, in those dialogs. Can you talk more about kind of like what we're what we're telling them in those letters.

Jacobson �>> Um, it's very case dependent. So it depends on the reason for withdrawal. You know, sometimes things are missing and attachment, um, and can't go to review because there's something missing that's required. There are other cases where, um, you know, if a, if an applicant decided to submit an application as a new application, but it had been reviewed, the project had been a similar project had been reviewed before. Um, because it's a new application, it's not allowed to to talk about the prior outcome of the review. So if that information is present in the application, if there's a score or it talks about, you know, what the previous review panel said, but it's a brand new application because it was submitted as a new application. We would have to throw that. Action would be explained in the letter that one of the requirements after an initial new application is submitted. If it comes back in as a as a revised application, we ask the applicant to include a required introduction to the application, talking about how they understood the feedback from the review panel and what actions they may or may not have taken in response to those. That's a required thing. And the applicants have one page for an ro1 to do that. You know, sometimes an individual will send, you know, 20 pages or 20 pages worth of material by attaching, um, you know, something through either like a hyperlink potentially, or, uh, as an appendix, um, to try to circumvent the page limit. So sometimes things will get withdrawn for that. Whatever the case was, whatever it was that led to the withdrawal, uh, the, the staff members and Dr.. Will will actually, um, talk about why, what the decision was. Why why it's a problem. Um, typically they'll quote the, the policy that that's been handled or that that's been violated, and then they'll, um, include their contact information in case there are any questions about, um, what to do. And in some cases, if an applicant has submitted early enough and, you know, if you submitted 2 or 3 weeks before a receipt date and we found something, it's actually possible to fix whatever's wrong, um, and then withdraw that application and resubmit the version that actually fixes the issues. So, uh, Dr. Staff tries to work quickly to find issues with things, and if applicants are sending applications early enough, they may have time to fix some of the problems that could lead to withdrawal. That's the best outcome. Actually.

Kosub >> I guess the two important takeaways is, is apply early, uh, don't wait till the last minute and don't try to overstuff those applications. Um, it's a you're also kind of hitting on this when, when the applicant or the researcher is responding to these letters, can you tell us more about like what they should be doing when they get these letters and when they want to try to resubmit? If they want to try to resubmit or do something else with that application.

Jacobson >> So typically in the letters, I think um, one, I think the first guidance is to read the letter carefully, you know, so I think it can be really kind of shocking to an applicant or very upsetting or, you know, frustrating that they they submitted an application that they spent a lot of time and they sent it to NIH, and they get a letter coming back saying, well, you know, there was this issue with your application, so it was withdrawn. Um, I know that I'm not the best at reading things when I'm upset, right? Sometimes I skip over lines or whatever. And so it's really good to read, you know, to take pause for a few minutes, maybe put the letter down, come back and read it carefully. Because sometimes there are things that you can do to fix the situation. Um, and if there are, then I think the, the staff member will have alerted, uh, the investigator to that. Um, so that's the first, most important thing is to read the letter carefully so you understand what the issue is. And if you have questions, reach out to DRr. The staff members are happy to talk to people. If there are questions about why something was withdrawn or something led to withdrawal. Um, and then the the next thing is actually, um, to talk to your program staff, your program officer, to talk about, um, what the next steps are, you know, how do you get an application that's compliant that can be submitted for the next receipt date that's available?

Kosub >> Can an applicant appeal one of our decisions to withdraw their application?

Jacobson >> Absolutely. So if there's a disagreement about the reason for the appeal, there's a few levels of appeal. So the first level of appeal would come to me as the acting director currently. Um, so that typically the director of DRR, um, will look at decisions that were made by staff so applicants can send a letter explaining an email, uh, explaining what the issues are, uh, and requesting reconsideration and potential potentially reinstatement of the application if they feel there was an error made. So I will look through that carefully. Um, read through the application, look to see what the basis were for the decisions, um, about the withdrawal. And I will either uphold or, um, reinstate the application. Uh, occasionally things are reinstated. I do think that the staff are quite careful. We try not to withdraw things. That shouldn't be so, um, you know, the appeal process is there because nobody's perfect. Everybody's human, and mistakes can be made. Likewise, I can make a mistake, and maybe my judgment is off in a particular day. So there's a next level of appeal, which actually goes to the CSR director. So the applicants can contact the CSR director. And there's an arbitration board that's staffed with various members of CSR and also other parts of NIH that look at, um, these cases. So they would look at the application, they would look at the grounds for appeal. They would look at the appeal letter, um, and they'll come back with a ruling of whether the the action was justified, whether the withdrawal was justified, or whether we should reinstate. Um, so that's the appeal process that's available to, to applicants.

Kosub >> Definitely. Good to hear that. There's lots of options, uh, reading those, uh, reading those letters key amongst them. Um, so in addition to those kind of tips that we've been kind of talking out throughout this whole process, do you have any additional thoughts that, you know, the audience should be aware of, kind of just to help improve the the likelihood that an application will not be withdrawn, that it'll actually make it to review.

Jacobson >> Yeah. So I think, uh, the first thing is what we already talked about a little bit, which is to submit early, um, you know, if you, if you wait to the last minute to submit and you get things in at 5 p.m. on the day that it's due, you have no room for error, right? It has to be complete. It has to be compliant because there's no way to fix something after the receipt date. So, um, it's good to submit a few days at least a few days before, uh, the application is actually due, but the receipt date, um, there is a two day period of time where you can look at the compiled application that made it to NIH. Um, and that's available to you so that you could actually fix an application so you can see what was submitted. You can look to make sure that all the required components are there. And if they're not, um, then we can still correct it. But if you wait till the to the due date and you submit it, there's really no way that we can, um, we can fix things after the fact. So, you know, your best strategy is to not wait till the last minute. Um, that that's the first thing. And I think the second thing is just to read. Read the application instructions carefully. Right. You know, so I think, um, NIH, um, notices of funding opportunities are very carefully written. And they have, uh, they outline all the things that must be there and things that aren't, you know, aren't allowed. And so you want to make sure that you understand the application instructions. Um, you know, of course, you can always reach out to staff, program staff to ask them if you're putting together an application for guidance and you need some guidance. Um, but those two things, I think if you look and carefully read through the application instructions from the NOFO, uh, and, uh, work with your, uh, sponsored office, project sponsors, office of sponsored Projects at your university, uh, and then work with NIH program staff. Um, you can go a long way to avoiding having the unfortunate situation of having an application withdrawn.

Kosub >> Well, thank you very much, Ray. This has been great to continue to learn more about the administrative withdrawal process. But before we go, I would like to give the opportunity for the guests to leave some final thoughts. Um, anything you would like to, to reiterate or to say about this process that you think the audience should take away?

Jacobson >> Um, I would just, I think, like to end in saying that, um, we don't withdraw applications lightly at all. I think before that action is taken, staff have typically tried to explore every option we can. You know, if something came in, uh, to a funding, a notice of funding opportunity where an institute isn't, um, actually signatory on that, we will try to find another notice that the application might fit instead. So we actually will, uh, do quite a bit to try to avoid withdrawing an application because our primary intent is to, I think, get applications to review. And in fact, you know, withdrawing applications is only a small part of what DRR does. You know, we're actually, I would call it a traffic dispatcher for NIH and other parts of, uh, HHS. As applications come in, one of the main functions of the division of receipt and referral does is actually not withdrawing. It's actually receiving the applications and referring them to the right place. So we make sure that when your grant does come in and it makes it through the process, that it goes to the places where there's scientific expertise to evaluate your application effectively. And so, uh, a lot of the time the staff is actually focused on that.

Kosub >> Well, thank you very much, Ray. This has been been great to learn more about this process of how NIH, or why NIH might be withdrawing an application that's submitted to reiterate some points that he made earlier, definitely contact your DRR division and receipt and referral staff, who, you know might be who are on that letter or any of the program staff to help, you know, answer any of these sorts of questions if you find yourself in a similar situation. This has been David Kosub with NIH's All About Grants.