NIH All about Grants Podcast: Milestone Driven Projects

Kosub >> So you've seen that funding opportunity that mentions milestones or phases? What Exactly. Does that mean or maybe you have an award that has a milestone component and you want to report on its progress? Well, let's talk about milestones some more. My name is David Kosub. And this is NIH is all about grants.

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

Kosub >> All right. Welcome to the show again. My name is David Kosub with the NIH Office of Extramural Research. And I'm glad to say that we have with us Doctor Craig Hopp. He is the deputy director of the Division of Extramural Research within the National Center of Complementary and Integrated Health. And he's going to be telling us everything we ever wanted to know about milestone driven projects. So welcome to the show, Craig.

Hopp >> Thank you so much. Pleasure to be here.

Kosub>> All right, well, just let's start right off the bat. Why do we have milestone driven projects?

Hopp >> So milestone driven projects from NIH perspective allows us to make what I would call riskier type of bets on funding by having an interim checkpoint where we're, you know, checking on how well they're progressing towards their objectives. We can, you know, have that as an interim period before we commit additional funds to that project.

Kosub >> So? So what makes them unique? I suspect what you just said about the funding is kind of contingent. But you know what makes them more? What makes them unique? Why are there phases, for that matter?

Hopp >> Right. So for most all other NIH awards, you know, when you when you get your award, whether you requested two, three, 4 or 5 years of funding, once you get the first year, you can pretty much safely guarantee, except in extremely rare circumstances, that you're going to get every other subsequent year of funding that you requested as well. Um, what makes these unique is that there is there are phases. There's, you know, first phase and a second phase, generally speaking, of these milestone driven projects. And it's important to distinguish this from like clinical trial phases. These aren't only clinical trials we're talking about, which also have phase one and phase two titles. To them. It's really just, you know, the phases of the project. Um, and there really is a point in the middle of that where NIH is assessing how well these milestones were met. Um, and if they are not met, then we do not provide that additional, um, bolus of funding. So unlike other awards where you can pretty much, you know, count on those, those out years of funding to happen for these phased awards. There's a certain percentage for most programs where we expect they will not transition to that second phase of funding. Um, and so these makes these types of awards very unique to NIH.

Kosub >> You mentioned like clinical trials? Some may have them, some may not. There must be like other types of these sorts of grants. Are there anything that, um are there any noticeable differences between these milestones, uh, between the milestones for these different type of grant types, or is it pretty much the same across the board?

Hopp >> So they're they certainly share some characteristics. Um, and they certainly are a little bit different than other types of, you know, non milestone driven projects. Lots of types of awards have some type of milestone in them. But for the most part, um, in those awards they are I would call them targets. Um, and if you don't meet those we can we can adjust. We can try to, you know, um, reconfigure things or try to help you get back on track. But for these types of milestone driven projects, what makes them different is that they're we also call them go no go criteria. Um, so they are very, very hard metrics. They're they should be written very quantifiably in terms of being very specific. Um, and again, if they aren't met, then there's this no go part of that, which means that, you know, you don't get the second phase of funding. So there in that way, somewhat different than other projects where you might have a general timeline or you might have a recruitment target, um, where again, you can you can adjust that as needed. Um, these milestones are much more, you know, written in stone, I would say.

Kosub >> Well, you actually kind of touched on this, uh, what I'd like to know. Like, let's just pretend I'm an applicant. I'm a researcher out there, and I want to apply for one of these things. Um, what should I be thinking about? How do I write my milestones into my application?

Hopp >> Yes, I would. I would suggest in that case, my advice would be to write the milestone, as you know, think about what you would be reading this as a reviewer, you know, are these milestones really rigorous enough? Are they specific enough? Um, because this, this these are very important, you know, components of this award. Again, that's what makes them somewhat unique, is you should spend a lot of time thinking about those milestones and what would be an appropriate, um, I guess, achievement in the first phase that would really de-risk that project and make it, um, a safe bet to go into the second phase of funding. So in that regard, uh, applicants should spend a lot of time thinking about those milestones. Don't make them too soft. Don't make the bar too low. Um, because this is, again, part of the things that we're considering when making an award.

Kosub >> I guess it's part of that thinking about taking time to think about these milestones and drafting and be thinking about what the reviewers are also going to be looking at as they're going to, you know, help score these applications, you know, from their vantage point how, how are they assessing milestones in an application.

Hopp >> Right? Again, from that same perspective. So what would it take to de-risk this overall project? Again, the whole point of these phased awards is that we're trying to fund more high risk, high reward type of research, but you have to make sure that the high risk part has been achieved before you go on to the high reward part. So really trying to what we instruct reviewers to do, generally speaking, at NCCIH, where I'm at is to consider these as, um, you know, how safe is it, how safe of a bet is it now to go into the second phase? And so they do look at these very much as part of the review process. Um, and there are, generally speaking, specific review criteria that ask reviewers to assess how rigorous are the milestones as proposed in the application.

Kosub >> And is there any additional thoughts from like program staff or NIH staff generally, like before we were to make an award, like after the reviewers have looked at it. Is there anything else that we're looking at?

Hopp >> Sure. Like other parts of the application and the review process, you know, program layers on basically their programmatic perspectives. Um, overall considerations about what else we're doing, but especially as relates to milestones, we may have specific ideas. Um, on what we think would be appropriate milestones. Um, and, and we will often, often, uh, renegotiate those milestones with the applicants, um, after review if we think they need. Again, if we're interested in making the award, but we think the milestones need to be tightened up a little bit, strengthened a little bit. We could oftentimes go back and forth with the applicant trying to, again, get those in a place where we would be happy with, um, you know, those as a term of award that we would then assess, you know, later on to make that second phase of funding.

Kosub >> Definitely, definitely a lot to be thinking about as you're putting together these applications with these milestones. And you mentioned term, terms and agreement of funding, that leads me, you know, like directly into let's say I got that award. I went through all the hoops and developed some good milestones, and I'm doing my research. And you know, now I've got something to show for it. I want to talk about my milestones. What do I need to be doing post award.

Hopp >> Yeah. So obviously the milestones are very should be, if they're done correctly have been written with very specific, you know, metrics. So you should clearly know what you're expected to do. And as you're doing the research you should be checking yourself against what you said you're going to accomplish. Um, and depending on when the second phase happens, um, there's different things that happen. So you're in let's say you're you're your first phase lasted two years, for example. Um, in your first year, RPPR is really no different than any other progress report that you would submit. You just submit what you've been doing. Maybe you reference the milestones and you talk about how far you've gotten. But then in the second year, when that first phase is supposed to end, you need to provide a very specific, um, documentation that will demonstrate that you have met all of those milestones. Again, unlike other types of awards, the milestones, generally speaking, it's an all or nothing. So even if you got 80% of the way there, that's that's not enough. You have to get, in most cases, 100% of the way there. Um, so really being sure that you're documenting that you have met to the letter of what the milestones said you should achieve, you need to demonstrate you've been able to achieve those things. And that will, of course, will make our job at NIH easier in being able to approve the second phase of funding. Again, this is a an administrative review that happens somewhere in the middle of that award. Um, before we then sign off, if you will, on that second phase of funding.

Kosub >> So all or none. Gotta keep that in mind. Um, and before we leave, I really appreciate this conversation on milestones. Any final thoughts? I mean, there's a lot to think about when we're putting these milestones together. Any final thoughts that you'd like to leave the listeners about this?

Hopp >> Yeah. So these are still relatively new. Um, you know, and one of the things that I have learned in discussing with applicants or grantees, actually, they've gotten got won these awards is they thought it was like other types of NIH funding where maybe they didn't quite exactly do exactly everything they said they were going to do. But we'll still we'll still make the next award and we'll just, you know, pivot a little bit. That's not what happens in these phased awards. So you really have to achieve exactly what you said you were going to achieve. Um, and for those reasons, I think it's very important for applicants for applying for these milestone driven projects to reach out to the program officer. Um, on that, you know, notice of funding, opportunity to really discuss their idea, make sure it's appropriate, and discuss, obviously the milestones, what would be appropriate milestones for whatever project it is that they're proposing. So as always, we encourage folks to reach out to their program colleagues, and we'd be happy to talk with you about your idea and how you can write those milestones to give yourself the best chance.

Kosub >> Here, here. Definitely want to second that. Reach out to your program staff about these. Well, Craig, I truly appreciate this opportunity to learn more about milestone driven projects. And, you know, pick your brain about this. You know, we definitely encourage those to reach out, ask questions. And, um, we appreciate you listening. This has been David Kosub with NIH is all about grants. Thank you.