Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.
Megan Columbus: Welcome to another addition of All About Grants. I’m your host Megan Columbus from the Division of Communications in the Office of Extramural Research. Today we are beginning a new series of topics focused on issues related to NIH review. In particular, today we’ll be discussing what happens after your application arrives at NIH, so topics related to application receipt and referral. We have with us today an expert in that field—Dr Suzanne Fisher, who’s the Director of Receipt and Referral at the Center of Scientific Review. Welcome.
Suzanne Fisher: Hi Megan. Glad to be here.
Megan: Suzanne can you tell us a little about your background and how you came into your position?
Suzanne: Okay. My scientific background is in biochemical genetics—did studies related to evolution of gene regulation in tumor viruses. I’ve been at NIH ever since I got out of grad school. I did two postdocs here in the cancer institute and child health. And then I switched to extramural. I was a Scientific Review Officer for a number of years, and then I came to receipt and referral in 1989. And since 1996, I’ve been the director of that part of NIH.
Megan: So the Division of Receipt and Referral at NIH is responsible for handling some, 80,000 applications, competing applications that come in to NIH. How large is the staff that you have to do that?
Suzanne: We like to think it’s a fairly small staff. We currently have seven full-time professional staff—people with PhDs or other advanced degrees—and then we have 20 referral officers who are Scientific Review Officers but work part-time for us. And we have a small staff that does some of the processing of the applications and two very hard working administrative staff who keep us all going.
Megan: So different people and systems at NIH check applications for their completeness and for their compliance with the submission policies and for responsiveness to the actual funding opportunity announcements from the time of submission to the time of award. One of things your office has responsibility for doing is ensuring that applications are received on time. Do you want to talk a little bit about that?
Suzanne: Right, that’s obviously very important to have a fair and level playing field for everyone who submits, so that is one of the things that we look at. I think I’ll talk mainly about electronic submission since that’s about 97, 98 percent of our applications, but similar things go on for the paper applications we get. And so we do look at when the application was received. We have our standing dates, such as the dates for R01s, regular research grants, or fellowships. And then we have NIH giving people a lot of special opportunities, a lot of special dates, one-time dates for requests for applications. So depending on what kind of application it is, it will have a certain due date. If it is received after that due date, then the first thing we look at is the cover letter to see what the reason for that is, to see if there is an explanation as to why it is late. And we will evaluate that.
Megan: So I know that NIH, on occasion, accepts late applications. Do you want to talk a little about when we might accept them?
Suzanne: Right, there are a number of reasons. One that we in each grant application cycle has its own weather-related, so whether its winter storms or hurricanes or something, NIH when there has been a major natural disaster somewhere in the country will often publish a notice in the NIH Guide saying that we realize because you had no power for five days that that will affect your application. And the standard policy is that applications will not be considered late if they are submitted no later than the number of days that the institution was closed. But of course, you have to write about it in the cover letter. That’s the only reason why we know that is why the application is coming late. NIH has a formal late application policy, which is published in the Guide and available on our website, and it sets windows of consideration and it talks about reasons why applications have been accepted to be late in the past. They generally involve traumatic events in the principal investigators life (it only applies to someone with the principal investigator role) illness, death in the family. So we also give an allowance to people who are reviewers, and there are other issues listed there. So it’s not an open-ended thing. It’s either one week or two weeks depending on when the due date is. NIH also has another opportunity, which I think is reasonable to discuss here but is not really the late application, and that is what we call continuous submission. And this is something that NIH has been doing over the last year and a half or so to, in a way, give consideration to people who are doing service to the NIH extramural process, particularly the review process. So people who are reviewers who sign up for a multi-year term or do a certain level of review in a set period of time get the opportunity to submit some of their applications, not all, but certain types, basically without any due date. And NIH agrees that we will review those applications within 120 days. So we call that continuous submission. We publish the lists of people again on the OER website, of people who are eligible to apply. And so those applications really are not late. We’ve told them they have no due date effectively for these R01, R21, or R34 applications. But again, it’s very important that if someone is using that opportunity that they mention it in the cover letter to explain to us why their application came in on a date that seems to be late but for them is actually okay as part of NIH policy. So every application may have a slightly different story, and so we look at it, we look at the cover letter, on occasion, if it’s not clear we may contact the PI or the institution to try and get more clarification.
Megan: So once you determine the application is indeed on time or has been granted an exception if they are one of the few that happen to be late, before you can go ahead and assign that application to an institute and to a review group, you need to check other things within that application. What other types of things do you check?
Suzanne: Right, we don’t check everything. Of course with electronic applications a lot of things have been checked by the validation process for us before. So it’s a lot easier with electronic applications. We look for things if the application is not in response to an RFA, but any other application, is requesting 500 thousand or more, and that starts at 500 thousand not 500 thousand and one. But 500 thousand or more direct costs in any year the applicant has to have the permission of one of the NIH institutes before we can assign that application. So we have to make sure that the appropriate documentation of that approval is there.
Megan: What happens if that approval is not there ahead of time?
Suzanne: If it’s not there ahead of time, we contact the PI and their institution and give them a very short period of time – a few days – to get that approval from the institute or center or the application is not assigned. We don’t let them reduce the budget after they’ve submitted it because we assume that the budget they submitted is for the science proposed to do. So that’s not an option. The reason for this is that if applicants are planning on a fairly big, expensive, involved application we really want them to contact the institutes in advance before they do all that work to make sure that one of the institutes is interested in supporting that. If no institute is interested in supporting such a large application, then we certainly don’t want people to go through the work of writing it and submitting it. So we are trying to do this to help the applicants, though if they get one of our emails they may not feel that way at the time. Another category of applications that we look at are rather small in budget, but important, which are conference grants. NIH as a policy that if you are submitting a conference grant you have to have approval from an institute or center in advance. And if you don’t do it we’ll give you just a couple days to try and get that approval or we won’t assign the application. Another thing we look at is the NIH policy that limits the number of resubmissions. And so we have to make sure that people are not submitting un-allowed second resubmissions, and we also have to make sure when they call it a new application that it really is new. That it’s not another resubmission that someone has tried to call new. So we will look at the application and previous ones to make sure it truly is a new, substantially changed in approach and aims application.
Megan: So Suzanne, I’m sure that our listeners are most interested in how applications get assigned, both to institutes and then to review groups.
Suzanne: Okay, one point I’d like to make is, though we do use some computer assistance in looking at applications and sometimes looking for duplicate applications and such, people are very much involved in this process. So the assignments both for review location and for the primary and multiple institutes for funding consideration are made by people. And it’s either one of the seven of us who are there full-time or one of the 20 referral officers. So again they are all people with PhDs or DVMs or advanced degrees, people who have had science research careers before they came to NIH, and they look at the application. Maybe I can anticipate one of your questions, which we get a lot. How much of the application do you look at before you make the assignment? And my somewhat flip answer is as much as we have to. But it really can vary. Let’s say it’s a program project, and it’s on cancer therapeutics. And it’s a program project, so it’s expensive. And there’s that piece of paper that says yes the National Cancer Institute will take this program project even though it requests over 500 thousand a year in direct costs. Well, we’re not going to look too much harder. It’s pretty clear that it would be assigned to the National Cancer Institute. We might look a little bit if it had a lot of focus on brain tumors, we might give a dual assignment to the Neurological Sciences and Stoke Institute, but that application would be pretty straightforward to assign. Others may be far more complicated and it may be an area, Alzheimer’s disease is a good example, an application on Alzheimer’s. Well, we have a National Institute of Mental Health. We have a National Institute of Aging. We have, as I said, the National Institute of Neurological Disorders and Stroke. We have the nursing institute. Some other applications, especially if it’s a regular research grant that all the institutes support, we’re going to have to go in much more deeply. We’ll look at the specific aims. We’ll look at the narrative—why they think this is important, what they are trying to do. And it may be more complicated. And that’s also why applications have to get a single primary assignment, but we can give as many dual or additional assignments as we think are appropriate to reflect the interests of the NIH institutes. At the end of WWII there were just a couple of NIH institutes and now there are 24 that make grant awards. So the pie has been cut in a lot of pieces.
Megan: So if an institute doesn’t agree with that assignment or if another institute sees that application and thinks that it should have come to then, what happens at that point?
Suzanne: Well there are a couple ways they can do it. Sometimes, and certain institutes like the ones involved in Alzheimer’s are kind of used to talking to one another, and so they may just discuss it among themselves and agree that we are going to switch this one from institute A to institute B. And then we have a simple way of their letting the Division of Receipt and Referral know about it. And we go into the database and make the change. Alternatively, the institutes can basically come back to us and say well I can see why you assigned it to us but for the following reasons we don’t think we’re a very good fit. Please look around and try and find another institute for it. That can really depend how easy or hard that is do on the activity codes. As I said, the R01, the most common research grant, all the institutes use. It’s fairly easy to make changes. Things like the exploratory developmental, the R21, or some of the career series maybe only two or three or five institutes use that particular activity. So then our field to choose from is very limited. So applicants have to be very careful. If they submit a career award that’s on breast cancer, but it’s a type of career award that the National Cancer Institute doesn’t participate in, we can’t make that assignment. So there are some assignments, especially for the more exotic if you will activities, that we cannot assign, and we have to inform the applicant and their institution that we cannot assign it. So applicants need to pay very careful attention to what kind of application they are writing and what institutes use that activity.
Megan: So clearly doing your homework and reading who is participating on that funding opportunity announcement is key.
Suzanne: Is very important. And all the funding announcements at the end have a list of contacts, so contacting that program director to say this is what I am thinking about do you think this a good match for the nursing institute or whatever. So institutes may have some limitations. They may say that their small grants, the R03s, are limited to people who have not gotten a grant from NIH before. They may have some other particular way that they are trying to target the use of that activity. So you really have to do your homework and make sure you are a fit for what you are applying for.
Megan: So then how does that translate into how you assign applications to review groups?
Suzanne: Well that gets a little more complicated, because NIH is a big place, especially since the 1950’s we’ve evolved to our current structure. And so we have agreements, in general, career awards and program projects are reviewed by the institute review groups, and then the Center for Scientific Review reviews things like the fellowships, and the research grants, and the small business applications, the more common activities. But each institute may have a slightly different agreement. So CSR reviews about three quarters of the applications that come in every year; the institutes review less. As someone who started out her extramural career in institute review, we always point out that the institutes tend to review the more expense ones. So if you did that calculation on dollars requested, it’s probably a little more closer to equal, because the program projects and centers cost a lot more money. Within CSR, which I think is what a lot of our listeners are interested in, where most of the applications are reviewed, each referral officer is responsible for assigning to one or more IRGs. And they make both the IRG, the integrated review group, assignment and the institute assignment. The integrated review group is a collection of study sections in a given area. So we have one on immunology and one on infectious diseases. We have several in the neuroscience areas, and so we make our first cut to that broad group. And then within the IRG, they decide which their study sections or other review committees it fits. And then just like the institutes, if they think it doesn’t fit, they can arrange a swap with another group or send it back and say I don’t think this one belongs to us can you find another place?
Megan: And if an applicant goes into the eRA Commons, and they see that assignment, and they don’t agree with that assignment, do they have any recourse?
Suzanne: They do. But maybe we can back up a little bit and say what they could do that might make it more likely for them to be happy with the assignment in the first place, and that’s my favorite friend the cover letter. So if applicants have a request for either a review assignment or an institute assignment, we ask them to put it in the cover letter. When they look at the instructions they’ll see have a particular format that we ask them to do to keep the institute request separate from the review and the positive from the negative. That again helps our computer system to help us mine, if you will, the cover letters and get that data out and into our system. And so they should make those requests there. Sometimes people call up and say, it’ll be the day before the due date and say, I don’t know what study section to suggest can you tell me? And I don’t think that’s a decision you should make quickly, but if you don’t have a particular one in mind, what’s also very helpful is just say what areas of science you think are important to understand your application. That will help the SRO in assigning reviewers. You say well to understand this application you really need to know about the chemistry of dyes that you use in imaging the brain and you need to know about brain imagining – I’m using kind of simple examples – but if they can give ideas, examples of topics that they feel are really critical to understanding their application that also helps us.
Megan: We’ll be having a future podcast that will go into the details of considerations for developing a cover letter that will get into this in a little more depth.
Suzanne: So maybe they wrote a cover letter, maybe they didn’t. Maybe we somehow missed it but now they are unhappy about the assignment. We will look into it assuming we are notified in time. They can contact the referral office. The easiest way, believe it or not so that anybody can grab it and work on it, is for them to fax in their request. If they could fax it to 301-480-1987. That way it’s not tied up in any particular mailbox. And we will try to negotiate the switch of the review or the institute assignment, and if we can’t, we will send them a letter back explaining we know they requested this but we were not able make the change.
Megan: Do you have any parting advice for how people can best help themselves through the process?
Suzanne: Well, I always like to say start early. And not only, start early by reading the instructions, reading the FOA, looking around at the FOAs available, making sure you’ve got that good match. Start early for submitting. Don’t expect that’s all going to go through the first time really well. Give yourself some time. And then very importantly keep track of your application. Don’t just hand it over to your university and abandon it. Go on eRA commons. you can really watch it as it goes through every step of the process. Make sure that you can see the image because until you see the image we don’t see the image of your application, for electronic submission. And if we don’t see it, we’re not going to work on it. Track that assignment. You know if you’re not happy with the assignment, if you let us know soon that’s fine. If you wait until two weeks before the review group is going to happen, there’s really nothing we can do at that late stage. So keep on top of it all the way.
Megan: And take control of the process.
Suzanne: Right. It’s your application. You’ve put a lot of hours and sweat and effort into it. Keep track of it all the way.
Megan: Thank you so much for joining us today. It’s been a pleasure.
Suzanne: Oh, I enjoyed it!
Megan: That wraps up today’s edition of All About Grants. For NIH and OER, I’m Megan Columbus.
Announcer: To read descriptions of review groups and view study section rosters, visit the Center for Scientific Review’s website at csr.nih.gov. That’s C-S-R dot N-I-H dot G-O-V. And to learn more about the grant application process, visit the Office of Extramural Research’s website at grants.nih.gov. Again that’s G-R-A-N-T-S dot N-I-H dot G-O-V.