Center for Global Mental Health Research Webinar Series: Submission and Peer Review of NIH Grant Applications

Transcript

ANNOUNCER: Hello and thank you for joining the 2022 Center for Global Mental Health Research Webinar Series: Submission and Peer Review of NIH Grant Applications. Before we begin we would like to review a few housekeeping items.

Participants have entered the meeting muted in listen-only mode and your cameras are disabled. If you require technical assistance, please use the Q&A Box to speak to the event production staff.

At any time during this webinar you can type your question to the presenters using the Q&A Box. Questions will be answered halfway through the presentation and at the end of the webinar. This webinar is being recorded and this recording will be made available in the coming weeks via the nimh.nih.gov website.

It is now my pleasure to turn the call over to Leonardo Cubillos. Please go ahead.

LEONARDO CUBILLOS: Thank you very much. Good morning everyone, and good evening. I am Leonardo Cubillos. I am the Director of the Center for Mental Health Research here at NIMH. I welcome you to today’s webinar on submissions and peer review of NIH grants.

This is the first of seven webinars in our NIMH 2022 Global Mental Health Webinar Services. The focus of this year’s webinar series is on writing, submitting and managing global mental health research grants to the National Institutes of Health.

During today’s webinar we will focus on four areas. First, we will focus on the preparation of grant applications for submission to the NIH, how those applications are processed and routed and then evaluated through the peer review process. We will discuss the importance of following both the SF424 application instructions and the instructions found in Section 4 of the Funding Opportunity Announcement. Third, we will cover best practices helpful tips to consider during the application preparation to improve your chances of success. And fourth and last, participants will also be directed to specific resources to guide them through the application process.

The second webinar series of this 2022 series is scheduled for May 13th at 9:00 a.m. The topic will be pre-award aspects of the grants management perspective.

We will archive these webinars so that you can view them later, and perhaps we will add additional points to your notes. You will see the web page on the screen at the end of the webinar today.

Today’s presenter is my colleague, Nick Gaiano. Nick is currently Chief of the NIMH’s Extramural Review Branch, a position he obtained in May of 2008. Prior to joining NIMH Nick was at the NIH Center for Scientific Review for six years, initially as a scientific review officer and later as a Review Branch Chief.

Nick obtained his PhD in developmental biology from MIT. He did his postdoctoral training at NYU Medical Center and then moved to a faculty position at Johns Hopkins University School of Medicine. There, his lab focused on the molecular regulation of cell fate determination during mammalian brain development.

In 2012, after 10 years of running a well-funded and productive research program at Johns Hopkins, Nick sought a career change and moved to NIH.

I want to thank you all for attending this webinar series. My gratitude to my NIMH colleagues who helped produced this first website and the entire webinar series and the Bizzell team for preparing also this webinar.

And finally to you, Nick, for taking the time to prepare and deliver this talk. Over to you.

NICK GAIANO: Thanks, Leo. It is a pleasure to be here and to give this first webinar in the series. As Leo told you, he gave a lot of details about my history, which is good, my name is Nick Gaiano. I am the Chief of the Extramural Review Branch.

Welcome. I am very excited to do this. I think this is a very important endeavor. NIMH is very focused on supporting global mental research, and individuals from other countries are faced with the added challenge of not being that familiar with the NIH process.

Investigators in this country see it all the time and their colleagues down the hall do it all the time, so there is a definite disadvantage to not being exposed to the process.

The process is not trivial. It is not like you can go read a quick one page of instructions and then sort of navigate the submission process and understand how it’s going to work and what sort of application content we’re looking for, not so much in terms of the science but really just even how the application is formulated.

So my purpose today is really just to help provide information -- this is in general for this series -- regarding the process of submission and some of the details associated with that, because we have seen sometimes the ways in which applications that come in from a foreign institution and international investigators can go wrong. And also to give you a little bit of insight, almost a mirror image on the inside of what the peer review process looks like so that you understand aspects of the submission process and then how those feed into what happens when your applications are evaluated.

Leo already gave you a look at the framework of the talk. I want to make a point, which is I am providing you with more content here than I am an absolute expert in, so while I am happy to field questions and very much want to do that, if there are questions that are posed that I don’t feel I can answer or I’m concerned about whether I know the answer definitively, we of course will document all of the content that happens today and we can hold onto those questions and incorporate addressing them in subsequent webinars.

Again, there are going to be six more of these, so the later ones will have the advantage of knowing what some of the more pressing questions may have been.

There is a little bit of redundancy in this but only because, again, if you’re talking about what is important for the submission process it is naturally going to relate to then what is important during the peer review part. Those are integrally connected.

First, I want to just give you a little bit of an overview of what the NIH structure looks like. This is not immediately obvious to anyone, frankly, unless you are told. The NIH is actually the National Institutes of Health, so there is actually an “s” at the end of the that in terms of the NIH at large. And the reason for that is that it is actually composed of 27 different components; 24 of those are what are called really institutes and centers that specifically support research in different areas. As you can see, they are all listed in the top grouping of 24. The Office of the Director is where the NIH Director sits and really oversees the whole process.

There are three additional components: the Clinical Center, which is basically a research hospital here; the Center for Information Technology which handles the IT issues for the institutes; and then the Center for Scientific Review, which is shown here. This is sort of highlighted as unique among these in that it is not a funding institute but it’s really where about 70 percent of peer review at the NIH occurs.

That is not where I am from. The Center for Scientific Review handles a lot of the incoming grant review. All applications initially go to the Center for Scientific Review, but then about 30 percent of them are shipped out to the different institute peer review branches. For example, I am the Chief of the Peer Review Branch at NIMH, and applications, in particular special groupings of applications where we have a particular focus or a very specific scientific interest, will come to my branch and we will review them. Of course I have highlighted NIMH since I am a fan.

Just a quick look at the NIH budget. It is quite large actually, which is great. The bulk of it goes to funding research project grants. These are things -- you may have heard the term R01, R21. Some also go to funding research centers which are large operations -- training, some contracts. About 10 percent is set aside to fund intramural research programs. So there is a fairly large amount of money to help support research in all the different areas of interest to NIH, and a component of that is meant to be used to fund foreign institutions.

The first part I want to talk about is the submission of NIH grant applications. It is actually a pretty complicated process in terms of what happens to the application, but basically, just to give you a quick look -- I don’t want to dwell on this slide but -- you have an idea, you write an application and that is then submitted by your institution. You can’t just put a grant application in the mail and send it to us. It has to be submitted through a grants administration office of some sort. They have different names at different institutions. These would typically be universities or other research organizations or foundations.

The institution will submit the application. It comes to us. Everything initially goes to the Center for Scientific Review. We have one area where they all go initially for some uniformity. Then it will be assigned to an NIH institute -- for example, we are at the National Institute of Mental Health. So that would be assigned programmatically to an institute where the science is identified as being relevant to that, which is distinct form questions about where the peer review will occur.

Then it will also end up in a scientific review group -- you may have heard the term study section. That scientific merit review may occur in CSR -- as I mentioned, about 60 percent does -- or in a specific institute, for example, in the NIMH Review Branch, where I work. Then those institutes and centers will take the peer review information and assess where a certain application fits in program priority.

Of course they will look at the score, how well the peer review process regarded the application. That content will then go to the Advisory Council of the institute and then funding recommendations will be made. The institute will make decisions, will actually award those applications and then you can begin your research.

This is really critical. If there is nothing else that you obtain from this webinar my hope is that you will understand that the place where many people end up having trouble in terms of what they end up submitting relates to the instructions. Now, “follow the instructions” sounds almost insulting in a way. Wouldn’t everybody follow the instructions? Yes. The problem is that the instructions are not simple, they are very complicated. Your best bet is to be hyper-diligent about looking at the instructions and reading everything carefully. If you have members of a research team they should all read them.

There are really two categories of instructions for the submission of any given grant application. The first is to start with what’s called the SF424 forms. Those are the main forms that would be used. That is the format.

There’s an application guide. This is a fairly large document and it covers the wide range of types of applications you might submit to the NIH, and this guide has content for all those different kinds of applications. This is really a critical document. You should print it out, you should put it on your nightstand. This is really a very important document. For any given application there are going to be massive amounts in here that don’t directly apply, but you really need to be sure that you are looking at this.

In addition, you are going to make an application for any given funding opportunity announcement. I have just taken a screenshot from one of ours, actually from the Center for Global Mental Health Research. This is one from that group. This is just a screenshot from the top. There is a lot of information in these Funding Opportunity Announcements and there are also instructions in these.

You need to look at both of these, the SF424 instructions and the Funding Opportunity Announcement instructions. The SF424 instructions provide the framework, but the FOA instructions provide any additional specifics. You can't just follow the instructions in the SF424. You have to understand those instructions and then follow the ones in the FOA.

Now, if you find that there are things in the FOA that don’t seem entirely consistent with the SF424, the FOA is always taking precedence. The FOA, if there’s something that doesn’t agree, it is not a mistake in the system; it just means the SF424 is more general for a wide variety of possibilities, but now the FOA is intentionally saying this aspect of things we want you to do this way, and that is where you should follow those directions.

As Leo briefly mentioned earlier, the instructions are in Section 4. When you look at one of these you will see a very nice kind of breakdown at the top and there are various sections including the overview eligibility issues. Section 4 is the instructions, Section 5 the review criteria, Section 7 is the agency contacts. That is where, for NIMH-specific opportunities like this, usually my name would be listed. Scientific contacts will be there. For example, Leo might be listed or one of the other members of the Center.

One thing that is I think also critical to be aware of if you’re applying from a foreign institution -- One point I want to make, by the way, I’m giving more sort of global information about just the general process. This is not meant to be specific to applying to the Center for Global Mental Health Research. This is meant to provide you information that will certainly be important for that, but also we want individuals from foreign institutions to feel that they can apply to the NIH more broadly, so I have really taken a more broad view of this.

Section 3 of the Funding Opportunity Announcement will include a component called eligible organizations. I have taken a screenshot from one such FOA. All FOAs have this particular section. You need to make sure that the FOA you are interested in accepts applications from foreign institutions.

I will say that in general the vast majority do. The NIH is not interested in creating restrictions in this regard, but on occasion there will be one where that is not the case, and you don’t want to find yourself in the unfortunate position of preparing an application only to discover that for some reason that FOA is not accepting from foreign institutions. So please make sure you double-check that. Again, it’s within the FOA.

It is also worth noting that panels are asked to comment on the justification. When foreign institutions are allowed to apply, panels are asked to comment on the justification for awarding a grant to a foreign institution. This does not contribute to scoring of the application. The science in your application will not be judged based on the fact that it is coming from a foreign institution; it will be judged as the quality of the application stands.

However, there is a requirement to justify funding foreign institutions later in the process, and so the panel will just provide some indication that they do feel that funding the foreign institution is justified. It is often good to indicate what is unique about what you might do, and there is a section of that in the application.

Obviously, if you are applying to a Funding Opportunity Announcement say from the Center for Global Mental Health Research, which is specifically for foreign institutions, the justification is kind of built in.

The key NIH staff involved in the extramural grant process are the scientific review officers -- and I will talk a little more about those later. These are the individuals that oversee the review process. There are, I believe, about 500 scientific review officers at the NIH.  About 240 are at the Center for Scientific Review and the remainder are distributed around the different institutes, for example, in my branch. We handle the scientific review process and we prepare the summary statements that document the review, and I will talk more about summary statements shortly.

In addition, a critical component for you in terms of your being able to engage with the NIH and ask questions about your application or the science in your applications are the program officers, sometimes called program directors. They are distributed throughout the institutes and centers. There are no program officers, for example, at the Center for Scientific Review, although there are review officers there, of course.

Program officers typically manage a portfolio of awarded grants or contracts, and they monitor the scientific progress of awarded grants and contracts. They also serve as a fundamental resource for you during the application process. If you were thinking about submitting to an FOA and you have some ideas for your project and you have maybe formulated the ideas ideally in a written document, you can reach out to a program officer. And you are really actively encouraged to do so if you are unsure about whether what you’re thinking of fits with the funding opportunity.

On the inside for awarded grants and contracts we also have what’s called a grants or contracts management specialist. These individuals are located within the institutes, and they handle all the mechanics of the funding process and they monitor progress -- really more the financial progress, whereas the program officers manage the scientific progress.

The submitting of an application -- this is something you really should receive help from your institution. Different institutions have different infrastructures in terms of readiness to handle this process. Again, that can be a challenge depending on where you are coming from and how much experience your institution has in submitting NIH grant applications.

There are main online portals for submitting an application. You would go to the site grants.gov and that is where you will find and apply for most federal grants. A fundamental component of this process is the ERA Commons. That stands for Electronic Research Administration, and the Commons is meant to be a sort of gathering spot. This is the electronic system where applications are received. This is the system through which you will receive your reviews. When your summary statement is completed it will be posted there and you will be able to access it. Any award information, if you have active grants, et cetera, you will find all of that in ERA Commons. That is really a critical part of your engaging in the process.

Institutes must register in both SAM, System for Award Management, and the ERA Commons. As an investigator, you are not going to be dealing with SAM, or I would anticipate not, but you will be dealing very actively with the Commons. Institutions register themselves in SAM and they would register themselves and also the principal investigators -- presumably many of you folks -- in the ERA Commons.

The electronic submission process would go through -- You must apply through a Funding Opportunity Announcement. You can’t just put an application together, look at the SF424 instructions, get a sense of what an R01 might look like and then, as I said, try and mail it in. If you are going to submit it electronically, which is what needs to be done, you need to do it through this system, and you need to have an active, open Funding Opportunity Announcement to do that.

We have what are called Parent Announcements, and I will give you a little bit of information about that. It doesn’t refer to being parents of children; it refers to being a more general announcement, that is, for a given type of application. There are also science-specific and NIH institute mission-specific FOAs on topics. You should visit the specific institute’s web page for information about current Funding Opportunity Announcements, or you can search more broadly at the NIH Guide, and there are links provided here. We will also be able to provide you with these links in a separate resource.

You would then download a specific application package with forms and instructions for that FOA. Make sure you download a fresh application package. By that I mean close to when you are actually constructing the application, as close as you can. On occasion, the NIH updates the forms. I think currently we are at what are called Forms F. At some point, I don’t exactly know when, they will come up with a Forms G. You don’t want to have downloaded Forms F and have the Forms G become the updated version.

If you have downloaded very early on -- and I am going to encourage you to begin the process quite early of formulating your application -- it could be quite a few months between when you download the application package and when you submit. So always be careful to make sure, as you are actually in the process towards the end of constructing the application content and submitting it, you want to make sure you get the most recent application package forms.

There are three main types of Funding Opportunity Announcements. There is what’s called a Parent Announcement, and I mentioned that a minute ago. Those are program announcements which are PA -- That’s what you will typically see in the funding announcement. It will be PA- and some numbers. PA by the way is not Parent Announcement; it stands for Program Announcement. Some Program Announcements are Parent Announcements. These are typically to support investigator-initiated applications. So if you have an idea and there’s no particular specific FOA you want to apply to and it is, say, for an R01, you can go find the NIH -- you can search Parent R01 in Google and it will pull up for you the Funding Opportunity Announcements that is the Parent R01. You are welcome to construct an R01 and simply submit it through that process and then it will be routed internally as is appropriate and reviewed where appropriate.

Parent Announcements use what are called standard receipt dates and these are built in and there is a resource on the internet regarding what those are. There are two other kinds. There are Parent Announcements with special receipt referral and/or review; those are called PARs, and the R can be either Receipt Referral and/or Review -- that is special in that case. These often have special receipt dates. They may or may not, but check the FOA, and they are often reviewed within the institutes or centers but they may also be reviewed by CSR. These may also have set-aside resources, so, funds that are dedicated to pay applications that come in to that PAR.

There are also requests for applications and I will talk more about those in a subsequent slide.

This is just an example of when I said Parent Announcements. Really the focus is that there are specific grant types that would then have -- so you can go find the Parent Announcement for an R01 or for an R13 if you want to apply for money to support a conference. I don’t want to dwell on this but just to make the point that this is what I mean when I say Parent Announcement. It is really a Parent Announcement focused on a type of application.

If you want to write an application for a certain kind of science, make sure that the institute that is most appropriate for that science accepts the type of Parent Announcement. For example, not all institutes and centers accept applications from the parent R21, so you really need to look carefully at the top of the FOA to see what the participating components of the NIH are.

Requests for applications in many cases would be applied to these and possibly PARs. These are often going to be -- The Center for Mental Global Health, at our institution, will put out RFAs specifically for members of the international community because there is clearly an interest in funding global mental health. In many cases, some of probably your most valuable opportunities, perhaps also your best opportunities, will come through things like RFAs, in particular ours, for example.

These typically solicit applications in a specific area of new or ongoing interests -- in our case, for example, global mental health research. They will address a well-defined area, so make sure that if you find an RFA from us and it’s from global mental health, it may not be in your area of scientific research, so make sure. That may sound obvious, but again, I think it is critical to keep in mind that these often have -- Leo and his group will publish multiple different funding opportunities typically in the form of RAs. Some of them will be more appropriate for your research than others.

RFAs will typically have a set-aside to support the awarded applications.

Applications for RFAs are going to be due on special receipt dates. If you are putting together an R01 for an RFA -- remember, R01s are the fundamental kind of research project grant unit at the NIH -- you can go look at the standard receipt dates at the NIH website and then think, well, I’m doing an R01; R01s are due on this date. But for RFAs in particular, actually for any FOA, check the receipt dates in that FOA. If it’s standard receipt dates it will just say standard receipt dates and it will link you to the table of standard receipt dates.

However, RFAs expressly cannot use standard receipt dates. That is an NIH practice, policy. If you are applying to an RFA don’t lose track of the fact that you need to make sure you know which receipt dates you are working with.

There are often special eligibility requirements and review criteria for RFAs, so, things that reviewers will specifically be asked to look at. And there can be special application format and/or submission instructions. Again, you’re looking at the SF424 but look very carefully at the FOA. It is critical to read the FOA as carefully as possible and to have all the RFA-specific information. I know I keep saying that but it is really critical.

The electronic submission through grants.gov will go through the SF424-based forms, but again, you will download forms that are specific. Any given FOA will have a way for you to access those forms.

Grant applications are submitted electronically. You will use a workspace through grants.gov. You will have access to these webinars so all of this content will be available. You would use PDF attachments for the content. There will be multiple different attachments that will be put into the system.

We have the Application Guide listed here. Once again, I am being repetitive, but it is imperative that you carefully follow the SF424 and FOA instructions.

Just quickly, the format for a research project grant -- really, I am just talking here in terms of R01, R21, R03. Those are the most common. You can look into the details and if you have additional questions you can always reach out to me or others with those kinds of questions about format.

The Specific Aims page is one of the fundamental components of any given grant application. It states the overall objectives. It is one page. It will provide a list and overview information about the specific aims, so you will set the background up on maybe the top half of that page or something and then you will have several different sections, little sections where you say this is the specific objective, a very specific one, and then maybe a few sentences just to give an overview. You will also on that page want to make it clear why this is important research, what impact will it have.

The research strategy is really where the meat and potatoes, so to speak, of the application are going to be present. There are different links for different types of applications. Here are some examples for these types but there are other types you may apply for.

There are really five elements that are critical to address in the body of the research strategy: significance, innovation, investigator, approach and environment. These are actually what are called the five core review criteria. When reviewers are asked to look at applications and evaluate them they will, in the critique template, typically be given sections to address each of these points.

I will say typically there is no reason -- and it is actually probably not helpful -- for you to break the application down -- In the research strategy you don’t need to put it this way. And really, information about the investigators won’t necessarily be found in the research strategy, so what I said was a little bit over-simplified. But nonetheless, these are elements when you’re putting your application together that you want to think very carefully about.

The research strategy will typically focus primarily on the significance, innovation and approach, and aspects of investigator and environment will often be addressed in other parts of the application.

Preliminary studies can be very important. They really make the case that you can do the research that you are proposing and that there is a firm grounding for that work, and there is reason to think that it’s worth pursuing, which is a different issue than whether or not you can do it.

There are other elements in these applications. I don’t want to dwell on this. I want to get questions relatively soon for this first section.

You need to describe the facilities so the reviewers can understand that you can actually -- that you have what you need to do the work. You can’t just be doing the research out of your house. So there needs to be some evidence that you have -- If you need specific kinds of clinical facilities or specific types of research facilities, you need to help the reviewers understand that you have those.

You will also submit bio sketches. These are customized for each application. Customized typically relates to you will do a personal statement which gives some background about yourself but also as it directly relates to the project, and you may have slightly different versions of that depending upon the project that you’re applying for. Then you would describe your most significant contributions to science, and what you need to do with that is also include any relevant publications. Typically those would be your own publications. That is what’s expected there.

Budgets can be challenging to put together. Hopefully you can get some help from your institution. If not, you should read the instructions carefully, think about what you need for your project. There are really two types of budgets that the NIH accepts. One is what’s called a modular project where you would -- the modules are $25,000, or you can submit a very highly detailed or itemized budget.

Not all FOAs accept modular budgets or detailed budgets. For example, R21s do not accept detailed budgets. R21s can only be modular budgets, so make sure you look carefully when you’re thinking about the budget.

There would also be information about vertebrate animals that you need to include. And appendix or appendices -- be careful to make sure. The NIH used to be more lenient with what could be included in appendices. That has gotten greatly reduced, so make sure that you are reading the instructions to make sure that you are only providing permitted appendices.

You will also provide a lot of information if you are doing human subjects research and in particular clinical trials. You need to provide information about the basic study, about the population characteristics, any scientific protocols and any other clinical trial-related attachments. For example, if you have a survey form, you can typically include as an appendix a blank survey form so the reviewers can see what you are planning.

You need to be careful, though, not to duplicate information, and don’t put a whole bunch of extra research strategy information in the human subjects section because that can be deemed a problem from our side of things in terms of compliance.

I want to also make the point that you can do what’s called a Multiple Principal Investigators Application where there is not just one principal investigator but if you feel like there are two of you who are really fundamental to this project you can both be listed as principal investigators. This can also involve principal investigators from different institutions. You can do from two international institutions; you can have one from a domestic and an international institution depending upon what the FOA allows.

This is a slide I showed you earlier. Principal investigators prepare the application. The institutions submit them. You may view the application in the system after you have submitted it. You absolutely need to check and make sure that it is what it should be. If there are problems with the way it was submitted you should be able to see those, and if you have given yourself sufficient time you should be able to correct those.

There is typically a two-day window of correction that is permitted. What that means is there will be a two-day window in grants.gov when a submitted application, before it really gets transmitted fully to the NIH and starts to get processed, it sort of sits, and that is a window where you can look and make sure everything is okay. If there is a problem, that is when you would be able to address it.

Now, there’s a critical thing to keep in mind here, however. The two-day correction window does not go past the deadline. So, if corrections are needed, including to correct any mistakes that you may have made in the application, you must submit the corrected application by the receipt date. So we very strongly encourage people to submit a day or two before the receipt date so you can see if there are any issues when you go and check the materials in grants.gov and you see what has been uploaded.

Sometimes it is possible that a figure could have been corrupted or something. You want to make sure everything is good. But you need to do that before the receipt date so you have an opportunity to make corrections such that those corrections will be in by the receipt date. The other version that had the problems will then ultimately be removed from the system.

I think now we can dedicate about 10 minutes to questions.

LEONARDO CUBILLOS: Thank you, Nick. I have a few written questions. One is whether these slides will be available. The answer to that is yes. The recording will be made public, the video recording, so you will see the slides through the video recording and Nick’s explanation of the content of each of those slides.

The next question is from Ana Luiza Zaninotto. Can I submit a K-award through the Center for Global Mental Health at NIMH?

NICK GAIANO: That is almost a question for Leo. You can if the Center for Global Mental Health Research, NIMH solicits those. If there is an RFA or some other FOA that is published, then of course we would be soliciting those.

However, if you just submit a K, say, through the Parent Announcement, that I think would typically not be routed to Leo’s center. He can comment further, but my guess is that if and when the center want (inaudible) they will specifically solicit those.

LEONARDO CUBILLOS: I would add just a tiny bit. A K award is part of what we consider a training grant. As part of these 2022 webinar series we will have four dedicated webinars for training grants, including the K43s, which are very important grants for international audiences. Luisa, my short answer is yes, it can, but stay tuned for more details as the new webinars come. They will occur over a few months.

A second question is from Ana Lucia Espinosa. She asks: initially could you have a collaboration between a US and a foreign institution, co-PIs in the US and non-US? Then she elaborates: I would like clarification as to who is considered the primary institution of a study when applying for a grant. Specifically for determining eligibility of foreign institutions to apply, who counts as the primary institution if we have two Co-PIs, one from a US institution and one from a non-US institution? Would that setup be considered a foreign institution application?

NICK GAIANO: That is a good question. That really ultimately is entirely determined by the investigators putting the application together. If the FOA accepts applications from foreign institutions -- which as I indicated the vast majority do, and obviously the ones from our center will, for the most part -- you can choose to have -- There is actually an interesting aspect to this process that I didn’t really spell out in the context of what I was saying.

The investigators put the applications together, but the applicant is actually submitted by the institution. It has to go through the institution. And a term that is often used is “applicant institution.” So technically, the applicant is the institution. Obviously, there always has to be a principal investigator. There are the people that are actually proposing the project, et cetera.

But if you are going to submit an application with collaborators, say, in the US and you are at a foreign institution, you can determine between the two of you which institution you want to primarily submit the application. If you want the US institution to submit the application, you would then most likely be what is called a subcontract on that application. So their institution would be the applicant institution, the resources would come directly to that institution, and then that institution would pay the resources out to a subcontract, say at your institution, to fund the research. That would be built in. There is no question you would get the money but it would just come that way.

However, you can do the exact other kind. You can have your institution be the primary applicant institution. Your institution would get the money, and if foreign institutions are allowed to apply, that is absolutely an option and then you can subcontract to the US institution.

Typically when that is the case, especially if you have a Multiple Principal Investigator application, which might be the case if you are collaborating with two different institutions, whether they are both in the same country or not, that doesn’t have to be an MPI application. But say it were. You would typically list one of the two as the contact PI. For example, the contact PI would most often be at the institution -- I think has to be at the institution -- that is the applicant institution.

I guess that’s a long way of saying it is really up to you, and ultimately, you are not required -- If you are collaborating with a United States institution, you are not required to submit through them. They can just join you in your submission.

LEONARDO CUBILLOS: I am going to bundle two questions that I find similar. One is from Haneefa Saleem and the other one is from Suur Ayangeakaa, and I should apologize if I am butchering people’s names.

It’s about preliminary status or preliminary data. How important is preliminary data for R34 applications, and are preliminary studies required for applications, or highly recommended but not required?

NICK GAIANO: That is a good question. I would say, for the most part, preliminary studies can be quite important. They really ground what you are proposing in reality in a way for the review panel. They provide evidence that you are producing data in this area that you’re proposing, that you have a kind of foundation for the research you are proposing.

There’s a term in the review process that often comes up and that is, the “scientific premise.” Actually I think that term was recently changed because it resulted in some confusion. It is the “rigor of prior research” that I think that is now being referred to. If you are going to propose research, what the reviewers would like to see is that it seems like a good idea, it is based on either believable published data or, I should say, believable published data and ideally some preliminary studies you include in your application.

If you are proposing certain research and you’re saying we are going to do thus and such to sort of advance an idea, it is often good to have content that supports why advancing that idea makes sense.

I will say this, however. A common mistake -- and this is true for investigators from every country including the US. Preliminary data should be reasonably compelling, so don’t throw in an experiment that isn’t particularly convincing because you actually can hurt yourself in that respect. Not only does it not provide compelling support for what you are contending, but it also can frame you as an investigator poorly.

We have all done experiments. We all know that sometimes the experiment doesn’t come out as convincing as it might or there are not enough points in the data or whatever. Don’t start putting that into the grant application because you feel like you should put in something. Preliminary studies usually means, or should mean, preliminary but solid studies, not that you did the experiment and maybe it kind of worked or kind of didn’t but here’s an example.

There are some kinds of grant applications that don’t -- actually, technically, no application. You don’t have to put preliminary data in any application, really, but it is usually advised. I will say there are some kinds of applications, the most common that is referred to is an R21, where reviewers are told that if an R21 doesn’t have preliminary data they should not judge it more harshly as a result. If preliminary data is included they are welcome to evaluate it and will evaluate it.

 But I want to make a point. For an R21, if you include preliminary data even though it is not really required, and in fact the review panel shouldn’t judge you if you don’t, but if you choose to include it, it needs to be solid. So don’t take the R21s may not have preliminary data as an indication that you can put kind of dubious preliminary data in.

R34s generally do have a fair bit of preliminary data. Ultimately,8 I think preliminary data is going to be a pretty component of any given application, so I strongly encourage you to do the best you can to collect strong preliminary data and to include it, and also to be very clear about it in the application and how it relates to what you are proposing.

LEONARDO CUBILLOS: Nick, we have two more minutes of the time we initially allocated for questions. Can I expand my approved and funded research project globally through a supplement process?  This is a question from Basheer Rahmoun.

NICK GAIANO: That is a good question. I believe you can. There are two ways that supplements can be funded. There are what are called administrative supplements, in which case -- and you could ask if you could have one of those or there might be information made available by an institute that they have some additional resources that they want to provide some additional supplements if awardees need some extra resources.

For example, when I was an investigator, there was such an opportunity and we had spent more money than we expected in a particular aspect of our project, although there was a good reason for it. So I communicated with my program officer and I said, look, this is how much we were awarded but we could use additional resources to cover the fact that we had to pay more for this than expected, and they were able to give me some additional money.

Administrative supplements, though, would not typically change the scope of the project. They would just be to facilitate moving forward with the project that has already been proposed.

However, you can also submit what are called competitive supplements. They are also sometimes called revisions, which is a little bit deceiving. It’s really just saying you have the main project, you are revising by adding some other things. So you’re adding an extra component to it and you’re requesting funds for that.

Competitive supplements or competitive revisions would normally come in through the standard submission process but they will be submitted as competitive revisions and they will be given a grant number, which is the same as the main grant, and then they will be reviewed in that context. So that is a possibility, but it needs to be permitted. Typically it is permitted, and if it isn’t, that would be indicated.

For example, if you look at the FOA where it says types of awards allowed, they all say new. They almost all say new. You would expect that. But they may say re-submission. That is if it didn’t get funded the first time and you want to submit again. Renewal. And if it says revision, that means it accepts supplemental applications.

LEONARDO CUBILLOS: Thank you, Nick. I think the 10 minutes are up.

NICK GAIANO: Okay. This part of the process doesn’t really relate directly to anything you can do because this is what happens when your application gets to us. However, I think the more you understand about this side of the process the more it will help you think about what you are preparing to put through this part of the process, so this is just to give you some insight into what happens when your grant gets to us.

The grant application evaluation process really has two levels of review. The first level of review -- this is really the part that my branch handles, say, for NIMH in particular. This is where scientific review groups, panels that are convened by our scientific review officers -- you have often heard the term “study section.” These are the groups that look at these applications, they do the scientific merit review, they score the applications and recommend appropriate budgets and durations of awards.

These panels do not make funding decisions. They, of course, provide information that feeds into funding decisions. Funding decisions are driven by multiple elements, but a huge central element relates to the scientific merit of the application. They provide direct information that plays a role.

But, for example, study sections are specifically told don’t talk about whether something should be funded or not. That is a very explicit instruction. They are not meant to make those kinds of assessments.

We have sometimes heard in that context -- because sometimes people will say things they forget they are not supposed to, or they’ll say we really need to fund this kind of research. Well, that is not really what they are meant to be determining. They are meant to be determining whether this particular application is high quality or not. We need to fund this type of research is a decision that will be made subsequently once the quality has been assessed. Now, that occurs at the second level of review where those kinds of decisions are made.

Each of the different NIH institutes has what’s called an advisory council. NIMH has an advisory council that meets three times a year. It is made up of many prominent members of the community. The NIMH Advisory Council has members that cover the full range of types of research NIMH is interested in. They will consider the reviews produced by the study section and they will consider funding recommendations and they will then also participate in making those recommendations. This is part of what goes on in an advisory council. But it also involves the program staff, involves the institute director.

The program priorities will be evaluated. Sometimes you may have applications that don't score quite as well as some others but still get a reasonably good score, and the decision maybe we want to support this particular project because it fills a gap in our portfolio, or, we want to advance this area. So that is where the issue of program priorities can come in.

Unfortunately, it can sometimes be the case that an application arrives that scores well in review but, for some reason, it is judged not to be of high program priority, and that may be because the institute is already funding 10 projects in that area. That does not happen often, so I don’t want anybody to worry about that. It can happen. It is very unfortunate when it does, and I just want to mention it as something that relates to the fact that program priorities will sometimes play a role. Fortunately, something with a good score not getting funded is quite uncommon.

What happens in a study section meeting? The SRO is the designated federal official. That is just another term used for the scientific review officer. That is the person who oversees the meeting, and in fact, nothing about the evaluation of your application can occur as a collaborative endeavor with -- so reviewers, of course, get your application. They sit in their offices and evaluate them before a review meeting occurs. They have to spend a lot of time reading the application, trying to understand what you’re proposing, thinking carefully about it, making decisions about the quality of all the elements of that application. That they do on their own.

But there can be no communication between reviewers about an application that occurs outside of the review meeting in the presence of the SRO. What's important to understand about that is there are no sideline discussions. If something about the review of your application is occurring that is going to impact the outcome, the SRO is aware of it, and that’s what it means to be the designated federal official. If during a review meeting the SRO has to run to the bathroom, the meeting has to be put on break. The meeting cannot continue until the SRO returns.

I wanted to point that out because it is important to know that there is a federal official, SRO, in our system that is aware of every aspect of any deliberations between panel members, and that I think is just meant to provide confidence that the process is regulated.

The SRO orients the review panel regarding what constitutes conflict-of-interest. Conflicts-of-interest are a critical issue. If you have a member of the community who you have evidence that you have had problems with, that there is some significant difficulty for some reason -- you can’t typically just say this person doesn’t like me. Actually, if you have a close collaborator in the community and they are not on this application you’re submitting but we have brought them into the peer review panel, that person cannot participate in the review of your application because they are considered to have a conflict-of-interest whereby they might be positively inclined towards your application.

So it is very important that we identify individuals that may have positive or negative potential conflicts-of-interest. I would say the vast majority of conflicts-of-interest relate to positive issues, people that are collaborators, former mentors, people that you co-published with, those kinds of things.

Confidentiality is also a fundamental part of what panels are instructed to respect. You don’t want to be submitting your application and have that shared with the community or have them jot down all your ideas and then talk to their colleagues down the hall about these great ideas that you have. So reviewers are really told quite emphatically that everything about the review process is confidential.

Do not contact reviewers. If you go into the ERA Commons for a given application, usually within about 30 days of the meeting you will have access to the roster of panel members. Do not reach out to them. That is considered a breach of confidentiality. That may sound insulting, of course, but I don’t think it is immediately obvious. You might think, well, here’s the group that’s going to review my application. There’s something that I think I didn’t make clear enough; maybe I’ll reach out and let them know just for clarification purposes.

In many ways, if you thought about it in a parallel universe, that might seem like a reasonable thing to do. But this system does not permit that. Once your application is in, you are really ultimately not meant to change -- you are not supposed to interact with the panel members. If you do reach out to a panel member they are supposed to tell you that that is inappropriate and they are not going to give you any input. I will say, though, that they will also let me know, or the SRO says if anybody reaches out to you about any applications please let us know.

The SRO also ensures that proper policies, process is followed, that the review criteria are adhered to. The SRO also, by the way, oversees the meeting when it occurs in person. I already indicated that.

The Study Section or Review Panel composition -- those are really the same thing. Panel size will vary depending upon the number of applications in the pool. If, for a given RFA, we received 30 applications, that is going to require a larger panel than if we only receive five applications.

The responses to RFAs can vary pretty widely. It is not common that we only get one, but we can get three, four, five in some cases. More typically we would get 10, 15, but it could be 20, 30, 40. Depends on how accessible the research area is. If it is a very focused research area there may be a limited number of people in the community that are well suited to write a proposal that’s competitive in that area. The panel size, as you can imagine, will depend on the number of applications.

The researchers are typically active research investigators. They are typically going to be academic, so, from academic institutions. However, they can also come from foundations, from companies, from research centers, so we are not limited. But we do need to have a sense that the person we are recruiting is qualified and is appropriate. I wouldn’t recruit my neighbor, for example, to participate in peer review unless they were a researcher at a local institution. But you get the idea.

Typically what will happen is we will get people with a range of expertise that is relevant to the content of the applications. For an RFA, usually it will cover an area of science but the applications will range in content. We are not just going to get a bunch of the same applications. Within the bounds of what is defined as the area of interest for that RFA, we will get a range of different scientific content in those applications, and that will require a range of expertise among the panel members. And so the application pool not only determines the size of the panel but sort of implicitly connected to that is also determining the range of expertise needed.

Scientific review groups, or study sections, review panels at the IAH can either be what are called standing study sections with defined members, so there are people who are members, they have a specific term of membership. It can be typically four years they will stand on that study section. The bulk of standing study sections are at the Center for Scientific Review; however, institutes will also have some of their own.

If you submit an application to a Parent Announcement, that is almost certainly going to go to a standing study section at the Center for Scientific Review. Most of what you would likely submit to it, at least in the context of the Center for Global Mental Health Research, those are going to come to us to review at NIMH and we are going to review them in what are called special emphasis panels. Although we have one and we are actually creating a second standing panel, those have very specific purposes within our institute.

For FOAs that are put together by Center for Global Mental Health Research, those are expressly designed and we will take those applications in. And when we construct the special emphasis panel, it has all the same properties of a study section, but it has no defined members, so we start from scratch. We get 10 applications, we look at those applications and then we start identifying people in the community who we believe would be appropriate to review those applications. So it starts from scratch.

There are I think advantages to this. If you have a specialized area that applications are being solicited to, you do need to construct a special panel, and that is what we do.

The peer review process. The SRO assigns at least three reviewers per application. The reviewers get four to six weeks to look at the applications. They are very busy so they need some time to schedule these. How many applications a given reviewer gets can vary. Reviewers will submit preliminary critiques and scores before the meeting and then the meeting will occur. It is typically one to two days. Most of our meetings are one day, depending on the number of applications and how many are discussed, and will typically will go on for three, four, five, six hours.

I don’t want to dwell on this. You will have access to all of these slides. For most research project grants that you are likely to submit, there are five core criteria that reviewers will look at. I mentioned these earlier in the presentation. These are the kinds of questions that reviewers are asked to consider. In the context of significance, it’s things like, does the project address an important problem or critical barrier.

Under investigators, it would be are they well suited to the project. Is the project innovative? These are questions that reviewers will be given to think about.

The other two of the core criteria are approach, which is really a central part of the application. Ultimately you can be spectacular investigators, have a fantastic environment and resources, but if the approach is not sound your application is extremely unlikely to do well. That is really a critical lynchpin. And, of course, the environment just helps make the case that you have a supportive environment and you have the resources needed, so you definitely want to make that case.

There are other review considerations that go into evaluating applications, and these will actually factor into the score of an application, as will these prior five core criteria. These are really fundamental to the score.

Also there is going to be consideration of, if you have human subjects are they adequately protected from any mistreatment or adverse events. A data and safety monitoring plan. These are elements, again. Vertebrate animal protections. There may be FOA-specific review criteria. For example, I mentioned earlier PARs and RFAs, and those do have specific review criteria. RFAs do and PARs often do.

Reviewers will be asked specific questions about the science in these applications, which is crafted after the fact that the RFAs and PARs are often in particular focal areas of research. And here are some additional elements that may be considered by the panel.

So, what is the output? There is what’s called an overall impact assessment and a priority score. The overall impact assessment, each reviewer provides an overall impact paragraph at the top of their critique. This is where they are asked to determine what is the likelihood that this project will exert a sustained powerful influence on the research fields involved. Typically, that paragraph sums up their assessment and they indicate what were the most important aspects of the application that drove that determination.

If they give it a weak score and they are concerned about whether it will have a powerful influence, there may have been 50 percent of the application was fantastic but 50 percent was a real problem, and that will often be what they would indicate. They may indicate the fantastic part but they may also then say, however, because of these elements I gave this a weak score. That would be what was considered score-driving.

They will be asked in their critique to indicate core criteria, the five that I indicated, and other review criteria. That content will be in the critique.

The priority score is not just an average. Each of the five core criteria that I mentioned will be given a score. Again, this is all in the context of sort of standard research project grants. Each of these will be given a score. For other types of applications -- Ks came up earlier, for example. There are five core criteria for Ks but they are actually a little bit different because Ks are a different type of application. They would be things more like the candidate would be one of these five as opposed to, say, the investigator. There might be a mentor if it’s a mentor K. These are given five scores, one through nine.

However, panels also give the application what ultimately kind of feeds from those five core criteria scores but is the more overarching score, which is what’s called an overall impact score. After the discussion of an application, the assigned reviewers will indicate this application is in a range of one to nine; one is the best score, nine is the worst score.

Each of the panel members in the room will put into the system, into the ERA Commons where they are monitoring the review process, their score. There are 30 panel members and they will all vote something one to nine, and that number will be averaged and multiplied by 10. That will then give the priority score which you will find in the ERA Commons when your application’s review is completed.

Ten is the best score. If you get a ten I’m guessing you can crack open some champagne. Tens are very uncommon. Typically you don’t get scores much past 50 or 60, because, as I mentioned earlier, the weakest applications are typically not discussed and they actually don’t get a score. They just document that it was not discussed. What you will get as the outcome is you will get a priority score.

Some types of applications are what are called percentile, which gives a sense of where they rank in the grouping. Anything that we review in-house does not get a percentile. For RFAs that the Center for Global Mental Health Research might put out there will be no percentile, so you will just get the priority score. And you will also get what’s called a summary statement which will include the priority score. This is prepared by the SRO. This is really the official document that encapsulates what happened in the review. As I said, there can be percentiles for applications that went to the Center for Scientific Review, often if they go to standing panels, but you will not typically get a percentile from us; you will just get the priority score.

There will be information about whether the human subjects protections and inclusion plans are acceptable. If an application is discussed, there will be what’s called a resumé and summary of discussion. The resumé is really just kind of a short condensation of what occurred. This will typically give you insight into what the panel discussed most significantly in the context of the discussion.

You will also get the critiques of the reviewers. That will include their core criteria scores, the five scores they gave those five core criteria, and their critique content. So the content that they have written down that fed into the review meeting you will be provided. You will get that whether or not your application was discussed at the meeting. For weaker applications that were not discussed there won’t be a resumé and summary of discussion because there was no discussion, but you will get this content so you see what the reviewers thought, which can be critical for you to move forward.

There will also be any budget recommendations, and you will see the roster of reviewers. You can obtain this content through the ERA Commons. The summary statement will then be used by the program staff and the advisory council. The summary statement of a review would be the fundamental document you would work with your program officer with respect to if you needed to understand how to interpret the review or to think about a re-submission.

So what determines if an application is awarded? Priority score is really a fundamental part of the process. Each of the institutes at the NIH has its own parameters regarding where they would draw a line as far as a priority score that is within a range that they would most likely look to fund.

I will say, though, when it comes to things like RFAs and maybe in cases of, say, the Center for Global Mental Health Research, typically there is more flexibility. Now, there is a limited amount of resources typically for a given RFA; they can’t just fund everything. But they are not necessarily held to the institute’s expectation regarding we’re going to fund, say, the top something percent most likely and then we can think about some in the next area.

When I say that, some institutes have what’s called a pay line. That would be if an institute said we’re going to fund everything in the top 10 percent or everything with a certain priority above something and then we’ll consider stuff perhaps in the next grouping. The pay lines can vary also depending upon the type of grant applications.

As I indicated, for many of the kinds of things you may apply to, pay lines may or may not be relevant. I am guessing they won’t be if you apply, say, to our center, but available resources and higher number of applications compared will of course be important.

Programmatic considerations include the balance of what the center wants to support and in situ priorities, and, as I indicated, also funds for competing grant applications will be limited typically. Typically the most competitive applications will be supported.

We have a few minutes for tips for preparing to write a grant application. I think it is critical that you start as early as possible. You cannot start working on a grant application before the FOA is published because in principle you shouldn’t know that it exists. Applicants are not made aware or they are not supposed to be made aware, because the risk we run is that some are made aware and some are not and then some people have an advantage. The system is very appropriately preoccupied with fairness.

But we are trying to publish FOAs to give a lot of lead time between the publication date and the due date. Technically it has to be at least 60 days or two months, but we have concluded that that is not nearly enough time, and so I think as an institute we are trying to go for a minimum of three months, more typically more. But as soon as it is published you need to start thinking carefully about it and be cautious not to think, well, I’ve got months, and then a month goes by and you think you still have months. Construction of a strong application really starts with giving yourself enough time.

Important elements also are to critically asses your ability to develop a strong application. You may have some ideas that you have been toying with but you may or may not be the ideal person suited to handle that research. You should think carefully about that. Do you really have what is in place to put together a strong application? It is not necessarily about you, but do you have the elements needed to put together an application where you can make a case that you can do this research.

I strongly encourage you to contact the program officer to talk about your ideas. That is part of their job, to work with applicants. There is a scientific research contact listed in Section 7 of any given FOA. That is the person you would want to contact. Typically there is also the peer review contact. That is often me for ours. I can’t help you with the science in your application, that is not my role.

If you can, find examples of NIH applications or awards to learn from. I cannot stress this enough. You may not all be able to find that, so I don’t want to make it sound like that is one of the benefits of being, say, in the US where the NIH operates largely and you can walk down the hall and ask your colleague. You may or may not be able to do that. But if you can, if you have friends, colleagues who are willing to share an application that they submitted, ideally one that has been reasonably successful, had a decent score or maybe even was funded, it’s good for you to look at that and just get some sense of what was successful in the system on some level.

You can also look in the NIH RePORTER. That is a system that documents all of the NIH’s funded grants, and it is valuable to look at and see what kinds of projects in your research area have been funded. That won’t have the applications but it will have the abstracts, so it will have a fair bit of content about what the project’s framework is, and I think that can be quite useful.

Finally, consider the process from the reviewer’s perspective. I think what is lost track of is that the reviewers are people. You don’t want to annoy reviewers, I guess is what I’m trying to say. Reviewers are very busy, they are over-committed, they are recruited to apply a critical eye towards applications. They are not recruited to like everything necessarily. If everything is great they can like everything, but generally they are going to see what they like but they are also asked to think critically.

They are knowledgeable about the work but they may not really know much about you as an applicant so they may not be able to judge -- and we are not asking them to judge -- do you think, sure, they can get that done so I don’t have to worry about how they presented their research project. So you want to make sure that you crossed all your Ts, dotted all your Is and have provided them with all the information they need.

Happier reviewers are more likely to be positive. A happy reviewer is not going to be happy enough to overcome a bad application in terms of the science, so prepare a well-organized, clearly written application. I cannot stress this enough. More does not mean better, so don’t try and use the minimum allowable thought -- and you will find some details about that in the SF424, how many lines per inch, those kinds of things. Don’t try and cram the research strategy. Use flow charts, diagrams, very clear figures. These can all make a huge difference in helping the reviewer understand.

Use readable legends. We have seen figures come in where, in the interest of cramming, the figure legend is made minuscule, or the figures are made too small. Reviewers do not like not being able to see the figures.

Finally, avoid mistakes that may reflect poorly on the research team. Not following the instructions -- that can result in a compliance issue which can have your application withdrawn, but if it does not, you can still have issues where you haven’t really followed what’s expected regarding the general format, et cetera.

Don’t put information in the wrong sections. You don’t want to omit and mislabel figures. We saw that recently with one application. Figure 2 was completely missing.

And please be careful about spelling, grammar, math errors, typos. You would be surprised. Applications come in and they can be riddled with typos. That really sets the panel off in the wrong direction. Some typos are almost inevitable in these large documents and panels understand that, but cut and pasters -- that is why preparing your application early, letting it sit, having colleagues read it is really fundamental.

That is where I want to stop. I have a little less time for questions now than I wanted, but we do have some.

LEONARDO CUBILLOS: Nick from Kwabena Kusi. Once an application has been submitted and the initial scientific review has been done, is there ever an opportunity for rebuttals/clarification of flagged issues before a final decision is made on an application?

NICK GAIANO: Well, formally speaking, there would not be. You couldn’t provide the SRO with feedback that would go to the review panel for clarification, for example. Once the review is completed, that is sealed.

However, depending on the nature of the criticisms and whether a little bit of clarity could help, it is often the case that applicants can interact with the program officer. Program officers will often receive a statement from applicants that says, okay -- although I typically say it should be solicited from the program officer. I don’t know as much about whether Leo’s group will do that, but I do know that that is a broad practice at the institute and I am imaging Leo’s group would.

If there is something you look at in the review and think, ah, they did criticize this because we didn’t make it clear we could do it and they weren’t sure we could do it, but we can clarify with the program staff that we can do it -- that clarification should usually be compelling, not just telling them we can do it.

If the deficiencies are major, though -- usually it is unlikely that anything is going to just have programs sort of blow up with concerns in the review. But usually minor clarification issues can be addressed.

LEONARDO CUBILLOS: We do provide that, Nick. Renee Peters from South Africa. With Human Subjects, the form asks for IRB approval date. Usually IRB approval is only obtained once the award has been made. Should the application state when the IRB approval will be sought or anticipated to be received?

NICK GAIANO: Unfortunately, this is something that has changed and is not something that I know the definitive answer to. This is actually quite important. My guess is that one of the subsequent sessions already is going to have content about things like IRB approval built in. We are going to have two presentations from somebody in the Grants Management Branch.

I am sorry that I cannot answer that specific question with confidence that I would get it accurate.

LEONARDO CUBILLOS: We will keep that question to be answered later.

From Sharon Marsh. Can you touch on what would be needed in the foreign institute justification section of the application?

NICK GAIANO: Foreign institution justification. As I mentioned, if you are submitting to one of the RFAs that we are putting out through the Center, the justification isn’t necessarily -- it is sort of built in. But typically, if you were going to submit to a parent R01, I do think foreign institutions will need justification in any instance including for our RFAs.

But really what the panel is asked is, is there something specific about why this research couldn’t be done in the United States. If the NIH is going to cut a check to pay a foreign institution, they want to have some sense of, okay, we are invested in supporting research that is going to advance health, et cetera, and so that means there may be valuable research going on in other countries and the NIH is willing to support that, but there needs to be some sense of what is unique about that undertaking.

I wouldn’t stress too heavily about it because usually what’s unique is these investigators have specific expertise, they have access to a specific population, they developed a certain approach. But if it’s really a sort of cookie cutter project it may be a little bit more challenging. But usually what would go into that would be a justification as to sort of what about the project being handled internationally is why you are making the case.

I would say don’t not apply because you’re concerned about that. Apply, do the best you can with that and usually panels don’t rake applications over the coals with that.

LEONARDO CUBILLOS: We have time for one or two questions at the most. We will try to answer in writing the other ones. If not, we will cover them in the grants management webinars.

Would international hospitals that have research and training services be eligible institutions to submit the application?

NICK GAIANO: They should be. You would have to check with the institution, but absolutely they should.

LEONARDO CUBILLOS: From Ashley Seiger-Jones. What is the benefit and drawback of requesting an application be assigned to a specific study section? And along those lines, there was another question: what are the benefits and drawbacks of withdrawing an application?

NICK GAIANO: If you submit to a specific RFA or something through our institution, say through the Center, you can’t really request -- It will go to a panel that is a specifically devised panel. If you submit, say, to a Parent R01 and you look at the study sections in CSR and you see several that might be appropriate, you may find that you think one is more appropriate than the other based on the panel involved or the description online. So, when you request a certain panel, the value is that you are giving your input regarding what you can see as far as information in the system. That can actually be quite valuable.

I will say again, though, most things that come in via a specific Funding Opportunity Announcement probably will not have the option to select.

Withdrawing an application -- the benefit is tough to say really. Usually applications are withdrawn when there’s a problem. I am not sure how to frame the benefit unfortunately.

LEONARDO CUBILLOS: Thank you so very much, Nick, for your time, for your knowledge and energy. I found myself learning a lot from this presentation as well.

Thank you again all of you who attended this webinar. Our next webinar is scheduled for Friday, May 13, at 9:00 a.m. Washington, DC time. The topic will be, as Nick was saying, grants management - pre-award elements.

We will have a second grants management webinar  on post-award elements but this one will be focused on pre-award. Our presenter is our colleague, Tamara Kees.

I wish you all a great Thursday, wherever you are.