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Transforming the understanding
and treatment of mental illnesses.

Mental Health Research Awards for Investigators Early in their Career in Low and Middle-Income Countries

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Transcript

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Andrea Horvath Marques: Good morning. Welcome, everybody, to the webinar from the Global Mental Health team, where we are going to share with you this new opportunity, RFA 21-120 Mental Health Research Awards for investigators early in their career in low and middle-income countries. I would like to welcome everybody and thank you for your interest. I would like to thank everybody who is here involved and developing and bringing this to you. We're going to have here with us NIMH staff from all divisions, DNBBS, DTR Center for Global Mental Health Research and also from the Division of AIDS Research. We also are going to have the pleasure to have people from grants management and also from the scientific review process, who is going to share with you information about this opportunity and how to apply. We're going to be able to share with you the slides later, and we are here to support you and to answer your questions. So welcome, everybody, and thank you for being here. And now I'm going to just ask Miri Gitik, who was the one who developed with the Global Mental Health team, this initiative. So thank you to her, this initiative is here. Thank you all. Miri, please.

Miri Gitik: Thank you very much, Andrea. Hello, everybody. Thank you for your interest and thank you for being here. I will just give you a brief overview and the specifics of this RFA. The Q and A box should be open. You can start typing in your questions. So this is a brief summary from the text of the RFA that you can find online. The goal of this RFA is to support the scientific work and career development of exceptionally talented scientists who are in the early formative stages of their careers and who plan to make a long-term commitment to the mental health research. So this RFA is, in addition to a scientific goal, it has also a career development goal for young investigators. This initiative seeks to assist these researchers in launching an innovative basic translational clinic service research program that holds the potential to transform understanding, prevention, diagnosis, and treatment of mental illnesses in low-resource international settings. So this RFA spans very broad spectrum of scientific interest from basic to translational and clinical and service intervention science. And like other RFAs that you might have encountered at NIH, applicants must have a long-term commitment to a career in research for mental health. So any of the following ones: causes, diagnosis, treatment and prevention of mental health illnesses, focusing on research priorities and gaps in LMICs, and that align with the NIMH strategic plan. The NIMH strategic plan can be found in this link, take a look and familiarize yourself with the priorities of NIMH.

Miri Gitik: Please note that any projects which are focused on animal models or other experimental models like cell lines, are not applicable and not responsive to this RFA. So this is a human-based RFA only. We are accepting HIV/AIDS applications. We have a representative from a division on the line. She will be able to answer any questions you have. Also NIMH encourages applications to consider RDoC or other like constructs. You can find more about that at the NIMH websites. This initiative, like I said, is distinguished from other research initiatives by the following aspects. All proposed projects should include a statement of career goals relevant to the research priorities and gap areas in LMICs that align with the NIMH strategic plan. Active participation of an external advisory committee. I will give more info on that in a minute. And then the commitment from the PI's institution to actively support the proposed research and career development of the PI, so we would like a letter from the institution committing time, protected time, for the PI to do the research that will be funded via this RFA.

Miri Gitik: The PI is expected to be to include in their application to be named External Advisory Committee. Please note not to include specific names of individuals that will serve on that committee because that will pose a conflict for reviewing this application. Once the application is selected for funding by NIMH, you will submit the names of these individuals via “Just in time”. The application should indicate the scientific expertise and anticipated input of the different members, and any critical consideration in the selection of potential members of the advisory committee. Advisory committee members cannot be collaborators or consultants on the proposed application. And I may suggest the following structure. This is a suggestion. You can structure it differently if that fits your project better. A least three scientists, one member should have research expertise similar to that of the PI, and one should be an individual who is an expert in human or clinical studies and who can provide input into the translation of the research. The PI will be expected to describe the proceedings of the advisory committee in an annual progress report that will be submitted after funding. So this is just a brief outline of advisory committee. More info can be found in the RFA text. So just to give you a sense of the timelines. Letters of intent - and I will just mention what letter of intent, as you can see it below - so a letter of intent is just to notify review officers to anticipate what type of science will be coming in. This is recommended, not required. So letters of intent are due October 14th, 2021. Application due date is November 15th, 2021. So please submit your applications before that date. Any application submitted after that date will unfortunately not be accepted.

Miri Gitik: Also, please note for HIV/AIDS research, we have a separate receipt date or due date, which is December 8th, 2021. So any HIV/AIDS applications are due by December 8th. All others are due by November 15th. The review is scheduled for March 2022. Once the official date is finalized, you'll get a notice. Advisory council will be May 2022, and the earliest start date of a project will be July 2022. This is subject to change potentially. The scientific review date, advisory council, and early start date may change. So eligibility criteria. We have received many questions about this, so I just wanted to go once again about-- to refresh everybody's memory about this. Eligible PIs should have a primary appointment at an LMIC accredited institution. LMIC, there's low, lower/middle-income, and upper-middle-income countries, and this is by the designation of the World Bank before or after January 1st, 2021. And there should be a link for World Bank designations in that slide, if you would like to take a look. Eligible PIs should be at early stages in their career, so completed their terminal degree, MD, or PhD, or any other equivalent after January 1st, 2006.

Miri Gitik: PI has not yet completed successfully for a substantial grant from NIH, and/or for an equivalent. You can find here a link of what is defined as an R01 or equivalent grant and there is more detail about that in the RFA. So eligible PIs are ones who have not received an R01 or an equivalent grant from NIH, be it NIMH or any other NIH institute. Additionally, use of multiple PI format is encouraged, but not required. All PIs of a multiple format must fit with previous eligibility criteria. PIs are expected to prepare their application jointly and should have a leadership plan detailing the responsibilities of each PI. US-based or high-income investigators are not eligible as PIs but may be included in another supportive role on the application, especially if they present special opportunities for furthering research programs for the principal PI, or if they can provide resources relevant to the proposed project, but either are not readily available in the eligible LMIC setting. So high-income investigators, the US-based investigators, investigators who have already received an R01 or equivalent, or have finished their terminal degree before January 1st, 2006, which do not fit the eligibility criteria mentioned before, can serve on the application in supportive roles, be it a co-investigator, consultant or other supportive role that's allowed by NIH. So I will pass this presentation along to our NIMH review branch chief, Nick Gaiano.

Nick Gaiano: Can you hear me? Hello?

Nick Gaiano: Oh, okay. So thanks, Miri. So my name is Nick Gaiano. I supervise the peer review branch at NIMH, as Miri just said, and so we thought it would be useful for me to give just a little bit of information about the peer review process, just so folks are aware, applicants are aware of what would happen when an application arrives with us. This is, of course, the process by which the applications are evaluated by a panel and sort of the outcome of those evaluations will determine which applications are prioritized for potential funding support. So the peer review process is managed by a member of the NIMH staff, someone that works with my group. And that person is called the scientific review officer. So that's the main sort of science administrator that oversees the project. The scientific review officer is involved in evaluating the science directly. So their scientific opinion about the application is not-- it's not relevant. However, so they will perform an administrative review. And there are sort of several levels of this. Also, the initial intake part of the NIH, which is called the division of receipt and referral, where when your institution clicks the submit button, it actually goes there. But they'll take a look at it, and then we would take a look at it and make sure that all of the instructions have been properly followed. So it's really important that you read the instructions both in the SF-424 instructions document, but also the instructions that are in the RFA. And something that seemed to be non-compliant, meaning there's some fundamental aspect of the instructions that hasn't been followed runs the risk of being withdrawn, which would basically means it would be sent back and that would be that. And if you submitted after the deadline-- or on the deadline, now it's been withdrawn after that, it would be a lost opportunity.

Nick Gaiano: So the next step is the SRO will, of course, look at all the applications, look at the scientific content of those, and will begin to recruit a panel from the scientific community. And this can be both domestic, but also the international community with the appropriate expertise to evaluate the applications. So depending upon the content and the science proposed in the applications, the SRO will assemble a panel that's qualified to look at them and make assessments about how well the experiments are constructed and just in general, how well-crafted the research plan is, and other sort of parameters that are relevant. Including things like investigator, environmental level of innovation, the significance of [inaudible]. The people that are deemed to have a conflict of interest will not be allowed to participate. And there's a variety of issues that would constitute conflict of interest. The reviewers will have about four to six weeks to evaluate the applications, so they have enough time to get this work and do it right. And it's usually expected that it would take them on the order of a day to really look carefully at any given application that was assigned to them. They'll have a customized critique template. So there'll be some uniformity in the reviews. The process ultimately comes together-- Oh, so the main thing that they're going to focus their attention on is section five in the RFA. So when you look at the RFA, you'll see there's different sections in the published document, and they're all important. But in particular, the reviewers will be looking at section five. And actually, I guess Miri is going to go over those in the next slides. Some of the components of that that are particularly important are how the evaluation will occur.

Nick Gaiano: Then ultimately what will happen is we'll convene a review meeting. So all of the reviewers that were recruited to look at the applications in this pool will be brought together for a meeting. You know, back in the old days, we probably would have had an in-person meeting. But at the moment, this is going to be a Zoom meeting, which is really how we've been doing all of our peer review for some time since the pandemic, etc. And what will happen is sort of the bulk probably of the applications will then be discussed. If there are some that were thought to not be particularly strong through the initial evaluations, pre-meeting, those may not all be discussed, but I suspect we'll discuss the bulk of these. And so the group will convene, the people that have looked at the-- there'll usually be three people that looked at them carefully. They will discuss. And then the group will chime in and ultimately some conclusions will be drawn about the merit of the application. And then finally, and this is what you'll get as an applicant, each discussed application will get what's called a priority score, which sort of is a function of how strong the application is judged. Those would range from 10 typically into the 60s, but a 10 is the strongest. It's very difficult to get a 10, I will say, so don't anticipate that. And there's also going to be a written set of critiques that an applicant will get that will help you in working with the program officer think about what the panel review assessment was. So I just wanted to go over all of that because in general, applicants - foreign and domestic - are not always aware of how the process works. And I think it can take a little bit of the mystery out of it. And it can also maybe help if you have some questions. So that's that.

Miri Gitik: Okay. Thank you, Nick. So like Nick has mentioned, section five has the review criteria that reviewers will be looking at, and also section four has details of these review criteria, of what you need to pay attention when you are writing your application. So we encourage you to familiarize yourself with section five, and the questions that reviewers will be evaluating your application by. In addition to the standard criteria that NIH uses, which outlined in our RFA, please note that we have special review criteria for this RFA, which includes the potential impact. So you need to describe how testing your hypothesis is solving an important problem to the mission of NIMH and LMICs. Explain how a successful outcome has the potential to transform a NIH research. Innovation. Please note, that this RFA is focused on unusually innovative projects, so please describe how your application will be innovative. Approach. Provide enough information so that reviewers can determine what you're proposing to do. If your methodology is standard, what is unconventional and exceptionally innovative about your approach? Again, innovation. If approaches entail a high degree of risk, what will you do if those approaches are unsuccessful, unfortunately? And how do the potential benefits, rewards outweigh the risk?

Miri Gitik: Last bullet of importance is the appropriateness of this program. Why is the proposed research uniquely suited for the stated goals of this initiative or RFA, rather than a more conventional research grant application? Please note that this RFA is intended for young investigators who are starting out their career with minimal results, so not the same scrutiny level as a regular R01 application. So please be mindful that when you're writing your application. So, again, thank you for expressing interest in this RFA.

This webinar will be published on the Center of Global Mental Health website. You can find the website here. And as I said before, the Q and A box is open. So please start typing in your questions. I want to leave you with this slide here of the contacts of the program's staff which are assigned to this RFA, and they have different expertise. So we have Dr. Andrea Horvath Marques, who leads the Global Mental Health program and her focus is dissemination and implementation science. We have Dr. Eric Murphy, who is focused on translational research, Dr. Susannah Alison, who is focused on AIDS and HIV research. And myself, I'm focused on genetic and basic research. Also, here's the email of Nick, our review science officer branch chief. So you can email us with any questions you may have. Thank you very much. I will now pass along the presentation to Tamara Kees, our lead grants management, who is going to describe the process further from her end.

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Alexander Denke: Looks good, Tamara. You're muted, though.

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Tamara Kees: There we are. I'm so sorry about that. Good morning, afternoon or evening, depending on where you are. And thank you so much for joining us today. My name is Tamara Kees, and I'm with the Grants Management Branch of the National Institutes of Mental Health. And I'm going to briefly go over some administrative requirements, rules and responsibilities, important registrations. And I have slides on resources and when they share this webinar, you'll have access to those. And I tried to put in there the most important or the ones that would help you the most in submitting your application. So in this RFA, the direct cost limit is $500,000 each year. And this limit does not include FNA for consortiums. So if you have a subcontract, you can add the indirect costs for that subcontract onto the $500,000. I always get questions for that, so it's important to know that you do not have to include it because it does cut into the research costs. So the project period can be requested for up to five years. But that doesn't mean you need to ask for five years. You need to ask for the amount of time that you need to complete the aims of your project. FNA is awarded in modified direct costs less equipment. And in one of the links I have in resources, the NIH grants policy statement is a very important tool for you, and you can find all of the definitions for what this means. And they do explain what a modified direct cost is, if you've not encountered it before.

Tamara Kees: The NIH provides 8% FNA to foreign grantees, and we award to our domestic grantees at their negotiated FNA rate. And they do, usually a domestic grantee will negotiate the rate with the agency that they do business with most of the time, so that's what cognizant federal agency means. But foreign grantees are awarded 8%. You can use that for overhead administrative costs and not just for compliance. In the past, it was only for compliance, making sure that you were compliant with federal laws and regulations, but now you can use it to help administer the grant. The budget format. So everyone will use the SF-424 application guide to prepare the budget in the application, but foreign grantees must use a detailed budget, and all the requested costs in the budget should support the science to complete the aims as proposed in the research application. Let's see here. So roles and responsibilities. Nick went over scientific review officer, so I'm not going to go over that because he does it in a-- so much better at explaining it than I will. So the program officer, the reason I picked the roles and responsibilities in is because when you go into the systems to register and you start inputting information or you start submitting your application, they're going to ask you for certain roles at your institution. But it's also important to know who does what at the NIH.

Tamara Kees: So the program officer is responsible for the scientific, programmatic and technical aspect of your grant. He or she is familiar with the review of your grant application and can discuss peer review critiques and issues with you. The program officer will also review your annual progress report and provide feedback and guidance over the life of your grant, and should be the first person that you contact when you are having extraordinary success or if you're having extraordinary problems. A great resource. The grant management specialist works with you to gather and submit all information to make an award effort. Once the grant is picked up for funding, the grants or management specialist will review the application to ensure that all regulatory requirements are met, and that all requested costs meet the cost principles in the NIH grants policy statement. The GMS will also review the annual progress report and conduct a financial analysis to make sure that the awarded funds are being spent per the terms of award on the notice of award each year. The grants management officer is the only person at the NIMH who's authorized to obligate federal funds. She's my boss and she grants authority to other grants management specialists to sign on her behalf. But at the end of the day, she's the one who makes all of the funding. She is the one who is allowed to actually say, "Yes, we're paying this grant," and obligate the money.

Tamara Kees: So the one thing I think you should take away from the roles at the NIH is that we all work together. Independently, we all can do nothing. But together we are able to successfully help our grantees manage their grants and stay compliant, so that when you're audited, everything goes well. And from a programmatic standpoint, that your science remains on track because a lot of things can happen that can defray success. So definitely engage with us and keep us in the loop on what's happening with your grant. Let's see now. Okay. So these are the roles that you're going to need when you go into the grant's .gov and ERA comments. They're going to ask you for all of this information. So the recipient institution. The thing you need to know about this is that the NIH awards grants to institutions. Although the science is thought of and prepared by the PI, the grant money goes to the institution and the institution is legally responsible for proper conduct and execution of the project, and provides fiscal management of the project and ensures compliance with all the US federal laws and regulations. The authorized organizational representative is the designated representative of the grantee organization and is accountable for the information presented in the grant application, signs all official correspondence, and ensures compliance with federal laws.

Tamara Kees: In fact, everybody - you're going to hear me say this again and again - everybody associated with your grant is required to adhere to federal laws and regulations. And you should be working together to make sure that everything is in place to prevent any issues later. The AOR is also responsible for submitting all of the required documentation that we need to document the official file for the institution. So, for instance, as a PI, if you have something that-- correspondence with the program officer, if you are just chatting, discussing science, that's one thing. But if you need to revise your aim, submit other support, add additional budget justification, anything we need to actually make an award to give you new money or change something on your grant, that needs to come from the AOR. The principal investigator is designated by the organization, and is responsible for all of the scientific, technical and administrative aspects of the science. And the PI works closely with the sponsored research office to ensure the project is on track and that all required submissions are on time. The research administrator acts as a local agent for the AOR and the PI by providing essential grant-related support. The ROA can work in the lab or in the sponsored research office and usually prepares documents on behalf of the PI and AOR. So when you are registering, you're going to be asked to submit contact information for your AOR and PI, and you'll be asked who's responsible for submitting documentation on behalf of the institution and all of these-- They'll use these roles specifically in the systems.

Tamara Kees: All right, registrations. So in order to submit your grant application to the NIH, you need to register in the ERA comments and grants.gov. But before you can register in any of these systems, you need to obtain a [dunce?] number, register in the system for awards management, which is SAM, and foreign applicants need to acquire an [in-page?] code. I've heard that it takes a lot-- it can take some time for foreign grantees to get through the system. I don't know why, why that would be, but the thing to know is that if you encounter problems, the first place you go is to their help desk, because here at the NIH - and I think maybe government-wide - these systems are outside of the NIH. So we have no access to actually help you maneuver through them. So start early. And of course, when you're in ERA comments or grants.gov, if you encounter huge problems, sometimes we can help facilitate assistance, but we cannot see what you see. So start with the help desk. And as always, you can contact us for additional help. Or maybe we can just pick up the phone and ask somebody else for assistance. So this is really all I have for you as far as the administrative requirements. There are a lot. And I believe you have to submit your application and go through the process to really know what is going to happen and experience it. But of course, we're all here to help you successfully submit your application so that they can be reviewed and hopefully picked up for funding.

Tamara Kees: So I've included resources, ERA comments, the online registration, grants.gov, SAM and SAM login, and frequently asked questions. I really do recommend looking at the frequently asked questions pages at the NIH website and NIMH website because somebody's had the question before, so it is helpful. And this is NIH grants policy statement. If you are not familiar with it, I believe you should become familiar with it. There are definitions in there that will help you when you work up your budget. It explains what every single line item thing you could ask for in your budget. Of course, it has policies for the NIH and it is a great resource for you. And I went through the NIH website and I found other links to how to apply, grants and funding, frequently asked questions. And for foreign grantees, Fogarty International Center has a great frequently asked questions site. So please peruse this when you get the slides and make yourself familiar. And best of luck to you. Thank you very much for your time.

Andrea Horvath Marques: Okay. Thank you so much. Thank you so much, Tamara. And thank you so much, everybody. We are here. And I think like what everybody was saying, we are here to help you, to support you, to learn the process or to help you to move on the process that we know is complicated. But please remember, reach out to us. Know you have our emails and we-- Now we're going to have many questions. So I'm going to start reading them. And Miri's is going to help us to answer. And each one of us also can help. But I think there is a lot of questions related to who is eligible to apply. And one of them, Miri, is about if somebody who has a double affiliation in a low and middle-income countries and in other, in US, and also in the US, if they are eligible to apply for this application for this.

Miri Gitik: Yeah, so Tamara, you can pitch in. But our first [date?] with a primary affiliation should be an LMIC university. So most of the time of this PI needs to be spent at LMIC, depending on the effort you devise. So at least 60%, to my understanding. Tamara, if you want to add additional details.

Tamara Kees: I don't. I mean, I know that there is a place online-- and I'd have to find it. I can find it and it has a list of low to middle-income countries. I didn't put that in my slide presentation, which I should have, now I'm thinking, now that it's come up.

Miri Gitik: I think we had a link to the World Bank designation in one of the slides so folks can look that up.

Tamara Kees: Oh, good, good.

Miri Gitik: Yeah, we're working by the 2021 World Bank designations, so.

Tamara Kees: Okay, yeah. I forgot about that.

Andrea Horvath Marques: Yeah, so the list is there. But you need to have certainly an appointment in the low/middle-income country. You may be in the US doing also something, your post-doc or other. But you have to have an appointment in the lower/middle-income country as your primary appointment. The support research is going to be sent to the country, to the country that your base, your research is also is going to be taking. So it's important for you to be connected and have a connection in an institution there.

Miri Gitik: Yeah. So that word, like Tamara said, is going to an institution. It's not going to the individual. So that word will be going to the LMIC institution that you are affiliated with. So be mindful of that. And not to the US Institution.

Andrea Horvath Marques: There is also a question about multiple PIs, and I think also we already answered what it means, what it is multiple PIs, but also if this-- do you mean that all PI should fall within the early career definitions that it was given?

Miri Gitik: Yes. So all PIs need to answer or be responsive to our eligibility criteria. If they're not responsive, they cannot be a PI. They can be a supportive role, co-investigator, consultant or any other supportive role, but they cannot be a PI.

Andrea Horvath Marques: And talking about co-investigators, Miri. There was a question about if the grants can cover the costs of the staff as a co-investigator.

Miri Gitik: Yeah, one of the costs that you can budget for is, of course, personnel. That goes into our cost.

Andrea Horvath Marques: Oh. There was also a question here saying that if the institution that the PI is linked with, does it have to be an academic institution or it can be a hospital or research center or a non-profit organization?

Miri Gitik: So I would start-- anybody? Oh, Tamara, do you want to pitch in

Tamara Kees: As long as they can fulfill the requirements, filling out all of the registrations, then yes. You can be a for-profit or a foundation or hospital as well as a grantee institution.

Miri Gitik: To add to that, we do request institution provides protected time or support for the PI to do the research, so it may be good to have a discussion with your officials at your institution that you will be given that time and that support, protected time to do the research.

Andrea Horvath Marques: And about protected time, Miri, there is a question here about the both PIs have to spend 75% of their time on the grants.

Miri Gitik: So-- okay. [crosstalk]. Tamara, do you want--

Tamara Kees: No, no. Go ahead.

Miri Gitik: So, I mean, we would like you to spend a significant portion of time. If there are two PIs, you need to provide a leadership plan that will detail how each PI will contribute to the project, how much time they will spend on the project. What will be the responsibilities of each PI. Hopefully that answers the question.

Andrea Horvath Marques: Tamara, do you need to add anything on this related to--?

Tamara Kees: I don't. I mean, it says applicants are expected to vote at least six person months. So when your grant comes in, the grants officer will evaluate to make sure that you have that. So, no, that's fine.

Miri Gitik: But we do expect both of the PIs if there are multiple PIs or more than two PIs to dedicate that time, so. To that.

Tamara Kees: Right. But they can split it between the two, correct? Yes.

Miri Gitik: Yeah, they can split it. But we would like to see a leadership plan designating what does each one of them does specifically.

Andrea Horvath Marques: Do we need a mentor to this application?

Miri Gitik: Like we mentioned, there is a whole section in the RFA about the advisory committee. Please go ahead and read it. You can take a look at our slides also about the advisory committee. These are mentors which are supposed to provide you feedback and meet with you at least annually to go over your progress. This RFA, and like other RFAs, is also focused on building your career as a young investigator. So, yes, there is a large portion for mentors to be involved in this study or project.

Andrea Horvath Marques: And then there was a question, if somebody can apply, if they are done with their PhD, but not yet received the degree.

Tamara Kees: Oh.

Miri Gitik: Tamara, do you have anything on that?

Tamara Kees: Well, let me see. It says eligible PIs should be at their early stages in their career, which is defined as completed his or her terminal degree or medical residency. So if you've completed it but you haven't received it, I would say, yes, wouldn't you? I mean [crosstalk]--

Miri Gitik: I mean, I'm okay with it unless there is an NIH rule that does not allow it. I mean, if you can provide an official document from your institution saying that you have completed our required degree and you're waiting for your final diploma or whatever that is, certificate, I think that will be helpful.

Tamara Kees: Yes.

Andrea Horvath Marques: Yeah. And then and then you can also reach out to us and we have more details on that. But I think they answer your question, but we'll be happy to talk to you and further clarify anything. And again, think about it. We are here to help. Don't be shy to send us an email, connect with us, it is helpful to send your concept to us, each one of us (NIMH divisions staff) here are responsible for different applications depending on its scope. We are here to support you and to help you how to do it. So when you send your concept to us, it's going to be very helpful to you and helping to us to guide you on the process. And I think they have some questions for you, Tamara, related to the--

Tamara Kees: Oh. Hold on a second. Nick, did you have something to add?

Nick Gaiano: Yeah, I just wanted to say that in the application process, there will be an opportunity after the initial submission, but typically 30 days before the actual review occurs to send in updates. So in the particular example, which prompted me to say that, if, for example, your degree wasn't awarded at the time you were submitting but did occur, you could send an update along those lines, which updates can sometimes be helpful when it comes to-- because the reviewers will, of course, have access to that. There would be other types of things you could send updates for, if you have additional public-- because sometimes they'll be months between the deadline for the application. They'll often be something like three months, right. So things can happen in that time window, and you will be given the opportunity to provide some additional information.

Andrea Horvath Marques: That's great, Nick. And Nick, to whom they should send this?

Nick Gaiano: Well, so when we get the applications, they'll be assigned to a certain SRO. That SRO will then begin to, I wouldn't say extensively correspond pre-meeting, but the SRO will send out an introductory email that, okay, I have your information on the SRO. This is a little bit of how the process is going to unfold, and that email will have the information regarding when the absolute latest you could get an update would be. Also any updates - and this is a little premature, but it's at least worth it, since I'm on it - any updates would have to come from assigning official at your institution. So you couldn't just email directly to the SRO, but that's usually pretty easy to sort out and you would have fair warning. But so ultimately the SRO that's going to be assigned to handle the review will be communicating with the applicants. And then they'll be available as a resource, regarding the review process.

Andrea Horvath Marques: Thank you, Nick. And thank you to remind them. And I know you can update the process with new publications that you're having during this period that Nick was mentioning. So this is very helpful with that. And I think I have some questions here related to the budget. And Tamara, so one of them is related to subcontract costs, if you can elaborate on what is a subcontract.

Tamara Kees: A subcontract is another organization that you have a contract with as the prime grantee, and you pay them for doing a portion of the research. So consortium has to be contributing to the research aims. So I can give you an example. Like here, Johns Hopkins might want to do business with the University of Maryland because there's a PI who's very good at the science or an expert in the field. So they subcontract. They ask for money in their grant, Johns Hopkins grant to pay the PI at University of Maryland. You must have a contract on file at the institution, and you must have oversight of that PI and be able to work with that person to complete the aims of your science. Does that answer the question?

Andrea Horvath Marques: I think so. So let's see if they have the person here who kind of can provide us any feedback on that. Also, can you elaborate a little bit of the consortium issue in the budget? I don't know if there was any consortium in this that you mentioned.

Tamara Kees: Well, when you submit your grant application, you're going to have an opportunity to submit a budget for your consortium. So it is basically the same type of form as what any budget looks like. You have line items and you fill it out and you give them their indirect costs. And then that is pulled in when you submit your application. All of that information is pulled into the grant institution's prime budget. What I meant when I mentioned consortium, was that the indirect costs for your consortium site, if you have a site that has $100,000 in direct costs and you have 8% of that is indirect costs, that portion over $100,000 does not count against your $500,000 direct cost limit. So let's just say you add up everything, including your consortium and their FNA, and you have $600,000. That's okay, as long as the indirect costs are adding up to that $100,000 over your 500. It's kind of complicated, but I think it's explained in the SF-424 budget forms. So once you see it on paper, it makes more sense than just having somebody tell you how to do it. But if when you're working on a budget, you need help, you can always give us a call. My name is on the RFA at the bottom, so you can always call me and I can help you over the phone.

Andrea Horvath Marques: Thank you, Tamara. Talking about this, there was a question, I think that you mentioned already, that if somebody, a person in the lower/middle-income country, a PI, can he/she spend some fundings in the US, with a subcontract or a collaborator.

Tamara Kees: Yes. Yeah. You can subcontract to domestic institutions.

Andrea Horvath Marques: Okay. So let's see. So and then there was a question here. If an early career physician who does not have a primary appointment in low/middle-income country join hands with a PI who are primarily appointed institution, as a PI contingent on the award of the grants and can provide 100% of their time for the grants. So the question is that if a PI here in US will be eligible to apply, providing 100% of their time for the grants, helping the PI really on the ground. But again, I think like Miri is going to explain a little bit about it-- a PI in the US, an investigator in the US, how he/she could collaborate with the PIs in the low/middle-income country.

Miri Gitik: Yeah, so they can help, right. The application, they can help the applicant submit the application, but unfortunately they cannot be a PI on this application. They can take a supportive role, like we said, a co-investigator, a consultant or any other supportive role that's allowed by NIH. And they can dedicate effort to the project also, if they want.

Andrea Horvath Marques: Yeah, and I think there's been a question around this, about this 75% effort. 75% effort is what each PI needs to provide? Is there a cut off, Tamara? -

Tamara Kees: Well, from reading the announcement, it says that a PI should-- we expect them to commit at least six calendar months to the project, up to 75, meaning you'd like them to, if they can, so nine calendar months. If they have multiple PIs, then the PIs could split that time because they're both PIs. But if you are a single PI, the expectation is that you commit, at very least, six calendar months.

Andrea Horvath Marques: Thank you. So there was also a question about if somebody who does not hold a PhD can apply. I'm not sure if the person means being an MD. That is already said so. But I think maybe the person is asking if he does not have a PhD.

Miri Gitik: So with those international degrees and, Tamara, correct me if I'm wrong, it's more fluid. So I think it should be a responsibility of your institution saying that you have afforded to conduct research and can be in the role of PI to do the research. So you should contact your institution and see if that will be allowed in your case or not.

Tamara Kees: Right. That's a good answer.

Andrea Horvath Marques: So there was also a question, if somebody can apply for a formative research idea, along with a pilot trial. And I would say that it depends. And this is a R01, we are normally looking for a whole clinical-- if you are thinking about a clinical trial, you're probably going to be doing a whole clinical trial here. We always have like some formative research in some of the implementation science and intervention science, intervention research that you're probably going to have, depending on your case. So I would say reach out to us with your concept and we can guide you how to-- you're going to do it.

I think there is another question: Is a private grant awarded by a foundation considered equivalent to NIH grant?

Tamara Kees: I don't know. I haven't really read anything about that. So I wonder--

Miri Gitik: Maybe that specific individual can reach out to us separately in email--

Tamara Kees: Yes. That would be good.

Miri Gitik: --so we can figure out what exactly they meant.

Tamara Kees: Yeah. Thank you. Thank you.

Andrea Horvath Marques: US citizenship is not a factor for this application, right?

Miri Gitik: No. You can be a US citizen or not the only requirement that your primary affiliation will be in LMIC as designated by the World Bank.

Andrea Horvath Marques: And Miri, does the advisory committee should be from US? Or can be from other countries

Miri Gitik: They can be from anywhere. You will need to justify why you're selecting these individuals, how they contribute to your project, and what exactly-- describe what exactly will be their role in mentoring you or helping you with the project.

Andrea Horvath Marques: And I think I--

Miri Gitik: I mean, we advise that at least one of the advisory committee members be from your institution because they know how your institution works, but that's not a requirement. We advise. It's a recommendation.

Andrea Horvath Marques: And can they receive compensation like the advisory committee?

Tamara Kees: You know, I believe they can. I have to look that up because I don't get that question very often, but if you would send me an email, I'll research it and get back to you. I'm pretty sure that you can, but I just want to be 100% sure before I say absolutely.

Andrea Horvath Marques: Yeah, there are some questions that we are not so sure, and sometimes we need to look and check again. Policies change. So don't be shy to ask  if you have any question, please reach out to us again if we were not able to clarify your question. There is another question here: If a US citizen is involved-- Can a US citizen be as a co-PI?

Miri Gitik: Yeah. Yeah, I mean, an investigator from a US institution or a high-income institution can be a co-investigator. They cannot be a PI. If they are, again, affiliated with a low/middle-income country or setting, they can be a PI. The citizenship issue does not really factor in here. It's the affiliation of a specific individual.

Andrea Horvath Marques: Yeah, so the question was, if he's a US citizen but has affiliation in a low/middle-income country and spends time there, that he can be a--

Miri Gitik: Yeah. But we will request that his primary affiliation is with a low or middle-income LMIC institution. So he spends his most time or she spends her most time there.

Andrea Horvath Marques: Okay.

Nick Gaiano: I just wanted to say something. I'm sort of out of sync here, and I hope I didn't misunderstand. There was a question like a few minutes ago, if a private grant awarded by a foundation is considered to an NIH equivalent. My guess is that what that's asking - I'm sorry if I missed something - was that should not impact someone's eligibility. So there is in the RFA an indication that you cannot have an R01 equivalent to be eligible. But that's one of a series of NIH grants, but typically, say, for ESI status at the NIH, you can have money from other sources and that should not impact eligibility. So if I understood the nature of that question, I just wanted to pipe up.

Andrea Horvath Marques: Yeah, thank you. Thank you, Nick. Yeah, well, we have more questions and I'm trying to read over them. And we are running out of time, but are we going to make sure to try to answer them all-- how long does it take to institution or a PI to be registered on the ERA?

Tamara Kees: That shouldn't take very long at all, I think. I don't know if there is a time lapse, but my understanding is you go in and you register, and then you have access. That's my understanding. I don't know, because, of course, I can't see on that site. But I can look it up while she goes on.

Andrea Horvath Marques: I think I have one more question about budget. Okay. So it's about subcontract. Does the cost of subcontract go in the direct or indirect costs?

Tamara Kees: Okay. Say that again, please?

Andrea Horvath Marques: If the costs for the subcontract go to the direct or indirect costs.

Tamara Kees: On the prime grantee? It would be a direct costs. The consortium costs would be direct costs. The indirect costs would be FNA, but it will be combined and line-itemed in your budget. So the consortium costs will be one total costs, and it will be a line item in your budget. Yeah.

Andrea Horvath Marques: And well, we are around- It's 11 o'clock right now. I know we were not able to answer all the questions. Please bear with us.  We going to be looking and answer your questions as we can. If you can send us an email with the questions that were not answered. So we can have your email address, so we can answer you. My apologies for not being able to go over the questions and I'm very happy to all your interests. We are looking forward to receiving your application. We're going to share the emails. Please Reach out to us. We can follow up with you with questions and we work with you and your concept. We are looking forward to seeing you all here. Thank you  Tamara, Nick, Miri and other NIMH staff.

Tamara Kees: Okay. I just wanted to say that it says that it can take up to 10 business days to register. So definitely start early.

Miri Gitik: So thank you very much, everybody. Like Andrea said, please reach out to us with any questions you may have. We're here to help. We're here to answer. If we are not the expert, we refer you to one of the members on this phone call or other NIMH members that can assist you. After you submit an application, there is less flexibility for us to help. So please, remember the deadline, submit in advance, ask questions. Don't be shy. Thank you.

Andrea Horvath Marques: Thank you.