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Transforming the understanding
and treatment of mental illnesses.

Technical Assistance Webinar: Effectiveness and Implementation Research for Post-Acute Interventions to Optimize Long-Term Mental Health Outcomes in Low-and Middle-Income Countries

Watch on YouTube.

Transcript

ALEXANDER DENKER: Hi, everyone. Welcome. We'll get started in a moment after the attendee list populates.

Okay, we'll get started. For anyone who needs, closed captioning is available by pressing the CC button on your Zoom screen. And Holly, I will hand it to you.

HOLLY CAMPBELL-ROSEN: Good morning. Welcome to this technical assistant webinar for the effectiveness and implementation research for post-acute interventions to optimize long-term mental health outcomes in low and middle-income countries. This is the R34 clinical trial optional RFA. My name is Holly Campbell-Rosen. I am a program officer in the Center for Global Mental Health Research at the National Institute of Mental Health. Welcome to the webinar. Today, you will hear from five presenters and have the opportunity to ask questions of them at the end of our presentations. Our technical staff has just announced-- well, I am announcing that, when you have questions, please enter them into the Q&A box, not the chatbox. The Q&A box, please. And you may do that at any time during the presentation. If available, excuse me-- you may also upvote other people's questions so that we attend to the questions most people are interested in having answered. For the next 15 to 20 minutes, I'm going to review the scientific and programmatic aspects of the RFA that you should consider when applying to it. The webinar will be recorded. Next slide, please.

This RFA seeks applications that focus on the implementation of methods to engage mental health patients in the post-acute management of their mental health conditions in low and middle-income countries. The slide lists the overarching purpose of the RFA and includes implementation science of post-acute management of mental health conditions, development of new implementation approaches to improve availability and accessibility of post-acute services, and the collection of new information about health systems which may inform potential policy interventions that address modifiable restrictions in the supply of post-acute services. Next slide, please. This slide shows more closely the type of research we would like to support with this funding opportunity. For example, the second sentence points out that all applications that will receive funding are expected to examine structures of the health system and their role in facilitating or preventing the dissemination of new post-acute interventions. Another type of research of interest to us includes assessing the facilitators and barriers to scaling up and sustaining interventions for the post-acute phase. This could be accomplished through a clinical trial or through secondary data analysis.

Next slide. This and the next slide provide examples of research topics-- examples of research topics relevant to the RFA. They include, on this slide, implementation studies of interventions in the community - and this is by no means exhaustive; this is just examples - identification of mechanisms that may underlie post-acute service utilization and mental health functioning, assessment of routinely collected data to examine population-level strategies for monitoring and improving engagement with patients. Next slide, please. Additional relevant examples are listed here. To mention a couple, I'll draw your attention to the top left, where the first bullet emphasizes strategies for prevention among children and youths who have been treated for gateway conditions to reduce the risk for downstream comorbidities. And on the lower right, studies of optimizing coordination, partnerships, and communication between hospital and outpatient-based care systems. Next, Dr. Lori Scott-Sheldon, a colleague, is going to present an example that involves the use of secondary data. This has been something we've received several questions on, and we wanted to provide the opportunity for you to learn from her. Lori, take it away.

LORI SCOTT-SHELDON: Thank you, Holly. As Holly mentioned, I'm Lori Scott-Sheldon, chief of the data science program in the Division of AIDS Research in the National Institute of Mental Health, assisting the Center for Global Mental Health Research. And I'm here to talk about data science approaches relevant to this RFA. So, in addition to primary research, we also encourage secondary data analysis to advance the development of novel and innovative implementation research to improve the availability, accessibility, and reach of post-acute mental health services in low and middle-income countries. Secondary data analyses must demonstrate the sufficiency of existing datasets in both quantity and quality to test hypothesized meditational pathways or to generate new hypotheses or predictions using data science approaches. So there are many different data science approaches that an applicant may use to address the research scope and objectives in this RFA, including the use of predictive analytics, machine learning algorithms, ensemble methods, and geospatial analysis. And I've listed a few examples of these approaches on this slide, such as decision trees and super-learner algorithms. But by no means is this list comprehensive, and I recommend carefully considering all computational approaches when selecting the approach or approaches that best fit your research question. Next slide, please.

All data science approaches should be mindful of the selection of model inputs or predictors, the modeling approach most appropriate for the research, the output or the outcomes, and the usability. So one example of a data science approach that would be responsive to this RFA and using the aforementioned criteria is to use machine learning to develop a clinic-based risk assessment tool that would identify patients who are more likely to temporarily or permanently relocate. Data could be drawn from multiple sources, such as electronic health records. These include patient-level data such as distance from the home to the clinic, clinic workflow, such as wait time and staffing, community-based service surveys that might get at some of the mental health stigma within the community, or national policy data that might indicate government expenditures on mental health clinics, as an example, to provide a more complete understanding of patient mobility and the likelihood of relocation, to enable healthcare staff to better support patients to minimize loss to follow-up, retain patients in care, and optimize long-term mental health outcomes. So while there are many examples of data science approaches that could be considered responsive to this RFA, I encourage you to reach out if you have any questions or concern when proposing secondary data analyses to address the research scope and objectives in this RFA. Thank you. Back to you, Holly.

HOLLY CAMPBELL-ROSEN: Thank you, Lori. That was really great. Hope that everyone learned from that. Next slide, please. So the mechanism of this RFA is the R34 NIH Planning Grant Program. The R34 mechanism with the clinical trial optional provides time and support to develop and finalize your plans for a clinical trial or research project. On the left is a list of the types of research that may be supported by the R34, and on the right are further details about the purpose of the R34 when you conduct a clinical trial. So when you conduct a clinical trial at NIH, you have to be very specific-- you have to understand our definition of clinical trial when you propose to do one, and I thought I would provide the definition for you. It is a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. You can find this definition on our web page, and if you have questions about it, please reach out. Next slide, please.

So eligibility, who can apply, this is a very important slide, and there are three key takeaways from the slide. First, for an application to be eligible, the PI or one of the multiple PIs must have a primary academic appointment in an LMIC institution. Secondly, research must be done in the LMIC in which the PI has the primary academic appointment. So, basically, you have to have research going on in an LMIC with a PI who has a primary appointment in that LMIC. Without that combination, your application will be deemed non-responsive. And then, to find a list of qualifying LMICs, please check the 2022 World Bank designations of LMICs. There's a link for this in the RFA, and we can put a link in the chatbox, at some point, if needed. Okay. I just wanted to make a comment about capacity-building. Although research-capacity-building was not required in the applications, the requirement to have a PI and an LMIC is actually a form of capacity building, something that the Center for Global Mental Health Research has and continues to value. Next slide, please.

Okay. There are several NIMH policies that all investigators need to know when funded-- or before funding in their application. One is to advance research through widespread sharing through the NIMH data archive, and this is-- there's some information about this on the left side of the slide. This is a secure informatics platform for scientific collaboration and data-sharing that enables effective communication of detailed research, data tools, and supporting documentation. Investigators funded with this RFA will be expected to use these technologies to submit data to the National-- NIMH Data Archive. And several aspects of this requirement are outlined on the slide. First, it's important to establish an enrollment strategy with the proper informed consent and plans to collect the required data. Without a proper consent, it's difficult to collect all the data that are required. It's a set of common data that we ask of you to collect in order to put in data that can be harmonized with other data that other researchers have input.

And secondly, this is not a trivial task that we are asking of you, so we want to make sure that you budget for the activity. There is a tool on our website that can help you identify the cost for submitting data for your application so that you don't find that you're without the funds should you be funded. Okay. On the right, another policy is summarized. The NIMH, in consultation with the Wellcome Trust and other funders of mental health research, has identified a minimal list of data collection instruments. These are called common data elements. These would be an ideal-- an ideally for use-- excuse me. They would ideally be used by all mental health researchers who are working on clinical settings, and NIMH expects grantees to collect the common data elements for mental health research, all human subjects research supported by NIMH. And so, in your application, you should prepare to address how you can include the common data elements in your study. Next slide.

Okay. Important due dates. The first one, November 9th, is the day on which applications may be-- the first applications may be received, and also, it's the due date for your letter of intent. And then we also have the application due date, December 9th, and additional dates for peer review, programmatic review with the council, and a potential start date of July 2022. Next slide, please. Here we have some examples of types of research that would be deemed non-responsive to the RFA. So these are examples. The slide doesn't say examples, but I need to emphasize that these applications would not be peer-reviewed, and a few key ones are effectiveness studies, effectiveness interventions only, studies done in laboratories, projects without a PI-- without a PI with a primary deployment in an LMIC in which the study will take place, applications that propose research to be conducted in and or by an institution in the United States or another high-income country, and applications that propose research that is not conducted in an LMIC. And I'd like to just mention that section five of the RFA lists the review criteria for this funding opportunity, and we'd like to encourage you to familiarize yourself with the questions and evaluate how well your application will meet these criteria. Before I turn the presentation over to the next speaker, I would like to leave you with one important tip. We encourage you to discuss your aims with a program officer to assess the suitability of your concept with this funding opportunity. Our contact information will be on the last slide. Please feel free to contact us, and best of luck. Our next speaker is Dr. Nick Gaiano. He is from the peer-review division, and he's going to speak to you about peer review. Thank you.

NICK GAIANO: Thanks. Thanks, Holly. So, as Holly said, my name is Nick Gaiano. I supervise the peer-review branch at the National Institute of Mental Health, and our primary function is to collect the evaluations of expert reviewers so members of the scientific community who can take a look at applications and help us determine which ones are the strongest ones that we might want to support. So, the slide here, I have some bullets I just want to go over quickly. The peer-review process is managed by a member of our staff that's referred to as a scientific review officer, or SRO. The SRO, when the applications come in, will first perform what's called an administrative review of each application to assure compliance with the SF424 instructions and also the instructions published in the RFA. This is really a critical point that I want to emphasize. Unfortunately, applications, a place where they sometimes go wrong is in following the instructions, and the instructions, I have to admit, both the-- well, primarily the SF424 instructions are not always crystal clear. So I would encourage you-- if you look at the RFA, you can find my contact information listed towards the bottom where it says, "Staff contacts," and I'm listed under, I think, scientific review contact or peer-review contact. If you have questions that need clarification with respect to what's in the instructions, please get in touch with me.

The SF424 is the framework that's used for all NIH applications, but it's also worth noting that the instructions that are specific to this RFA would take precedence. So if there are some instructions in the RFA, those are the primary ones that you should follow when they're, perhaps, different from what's in the SF424, but you really need to look at both of those very carefully. So non-compliant applications, though, will be withdrawn. That can mean a variety of things. Some of the easiest things to think about is, if you try and cram-- for example, six lines per vertical inch is the maximum you're allowed to include, say, in the research strategy. If you try and use a minuscule font and squeeze eight lines per inch, that will be returned, right? A lot of non-compliance issues relate to just sort of the details about how the application is constructed. Say you do a clinical trial and there are additional attachments and you put a bunch of additional preliminary data in the context of those attachments that is not-- should not be there but really needs to be in the research strategy, that would be an example of non-compliance. So we very much don't want to have any applications come in that are non-compliant. So, again, if you're not sure, please reach out to me, and if I can't help you with the specific details, I'm sure a member of the branch can.

So the way the process works: once we have the applications and we've determined that they're all compliant with the NIH and RFA rules and, also, once program staff like Dr. Campbell-Rosen has looked them over to make sure that they are responsive - say, for example, not including many of the examples or related concerns that might make them seem non-responsive - then we'll have the pool of applications that are going to go to peer review. What the scientific review officer does is that person will look at the applications and determine what kind of expertise is needed to properly evaluate them. So, of course, we see not all the applications that come in are going to be the same. They're going to be actually-- it's going to be a range of topics and a range of methods used, a range of populations, potentially, clinical populations, whatever type of work you're doing. And so we'll need to look at the full profile of applications that we get and determine who are the best experts in the community to look at those and draw good evaluative assessments of those applications.

The process does involve also the consideration of those folks that might have conflicts of interest. So, for example, we can't have a friend of yours reviewing your application or a collaborator or someone that you have a close professional association with. So even if we were to bring someone into our review meeting that might have suitable expertise, it's possible that, if that person is too close to you professionally or personally, that that person would not be able to review your application and would have to not participate in that one, but could potentially participate in others in the meeting. I also encourage you, if you have concerns about anybody in the community who you think you would prefer not to look at your application, you can include that in your cover letter, and we will take a look at that. Your cover letter is what you submit with the application just to kind of say, "Here it is. Here's the title," and if you want to provide any additional information. You're also welcome to suggest reviewers that you think might be suitable in that setting, but we may or may not take those into consideration, depending upon other considerations.

So what will happen is, once we have all the applications and we've identified all the reviewers that we need, we will give those reviewers, typically, four to six weeks with the applications to evaluate them. This is in an effort to respect the fact that they have a lot of responsibilities, and we certainly want them to spend sufficient time to actually look at these applications deeply and really think about them carefully. They will follow the review criteria listed in section five of the RFA. So section four has instructions. Those are really fundamental for you when you're preparing your application. When you look to section five, what you'll see are the different review criteria, and those are what the reviewers are going to be asked to look at. And there is usually a pretty good parallel between what's in the instructions, so what you've been asked to provide, and then what the reviewers are asked to evaluate. So please look at those sections very carefully. A customized critique template will be provided to the reviewers that will be specific to some aspects of this RFA, and all the reviewers-- depends on the size of the meeting, actually, and that will depend upon the number of applications we get, but review meetings are often something like 20 to 30 panel members. And if we get very large numbers of applications, they can be quite a bit bigger. If we get a limited number, they could be smaller.

The typical application would have three to four assigned reviewers. So you're not going to be looking at a single person determining how your application is assessed. But there will be a group-- initially, a group of three to four that will look at it during that four-to-six-week period and will form initial enthusiasm levels, and they'll write up their critiques. Then we will have a meeting where the whole panel will come together. This will most likely be done virtually at this point, since that's how we're doing all of our review meetings for the time being. And at that meeting, then the whole group will come together, and we will-- they'll discuss the applications. So that'll help, perhaps, if there are differences of opinion or whatnot. And then my last bullet is a little bit cut off, but I think it's-- at least on my screen. I believe it says, "Each discussed application will receive a priority score," and the priority scores, of course, will help program staff determine which are the strongest applications and which are, perhaps, less strong. And they'll also all receive a written summary-- what's called a summary statement. So the written critiques that were prepared for by the reviewers, you will receive that feedback. I should point out that it's possible that not all applications will end up discussed in the meeting. It depends on the initial enthusiasm level. If there are some applications where all the assigned reviewers just did not think it was a good application at all, that may not come up for discussion, so it won't get a score. However, it will get a summary statement, so you will still get the written critiques, which will be valuable feedback.

I think that's my last bullet, but I can't see the bottom. My slide is cut off for some reason. Anyway, I'll be on for the rest of the call, and like I said, my contact information is in the RFA, and I believe it was posted in the chat. So please feel free to get in touch with me. We absolutely want you to be successful with the submission of these applications, that that should not be a hindrance to them being potentially supported. Okay, I'm going to turn this over now to Heather Weiss, who will take you through another aspect of the process that relates to grants management and administration. Thanks.

HEATHER WEISS: Thank you, Nick. So, as you said, I'm Heather Weiss. I'm a grants management specialist in the grants management branch at NIMH. And I'm speaking to you today on behalf of Tamara Kees, who is listed on the published RFA as the financial management contact. And so we answer questions on financial administration and policies that affect applications. Today, I'll be going over the administrative portion, the roles and responsibilities, registration, and resources for this RFA so that you can complete your application. The first thing I want to mention is the budget requirements. As stated in the-- so you can go to next slide, yeah. As stated in the RFA, drug costs are limited to $450,000 total, and no more than $225,000 direct costs can be requested each year. When you request your dollars, they must be in US dollars. You may request up to three years total for the project. And please keep in mind that indirect cost will be 8% modified total direct cost for the project, as stated in our NIH grants policy statement. However, if you have a sub-award, you're planning to have a sub-award on the grant that is a domestic sub-award in the US, NIH must use their negotiated F&A rate for those direct costs for the sub-award, if you plan to have one.

For the format, please follow the SF424 application instructions. And I want to mention they describe two different kinds of budgets in there. One is called the R&R budget, and one is called the modular budget. You are being asked in the RFA to follow the R&R budget. You can use Develop Your Budget, which I've linked here for help on how to categorize costs and what to include in your budget justification. And Alex, do you want to put up a page that shows-- just so you can see what it looks like. There, he put the link in the chat there. And so you can take a look at that and scroll, and you'll see a bunch of links on detailed budget, which is what you'll be following, and how to request these costs, and what you should include or what we're looking for in a budget justification. Thank you. So, to continue, you want to go to the next slide, please?

So, on the NIH side, the application is reviewed-- oh, sorry. So this is the registration portion. All organizations applying to NIH must have registered using these systems we've listed here. To register your organization, you need to register at eRA Commons, grants.gov, and the System for Award Management, which we call SAM. So there are some things that you need to do in order to register in SAM. For example, you need to obtain a DUNS number, which is the data-universal numbering system, which is a number unique and non-indicative, nine-digit identifier, issued and maintained by Dun & Bradstreet, that verifies the existence of a business globally. So that is assigned to you, but you must apply for it if you do not already have one. So if you've never registered before, you need to do that first before you can register in SAM. And if you already registered in SAM, you can go ahead and use those numbers.

Please note that all foreign organizations must have an NCAGE code. If you've never applied for one, you will need to do so early because it can take a while. It takes at least a few business days, and then you'll be able to establish a international number to use with NIH grants. And so the take-home message that we want to do here is please start early. A lot of these-- if you've never applied to NIH before and you need to register through all of these systems, it takes a while. And so please do this as soon as possible, especially if NIH has to come back or the system manager has to come back and ask questions or ask for additional information, you may need to do extra steps, so it may take a few weeks. It could take months in order to get all of these things established and registered. Now, the next slide, please.

So here is a link of all of the resources available to you for all of these registrations. There is also a direct link for Develop Your Budget, which I showed here today in the chatbox, but it's mentioned here again. And then here are some additional links for NIH and grants and funding FAQs and foreign FAQs. Now the next slide, please. So here are our contacts. As mentioned before earlier today, we have programmatic scientific contacts Leo Cubillos and Holly Campbell-Rosen and Dr. Nick Gaiano, which is the peer-review contact, and I am listed here as the financial grants management contact, although you may also contact Tamara Kees, whose information is found in the RFA that's published under the financial grants management contact, and we can answer questions. Yes, thank you, Alex. He posted her email address there in the chat. And we can answer policy questions, financial administration questions, etc. So I am going to hand this over to Holly, who is going to read some Q&As for us to answer.

HOLLY CAMPBELL-ROSEN: Yes, thank you. Thank you, Heather. That was great. So, now, we get to do the Q&A, and I think all the presenters should probably put on their video so we can see you and participate in the Q&A. Thanks. So we have four open questions, and I'll just start at the top. Does NIH favor collaboration with US partners for co-applying? I think several of us could answer this. I'm going to ask Nick, and if you don't want to, we will do it on the program side. Nick?

NICK GAIANO: I'm sorry, can you-- which of the questions are we talking about?

HOLLY CAMPBELL-ROSEN: Does NIH favor collaboration with US as partners for co-applying?

NICK GAIANO: Oh, I don't think that's a great question for me in review to answer. Sorry.

HOLLY CAMPBELL-ROSEN: Okay. Yeah, thank you. I think that the person is getting at the same question, the third question we have, which is, "Can US institutions apply, or is the intention for an LMIC-based institution with a PI apply and a sub to a US institution be put in place?" So my understanding of this RFA is that yes, a US institution could apply, but that you still have to maintain a PI who has the primary appointment in the LMIC, and the work should be done in the LMIC. And if the US institution applies, the PI there could not supersede the LMIC investigator. They would need to be multiple PIs together. And I'll ask Dr. Cubillos if he'd like to add anything additional.

LEO CUBILLOS: Just one minor point, Holly. To the first question, "Does NIH favor [inaudible]?" not necessarily, I think, as long as they meet-- the application meets [separate?] issues [inaudible], it would be reviewed based on [findings?], not on [inaudible].

HOLLY CAMPBELL-ROSEN: Great. Okay. So we've answered two of them, and we now have another one. Is there a preferred specific population within mental health, like psychotics, schizophrenia, depression, anxiety, PTSD, ADHD, mild cognitive impairment, etc.? Are all of them valid? And again, Leo, do you want to address that one?

LEO CUBILLOS: Sure. No, there is no preferred condition or collection of conditions. So long as they are in need of post-acute care, any of them can be validated as relevant and would be according to the context, right? [inaudible]. But no, there is no preferred condition or set of conditions.

HOLLY CAMPBELL-ROSEN: Thank you. Okay. The next question. How about the US institution be the PI and the foreign institution be a sub, provided that work will be done at the foreign institution? The answer is no. You must have a PI in the LMIC who is a PI; not a key personnel, but a PI of the application. Okay. Hopefully, that was clear. If not, please ask again. Oh, and the next question. So MPI, which just stands for multiple PI, is allowable. Can the contact PI be US? MPI is allowable, and I believe the contact PI could be in the US, but I will look to my colleagues to correct me if that is not right.

HEATHER WEISS: The contact PI is the PI of the institution or organization to which we are awarding.

HOLLY CAMPBELL-ROSEN: Great. Thank you.

HEATHER WEISS: So if your application is the prime from US, then yes. If it is not, then no.

HOLLY CAMPBELL-ROSEN: Thanks. So we have answered all of the open questions. Folks, we're open to more Q&A questions in the online, but also, if you're interested in unmuting and putting your camera on, we're not opposed to answering questions live. So please let us know what you want to ask.

ALEXANDER DENKER: Holly, we have one question from Judy [Nass?]. I'm going to unmute her and allow her to talk. Judy, go ahead.

WEBINAR PARTICIPANT: Hi, I'm not completely sure how to make a video on, but anyway--

ALEXANDER DENKER: You won't. Sorry. To clarify, attendees won't be able to turn their videos on, but we can unmute your audio.

WEBINAR PARTICIPANT: Great. Thank you. I wanted to ask about sort of the specification of returning to function and sort of the frequent mention of functionality. And if you could give any more information about what you are intending with the term of optimal functional baseline and sort of the use of the term functioning and functional outcomes throughout the application, throughout the background?

HOLLY CAMPBELL-ROSEN: Okay. This is a question that Leo is best suited to answer.

LEO CUBILLOS: Absolutely. Judy, that is a terrific question. Thank you for asking it. In this period of understanding that all patients with psychiatric conditions, even the most severe ones, have the opportunity and the right to live perfectly otherwise considered normal life, including work, education, community-functioning, paying taxes, all these things that are considered community-functioning for individuals without a psychiatric condition. That could be understood as one of the goals for patients with psychiatric disorders. So, in the RFA, the term functioning can be understood in that context, restoring all the aspects of social function outside of the clinical setting that we all human beings aspire to. Is that clear? Is that helpful?

WEBINAR PARTICIPANT: Yeah, that's helpful. Thank you.

HOLLY CAMPBELL-ROSEN: Okay. And now, we have another question for Nick. Are applicants able to submit requests for reviewers in their applications?

NICK GAIANO: I would call them suggestions rather than requests. So if you feel that there are members of the community that are particularly well-suited to evaluate the research and your proposal, you're absolutely welcome to put that in your cover letter, or there's also a component of the application called an assignment request form where you could put some information. I would suggest you put it in the cover letter. However, you can put it in both if you choose. But it's worth pointing out that the SRO may or may not take those suggestions and use them. As you can imagine, we have a lot of considerations that go into constructing a review panel. But my point is not that you should be discouraged from making suggestions. You absolutely are welcome to. But if you make suggestions and you ultimately look at the roster of the meeting once it's occurred-- and you'll see the roster of the reviewers. It will become available to you in the NIH system. Usually, 30 days before the meeting, you'll be able to see the roster, where it stands at that point, which usually is, hopefully, complete, but also, the final roster will be present at the end of the summary statement. And my point is just, if you've made some suggestions, you may or may not see those individuals' names as participating in the meeting. And that will depend.

ALEXANDER DENKER: Holly, we have a couple more hands raised. I'm going unmute Juan [Galego?]. Juan, you should be able to unmute and ask your question.

WEBINAR PARTICIPANT: Yes, thank you. So [inaudible] we need PIs both in the US and also in the foreign institution, so that's clear. The question is more about the administrative sort of thing, about having a DUNS number and all the stuff for the foreign institution, since that may take a long time. So if the top-line institution is the US institution, then would the foreign institutional also require a DUNS number, [inaudible] number, and all the stuff, or that would sort of suffice with the applying institution here in the US?

HOLLY CAMPBELL-ROSEN: Heather, can you take that one?

HEATHER WEISS: Oh, me? Yeah, so can you hear me? I can't see myself.

HOLLY CAMPBELL-ROSEN: Yes.

HEATHER WEISS: Okay. If the US institution, which is your sub-award, has applied to the federal government before, they will already be registered, so they will already have that information, and you'll need to contact the administrator at your sub-award site in the US. If they have not, then yes, they would need to go through those registrations.

WEBINAR PARTICIPANT: I guess I am in the US institution, and I work with somebody in the foreign institution. I'm not sure, by being a small community clinic, that they have all these sort of all these sort of DUNS numbers and all that stuff. So I was wondering, if the US institution, obviously, has all those numbers, how to add on this international side with the PI and the international site to the award.

HEATHER WEISS: Okay, so the foreign site is going to be the sub-award, correct?

WEBINAR PARTICIPANT: Yes.

HEATHER WEISS: So they will need to have-- be registered in eRA Commons. I believe the organization should be registered in SAM. Actually, I don't know off the top of my head. Does anyone else know? Because they're not going to be the ones applying.

LEO CUBILLOS: May I step in?

HEATHER WEISS: Yes.

LEO CUBILLOS: Heather, my understanding is that the foreign site has to be the primary PI and [would go?] to the foreign institution, not the US institution.

HOLLY CAMPBELL-ROSEN: So, Leo, that's contradictory to what we've told people earlier in the--

LEO CUBILLOS: So let me take that back on this.

HOLLY CAMPBELL-ROSEN: No, no, no, no, no. We need to clarify and have it be correct if that's the way it's supposed to be.

NICK GAIANO: Well, the instruction in the RFA says, "Applications proposing MPIs must have at least one PDPI who has a primary appointment in an LMIC." So that's not specifying that it needs to be the contact PI. The following sentence in that instruction, though, says, "Research projects must be conducted in an LMIC in which at least one PDPI has a primary appointment." So that does suggest that you can't just have an applicant institution in the US where all the work is done there but somebody at an LMIC is made the PI. But we'll have to look at that a little bit more. I think the point, though, is that we want the research, largely, to be performed-- or not we, but program staff wants the research-- the objective here is to have it performed in a low or middle-income country.

ALEXANDER DENKER: Dr. Diego, we will have Tamara Kees follow up with you following the meeting.

WEBINAR PARTICIPANT: Thank you.

Dr. Abbas, you should be able to ask your question now.

WEBINAR PARTICIPANT: Yes. Hello. So I have a more technical question. In section four, it mentions a series of guides that must be followed for the application itself and, within these guides, a series of forms that have to be filled out. In my understanding, none of these forms have yet been uploaded. Could we have an estimate of when they would be uploaded?

ALEXANDER DENKER: Are you referring to the SF424 forms?

WEBINAR PARTICIPANT: Yes.

ALEXANDER DENKER: So those are available online.

WEBINAR PARTICIPANT: Yeah. So when you try to access the forms, it says that they have not been uploaded yet. Sorry, let me quote them.

[silence]

It says the following, "If this message is not eventually replaced by the proper contents of the documents, your PDF viewer may not be able to display this type of document." Unfortunately, my PDF viewer is updated, so I'm assuming this has not yet been uploaded.

ALEXANDER DENKER: Do you mind sending us an email with that exact text and link that you're going to, please? And then we can help figure that out, to see if it's a technical issue or an old link.

WEBINAR PARTICIPANT: All right. Thank you.

ALEXANDER DENKER: Thanks.

NICK GAIANO: Yeah. Just to follow up, because, usually, these are NIH-provided. We don't typically provide forms that are specific to any given RFA. So I think Alex's point, that it's possible there's a technical glitch that's sort of outside the range of what we typically control, is worth looking into.

ALEXANDER DENKER: That's all the hands we have raised. If anyone has any further questions, you can either raise your hand or put your questions in the Q&A. The recording will be made available on the NIMH Center for Global Mental Health Research website, we hope, in the next couple of weeks. So please check back on that site over the next couple weeks for that link to be posted. We hope that our NIMH communications team will be able to get that information out as well when the video becomes available. Holly, do you have any closing remarks, or Leo?

HOLLY CAMPBELL-ROSEN: I'll allow Leo to do that.

LEO CUBILLOS: Well, thank you for attending today's technical assistance webinar on [RFA NIH 22100?]. We'll be happy to answer any additional questions that you may have. You have the email, and as Alex said, within a few days, the webinar with the recording of the slides will be uploaded to the Center for Global Mental Health Research webpage. So thank you for your time, and have a great day.