FAQs for Research Partnerships for Scaling Up Mental Health Interventions in Low- and Middle- Income Countries (U19) - PAR-MH-16-174

General

1. The Program Announcement (PAR) includes a link to the World Bank classification of country economies . Some countries appear on two lists, such as "developing only" and "upper-middle-income." What does this mean?
   The World Bank uses the term "developing only" to denote low-income, lower-middle-income, and upper-middle-income countries collectively. Some countries, therefore, appear under two categories (e.g., "developing" and "upper-middle" or "developing" and "lower-middle").
2. In how many LMICs should implementation research be conducted? And in how many LMICs should capacity building research be conducted?
   The implementation research study should be conducted in one or more low- or middle-income country (LMIC) and the capacity building component should be conducted in two or more LMICs, including the country in which the research study is to be conducted.
3. Is PAR-16-174 intended exclusively for the currently funded Collaborative Hubs for International Research on Global Mental Health?
   No. PAR-16-174 is a broad call for applications from all eligible researchers and institutions proposing to conduct implementation research focused on the scale up of mental health care in a low- and middle-income country AND research capacity-building activities.
4. The Collaborative Hub U19 grants all have two or more research sites. If a Collaborative Hub applies for a grant under PAR-16-174, is there an expectation that the scale up will occur at more than one site?
   No. PAR-16-174 is a distinct call for applications. All applicants must meet the requirements noted in the PAR-16-174 requires that the implementation research study involve one or more low-and middle-income countries (LMICs).
5. How many applications can an individual organization and/or researcher submit?
   Applicant organizations may submit one or more applications. Each application must be scientifically distinct and can have no overlap or dependence on the other submitted application(s). NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual researcher may serve a role on more than one application, provided he/she can fulfill all roles if multiple applications are funded.
6. What is adequate evidence that the LMICs existing or imminent scale-up efforts will proceed or continue to proceed as planned?
   Applicants should make a compelling argument using the most convincing evidence available that the scale-up effort to be studied has sufficient support to proceed or continue as planned. Peer review will evaluate the evidence presented about the viability of the scale-up effort.
7. Should the implementation research be conducted in one or more LMICs and the capacity building component in two or more LMICs?
   Yes.
8. Can the mental health intervention be a prevention program or must it be a treatment intervention?
   The mental health intervention to be scaled up may be a prevention intervention or a treatment intervention, provided that it is evidence-based.
9. Can more than one non-governmental organization (NGO) be in the research partnership? May one of the NGOs be a psychiatric hospital?
   Yes. The research partnership may include more than one NGO. Yes. A psychiatric hospital may be one of the NGOs in the partnership. The intent of the NGO requirement is to ensure that the right organizations and individuals in the participating LMIC(s) are represented.
10. Must the required "LMIC non-governmental organization(s)" be an officially registered local NGO or can it be a local office of an international NGO that employs local staff and conducts grass-roots, community-based work that includes service user viewpoints?
    The required "LMIC non-governmental organization(s)" should provide access to service user and service provider viewpoints. As such, it does not have to be an officially registered local NGO. It may be a local office of an international NGO that employs local staff and conducts grass-roots, community-based work that includes service user viewpoints.
11. Must the mental health intervention/program being scaled up be government run, or can it be an independent intervention program with potential for integration into government-run services?
    The mental health intervention/program being scaled up does not have to be government run. It may be an independent intervention program with potential for integration into government-run services. Note, however, that the research partnership to conduct the research and capacity-building activities must include representatives from one or more government agencies (along with representatives from one or more research institutions and non-governmental agencies) to ensure that the proposed research and capacity-building activities are responsive to local needs, interests, and capacities.
12. Can the research partnership include two university partners from high-income countries?
    Yes, but not just them. This initiative is not intended to support research that can be conducted primarily in and/or by United States or other high income country institutions. The proposed research partnership should include researchers, individuals, and organizations in the LMICs where the research and capacity-building activities will take place.
13. Must all the partners in the research partnership be in the same WHO or World Bank region? For example, may the partnership be multiple LMICs from Asia and Africa?
    The investigators may be from different regions (e.g., co-PD/PIs from the US and Asian LMICs), but the project should conduct implementation research and research capacity-building activities within LMICs in any one of the following geographical regions: East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa.
14. Must the PD/PIs be from or living in the LMIC country where the scale up research will be conducted? Or is it sufficient to identify local academic, clinical/health system, and ministry-level collaborators while the PD/PIs are all from high-income country institutions?
    The overall PD/PI, who will also serve as the Administrative Core Lead, must commit at least 3 calendar months per year to conducting research and related activities in the LMIC where the research is based. For projects with multiple PD/PIs, one must be the Administrative Core Lead, and the combined full-time professional effort for all PD/PIs together must equal at least 3 person months devoted to conducting research and related activities in the LMIC. The proposed research partnership should include researchers, individuals, and organizations in the LMICs where the research and capacity-building activities will take place.
15. Is there an advantage to including more countries (e.g., 3 countries vs. 2 countries)?
    The scale-up study must take place in one or more LMICs; the capacity-building component must be implemented in two or more LMICs.
16. Is this funding opportunity open to interventions on use of alcohol and drugs like Khat?
    PAR-16-174 is intended for mental health interventions, so interventions focused principally on alcohol and drugs such as Khat would not be responsive. NIH funding on substance use and alcohol use disorders comes from Institutes that are not participating in this announcement (i.e., the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism), so it is very important that proposals have a clear focus on scaling up care for mental illnesses. Questions about studying the scale up of intervention(s) to address co-morbid mental and substance use disorders should be directed to the Scientific/Research Contact specified in the PAR.
17. Are there any restrictions of the target population? The PAR lists children, women and men. Does this include older people?
    There are no restrictions on the age of the target population.
18. Do applicant organizations (e.g., universities) need a DUNS number?
    Yes. Please refer to Section III.1. under the header "Required Registrations  " for details.
19. The PAR asks for scaling up existing mental health interventions; what are some examples?
    Multiple randomized clinical trials involving multiple LMICs have demonstrated the effectiveness of various mental health interventions, including cognitive-behavioral, interpersonal, and cognitive processing therapies. The delivery of mental health services via task sharing (i.e., delivery of mental health services by providers with more abbreviated training under the supervision of specialists) has been shown to be acceptable, feasible, and effective in LMICs in Africa, Asia, and Latin America, where specialty mental health care is vastly under-resourced.
20. Will applications proposing to conduct research in countries already funded under the initial RFA be disadvantaged in the current PAR?
    Not necessarily; however, funding decisions will include consideration of the global balance of all funded grants under this initiative.
21. May I submit a new application following an unsuccessful application to RFA-MH-16-350?
    Yes.  The policy does not require a resubmission (A1) before submission of a new (A0) application.
22. My new application follows an unsuccessful application on the same topic. May I include information elsewhere in the application to address the previous review?
    No. A new application must be prepared as a new application. You may not include previous scores, comments of the previous reviewers, your responses to those comments, or place marks in the text of the research strategy or any other section of the application to indicate changes from a previous submission. Remind collaborators providing letters of support not to refer to previous submissions or reviews, and for applications requiring reference letters, remind your referees that these letters should not include any references to a previous application or review.

Implementation (Scale-Up) Research

1. Would the implementation project need to take place in a low-income economy country?
   The implementation research must take place in a low-income, lower-middle-income, or upper- middle-income economy country. Countries in the high-income category are not eligible, under the terms of this PAR, to be the research site. However, an institution in a high-income country could propose to conduct research in a LMIC and with the requisite collaborators in that LMIC.
2. Can one of the sites be an HIV care system (focused on treatment of mental health among HIV+ individuals), as long as there is another study site in the country that treats general populations?
   Yes.  The treatment sites for the proposed research on scale up of mental health intervention(s) may include an HIV care system delivering mental health care for HIV+ individuals among other sites that treat non-HIV populations.  Indeed, studies of scale-up efforts that build on HIV care platforms are welcome, such that the HIV+ population is one portion of the target population and those without HIV (and without access to the often better HIV service system) constitute another portion of the target population.  Applications should not propose research on the scale-up of mental health services exclusively for HIV+ populations.
3. Does the research element of the grant allow conduct of a Randomized Controlled Trial (RCT)?
   Yes.
4. Does the intervention being scaled up have to have been subjected to an RCT in the country in which the scale up research is being conducted?
   No, but the intervention(s) must be evidence-based.
5. Are there a required number of evidence-based interventions for the scale-up study?
   No. There is no required number of interventions for the scale-up study.
6. Does the evaluation of intervention have to include cost evaluation?
   No. A cost evaluation is not required to be part of the implementation research study.
7. Is there a definition of "scale up"? For example, should it be multisite? Is there a minimum sample size? Is the ultimate goal to scale up or to learn about scaling up? In other words, is it preferable to have narrower reach (smaller N) but more in-depth research, or to have a wider reach (larger N) with less in-depth research?
   For this PAR, "scale up" means intentional effort to maximize the positive impact of evidence-based mental health interventions in order to benefit a country or region within a country, and to foster evidence-based mental health policy and program development on a lasting basis. Note that NIMH is not funding scale-up or implementation activities per se; rather, NIMH is funding research that will accompany the scale-up or implementation activity occurring at the LMIC site(s) and thereby generate knowledge about how to scale up mental health interventions effectively. Investigators should propose research questions that are pertinent and feasible given the proposed study budget and given the context on the ground. No minimum numbers of sites, agencies, or individuals are specified.

Capacity Building

1. What does it mean to involve two or more LMICs in capacity-building endeavors?  What does ‘involvement’ entail? 
   Research capacity must be expanded in two or more LMICs in two areas: (a) Capacity for researchers and technical personnel to conduct mental health care implementation research, and (b) Capacity for policymakers or technical personnel in government or NGOs to become informed consumers of research and able to apply scientific evidence in developing mental health policies and programs.
2. In a very large country, can the capacity-building component involve multiple states, provinces, or regions rather than multiple LMICs?
   No. The capacity-building component must involve two or more LMICs.
3. Is the expectation that the capacity building component will be implemented with the capacity building sites during each year (I.e. Years 1-5) of the grant? Or could it start in Year 2?
   Applicants may propose a plan and timeline for refining, implementing, and assessing the capacity building component, using up to $75,000 in direct costs per year over the life of the grant. The capacity-building plan should be justified in terms of the overall project plan, including the scale-up study component. Full implementation of the capacity-building component could begin in Year 2.
4. How specific does the capacity-building plan have to be in the grant application? Does the application need to specify which universities will be involved in research capacity building?
   Applicants should be as specific as possible in describing the capacity-building plan in order to demonstrate that the plan is both sound and feasible and that the requisite relationships exist for successful implementation.
5. What are (and are not) allowable capacity-building costs? What categories of costs are allowable for the capacity-building component?
   Applicants should propose research capacity building for two different target groups: (a) Researchers and research technical personnel seeking capacity to conduct mental health care implementation research, and (b) Policymakers or technical personnel in government or NGOs seeking to become informed consumers of research and facile in applying scientific evidence in developing mental health policies and programs. Activities may include but are not limited to implementation research methods seminars, webinars, or short courses in implementation research; research-practice communities focused on implementation science; distance-learning courses in implementation research methods; seminars or webinars on evidence-based mental health policy and program development; short courses in the application of research in developing mental health policies and programs; research-policy communities focused on closing the mental health treatment gap; distance-learning courses in research interpretation and use for policy and program development. Costs for formal training or academic degree programs, including development of new courses for academic degree programs, are not allowable.
6. Does the fact that capacity building costs may not support formal training or an academic degree program mean that capacity-building courses shouldn't/can't be credit bearing?
   Capacity-building courses may be credit-bearing. However, the capacity-building activities allowable under the grant should not supplant formal training in the LMICs" academic degree programs (e.g., costs for development of new courses for academic degree programs are not allowable).
7. Since the capacity-building component focuses on researchers and policymakers, does this mean that it does not cover capacity-building for service providers? Is training for front-line service providers allowable? For example, if the researchers identify implementation hurdles during the study that impede scale up, would it be allowable to train providers in order to build their capacity to deliver care?
   Grant funds are to be used for research and research capacity-building activities, not for service delivery. The intent of this PAR is to fund research and research capacity-building activities that support – not supplant – LMIC efforts to scale up sustainable, evidence-based mental health interventions. For this reason, applicants are asked to demonstrate that there is adequate funding and other material support for the scale-up effort apart from the NIMH grant-funded research. Applicants may, however, use grant funds for training service providers in procedures (e.g., data collection, fidelity checks, supervision, or training of trainers, etc.) that are directly related to the conduct of the research and the research capacity-building components.

Budget

1. Is the budget cap of $500,000 per year for direct costs per year, or for total costs per year?
   The budget cap of $500,000 per year applies to direct costs only. Consortium F&A does not count toward the $500,000 cap.
2. Given that there are budgets for the 3 components (Core, Scale-up, and Capacity Building) what are the implications for splitting the budget between the country partners?
   The budget and allocations to country partners should accurately reflect the work that each partner will conduct.
3. Are there caps for indirect costs?
   For domestic US institutions, indirect cost rates are established through a formal agreement between the grantee organization and the US Department of Health and Human Services. For foreign grantee institutions, the indirect cost rate is capped at 8%. The indirect cost rate is applied to the applicable direct cost base to determine the amount of indirect costs to be awarded.
4. How are indirect costs divided between institutions in multiple countries?
   The indirect cost rate is applied to the applicable direct cost base for each awardee institution to determine the amount of indirect costs to be awarded to that institution.
5. Does the application budget have to include $75,000 for capacity building in all five years of the grant?
   No, this is not required. Applicants may propose a plan and timeline for refining, implementing, and assessing the capacity building component, using up to $75,000 in direct costs per year over the life of the grant. The capacity-building plan &and the years in which activities are conducted – should be justified in terms of the overall project plan.
6. Are costs for building capacity to deliver care allowable under the capacity-building component in the lead LMIC? For example, if an evidence-based intervention has not previously been implemented in the LMIC, may grant funds be spent to train providers to deliver services?
   Grant funds are to be used for research and research capacity-building activities, not for service delivery. The intent of this PAR is to fund research and research capacity-building activities that support – not supplant – LMIC efforts to scale up sustainable, evidence-based mental health interventions. For this reason, applicants are asked to demonstrate that there is adequate funding and other material support for the scale-up effort apart from the NIMH grant-funded research. Applicants may, however, use grant funds for training service providers in procedures (e.g., data collection, fidelity checks, supervision, or training of trainers, etc.) that are directly related to the conduct of the research and the research capacity-building components.

Application Submission and Peer Review

1. Is it mandatory to submit a letter of interest prior to application submission?
   No. It is not mandatory to submit a letter of intent to NIMH; however, it does help NIMH staff prepare for the application submission phase.
2. Will applications be reviewed at the Center for Scientific Review or NIMH?
   NIMH is the locus of review for this PAR. Questions about peer review processes should be directed to the Peer Review Contact specified in the PAR.
3. Will a NIMH standing committee review applications?
   No. For this PAR, a special emphasis panel of experts is convened to review the applications.
4. When will the peer review meeting be held?
   The Scientific Peer Review is intended for October 2016. Once the date is finalized, applicants will be able to see the date for the review meeting as well as the roster of reviewers via eCommons.
5. Can I include a few manuscripts in the appendix?
   Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.