Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Collaborative Hubs for International Research on Mental Health (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-MH-11-070

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-12-110

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242 

FOA Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), invites cooperative agreement research applications to establish regional research hubs to increase the evidence base for mental health interventions in World Bank designated low- and middle-income countries (LMICs).  Each regional hub is to conduct research and provide capacity-building opportunities in one of six geographical regions (i.e., East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa).  As a group, awardees will constitute a collaborative network for mental health research in LMICs with capabilities for answering research questions (within and across regions) aimed at improving mental health outcomes for men, women, and children.

Key Dates
Posted Date

September 27, 2011

Letter of Intent Due Date

December 11, 2011

Application Due Date(s)

January 11, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 1, 2012

Expiration Date

January 12, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Institute of Mental Health (NIMH) invites applications to establish Collaborative Hubs for International Research on Mental Health (CHIRMH).  This program aims to establish two regional hubs to increase the research base for mental health interventions in World Bank designated low- and middle-income countries (LMICs) through integration of findings from translational, clinical, epidemiological and/or policy research.  Each regional hub is to conduct research and provide research capacity-building opportunities in one of six geographical regions (i.e., East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa).  The purpose of the CHIRMH program is to expand research activities in LMICs with the goal of providing the necessary knowledge, tools, and sustainable research-based strategies for use by government agencies, non-governmental organizations, and health care institutions to reduce the mental health treatment gap.  The mental health treatment gap refers to the proportion of persons who need, but do not receive care.  As a group, awardees will constitute a collaborative network of regional hubs for mental health research in LMICs with capabilities for answering research questions (within and across regions) aimed at improving mental health outcomes for men, women, and children. 

The treatment gap for mental disorders across the world is large and leads to chronic disability and increased mortality for those affected.  Research is needed to identify effective treatment and prevention strategies to close this gap. Mental health research that ultimately enables effective services to preempt, prevent, and treat mental disorders requires both infrastructure and partnerships.  Tackling the urgent challenges of the treatment gap demands effective collaborations among researchers, mental health service users, mental health service providers, and government agencies that will implement and sustain services.  Therefore, a goal of this Funding Opportunity Announcement (FOA) is to support research partnerships and activities in LMIC settings that will stimulate research to address the prevention and treatment of mental disorders and ultimately increase the evidence base for mental health interventions.

Background

The prevalence of mental disorders worldwide is approximately 30% (Demyttenaere et al., 2004).  In addition, mental disorders account for 37% of healthy years lost from disease (Wang et al., 2007), and are the leading cause of disability worldwide (Lopez et al., 2006).  Despite this dramatic need, only a fraction of those with mental disorders receive effective treatment, even in well-resourced settings like the United States.  According to a recent report from the World Health Organization (WHO) World Mental Health Survey, disorder severity was associated with service use, yet service availability was directly proportional to a country’s Gross Domestic Product (Wang et al., 2007).  Moreover, among patients who initiated treatment in settings with impoverished resources and infrastructure, few received treatment meeting minimum standards for adequacy or follow-up care (Wang et al., 2007).

The mental health treatment gap is exacerbated by the dearth of health care workers available to provide evidence-based mental health services that meet minimum standards.  While a growing evidence base exists for higher income countries like the United States, far less research has been conducted regarding the treatment gap in LMICs, which face special human resource challenges.  For example, the WHO Africa region has the fewest psychiatrists per capita with approximately four psychiatrists for every 10,000,000 people (WHO Mental Health Atlas, 2005b).  Across South East Asia, there is, on average, one psychiatric nurse for every million people, compared with 248 per million persons in Europe (WHO, 2005b). These limitations also apply to other mental health specialists.

The challenges of too few mental health professionals in LMICs have strengthened the argument that mental health care should be integrated into primary care, enabling access to these services in the community.  This example of task shifting, defined as the rational redistribution of tasks among health workforce teams, involves the appropriate transfer of specific tasks from specialists to those with abbreviated training (WHO, 2007).  Task shifting permits judicious use of valuable human resources by engaging qualified health workers in the community.  In the context of mental health services where systems lack specialists, primary care providers (i.e., doctors, nurses, community health workers, etc.) may offer much-needed care for mental disorders in the community.  A sizable and growing body of research demonstrates that task shifting in both high-income countries and LMICs can be efficient, cost-effective, and sustainable for the delivery of HIV services, improving tuberculosis treatment outcomes, and a wide range of maternal and child health interventions (Lewin, et al., 2010; Lehmann, Van Damme, Barten, & Sanders, 2009; WHO, 2007; Samb et al., 2007). Recent recommendations from the WHO address areas of task shifting in the delivery of HIV services that may be relevant to the strategic delivery of other health services, including mental health interventions (WHO, 2007).  While a small, but growing evidence base on the use of non-specialist mental health workers is emerging from LMICs, many empirical questions remain. 

An expanded mental health evidence base in LMICs is needed; studies from these countries are underrepresented in scientific literature.  Notable gaps in research exist in the domains of health policy and systems, cost-effectiveness of interventions, and scale-up of evidence-based services.  A range of factors contributes to the dearth of mental health research in these settings, from limited access to relevant literature to the lack of collaborative networks of investigators of all experience levels.  Enhancing resources and improving capacity have been identified as priorities in enriching mental health research in LMICs (Wang et al., 2007).

Research partnerships are key to enhancing resources and improving capacity for mental health research in LMICs.  A partnership model of research, in which LMIC nationals lead research projects with any needed technical support from colleagues in more developed countries, can lead to ownership, sustainability, and the development of local and national research capacity (Costello & Zumla, 2000).  Cultural and national influences play a large role in the interpretation and application of research findings (Costello et al., 2000).  Similarly, local and national researchers in LMICs have critical knowledge of the cultural and national influences regarding health problems and treatment issues.  Thus, in mental health research conducted in LMICs, local and national researchers should engage in partnerships, as needed, to provide technical assistance, enhance resources, and build capacity. 

Research Scope and Objectives

The objective of this FOA is to establish regional hubs in LMICs that will conduct innovative public health-relevant mental health research, build research infrastructure, and develop research capacity.  The work supported under this FOA is expected to: (1) develop and strengthen regional collaborations, including partnerships among governmental and non-governmental organizations, research institutions, and mental health service user advocacy groups; (2) facilitate the conduct of high quality, state-of-the-science mental health services and/or policy research, taking advantage of health system and socio-cultural diversity; (3) support research capacity building; and (4) generate collaborations with local communities on the research process and the interpretation of study outcomes.

The majority of each regional hub’s capacity-building and research activities must be conducted within LMICs and must provide for significant involvement of local/regional LMIC researchers in study design, development, implementation, and interpretation.  The CHIRMH program is not intended to support research that can be conducted primarily in and/or by U.S. or other high income country institutions. In addition, each regional hub must develop and collaborate with local/regional government agencies and established institutions in the region to: (1) ensure necessary coordination of research activities with existing policy, clinical service demands, and community priorities; (2) facilitate, through partnerships with community stakeholders, access to and involvement of locally-identified high priority study populations and treatment centers; and (3) ensure dissemination of study findings to key stakeholders.

Hubs:  A hub is defined as a multidisciplinary research group of investigators and their collaborators focused on a common research topic.  Hubs are expected to serve as a focal point for all research, research capacity-building, and collaborative activities supported under this FOA.

Applicants must describe existing or planned research collaborations in the region of interest (eligible regions defined below) and relevant areas of methodological expertise.  Collaborative teams should minimally include experts in behavioral and social science, epidemiology, mental health policy, and mental health services research.  Each regional hub must have an existing on-site administrative structure in its respective region along with scientific and mentoring capacity to perform the research activities proposed in the application at the time of award.

Regions:  Research must be conducted in World Bank designated LMICs in one of the following geographic regions:

To be considered responsive, applications must describe the conduct of research and research capacity building activities in at least two countries within the geographic region of interest and should provide sufficient evidence of relationships, infrastructure, and knowledge of those regions.

Partnerships:  To be considered responsive, applications must describe partnerships within the hub’s selected geographic region with:

Applications considered responsive to this FOA must demonstrate that a research partnership currently exists (or can be developed and maintained) between the applicant and the partnership entities listed above via official documentation of the partnership (i.e., letter(s) of support provided within the application).  The partnership is intended to ensure that the viewpoints of multiple stakeholders (i.e., investigators, service providers, service users, and policymakers) contribute to the development and conduct of the research and research capacity-building efforts, thereby increasing the likelihood of public health-relevant research findings, and ultimately, the uptake of research findings by service systems.  Partnerships are expected to be integral to the conduct of the research proposed in the application and the application should describe the activities and responsibilities of each of the partners.  The rationale for including named partners should be clearly articulated in the application.

CHIRMH PROGRAM COMPONENTS

Responsive applications will address each of the following components:

1.  Hub Overview and Administrative Core;

2.  Research Component focused on task shifting for delivery of mental health interventions; and

3.  Research Capacity-Building Component.

1.  Hub Overview and Administrative Core

Each application must include an overview that provides a synopsis of the applicant’s plan to develop a program in the designated LMIC(s) that will increase opportunities and capacity for conducting mental health research in the region.  The hub must provide an environment that promotes the conduct of the highest quality, state-of-the-science research, exhibiting leadership and innovation in its particular area(s) of investigation.  Through its activities, the hub must demonstrate that it is a significant scientific research resource.  Applicants should be very specific in describing the advantages of the overall hub structure, how the hub will be beneficial, and how the hub will contribute to advancing the field. The applicant should articulate how the aims of the proposed research, and research capacity-building components intersect to achieve this end. Similarly, the activities of the administrative core that will support these components should be described. This section should include a description of existing partnerships with governmental and non-governmental organizations, as well as research collaborations, that will strengthen the likelihood of uptake of the hub research activities by public health agencies in the region.

Each application must include an Administrative Core headed by the PD(s)/PI(s).  The Administrative Core is responsible for the overall administration, coordination, and management of the entire range of regional hub activities, including monitoring progress and ensuring that the project milestones are being met and implemented effectively within the proposed timeline.  A structure must be provided that has clear lines of authority to promote planning and evaluation activities as well as collaborations and interactions within, among, and between programmatic elements of the hub in an efficient and cost-effective manner.  A mechanism for internal review, decision-making, and priority-setting processes appropriate to conduct the activities of the hub must be defined.  A well-developed administrative plan is integral to the success of the hub and must be clearly defined in the application.  The administrative plan should include a discussion of the structure of the core, roles of administrative staff within the core, and lines of authority within the core.  This description should also include the training and experience of proposed staff and the functions to be performed, as well as a discussion of how the regional hub will ensure effective and timely communications between regional hub partners and NIMH staff.  The Administrative Core must provide both an organizational and administrative structure that is conducive to ensuring collaborative efforts and interaction among the hub and its partners, and appropriate integration of regional scientists into the research project.

The Administrative Core should clearly identify personnel and resources needed to oversee the hub and must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed.  Each hub must have a well delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of research, enable translation of research findings to clinical applications, and ensure a productive research effort.  The PD(s)/PI(s) is responsible for ensuring that shared scientific resources are utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team in a timely manner.  The Administrative Core should also have a research administrator who is responsible for daily administration and fiscal management.

2.  Research Component

Each application must include at least one research project on task shifting for delivery of mental health interventions.  Research topics might include, but are not limited to, the following:

NOTE: This FOA will NOT support:

3.  Research Capacity-Building Component

One goal of the CHIRMH program is to establish resources and infrastructure for research that will benefit the hub’s region. Hubs are expected to serve as local, regional, national and international research resources for established and promising investigators, and to provide opportunities for research training, career development, and mentoring, with an emphasis on fostering the career development of individuals from the hub's region who show potential for significant contributions and independent mental health research careers.  Hubs should provide opportunities for research capacity-building and use regional collaborations to take advantage of scientific opportunities that will ultimately work to decrease the mental health treatment gap. Applicants must articulate a plan for outreach, engagement, and collaboration with regional partners in research capacity-building.  As different regions may have different levels of research capacity-building and readiness for research participation, a hub’s research capacity-building component should clearly describe a principled approach to engagement and subsequent activities.

Each hub shall develop and implement a research capacity-building component for regional investigators to increase the number of qualified scientific and technical personnel capable of conducting mental health research.  Applicants shall articulate a plan for sustained research capacity-building suited to the needs of the region, which will significantly enhance the future capacity for mental health research in the region by the end of the project period.

Applicants are encouraged to develop innovative models of mentoring, career development, and research training.  Capacity-building programs may focus on the development of independent researchers by providing mentorship and supporting career development projects for graduate students, advanced post-doctoral candidates, early career faculty, or established investigators who wish to refocus their careers on mental health research.  Applicants may also direct career development and training activities to groups of individuals; for example, a regional hub may establish research training programs for community health workers, Ministry of Health employees, graduate students, clinicians and staff of regional mental health non-governmental organizations, or other technical personnel to learn specialized skills. Applicants are encouraged to incorporate multiple and varied forms of technology and distance learning opportunities to assist in their research capacity efforts and mentoring.  Applicants should provide a description of the career development and training activities that may be made available through this FOA.  Funds may not be used to support an academic degree program or clinical training activities.

Research capacity-building activities may include, but are not limited to:

Where training activities are directed toward graduate students, post-doctoral candidates or other investigators seeking independent research careers, the plan for the Research Capacity-Building Component should include and  describe the process for solicitation, submission, review, and award of career development traineeships.  Each trainee must have a mentor and trainees must devote at least six person months (50% of full-time professional effort) to the hub research project.  The Research Capacity-Building Component should support the salary and costs of candidates with outstanding potential, as well as other reasonable costs for career development and training activities.  Do not submit descriptions of individual candidate career development projects in the application.

Funds may be allocated to provide start-up funds for new, innovative pilot projects by independent investigators.  The maximum amount that can be allocated for a single pilot project is $5,000 in direct costs per year.  Because the nature and scope of pilot research projects will vary the amount allocated per pilot project may vary.  The intent of the pilot projects is to support scientific studies for short periods of time (e.g., 1-2 years) to develop preliminary data for peer-reviewed research applications.  Funds can be used to support pilot projects, feasibility studies, new or emerging research opportunities, and mental health research and/or research on task-shifting.  These projects should have the potential for developing into larger projects that could compete for funds on their own.  A process by which high-quality, innovative pilot proposals are identified by or solicited from investigators must be developed and clearly described.  The mechanism for reviewing potential projects, making funding decisions and awards, and monitoring projects to ensure effective use of pilot project funds must be clearly described.  All pilot research proposals must be administratively reviewed by and receive written approval of the NIMH Project Scientist prior to the release of funds designated for pilot research projects.  As with all research conducted under the hub's auspices, pilot projects must comply with applicable NIH policies, and the necessary human subject assurances must be submitted.  Do not submit descriptions of individual pilot projects in the application.

Funds for the Research Capacity-Building Component, not to exceed $100,000 in direct costs per year, should be included in the overall budget of the application.  All trainees should be from the hub’s geographic region.  Up to $25,000 in direct costs per year may be allocated for pilot projects for independent investigators.

NOTE: Applications without each of the above required three sections will be considered non-responsive and will not be reviewed.

Steering Committee

A Steering Committee will be established to direct the collaborative work of the awardee hubs.  All major scientific and budgetary decisions will be made by the majority of the voting members of the Steering Committee.  The PD(s)/PI(s) of each CHIRMH U19 or, in the case of a Multiple PD(s)/PI(s) award, a designated representative, as well as the NIMH Project Scientist will be members of the Steering Committee. See Section VI.2. for a full description of Steering Committee responsibilities.

Network Scientific Advisory Group

The NIMH will appoint, in consultation with the PD(s)PI(s) of the awardee hubs, a Network Scientific Advisory Group (NSAG). This group will comprise no more than seven Federal and non-Federal experts who will provide scientific advice for  the activities of the awarded projects. See Section VI.2. for a full description of the NSAG.

References

Costello, A., & Zumla, A.  (2000).  Moving to research partnerships in developing countries.  BMJ, 321, 827-829.

Demyttenaere, K., et al., (2004).  Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys.  JAMA, 291(21), 2581-2590.

Lehmann, U., Van Damme, W., Barten, F., & Sanders, D.  (2009). Task shifting: the answer to the human resources crisis in Africa?  Human Resources for Health, 7, 49. doi: 10.1186/1478-4491-7-49

Lewin, S., Mubabi-Babigumira, S., Glenton, C., Daniels, K., Bosch-Capblanch, X, van Wyk, B.E., Odgaard-Jensen, J., Johansen, M., Aja, G.N., Zwarenstein, M., Scheel, I.B.  (2010). Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases.  Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD004015. doi: 10.1002/14651858.CD004015.pub3.

Lopez, A. D., Mathers, C.D., Ezzati, M., Jamison, D.T., & Murray, C.J.L. (Eds; 2006).  Global burden of disease and risk factors.  Washington, DC: World Bank.

Samb, B., et al.  (2007).  Task shifting: An emergency response to the health workforce crisis in the era of HIV. Lessons from the past, current practice and thinking.  New England Journal of Medicine, 357, 24.

Wang, P.S., et al. (2007).  Use of mental health surveys for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys.  Lancet, 370, 841-850.

World Health Organization (2005a).  Preventing chronic diseases: A vital investment: WHO global report.  Geneva, Switzerland: World Health Organization.

World Health Organization (2005b).  Mental health atlas: 2005.  Geneva, Switzerland: World Health Organization.

World Health Organization (2007).  Task shifting: Rational redistribution of tasks among health workforce teams: Global recommendations and guidelines.  Geneva, Switzerland: World Health Organization.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIMH intends to commit approximately $1,000,000 in FY 2012 to fund up to 2 grants in response to this FOA.  Awards issued under this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Award Budget

An applicant may request up to $500,000 direct costs per year.  Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period. The total project period may not exceed five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

Each PD(s)/PI(s) must commit a minimum of 3 person months (25% of full time professional effort) conducting research and related activities specified in the application on-site where the research is based.  In the case of a Multiple PD(s)/PI(s) application, each PD(s)/PI(s) must commit a minimum of 3 person months. 

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.  Unfunded applications submitted in response to RFA-MH-11-070 are eligible to apply.  However, all submissions will be considered new due to some changes to components and budget amounts in this new FOA.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Pamela Y. Collins, MD, MPH
Office for Research on Disparities & Global Mental Health
National Institute of Mental Health
6001 Executive Boulevard, Room 8125, MSC 9659
Bethesda, MD 20892-9659
Rockville, MD 20852 (for express/courier service)
Telephone:  301-443-2847
Email: pamela.collins@nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Jean G. Noronha Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room. 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Presentation of the Application

The order of presentation should be as follows, in accordance with the Special Instructions for Multi-Component Applications:

1.  PHS 398 Form Page 1 – Face Page

2.  PHS 398 Form Page 2 – Summary, Relevance, Project/Performance Sites

3.  PHS 398 Form Page 3 – Table of Contents

4.  Composite Budget (See special instructions, below)

5.  PHS 398 Form Page 5 – Budget for Entire Proposed Project Period

6.  Biographical Sketch Format Page

7.  Resources Format Page

8.  Hub Overview and Administrative Core

     8.a. Hub Overview and Administrative Core Cover Page (see special instructions, below)

     8.b. Hub Overview and Administrative Core Summary & Key Personnel (PHS 398 Form Page 2)

     8.c. Hub Overview and Administrative Core Table of Contents (PHS Form Page 3)

     8.d. Administrative Core Budget Pages (PHS Form Pages 4 and 5; with budget justifications

     8.e. Specific Aims – 1 page

     8.f. Overall Research Objectives, Strategic Plan, & Administrative Core Management Strategy – 12    pages

9.  Research Component

     9.a. Research Component Cover Page (see special instructions, below)

     9.b. Research Component Summary & Key Personnel (PHS 398 Form Page 2)

     9.c. Research Component Table of Contents (PHS 398 Form Page 3)

     9.d. Research Component Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

     9.e. Research Component Specific Aims – 1 page

     9.f.  Research Component Research Strategy – 12 pages

     9.g. Bibliography and References Cited

     9.h. Research Component Protection of Human Subjects

     9.i.  Research Component Inclusion of Women and Minorities

     9.j.  Research Component Targeted/Planned Enrollment Table

     9.k. Research Component Inclusion of Children

10. Research Capacity-Building Component

     10.a. Research Capacity-Building Cover Page (see special instructions, below)

     10.b. Research Capacity-Building Summary & Key Personnel (PHS 398 Form Page 2)

     10.c. Research Capacity-Building Table of Contents (PHS 398 Form Page 3)

     10.d. Research Capacity-Building Budget Pages (PHS 398 Form Pages 4 and 5); with budget

              justifications

     10.e. Research Capacity-Building Specific Aims – 1 page

     10.f.  Research Capacity-Building Research Strategy – 6 pages

11. Multiple Project Director/Principal Investigator (PD/PI) Leadership Plan

13. Letters of Support (e.g., Consultants)

14. Resource Sharing Plan

15. Checklist

Special Instructions for Multi-Component Applications

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application (U19).  Additional instructions are required because the PHS398 application Form 398 is designed primarily for the traditional individual, free-standing research project grant (R01) application and several sections have to be modified and expanded so that the form can be used to provide the information needed for a multi-component project grant application.

The supplemental instructions for multi-project applications below are divided as follows:

A. General Instructions—Addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for the Hub Overview and Administrative Core—Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

C. Specific Instructions for the Research and Research Capacity-Building Components—Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398.  The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 1—Face Page

Items 1-14: Complete these items as instructed.  This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

When multiple PD(s)/PI(s) are proposed, use the Face Page-Continued page to provide items 3a-3h for all PD(s)/PI(s).  The Contact PD(s)/PI(s) should be listed on block 3 of Form Page 1-Face Page, with additional PD(s)/PI(s) listed on the Face Page-Continued.

2. Form Page 2

Using Page 2 of Form 398, provide a succinct, but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program.  Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under “Key Personnel,” list the PD(s)/PI(s) of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, and other key personnel and then other significant contributors.

3. Form Page 3—Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core.  A page reference should be included for the budget for each project component and each core.  Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and the Core should be identified by letter (e.g., Core A) and title.  The page location of a COMPOSITE BUDGET should be indicated in the “Table of Contents.”

4. Composite Budget

Do not use Form Page 4 of PHS Form 398.  Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support (Justification for budget elements should not be presented here, but in the individual budgets of the projects and core).

Start-Up Meeting

In the first year of the award, requested budgets in the Administrative Core must include funds for travel by the PD(s)/PI(s) and two additional Key Personnel (e.g., Project Leaders) to participate in a start-up meeting in Cape Town, South Africa at a location determined by NIMH staff.

Annual Meetings

Each regional hub will be responsible for hosting up to two annual meetings and attending the remainder during the life of the grant that will have the participation of 3 key staff from each of the awardee hubs, selected experts, and the Network Scientific Advisory Group (Defined in the Cooperative Agreement Terms and Conditions of Award), and appropriate NIMH staff.  These meetings are intended to identify areas of collaboration among hubs.  The focus of the meetings will include determining how the expertise, facilities, and other resources of the hubs can contribute to ongoing or new projects; sharing of data; and identifying opportunities for research involving participating hubs.  Investigators will also be expected to present their scientific progress and future plans.

For planning purposes, applicants should request funds to host two annual meetings and to attend this meeting in the other three years.  Therefore, support is requested yearly for this meeting either as a host or for attendance.  Each applicant should also budget for travel costs for the PD(s)/PI(s) and key staff (up to three persons) to attend annual meetings in the years in which they are not hosting the meeting.  At the time of award, budgets may be reduced to reflect the number of awardee sites and the funds needed to host annual meetings.  Requested budgets in the Administrative Core must include funds for either hosting or attending Annual meetings

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Research Component

 249,998

 249,998

 249,998

 225,000

 198,782

1,173,776

Project 2. Research Capacity-Building Component

 100,000

 100,000

 100,000

 100,000

 100,000

   500,000

Core A. Admin. Core.

 140,000

 140,000

 140,000

 164,999

 190,000

   824,999

Annual Meeting

   10,000

   10,000

   10,000

   10,000

   10,000

     50,000

Totals

 499,998

 499,998

 499,998

 499,999

 498,782

2,498,775

 

 

 

 





5. Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.  Detailed budgets are required within the descriptions of each project and core (see below).

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed in the application with the PD(s)/PI(s) first, followed by those of other key personnel in alphabetical order.

7. Resources Format Page

Describe the organizational resources available at each site to perform the effort proposed and how the scientific environment in which the research will be done contributes to the probability of success.  In describing the scientific environment in which the work will be done, discuss ways in which the proposed research and research capacity building will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.

8. Leadership Plan for Multiple PD(s)/PI(s) (required if applicable)

Applications designating multiple PD(s)/PI(s) for the overall hub program must include a new section, entitled "Multiple PD(s)/PI(s) Leadership Plan," as part of the Hub Overview.  This plan must describe: a rationale for choosing a multiple PD(s)/PI(s) approach; the governance and organizational structure of the leadership team and the research projects and cores; communication plans, administrative, technical, and scientific roles and responsibilities for the PD(s)/PI(s) and other collaborators.  If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD(s)/PI(s) should also be delineated.  In the event of an award, the requested allocation may be reflected in a footnote on the Notice of award.

9. Correspondence from Partners and Collaborators

A letter of collaboration or support from each partner’s participating investigators should be included in the application and co-signed by the institutional official responsible for binding the organization to such an agreement.

10. Resource Sharing Plan.  One resource sharing plan, placed at the end of the application, is to be submitted for the entire application.

11.  Checklist

One checklist, placed at the end of the application, is to be submitted for the entire application.

12. Appendix Materials

Refer to paragraph on Appendix Materials below, for instructions on submitting appendix materials. 

B. Specific Instructions for the Hub Overview and Administrative Core

Except for the requirements below, follow the instructions available in the PHS 398 in preparing each proposed core.

For the Hub Overview and Administrative  Core, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Administrative Management Strategy

1. Cover Page

The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application.  Instead, use the 398 continuation page to create a "Cover Page" containing selected data about the administrative core.  This Cover Page will demarcate the core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):

Core Letter and Core Title:  (e.g., A. Hub Overview and Administrative Core)

Name of Core Leader:  (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

            If Yes, Exemption Number, -or- IRB Approval Date (e.g., 5/14/06, or Pending), and Federal-wide Assurance (FWA) number

Proposed Period of Support

            From: (mmddyyyy, e.g., 07/01/2007)

            To: (mmddyyyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

Direct Costs (e.g., $50,000)

Total Costs (e.g., $70,000)

Costs Requested for the Entire Budget Period

Direct Costs (e.g. $212,323)

Total Costs (e.g. $297,252)

Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual.  For all other items in the core application, follow the usual PHS 398 instructions.

2. Form Page 2

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398.  In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the core using page 3 of Form PHS 398. 

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

Funding for the overall administrative efforts, including administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, and expenses associated with hosting and travel related to the annual meeting should be requested in the administrative core budget.  The application should also include a budget and plan for how research related travel and training will be organized and managed.  All travel should follow NIH travel guidelines.

5. Research Plan

Specific Aims (Limited to 1 page)

List in priority order, the broad, long-range objectives and goals of the overall program in the designated LMICs that will increase opportunities and capacity for conducting mental health research in the region.  Concisely and realistically articulate how the aims of the proposed hub research and research capacity building components intersect to achieve this end.

Research Objectives and Strategic Plan (12 pages)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 12 pages.  The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another.  This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program—by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.  As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme.  Summarize the special features in the environment and/or resources that make this application strong or unique.

Organize the Research Strategy in the specified order as stated in the PHS398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.

Each application must include an Administrative Core and must describe the overall management, coordination and supervision of the regional hub.  Provide an administrative plan discussing the structure and roles of administrative staff, including the training and experience of proposed staff and the functions they will perform; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research-related travel and training will be budgeted.  Funding for the overall administrative efforts, including administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here.  Use this section to describe how the proposed core activities will contribute to meeting the hub's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the hub’s specific aims.  In addition, this section should indicate the relevance of the administrative core to the primary theme of the multi-project application.

Milestones for the Hub, Administrative Core, Research and Research Capacity-Building Components

Each regional hub must propose milestones to measure the progress of the individual projects, as well as the hub as a whole.  Milestones should identify partnership strengthening activities, research, and research capacity-building outcomes by providing measures of success within specified timelines and across project years.  In addition to providing quantifiable program outcomes, milestones will facilitate tracking progress toward each hub’s proposed aims and objectives.  For the Research and Research Capacity-Building Components, applicants must provide well-described, quantifiable, and scientifically justified milestones for all study activities, including protocol development, development of Standard Operating Procedures, goals for data collection and analysis, obtaining clearances from in-country human subject review boards, partnership strengthening activities, research capacity building, study completion, and analysis of final study data.

Milestones should be presented via a Gantt chart or equivalent, with associated timelines and identified outcomes.  Milestones must specify the outcome(s) for each activity.  Milestones should be integrated with the overall goals of the proposed program.  Applicants should include plans for periodically revisiting and revising milestones and timelines, if needed, as new information becomes available, challenges to the proposed development path are encountered, and research outside the hub goals modifies the science proposed.

Milestones and timelines should be placed at the end of the Research Strategy for the Hub Overview and Administrative Core and fall within the page limitations for the section.

6. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the beginning of the overall application (and therefore will be referenced in the Overall Table of Contents).

C. Specific Instructions for the Research and Research Capacity-Building Components

Except for the requirements below, follow the instructions available in the PHS 398 in preparing each the research project.

For the Research and Research Capacity-Building Components include:

Cover page (See special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Strategy

1. Cover Page

The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application.  Instead, use the PHS 398 continuation page to create a “Cover Page” containing selected data about the research project.  This Cover Page will demarcate each research component (i.e., Research, Research Capacity-Building) and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Project Number and Title (e.g., 1. Research Capacity-Building)

Name of Project Leader (e.g., Jones, Roberta A.)

Human Subjects (Yes or No)

            If Yes: Exemption number, -or- IRB approval Date (e.g., 12/13/2006, or “Pending”, and Federal-wide Assurance (FWA) number

Proposed Period of Support:

            From (mmddyyyy - e.g., 07/01/2007)

            To (mmddyyyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period (e.g., 07/01/2007-06/30/2008)

Direct Costs (e.g., $150,000)

Total Costs (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2012)

Direct Costs (e.g., $700,000)

Applicant Organization (full address)

2. Form Page 2

Provide a description (abstract) of the research or research activities proposed in the component according to the instructions on Form Page 2 of PHS Form 398.  In addition, the abstract should contain a brief description of how the research project or component will contribute towards attainment of the multi-program objectives.

List the performance sites where the research or research component activities will be conducted.

Under “Key personnel” list the Project Leader followed by other key project personnel and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the research project or component using Form Pages 4 and 5 of the PHS 398.

5. Research Plan

Specific Aims (Limited to 1 page)

List in priority order, the broad, long-range objectives and goals of the individual research component (i.e., Research, Research Capacity Building).  Concisely and realistically describe the hypothesis or hypotheses to be tested.  In addition, state the individual component’s relationship to the multi-project program goals and how it relates to other components or the Administrative core.

Research Strategy

The Research Strategy section for the Research component may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.  The Research Strategy section for the Research Capacity-Building component may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.  Use this section to describe how the proposed research will contribute to meeting the hub's goals and objectives and the objectives of this FOA and explain the rationale for selecting the methods to accomplish the specific aims.  In addition to stating the significance of the research, indicate the project’s relevance to the primary theme of the application.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. 

6. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the beginning of the overall application (and therefore will be referenced in the Overall Table of Contents). 

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Is the proposed research relevant and important to the foreign [non-U.S.] countries or region?  Will the work inform the public health system or mental health policy of the foreign country?  Is the program as a whole scientifically compelling?  Are the overall program goals significant and focused on studies that increase the evidence-base for mental health interventions in low- and middle-income countries?  Is the project likely to significantly increase research capacity in low- and middle income countries?  Is the proposed project important to public health in the geographic region in which the research activities take place?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Does the PD(s)/PI(s) have experience leading a multidisciplinary team and demonstrate the ability to manage administrative functions in the region and countries in which the research will be based?  Is there substantial and appropriate integration of partner investigators into the research plan?  Do the investigators commit adequate time to successfully fulfill the proposed projects’ needs?  Does the research team include a representative from the appropriate government agency that can ensure uptake of research findings and ensure public health relevance for that setting?  Does the PD(s)/PI(s) possess the leadership skills and scientific ability to develop a program of integrated research projects with a well-defined central research focus?  Have the PD(s)/PI(s) and Project Leaders planned to devote adequate time onsite in the geographic region in which the research will take place?  Does the PD(s)/PI(s) demonstrate a strong management approach in terms of staffing, organization, communication, leadership, lines of authority, as well as the ability to manage subcontracts and consultants?  Does the PD(s)/PI(s) demonstrate the ability to coordinate, monitor, and manage all activities, including appropriate research milestones?  Are the qualifications, competence, and commitment of project leaders and key personnel appropriate?  Are there adequate methodological expertise and data management support?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Are the applicant’s overall approaches to overcoming obstacles and limitations sound and feasible?  Are the overarching hub milestones applicable to the overall program, feasible within the proposed timeframes, and integrated with the milestones for individual projects and cores?  Do the milestones present quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?  Are the proposed timelines for the initiation and completion of proposed studies appropriate and feasible?  Are there coordination and synergy of the individual research projects and core towards the achievement of the central hypothesis?  Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently?  Are the significance and/or the innovation of the individual projects enhanced by the integration into a single program?  Are there sufficient plans for communication among the individual projects?  Is there a plan for dissemination of findings to local communities and regional stakeholders? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Are the sites and/or facilities where research will be conducted within the region appropriate for the research?  Is there a process to identify, evaluate the capabilities of, and add new research sites based on the emerging needs within the geographic region?  Is there sufficient commitment of support from the research partners to carry out the proposed research?  Is the provision of resources to the research projects justified?      

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Review Criteria for the Research Capacity-Building Component

Do the project leaders have the demonstrated expertise to support the research capacity-building activities proposed in the U19 application?  Does the research capacity-building component present opportunities for building capacity throughout the geographic region rather than in a single country?

Review Criteria for an Administrative Core

Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed program?  Is the management plan for fiscal accountability and communication within the hub appropriate?  Are the plans for coordination, communications, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?  Are the experience, level of commitment, and availability of the PD(s)/PI(s) and administrative staff adequate to manage the program?  Are the training plans adequate to ensure training of local scientists in mental health research?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.   

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIMH,, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the  NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH’s purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) of the CHIRMH will have the primary responsibility for defining the research objectives, approaches, and details of the projects and core within the guidelines of the FOA and retain primary responsibility for the performance of all U19 supported research activities.  The PD(s)/PI(s) will be responsible for:

All awardees are required to perform the duties of organizer and host of an annual meeting to be attended by all awardee PD(s)/PI(s), Project Leaders, key personnel, and NIMH staff.

PD(s)/PI(s) agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIMH staff in accordance with the guidelines described under “Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.”

All awardees proposing clinical research must comply with Federal, State, and Local regulations regarding clinical research and monitoring of clinical trials, and oversee that all training requirements for the protection of human subjects are in compliance.  All clinical research performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.

The PD(s)/PI(s) will ensure that on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant.

The PD(s)/PI(s) will ensure that research and research capacity building activities conducted under this cooperative agreement employ an approach that integrates findings from translational, clinical, epidemiological and/or policy research to increase the research base for mental health interventions in LMICs.  The PD(s)/PI(s) will provide a process for assessing ongoing research and research capacity building projects and modifying, redirecting, and/or curtailing ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions within the geographic regions.  PD(s)/PI(s) will ensure the development of research-based strategies for use by government agencies, non-governmental organizations, and health care institutions to reduce the treatment gap for mental disorders.

The PD(s)/PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement.  Manuscripts shall be submitted to the NIH Program Official within two weeks of acceptance for publication and must comply with the NIH Public Access Policy (see http://publicaccess.nih.gov/).  Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIMH support.  Timely publication of major findings is encouraged.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

An NIMH Project Scientist will have substantial scientific involvement that is above and beyond the normal stewardship role in awards, as described below:

The role of the NIMH Project Scientist will be to facilitate and not to direct the activities.  It is anticipated that the NIMH Project Scientist will offer advisory input.  The NIMH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIH-supported resources and services.  The NIMH Project Scientist may provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct.  The NIMH Project Scientist may:

A Network Scientific Advisory Group (NSAG) will be appointed and supported by the NIMH to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA.  The NSAG will be comprised of no more than seven Federal and non-Federal experts selected by the NIMH to participate in NSAG activities in an advisory capacity when appropriate.  The NSAG will meet annually at the annual meeting of the Network of awardee hubs.

Additionally, an NIMH Program Official will be responsible for the normal programmatic, scientific, and/or technical aspects involved in the normal program stewardship of the award and will be named in the award notice.

An NIH Intramural scientist may not serve as the PD(s)/PI(s) of a CHIRMH, but may participate as a collaborator or consultant.  However, an intramural scientist may not receive salary, equipment, supplies, or other remuneration from this FOA.  The intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project; this amount must be specified in the letter, and cannot exceed $200,000 in direct costs of intramural resources.  The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if applicable).  For CHIRMH applications that include NIH intramural components, the involvement of intramural scientists needs to be consistent with NIH policy http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm.

Areas of Joint Responsibility Include:

A Steering Committee will serve as the governing board for CHIRMH awardees.  All participants in the CHIRMH program are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote.  Awardees under this FOA will be required to accept and implement policies approved by the Steering Committee.

Membership in the Steering Committee will include the PD(s)/PI(s) of each CHIRMH U19 award, or a designated representative in the case of Multiple PI award. The NIMH Project Scientist will be a voting member of the Steering Committee.  Each member will have one vote. 

The chair will be chosen by a majority vote of the Steering Committee, with years of service as chair determined by the committee.  The chair is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to steering committee members within 30 days of the meeting.  Virtual meetings are appropriate.  The NIMH Project Scientist may not serve as the Chair of the Steering Committee.

Steering Committee responsibilities will include:

NIMH will arrange regular Steering Committee meetings via teleconferences, and annual Steering Committee meetings in conjunction with the annual CHIRMH meeting.  The annual meeting is a forum for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among members of the CHIRMH.  Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance the CHIRMH’s overall goals.  The PD(s)/PI(s) of each CHIRMH (or a designated representative for multiple PI awards) is required to make an oral presentation on current and planned activities and projects at each annual meeting.  Each hub will be responsible for hosting at least two annual workshops during the life of the grant.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution.  A Dispute Resolution Panel composed of three members will be convened.  It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.  This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.      

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Pamela Y. Collins, MD, MPH
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2847
Email:  pamela.collins@nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3534
Email:  armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Aleisha James
National Institute of Mental Health
Telephone: (301) 451-9948
Email: hamesaleisha@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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