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)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Implementation Science for the Prevention and Treatment of Mental and/or Substance Use Disorders in Low- and Middle-income Countries (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-MH-17-650

Companion Funding Opportunity

None

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

 93.242, 93.279 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits grant applications to address implementation research questions facing World Bank designated low- and middle-income countries (LMICs) and previously designated LMICs re-categorized as high income on or after January 1, 2011, in their efforts to deliver sustainable, evidence-based interventions for the prevention, early intervention, and treatment of mental and/or substance use disorders in women, men, and children. Each awarded project is to conduct implementation research 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 network for mental and behavioral health implementation research in low-resource settings with capabilities for answering research questions about delivering interventions, sustaining high-quality care in resource-limited settings, and fostering evidence-based policy and program development for preventing and/or treating mental and/or substance use disorders. This program is not intended to support research that can be conducted primarily in and/or by the United States or other high-income country institutions that do not meet eligibility criteria.    

Key Dates

 

Posted Date

December 23, 2016

Open Date (Earliest Submission Date)

March 7, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

April 7, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted under this FOA.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

September 2017

Advisory Council Review

January 2018

Earliest Start Date

New Date: April 2018 as per issuance of NOT-MH-17-012

Expiration Date

April 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) 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. 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the 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) and the National Institute on Drug Abuse (NIDA), in collaboration with the Global Alliance for Chronic Diseases (GACD), invite applications that develop implementation research on evidence-based interventions for mental and/or substance use disorders (e.g., psychotherapeutic interventions, psychopharmacologic interventions, prevention, treatment, rehabilitation) for child, adolescent, and adult disorders including, but not limited to, depression, psychosis, bipolar disorder, and substance use disorders, etc., in World Bank designated low- and middle-income countries (LMICs) and previously designated LMICs re-categorized by the World Bank as high-income on or after January 1, 2011. Countries reclassified as high-income (from LMIC) in the past five years continue to have low-resource regions and population sub-groups similar to those in LMICs and, consequently, are eligible for this Funding Opportunity Announcement (FOA). Throughout the rest of this FOA, the term LMIC is used to denote countries currently designated as LMIC plus those countries designated LMIC prior to January 1, 2011, that have since been re-categorized as high-income by the World Bank.  Note that NIMH and NIDA do not support research exclusively focused on alcohol use disorders, so applications solely focused on alcohol use disorders will be deemed non-responsive to this FOA and will not be reviewed.

The GACD is a partnership among research funding agencies in twelve countries and the European Commission focused on tackling the world's most pressing global health challenges - especially the emerging tide of chronic, non-communicable diseases. GACD funding agencies, including the U.S. National Institutes of Health (NIH), work together in selecting research focus areas, issuing calls for applications, organizing peer review of applications, and facilitating collaboration and joint learning across awardees globally. This NIH FOA is part of the fourth joint GACD call for applications, which focuses on implementation research on evidence-based interventions for mental and/or substance use disorders. Applicants may apply to the FOAs of individual GACD funding agencies, such as this FOA from NIMH and NIDA, of the U.S. NIH. The total investment by all GACD funding agencies in this fourth joint research venture on mental and substance use disorders is expected to be about USD $60 million.

The proposed research is to take place in a World Bank designated LMIC or LMICs. The research is to be designed and planned in collaboration with government agencies, non-governmental organizations, and health care institutions in the research site(s) so as to be responsive to local needs, interests, and capacities. Further, the research is to align with the designated country’s, region's, or local jurisdiction's existing or planned efforts to implement services for mental and/or substance use disorders. The products of the proposed research are expected to provide participating countries, regions, or local jurisdictions with the knowledge, tools, and strategies needed to maximize the positive effects of mental health and/or substance use interventions, to scale up services to a wider population, to sustain delivery of evidence-based care for mental and/or substance use, and/or to foster evidence-based policy and program development for meeting the needs of individuals with mental and/or substance use disorders.

Efforts to make evidence-based health care for mental and/or substance use disorders equitably available at a national, regional, or local level require both infrastructure and partnerships, especially 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 FOA is to support research partnerships and activities in LMICs that will stimulate implementation research and thereby increase the evidence base for sustainable delivery of preventive, early intervention, treatment, and rehabilitative services for the care of people with and at risk for mental and/or substance use disorders in resource-limited settings.  

As a group, awardees funded by all GACD partners under this joint GACD initiative will constitute a network for implementation research with capabilities for answering research questions about the delivery of evidence-based prevention, early intervention, treatment, and care for mental and/or substance use disorders in resource-limited settings, and fostering evidence-based mental health and/or substance use policy and program development on a lasting basis.  Awardees funded by all GACD partners will exchange research findings and information by means of cross-project working groups and annual joint meetings that will be organized by the GACD.

Background

Mental and behavioral health are integral parts of health as underlined in the World Health Organization (WHO) definition of health as a 'state of complete physical, mental and social well-being and not merely the absence of disease or infirmity'. Mental and substance use disorders cause tremendous suffering for individuals, families, communities, and societies. They also increase risk for co-morbidities and social exclusion. There are obstacles to achieving effective prevention, early identification, early intervention, treatment, and management of mental and substance use disorders and to ensuring individuals' adherence to therapies. Effective management approaches exist but their implementation in low-resource settings is hampered by demographic, socioeconomic, and other contextual factors that affect access to care. These impediments may include, among other things, disparities based on gender, age, or race/ethnicity; the stigma associated with these disorders in the workplace, in health care, and in communities; circuitous pathways to care for mental and substance use disorders; and limited communication between traditional and biomedical practitioners. There is a need to strengthen the evidence base on implementation of scalable interventions of proven effectiveness in order to promote mental and behavioral health, identify individuals in need of care early in the disease process, intervene early to preempt disease progression, and treat and manage their illness and care - all while taking into account the varying needs of different population groups across the life course.

The Grand Challenges in Global Mental Health initiative identified the implementation of prevention and early intervention, plus the expansion of early access to effective services for mental and substance use disorders, as major challenges worldwide. The WHO's comprehensive Mental Health Action Plan 2013-2020 has set a goal for increasing service coverage for severe mental illnesses 20% by the year 2020. The treatment gap (i.e., the proportion of persons who need, but do not receive care) for mental and substance use disorders exists globally, and collateral issues in low-resource settings make closing the treatment gap especially challenging. The need for rigorous health services research focused on mental and substance use disorders is great, and in the global context, research activity in this area is disproportionately lower than for other areas of health. At the same time, financing for mental health and substance use disorders is insufficient. These situational factors require innovative solutions for the delivery of sustainable evidence-based services for mental and substance use disorders in low-resource settings.

Recent policy shifts and growing evidence of the efficacy, cost-effectiveness, and successful delivery of a range of services for mental and substance use disorders in low-resource settings have set the stage for larger-scale efforts to reduce the treatment gap in these contexts. Multiple randomized clinical trials involving multiple LMICs have demonstrated the effectiveness of various 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. Moreover, the use of lay health workers to provide care to individuals with common mental illnesses appears to be both cost-effective and cost-saving. However, few of these innovations are delivered with sufficient breadth and depth to benefit large populations or large geographic areas in LMICs. Services for mental and substance use disorders in LMICs are often limited and fragmented, lacking in scientific evidence of their effectiveness, and poorly aligned with the cultural contexts in which they are implemented.

In attempting to remedy this situation, the WHO and, increasingly, LMICs themselves are promoting programs and policies to expand services for individuals with mental and substance use disorders. Various countries in Asia, Africa, and Latin America have responded to the WHO’s challenge to expand service coverage by developing or revising their mental and behavioral health policies; others are following suit. Taken together, emerging evidence-based interventions, increasing awareness of need, and mounting political will have created a range of fruitful research contexts in which to ask and answer critical questions about how to implement, scale up, and sustain high-quality mental and behavioral health services and how to foster and sustain evidence-based mental and behavioral health policy and program development in low-resource settings globally.

Research Scope and Objectives

The objective of this FOA is to stimulate and support research partnerships that will conduct implementation research on closing health services gaps through expanded efforts to prevent, preempt, treat, manage, and otherwise minimize disability due to mental and substance use disorders. These partnerships and associated activities may take place in any of six geographic regions:  East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, and Sub-Saharan Africa. 

Each application must propose an implementation research study focused on an aspect of implementing, scaling up, or sustaining evidence-based interventions to prevent or treat mental and/or substance use disorders at the national, regional, or local level within designated LMIC(s). The study should include assessment of implementation costs as an integral part of the proposed research.  The study should also be designed to inform understanding of key mediators/mechanisms of action of the implementation, scale-up, or sustainment effort. Applicants proposing to conduct a clinical trial of mental health care under this FOA must adhere to NIMH's new requirements for clinical trials research.  See: http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml.

Relevant research topics include, but are not limited to, research that:

  • Tests the effects of local and national policies/guidelines designed to achieve equitable access to and quality and outcomes of services for mental and/or substance use disorders across population subgroups (e.g., women, poor, rural, racial/ethnic minorities) in designated communities, cities, or provinces/states.
  • Examines the implementation and impact of structural interventions (i.e., interventions that alter the social, economic, and/or political environments in ways that increase availability, acceptability, and/or accessibility of health care) designed to prevent, preempt, treat, and/or manage mental and/or substance use disorders. 
  • Examines implementation models and measures of care quality and outcomes that produce the best results for:

o   Delivering evidence-based interventions for early identification and treatment of mental and/or substance use disorders

o   Scaling up of training and supervision for providers of health services (including non-specialist health workers) for mental and/or substance use disorders

o   Integrating screening for mental illness and/or substance use and core packages of care for mental illnesses and substance use into existing delivery platforms (e.g., primary health care, schools, HIV service delivery systems, work places, etc.)

o   Delivering transdiagnostic interventions for mental and substance use disorders in health sector and non-health sector settings

  • Assesses which data collection and feedback models are most effective for monitoring the reach, accessibility, quality, costs, and/or effectiveness of preventive, treatment, or rehabilitative health services for mental and/or substance use disorders in a given service delivery system (e.g., how  models enable data-driven decision-making for optimal delivery of care)
  • Tests which systems- or community-level strategies are most effective in nontraditional mental health care settings (e.g., workplaces, faith-based settings, schools, etc.) to identify, support, and monitor the effectiveness of preventive and treatment interventions for individuals with mental illnesses and substance use disorders (e.g., using technology and other approaches)
  • Tests the implementation of evidence-based models of peer-delivered or caregiver-delivered support for people with mental and substance use disorders in low-resource settings
  • Tests the implementation of low-cost, technologically-assisted strategies for supporting providers, delivering care, and/or supporting adherence or engagement with treatment in low-resource settings
  • Tests implementation strategies to enhance the delivery of prevention or treatment services, including effective pharmacotherapies for mental disorders and substance use conditions, in justice and social service settings

NIMH and NIDA aim to stimulate and support research that results in a valid evidence base about effective health services for all groups and serves to inform our understanding of disparities based on gender, age, race/ethnicity, and other domains of inequity. This first requires inclusion in research studies of adequate numbers of males and females and members of racial/ethnic minority groups in order to detect gender and race/ethnic differences. Analysis of these data can expand our understanding of differences and disparities in receptivity to prevention and treatment intervention, in access to and engagement in care, and in response to care and outcomes of care. To the extent possible given the proposed study context and population, applicants should address disparities in accessibility, use, or outcomes of services due to gender, age, race/ethnicity, or other domain of inequity. 

NIMH and NIDA encourage research activities that leverage other service delivery systems or platforms (e.g., HIV care and treatment, maternal and child health care, education, justice, work places) for delivering evidence-based services for mental and/or substance use disorders. Note, however, that research on mental and/or behavioral health services exclusively for HIV+ populations will be considered non-responsive to this FOA. Similarly, research on services exclusively for alcohol use disorders will be considered non-responsive to this FOA.

NIMH and NIDA also encourage the use and enhancement of existing, sustainable data bases, where possible, in answering study questions.

The NIMH, NIDA, and other GACD funding agencies will work together with all awardees to harmonize the research and outcomes assessments of funded projects in order to maximize learning across the network and the impact of the joint GACD initiative as a whole. Accordingly, applicants are expected to propose the use of indicators and measures of project context, reach, outcomes, and scale-up potential in their plans and protocols. The GACD will facilitate harmonization of indicators and measures of these factors during cross-project working groups and annual joint meetings that the GACD will organize and that all awardees are expected to attend. .

Proposed studies should include all of the elements below:

  • Research must be conducted in World Bank- or World Health Organization-designated LMICs in one of the following geographic 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
  • Collaboration among one or more academic institutions, government agencies, non-governmental organizations, and health care institutions in the research site(s) to (a) design and plan the proposed research, and (b) develop a strategy for incorporating positive findings into policy and practice.
  • Implementation research - including hybrid effectiveness/implementation study designs - on delivering, scaling up, or sustaining the delivery of evidence-based interventions (e.g., psychotherapeutic interventions, psychopharmacologic interventions, prevention, treatment, rehabilitation) to prevent or treat mental and/or substance use disorders.
  • Evidence that the proposed research is responsive to local needs, sociocultural and economic contexts, interests, and capacities.
  • Implementation research design that will inform understanding of key mediators/mechanisms of action of service delivery, scale up, or sustainment.
  • Assessment of the implementation costs of service delivery, scale up, or sustainment.
  • Use of indicators and measures of project context, reach, outcomes, and scale-up potential.

Applications that are not responsive to this FOA and will not be reviewed include those that:

  • Propose research to be conducted primarily in and/or by United States or other high income country institutions that do not meet the eligibility criteria.
  • Propose research on the scale up of mental health and/or substance abuse services exclusively for HIV+ populations.
  • Propose research on health care services exclusively for alcohol use disorders.
  • Do not propose or provide evidence of collaboration among one or more academic institutions,  government agencies, non-governmental organizations, and health care institutions in the research site(s) to (a) design and plan the proposed research, and (b) develop a strategy for incorporating positive findings into policy and practice.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025).  The application’s Protection of Human Subjects section should reflect the policies and guidance in this notice and should be consistent with the NIMH and NIH policies as well as federal regulations. Describe key features of a safety monitoring plan including plans for efficient IRB review and approval, including the use of single IRB models when multiple clinical sites are planned (see NOT-OD-16-04 and NOT-OD-16-109 for NIH policy on single IRB use). 

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

 Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2018:

NIMH, $2,500,000, 3-4 awards

NIDA, $500,000, 1-2 awards

Award Budget

 Application budgets are limited to $425,000 direct costs per year and need to reflect the actual needs of the proposed project

Award Project Period

 The scope of the proposed project should determine the project period. The maximum project period is 5 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

Other

  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

Eligible organizations must be in (a) a LMIC, as defined by The World Bank, or (b) those countries designated LMIC prior to January 1, 2011, that have since been re-categorized as high-income by the World Bank.  This includes research institutions in these countries.  US and other high-income country institutions may participate as collaborators but may not be the grantee organization.

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:


Email: nimhreferral@mail.nih.gov 

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

Cover Letter: All applicants interested in consideration for funding and participation in this GACD aligned network must indicate in the cover letter their willingness to participate in this global competition and to submit a duplicate version of the NIH application to the GACD Secretariat.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

As a group, awardees funded by all GACD partners under this joint GACD initiative will constitute a network for implementation research. GACD will organize and lead the network, arranging cross-project working groups and annual joint meetings that all awardees are expected to attend.  Accordingly, applicants must budget for annual costs of having two team members participate in one annual face-to-face meeting of the GACD network for implementation research (location to vary annually). Attendance at this meeting is required for two team members from each funded project, with at least one participant from the LMIC team where relevant. Teams are strongly encouraged to include one junior team member in each annual meeting.

Applicants should also budget for the annual costs of two team members attending the annual Global Mental Health workshop that NIMH hosts in collaboration with Grand Challenges Canada each year.  The Global Mental Health workshop is held in Washington, DC, or in a city in Canada, on a rotating basis. Each awardee (i.e., all PDs/PIs at a minimum) should plan to attend the annual Global Mental Health workshop during the life of the award. For planning purposes, applicants should request funds to attend this workshop for all years of the award.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Research Strategy:

  • Provide a concise description of the aims for the implementation research study to be conducted. Explain how the study addresses a particular aspect of delivering, scaling up, or sustaining one or more evidence-based interventions to prevent or treat mental and/or substance use disorders at the national, regional, or local level within a designated LMIC(s).  Provide evidence that the proposed research is responsive to local needs, sociocultural and economic contexts, interests, and capacities. 
  • Propose the use of indicators and measures of project context, reach, outcomes, and scale-up potential. The study should also include assessment of implementation costs as an integral part of the proposed research. 
  • Describe how the study is designed to inform understanding of key mediators/mechanisms of action of the implementation, scale-up, or sustainment effort.   Note that applicants proposing to conduct a clinical trial of mental health care under this FOA must adhere to NIMH's new requirements for clinical trials research.  See: http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml.

A Timeline and Milestones section must be included for the implementation study, describing the expected progression of activities and milestones specific to the research. The milestones should be regarded as criteria for evaluating the progress and direction of the study and should not be just a restatement of the specific aims. During the project period, awardees will be expected to refer to these milestones in annual progress reports. Milestones must specify the outcome(s) for each activity and should be presented via a Gantt chart or equivalent. Applicants should include plans for periodically revisiting and revising the timeline and milestones, if needed, as new information becomes available, challenges are encountered, and research outside the study goals modifies the science proposed.  The timeline and milestones should be placed at the end of the Research Strategy and fall within the page limitations for the section.

Letters of Support: Include letters of resource support specific to the implementation study, including support provided by the applicant institution and partner organizations and which will enhance the potential for success. Examples of such support would include (but are not limited to): institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as assurances that partner organizations are committed to providing these resources to the implementation study should be included in this section. Also include individual letters of commitment to the partnership specific to the implementation study by all other partners and consultants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

 Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

This NIMH FOA represents NIH participation in the Global Alliance on Chronic Diseases (GACD) program initiative on mental health http://www.gacd.org/funding/calls-for-proposals/mental-health. As a result, additional application submission procedures are required.   Instructions for GACD submission will be provided to applicants and added to the above website as soon as they are available. The GACD Secretariat has data security and confidentiality systems in place. However, applicants should be aware that submission of this application to the globally coordinated GACD competition will conceivably increase the possibilities that application contents may become available more widely than is the case when restricted to the NIH data systems. NIH may share information about the application submitted to the NIH and the outcome of review with the GACD agencies. 

Note that across the GACD network there are multiple funding agencies receiving applications for this coordinated program on mental health.  However, you may not submit an application for the same project to multiple GACD funding agencies.  The required submission of a copy of your NIH application to the GACD Secretariat is NOT considered to be submission of the same project to multiple funding agencies.  Rather, submitting a copy to the GACD Secretariat will facilitate collaboration across the various GACD funding agencies. The GACD Secretariat in collaboration with the funding agencies, will screen the applications for multiple submissions, and only one will be advanced to peer review and consideration for funding. 

Use of Common Data Elements in NIH-funded Research

NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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

Reviewers will provide an overall impact 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

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? Is there a strong scientific premise for the project? 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?

Does the application propose to conduct implementation research on delivering, scaling up, or sustaining the delivery of evidence-based interventions (e.g., psychotherapeutic interventions, psychopharmacologic interventions, prevention, treatment, rehabilitation) to prevent, preempt, treat, manage, or otherwise minimize disability due to mental and/or substance use disorders?   

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Are the PD(s)/PI(s) adequately prepared to work in a global context?  Does the application propose or provide evidence of a collaboration among one or more academic institutions, government agencies, non-governmental organizations, and health care institutions in the research site(s) to (a) design and plan the proposed research, and (b) develop a strategy for incorporating positive findings into policy and practice? 

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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application provide evidence that the proposed research is responsive to local needs, sociocultural context, interests, and capacities?

Is the proposed research designed to inform understanding of key mediators/mechanisms of action of the implementation, scale-up, or sustainment effort?

Does the proposed research include an assessment of the implementation costs of service delivery, scale up, or sustainment?

Does the proposed research include indicators and measures of project context, reach, outcomes, and scale-up potential in their plans and protocols? 

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?   

Additional Review Criteria

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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 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)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 NIH in coordination with the GACD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. 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 appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 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:

  • Define the details for the project within the guidelines of this FOA.
  • Oversee and perform the scientific activities.
  • Administratively manage the grant.
  • Accept close coordination, cooperation, and participation of NIH Program staff in the scientific, technical, and administrative management of the grant. Inform the NIH Program Official of all major interactions with other members of the GACD.
  • Provide milestones and cost for the grant to the NIH Program staff as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by the Program staff).
  • Work with NIH Program staff, GACD representatives, and other awardees globally to harmonize the research and outcomes assessments of funded projects in order to maximize learning across the network and the impact of the joint GACD initiative as a whole.
  • Ensure that the products of the production effort meet the quality standards.
  • Share data and resources according to the data release and resource sharing policies developed for and by this project as appropriate and consistent with achieving the goals of the program.
  • Not disclose confidential information obtained from other members of the GACD implementation science network.

Adhere to NIH policies regarding intellectual property and other policies that might be established during the course of this activity. Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • A NIMH/NIDA Project Scientist will be substantially involved in the grant project, providing technical assistance, advice, coordination, and/or other functions above and beyond the usual level of scientific stewardship for grants. This level of staff involvement does not alter the awardee’s dominant role and prime authority in conducting the activity (see NIH Manual 1820). Specifically, the NIMH/NIDA Project Scientist will be responsible for coordinating selected tasks of the NIMH-supported network of awardees, including assisting in (a) the GACD organization and leadership of cross-project working groups and annual joint meetings that all awardees are expected to attend; (b) harmonization of research and outcomes assessment in order to maximize the potential for learning across the network and the impact of the initiative as a whole; (c) regular exchange of research findings and information across awardees; (d) committees (other than peer review) as a voting member as needed (the chairperson will be someone other than an IC staff member) or in other functions responsible for helping to guide the course of long-term projects or activities; and (e) the presentation of research results, including publications from the project.  The NIMH/NIDA Project Scientist may not attend peer review meetings of Renewal or Revision applications unless IC waiver obtained per IC procedures for management of concern about bias.
  • Additionally, a NIMH/NIDA Program Official, who is a separate and independent staff member from the Project Scientist, will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The Program Official will:
  • Enforce general statutory, regulatory, or policy requirements;·       
  • Approve the awardee plans prior to award and review of performance after completion;
  • Evaluate progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award;
  • Provide technical assistance to correct programmatic or financial deficiencies in awardees' performance;
  • Participate in scientific/technical discussions with awardees, or actions to facilitate or expedite interactions between awardees, e.g., organizing and holding meetings of investigators;

Areas of Joint Responsibility include:

  • Awardees, NIMH/NIDA Program Official and Project Scientist, in collaboration with the GACD Secretariat and the larger scientific will share responsibilities for planning and conducting cross-project working groups and annual joint meetings (described above).  The annual joint meeting is a forum for awardees to provide the latest update on their research, exchange ideas and information, and discuss collaborations. Meeting participants will identify the group's tangible resources, capabilities, and needs to advance the initiative's overall goals. The PD/PI of each (or a designated representative for multiple PD/PI awards) may be required to make an oral presentation on current and planned activities and projects at each annual meeting.
  • Awardees, NIMH/NIDA Program Official and Project Scientist, GACD representatives, and other awardees globally will jointly harmonize the research and outcomes assessments of funded projects in order to maximize learning across the network and the impact of the joint GACD initiative as a whole.
  • If the PD/PI determines workgroups are needed to oversee specific aspects of an individual project, all workgroups will include the NIMH-Project Scientist and additional members from the scientific team of the grant, consultants, and NIH staff as needed to ensure project success. Work groups will meet as needed and will produce minutes and progress reports for circulation to the project team.

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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Recruitment Reporting and Trial Registration

NIMH requires reporting of recruitment milestones for participants in all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size (seehttp://grants.nih.gov/grants/guide/notice-files/NOT-MH-16-013.html).  While research in response to this FOA might not seek 150 subjects or more (the level at which this reporting has been required), all trials funded under this FOA must report recruitment milestones, including those with fewer than 150 subjects. This expectation will be stated in the notice of grant award. 

The NIMH expects the registration and results reporting for all NIMH-supported clinical trials, regardless of whether or not they are subject to FDAAA (see http://grants.nih.gov/ClinicalTrials_fdaaa/at-a-glance.htm). This expectation will be stated in the notice of grant award

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-710-0267

Scientific/Research Contact(s)

Beverly Pringle, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email: bpringle@mail.nih.gov


Tisha R. A. Wiley, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone:  301-594-4381
Email: tisha.wiley@nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.

National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstada@mail.nih.gov

Rene Etcheberrigaray, M.D.
Center for Scientific Review (CSR)
Telephone:  301-435-1111
Email:  etcheber@csr.nih.gov 

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6695
Email: mconnell@nida.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 Part 75.

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