Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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. You must use one of these submission options to access the application forms for this opportunity.

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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

For the purposes of this NOFO, use the following definitions:

Non-Health Settings are “services beyond the health sector that deliver mental health care in non-health settings such as schools, workplaces, and prisons; and that support access to key social services such as housing, education, employment, social benefits and livelihood support” (Ref: 2022, WHO -World Mental Health Report – Transforming Mental Health for All. Section 7.1.2 and Fig 7.1)

Low and middle-income countries (LMICs) and High-Income Countries (HICs) are categorized based on the fiscal year 2025 World Bank designations (refer to World Bank Data).

Reciprocal learning involves a multidirectional flow of research advancements, necessitating the sharing of ideas and collaborative efforts. Through this process, the benefits of research innovations are extended to various contexts, communities, and populations, thereby fostering equitable improvements in health outcomes.

Chronic conditions refer to non-communicable and communicable conditions that last at least three months, remitting and recurring symptoms, and often slow progression.

Person-centric approach the management and delivery of health services so that clients receive a continuum of preventive and curative services, according to their needs over time and across different levels of the health system (WHO)

Syndemic is the aggregation of two or more concurrent or sequential disease clusters, interacting synergistically at both the population and individual levels, contributing to excess burden of disease and prognosis.

Implementation research is defined as the scientific study of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

Dissemination research is defined as the scientific study of the targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions.

Background 

Globally, over 75% of individuals requiring treatment for mental, neurological, and substance use disorders do not receive adequate/appropriate treatment/care. Mental illnesses can often coexist with other health conditions, and if left untreated, they can exacerbate the risk of developing physical ailments such as cardiovascular disease, diabetes, alcohol, and substance use disorders. Similarly, stress, anxiety, stigma, and isolation linked to communicable diseases such as Tuberculosis (TB) and COVID-19 can worsen pre-existing mental health issues or trigger new ones in affected individuals. These comorbidities are associated with reduced treatment adherence, poorer clinical outcomes, and increased risks of disability and mortality. This complex relationship between mental illness and chronic diseases involves biological, psychosocial, environmental, and economic factors. Understanding these interactions is therefore needed to effectively address both mental and co-occurring chronic health conditions.

Integrating mental health care within existing healthcare systems presents a multifaceted approach to enhancing accessibility and addressing concurrent conditions, thereby improving the overall quality and effectiveness of care delivery. While some integrated care models have shown success in managing depression and anxiety, their impact on other physical ailments remains uncertain. Exploring service delivery and community-based care approaches in LMICs could highlight successful integration strategies. In addition, analyzing factors like workforce readiness, provider procedures, and financial mechanisms is essential for expanding and maintaining these approaches.

Efforts to integrate mental health care beyond traditional healthcare settings, alongside establishing efficient referral processes, hold promise for early intervention, improved access, and cost reduction. Collaborative approaches like crisis intervention teams and mental health courts have demonstrated efficacy in various systems, including juvenile and adult justice systems. Similarly, digital health and critical time interventions have shown promise in many global settings. Non-healthcare settings, including schools, workplaces, and faith-based organizations, offer valuable opportunities for providing mental health services and strengthening the existing health systems in LMICs. By integrating mental health care across health and non-healthcare settings, and exploring effective models in various socio-economic contexts, we can optimize treatment outcomes and enhance accessibility for a wide range of mental and physical health conditions worldwide.

Research scope and objectives

This NOFO aims to support innovative implementation research focused on developing, optimizing, and testing strategies to address barriers in adopting, adapting, integrating, scaling up, and financially sustaining integrated mental health care models to improve demand, utilization, quality, access, and availability of mental health care. Additionally, this NOFO aims to strengthen the sustainable research capacity in LMICs and enhance multidirectional knowledge exchange.

The proposed project must include a research capacity building element and have significant representation of LMIC researchers as key personnel. Applicants are also encouraged to include opportunities for reciprocal learning.

For applications with a single PD/PI, the PD/PI is required to have a primary academic appointment in the LMIC institution where the study will be conducted. Applications with MPIs are required to include at least one MPI who has a primary academic appointment in the LMIC institution where the projects occur.

NIMH encourages person-centered, multidisciplinary, and multilevel approaches, focused on competency-based training, digital health technologies, and syndemic frameworks. For applications proposing a syndemic approach to implementing integrating mental health care into health care system and other community settings, applicants should operationalize the proposed framework based on appropriate methodological techniques to develop (e.g., epidemiological data, mixed methods, qualitative and ethnographic research) and evaluate (e.g., appropriated statistic methods) the impact of the syndemic model to improve mental and other clinical health outcomes. For applications proposing multi-component interventions or applying a syndemic approach, applicants should examine how different components contribute to and/or interact synergistically to produce the observed mental and clinical health outcomes. This could entail employing sophisticated data analytic techniques, modeling, structuring, harmonizing, and extracting significant features from various data streams, along with utilizing advanced computational and statistical methodologies

Applications may propose new studies or secondary data analyses. Applications proposing secondary analyses must highlight sufficiency of data for testing hypothesized pathways. Primary data collection applications must specify models, variables, and measures, aligning with the NIMH experimental therapeutics approach. Valid and reliable measures, beyond self-reports, are encouraged, spanning multiple assessment levels. NIMH encourages applicants to consider RDoC or RDoC-like constructs when defining intervention targets and outcomes, as feasible in the setting. 

Applications collecting data from multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) are expected to include plans for protecting human subjects and establish clear informed consent procedures for each participant group involved. 

Research capacity element

The proposed study must describe a detailed plan and activities to strengthen the research capacity in the LMICs where the research will take place.

Activities may include but are not limited to:

• Sharing educational platforms to strengthen and develop the expertise across research team members in different institutions and countries.
• Engaging junior and early investigators from the partner country institutions in bilateral training and exchanging knowledge for the research project.
• Support research projects as part of research training for graduate (Master's or Ph.D.) programs for trainees from LMIC institutions.
• Develop or adapt didactic implementation research training modules tailored for the specific LMIC context for training local implementers/practioners.
• When applicable, provide training for manuscripts development (including analysis, writing) as well as grant writing and grants administration.

Examples of relevant research topics include but are not limited to:

This NOFO aims to support innovative implementation research to develop, optimize, and test innovative strategies for implementing, scaling up, and financial sustainment of integrated mental health care models in LMICs.

The research supported by this NOFO include, but are not limited to studies that:

• Identify and implement optimal integration models to ensure scalability and sustainability.
• Determine the core elements of integrated mental health care models (e.g., routine screening, training/hiring case manager and consulting, disease registry) to facilitate implementation, scale-up, and sustainability.
• Develop and test implementation strategies and innovative health technologies to improve health system-, community settings-, patient-, and family-level outcomes while ensuring the quality of integration.
• Develop and test models/strategies for training, supervising, and supporting providers, including identifying the optimal functions, roles, and composition of integrated care teams.
• Test mechanisms of action/ target mediators of implementation strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of integration care models.
• Examine supply-side interventions, strategies, or policies that influence the availability or scaling-up of integration models with evidence of effectiveness in the same location where the interventions will be tested. 
• Examine the independent and complementary or synergistic effects on the mental and physical health outcome of integrated care models with multilevel interventions targeting conditions such as health system structures, community systems, health policies, and other social drivers of mental illness.

For applications involving clinical trials:

In alignment with the NIMH experimental therapeutics approach, this NOFO aims to support trials that go beyond testing intervention effects on specific outcomes to enhance our understanding of whether the intervention activates the identified change mechanisms. The goal is to reaffirm if the previously identified change mechanisms developed initially under controlled conditions can effectively translate to real-world settings (see NIMH webpage on Clinical Trials). The findings from these effectiveness trials should contribute to our understanding of the mechanisms underlying therapeutic change and remain valuable irrespective of trial outcomes. For instance, even in cases of negative results, insights into the intervention's effectiveness in engaging its intended targets can aid interpretation.

The NIMH encourages projects that test the effectiveness of preventive, therapeutic, or services interventions designed as hybrid effectiveness-implementation trials, depending on the level of existing effectiveness evidence and readiness for implementation. This NOFO promotes research that not only evaluates intervention effectiveness but also aims to study strategies to facilitate successful implementation, akin to Hybrid Type II trials. Studies that primarily focus on testing an implementation or dissemination strategy should also assess the intervention's outcomes and efficacy, as appropriate and feasible, similar to Hybrid Type III trials.

NIMH encourages studies that test intervention and service delivery strategies aimed at preventing threats to fidelity of both interventions and the implementation strategies when appropriate. Strategies to enhance scalability and sustained implementation may include consumer-facing technologies (e.g., self-administered content), provider-facing technologies (e.g., support for provider training and fidelity), expert consultation (e.g., telehealth, collaborative care), or other design elements that promote provider competence and fidelity.

Applications not responsive to this NOFO (all applications)

The following will be considered nonresponsive to this NOFO and will not be reviewed:

• Studies focused on training, supervising, or supporting providers without defined or measurable implementation outcomes for mental health services. 
• Studies proposing research primarily in High-Income Countries (HICs), including the US. 
• Studies that do not include at least one-third of key personnel from LMICs as part of the research team.
• Studies lacking a specific element focused on building research capacity.
• Studies that lack data to test the proposed pathways through secondary analyses. 
• Clinical trials that do not specify models, variables, and measures aligned with the NIMH experimental therapeutics approach.
• Studies focused on integrating chronic condition care into specialized mental health programs. 
• Studies examining the efficacy and effectiveness of new pharmacologic therapies. 
• Studies limited to descriptive analyses of disease prevalence or health systems. 
• Studies conducted exclusively in academic research laboratories, rather than in community practice settings. 
• Studies involving research-specific conditions that limit the generalizability of the findings.

Technical assistance:

NIMH will hold a pre-application informational webinar for this NOFO. Please check the NIMH Center for Global Mental Health website for webinar updates.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. 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 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply-Application Guide.

Institutions/organizations proposing a single PD/PI will be required to have a primary academic appointment in an LMIC institution.

Applications proposing MPIs will be required to include at least one PD/PI who has a primary academic appointment in an LMIC institution where the projects occur and have a contact PI from either institution.

Research projects must be conducted in the LMIC in which the single PD/PI or at least one PD/PI has a primary appointment.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

• 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: [email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

Biographical Sketch

• Detail the responsibilities and involvement level of all key personnel in the proposed research project. Non-LMIC researchers must highlight their past experience in the proposed LMIC setting or comparable LMIC settings.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

The PD/PI is encouraged to budget sufficient costs to present results of the research (in person or virtual) at a minimum of one high-caliber technical meetings, at least one of which is devoted directly to mental health research and is widely attended by other NIMH grantees. 

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Factor 1. Importance of the Research

Significance

The proposed project must:

• Assess the alignment of the integrated model with the local context, considering factors such as the current healthcare system, financial resources, community networks and infrastructure.
• Discuss the potential for dissemination into practice and policy by analyzing how well the proposed model adapts to existing service delivery arrangements, payment mechanisms, and routine service structures, while also considering public health impact.
• Articulate how the proposed research will generate novel insights into an optimal integration model and generate new knowledge for scalability and sustainability

For studies that involve clinical trials:

• Provide rationale for the model of integration by considering the estimated hypothesized effect size, such as its impact on mental and physical health outcomes as well as implementation outcomes.
• Address the potential impact of the integrated model in terms of:
  • The empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies),
  • The clinical meaningfulness of the anticipated increment in effects compared to existing approaches, and
  • Public health impact in the LMIC setting.

Innovation

When applicable, highlight the use of innovative approaches such as digital technologies, including telemedicine and telehealth, task-shifting and task sharing to optimize workforce capacity, Health Information Systems, leveraging Public-Private Partnerships to implement, scale, and sustain integrated mental health care models in the proposed study.

Factor 2. Rigor and Feasibility

Approach

• Proposed studies must include a research project and a research capacity building element.
• Provide evidence that outcome measures are valid and reliable for the proposed population(s).
• Outline the process for identifying and quantifying resources needed for implementing and scaling the integration strategy.
• As relevant, address how the study contributes to advancing the personalization of mental health care and describe the collection of clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers) that might be used to examine moderators or inform/test algorithms for more prescriptive approaches. Address plans to examine moderators and/or the potential to contribute information regarding potential moderators to larger databases.
• Detail plans to establish research partnerships with local decision-makers, including clinic or hospital administrators, government agencies, non-government organizations, and provider organizations at the study location. Partnerships with global health organizations and developmental agencies are encouraged.

Applications that will involve the acquisition of new data must: 

• Propose a culturally appropriate and feasible evidence-based mental health intervention (or a combination of evidence-based interventions), as part of the mental health service provided in the LMIC setting.
• As appropriate, propose implementation science measures applicable in LMIC settings and incorporate outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., functioning, health services use).
• In the case of studying the integration of mental health care into health care systems, target and assess outcomes from more than one mental condition (e.g., depression, bipolar disorder, generalized anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorders, and/or schizophrenia AND one or more physical or chronic diseases which could include but are not limited to substance use disorders, neurological disorders, metabolic diseases, hypertension, cardiovascular disease, chronic respiratory disease, cancer, HIV, tuberculosis, neglected tropical diseases, and COVID. The use of a transdiagnostic approach is encouraged, and implementation outcomes are required.
• In the case of studying the integration of mental health care into non-health settings, target and assess outcomes from one or more mental health conditions AND one or more outcomes relevant to the setting where integration takes place (e.g., academic performance if studying integration into schools). Implementation outcomes are required. 
• In the case of studying supply-side interventions to scale up integration models with established evidence of effectiveness, target and assess provider and/or system outcomes, mediators, or moderators that earlier studies have already identified as critical to the implementation of said model.
• Propose (1) an economic evaluation with two perspectives of analysis: a) societal perspective and b) health care perspective or from the perspective of the social sector where the integration takes place, and (2) a budgetary impact analysis.

Applications proposing multi-component intervention and or syndemic approach studies must:

• Describe how different intervention components contribute to and/or interact synergistically to produce the observed outcome (mental and physical health outcomes, implementation outcome).
• Describe how the application applies appropriate methodological techniques to operationalize the syndemic framework to develop and evaluate the impact on mental and other clinical health outcomes or other relevant social outcomes depending on the social sector where the integration takes place.

For applications proposing research involving secondary analyses of existing data sets must:

• Demonstrate the sufficiency of existing data sets in quantity and quality to test hypothesized mediational pathways or generate new hypotheses.
• Demonstrate that the data are available and accessible.

Advisory Board:

Applicants are expected to propose an Advisory Board with detailed plans that include the board's structure, roles, and budget justification. The plan should emphasize stakeholder engagement— including patients, family members, community members, advocates, peers, healthcare providers, and policymakers— throughout all phases of the project, from design to dissemination. It should also outline how the advisory board will contribute to the research and ensure its relevance and usefulness to end-users. The application should outline the areas of scientific expertise needed, the anticipated input from the board, and key considerations for selecting members. Note that advisory board members should not be collaborators or consultants on the proposed project. The application should include a schedule for the Advisory Board meetings during the project period and the PD/PI should include on the advisory board’s activities in annual progress reports.
 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this Notice of Funding Opportunity (NOFO) are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. For more guidance on submitting data to NDA, refer to the NDA Data Management and Sharing Plan on the NDA website.   NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

 Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage 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.

NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Management and Sharing for Applicants and Awardees.

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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review 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 will receive a written critique.

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.

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial’s data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Vidya Vedham, Ph.D.
National Institute of Mental Health (NIMH)
Email: [email protected] 

Leonardo Cubillos, MD, MPH
National Institute of Mental Health (NIMH)
Email: [email protected]

Mark Parascandola, PhD, MPH
National Cancer Institute (NCI)
Phone: 240-276-6871
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-811
Email: [email protected]

Dawn M. Mitchum
National Cancer Institute (NCI)
Phone: 240-276-5699
Email: [email protected]

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.

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 2 CFR Part 200.