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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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

Purpose

The purpose of this Notice of Funding Opportunity Announcement (NOFO) is to encourage formative research and pilot testing of culturally appropriate preventive and therapeutic interventions to detect and reduce the risk of suicide ideation and behavior (SIB), and/or non-suicidal self-injury (NSSI) across the life span in low- and middle-income countries (LMICs). The research resulting from this NOFO is anticipated to contribute to the long-term goals of strengthening the sustainable research capacity in LMICs.

Background

Suicide represents a critical issue in global public health, significantly adding to the overall burden of disease and affecting several age groups. Annually, approximately 700,000 individuals succumb to suicide, reflecting a global age-standardized rate of 9.0 per 100,000 people. Nearly one-third of suicides occur among young individuals, aged 15–19, and it remains the fourth leading cause of death in this age group. Similarly, suicide rates are notably higher among those aged 50–69 (16.2 per 100,000) and those aged 70 and above (27.4 per 100,000), underlining its prevalence across the lifespan.

Approximately 77% of the suicides reported occur in LMICs, where majority of the world's population resides. However, the actual suicide rate in LMICs is likely higher than reported due to the absence of comprehensive national suicide surveillance systems and reporting systems. Factors such as stigma, religious beliefs, and local laws may further contribute to under-reporting of suicides and suicidal behavior within these regions.

Moreover, our understanding of the underlying factors contributing to higher rates of suicide in LMICs remains incomplete. Healthcare system barriers, economic instability, societal discrimination, community/ social isolation, interpersonal violence, and individual trauma all contribute to the development of effective suicide prevention strategies tailored to different contexts. Understanding protective and risk factors for suicide is critical for prevention and intervention.

It is imperative to investigate the integration of culturally tailored preventive strategies at both the population and individual levels. Additionally, there is an urgent need to develop service interventions that target a range of risk and protective factors across broad health and non-health contexts.

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

R34 Pilot Studies: R34 pilot projects, as defined by the NIH, are small-scale research or clinical trials aimed at gathering preliminary data to evaluate the feasibility, safety, and potential efficacy of interventions. These projects inform the development of larger research initiatives and are funded to support planning and implementation phases. The pilot studies do not definitively establish efficacy but provide evidence to justify further investigation. These pilot projects do not assess generalizability to broader populations or settings. Please refer to NIH website for additional guidance.

Preventive interventions: Actions or approaches taken to minimize or stop the development of symptoms prior to their onset.

Suicidal behavior: Suicide ideation (frequent thoughts of ending one's life), suicide attempts (the actual event of trying to kill oneself), other preparatory acts, and suicide death.

Other suicidal behavior and preparatory acts: Includes behavior or acts beyond a verbalization or thought, such as assembling a method (e.g., buying a gun, collecting pills) or preparing for one's death by suicide (e.g., writing a suicide note, giving things away).

LMICs and HICs: are defined according to the fiscal year 2024 World Bank designations of low- and middle-income countries (LMICs) and high-income countries (HICs) respectively (see World Bank Data Helpdesk webpage).

Non-Health Settings: “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)

Research Scopes and Objectives

This NOFO seeks to support research aimed at refining and testing culturally adapted sustainable approaches and interventions to mitigate the risk of self-injurious behavior (SIB) and/or non-suicidal self-injury (NSSI) across life span in LMICs. 

Opportunities to detect and prevent suicide, SIB, and/or NSSI risks in individuals across their lifespan may arise in diverse healthcare and non-healthcare environments. Recognizing the significance of cultural, social, and contextual influences, interventions should address factors at the individual, family, community, provider, and organizational levels to enhance effectiveness, feasibility, acceptability, rapid implementation, and ongoing delivery.

This NOFO supports pilot projects that develop and test new interventions, adapting existing ones, or exploring innovative approaches and technologies for suicide prevention. Hence, it is critical to gather initial data on feasibility, acceptability, implementation costs, and seek input on interventions from the intended recipients. Applications aiming to adapt existing interventions must be supported by: (a) theoretical and empirical basis for adaptation that must address issues related to non-response, partial response, and participant disengagement when necessary; (b) a clear explanation of how a moderator variable affects a subgroup either positively or negatively; and/or (c) evidence indicating that the adapted intervention leads to significant improvements in aspects of care or adoption within community or practice settings when compared to existing methods.

Pilot studies for this NOFO should be designed to lay the groundwork for future investigations into the effectiveness and implementation of intervention strategies aimed at detecting risks, engaging individuals in care, and assessing the reduction of self-injurious behavior (SIB) and/or non-suicidal self-injury (NSSI) within targeted populations in LMICs. Preliminary evaluations of feasibility, usability, acceptability, and cost are essential components for proposed pilot studies. These evaluations are critical for highlighting the mechanisms of action of interventions within their specific contexts that can inform successful implementation and long-term sustainability.

Various methodologically rigorous approaches, including randomized controlled trials (RCTs), quasi-experimental designs with non-randomized comparison groups, time series designs, and equivalents of rigorous relevance, can be used in these proposed studies. However, in the case of pilot R34s, there isn't an expectation to conduct fully powered tests of outcomes or strive for an estimate of effect size feasibility.

Pilot studies should be crafted to not only assess feasibility but also to scrutinize the viability of the research design for a subsequent, adequately powered investigation of the intervention strategy, potentially involving the assessment of randomization feasibility. These studies must meticulously address practical and local constraints, ethical considerations, and importantly, contribute to understanding the generalizability and sustainability of the research within the context.

Research collaborations with diverse local stakeholders, such as grassroots organizations, clinic or hospital administrators, government agencies, non-governmental organizations, and provider groups in LMICs are encouraged. Partnerships with global health organizations and developmental agencies are encouraged.

For clinical trial applications: The scope of work should be formulated following NIMH requirements for clinical trials (see: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml) and should address the following elements: 1) empirical/conceptual basis for the selection of the proximal targets of the implementation strategy, 2) plans for assessing preliminary changes in those proximal targets, and 3) plans for preliminary examination of whether changes in the targets are associated with more distal changes in clinical and functional outcomes that contribute to reducing disparities.

Applications must specify the models, variables, and measures used to identify and test potential pathways and mechanisms that may account for changes in key outcomes. Proposed studies should be consistent with the NIMH experimental therapeutics approach. Pilot testing of the validity of intermediate mechanisms of change measures will provide helpful information about pathways and mechanisms that may account for intervention effects. Accordingly, applicants should use the most direct and objective measures possible in the study setting, including validated mental and physical health measures beyond self-reports and other subjective measures, where possible, and include measures that span more than one level of assessment if possible and appropriate.

Applications with data collection plans involving multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups.

Examples of Relevant Research Topics:

The general scope of the research includes, but is not limited to:

• Pilot studies aimed at developing or customizing universal prevention interventions, such as promoting safe storage of lethal means and responsible suicide reporting in the media.
• Pilot studies to test implementation of media guidance programs and policies in diverse contexts to reduce the likelihood of suicide, self-harm, and non-suicidal self-injury across lifespan.
• Adapting and testing effective suicide prevention efforts, including safety planning and post-attempt follow-up, community-based programs, and crisis intervention for managing SIB.
• Adapting resilience-building programs for youth and adults, focused on socio-emotional skills like problem-solving, stress management, anti-bullying initiatives, and strengthening connections to support services in both health and non-health environments.
• Exploring care continuum models within healthcare and non-healthcare settings, that inform interventions at patient, provider, organizational, or policy levels to enhance care quality, coordination, and delivery. 
• Developing innovative integrated suicide prevention and treatment service models for implementation within health systems and non-health settings.
• Studies piloting scalable and sustainable strategies for training, supervising, and supporting providers, including technology-assisted methods and competency assessments, to enhance the reach and quality of suicide prevention and treatment interventions.
• Studies conducting acceptability or feasibility to complement ongoing effectiveness trial of preventive, treatment, and /or service intervention.
• Pilot studies to develop public policies affecting the social determinants of health with a proven association with increased risks of suicide, SIB and/or NNSI.

Applicants are encouraged to consider:

Developing pilot studies to gather evidence supporting the methods outlined in the World Health Organization's LIVE LIFE and/or Zero Suicide initiatives. Actively engaging with LMIC communities to develop the study design and effective dissemination plans of research outcomes.

Research Capacity Element

This NOFO also seeks to support studies that will strengthen sustainable research capabilities in LMICs. The applications must include a comprehensive plan to strengthen the research capabilities in the LMICs where the research will take place.

Activities may include but are not limited to:

• Sharing education platforms to strengthen and develop the expertise across research team members in different institutions and countries.
• Engaging students and early investigators from the partner country institutions in bilateral training and exchanging knowledge on topics relevant to the research project.
• Develop or adapt didactic implementation research training modules tailored for the specific LMIC context for training local implementers/practioners.
• Provide professional development in writing manuscripts as well as grant writing and grants administration.

Applications Not Responsive to This NOFO

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

• Applications that propose research to be conducted primarily in a HICs.
• Studies examining the efficacy and effectiveness of new pharmacologic therapies.
• Studies limited to descriptive analyses of suicide prevalence and health systems.
• Studies conducted exclusively in academic research laboratories as opposed to effectiveness studies in community practice clinics/settings (e.g., studies in research clinics that involve research therapists or other features that are not representative of typical practice settings and substantially impact generalizability).
• Studies focused only on developing new screening/assessment instruments.
• Studies that do not include capacity-building components and /or lack adequate LMIC community partner(s).
• Applications whose scope of work involves examining intervention effectiveness without studying whether the intervention engages the target(s) presumed to underlie benefits and without examining whether intervention/implementation strategy-induced changes in targets are associated with clinical or service benefits.

Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

The NIMH has published updated policies and guidance for investigators regarding human research protection, clinical research data, and safety monitoring (NOT-MH-19-027). The PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, in the applications should reflect the policies and guidance in this notice. The NIMH will review plans to protect research participants and data and monitor safety for consistency with NIMH and NIH policies and federal regulations.

Technical Assistance Teleconference

An informational webinar for potential applicants will be held via Zoom on 1 August 2024, from 9:30 AM -10:30AM ET. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

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

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

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 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.

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.

For applications proposing a single PD/PI, the 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. Applications proposing MPIs can have a contact PI in 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 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 How to Apply - 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: nimhpeerreview@nih.gov

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.

R&R or Modular Budget

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

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:

The following elements must be included in the application:

Significance

• Describe the extent to which the proposed study aligns with the specific needs and contexts of the LMIC communities.
• Describe how the proposed research aims to generate novel insights into interventions aimed at mitigating the risk of suicidal ideation and behavior (SIB), as well as non-suicidal self-injury (NSSI). This new knowledge shall be universally relevant and relevant to the LMIC where the proposed study takes place. 
• Describe how the pilot work will inform subsequent studies testing the efficacy or effectiveness of the intervention under research.

Investigator

• Demonstrate that the research team is equipped with the necessary expertise in suicide prevention, therapeutic interventions, health disparities, health services, and community-engaged research to ensure the success of the project.
• Detail strategies for engaging relevant stakeholders to inform the research process, ensuring intervention approaches are acceptable, feasible, and scalable in the LMIC community.

Innovation

• Where applicable, highlight the innovative methodologies or frameworks in the application to mitigate the risk of suicide ideation and behavior (SIB), and/or non-suicidal self-injury (NSSI) including use of community-based participatory research (CBPR) models; adoption of interdisciplinary (anthropology, sociology, public health) frameworks; digital technologies etc. 

Approach

• Provide a rationale for the selection of suicide-related constructs and corresponding assessment instruments for the proposed population(s); including any relevant time periods assessed and the assessment schedule.
• Provide a clear rationale for proposed experimental design and methods.
• For studies proposing adaptations of existing interventions, provide the empirical justification for the proposed adaptation.
• Describe how the pilot work will support and strengthen the methodology anticipated in the future study.
• Describe plans to establish partnerships with all relevant stakeholders. Highlighting partnerships with global health organizations and developmental agencies is encouraged where applicable.

For studies that involve the assessment of patient-level outcomes, describe plans for the assessment of suicidal behavior and related outcomes using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009 and https://www.phenxtoolkit.org/ for constructs and corresponding assessment strategies), as appropriate, or provide a rationale for excluding such measures if they are not included. Accordingly, the application should provide the rationale for the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during the intervention, post-intervention, follow up), taking into account the nature of the target population, participant burden, etc. The application should also address provisions for clinical management when suicidal behavior is reported.

Consistent with NIMH's experimental therapeutics approach, detail plans to explicitly address whether the intervention engages the mechanism(s) presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes, changes in patient or provider behavior, etc.). Include the following: (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the patient-, provider- or system-level behaviors/processes that the intervention seeks to improve; (2) plans for assessing the engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and (3) an analytic strategy that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in the pilot trial. In the case of multi-component interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention component, as appropriate in the effectiveness context.

Letters of Support: 

Provide all appropriate letters of support, including any letters necessary to demonstrate the support including salary commitment, protected time for research, shared core facilities, specialized training signed by a business official on organization letterhead.

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): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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 by NIMH under this 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.

7. Other Submission Requirements and Information

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 NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Any instructions provided here are in addition to the instructions 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.

For this particular announcement, note the following:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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).

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.

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.

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 NIMH, 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.

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

Applications will be assigned 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.

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

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

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

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

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.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. 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 addition to the information available in the responsibility/qualification records in SAM.gov, 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 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.

Not Applicable

3. Data Management and Sharing

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.

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. 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.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Vidya Vedham, Ph.D.  
National Institute of Mental Health (NIMH)
Email: vidya.vedham@nih.gov 

Leonardo Cubillos, MD, MPH
National Institute of Mental Health (NIMH)
Email: leonardo.cubillos@nih.gov

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-811
Email: tkees@mail.nih.gov

Section VIII. Other Information

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

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.