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 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.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Adolescents have increasing access to and spend an increasing amount of time engaging in online social interactions and consuming content on social media platforms, yet there is limited knowledge of how online social behavior and experiences interact with adolescent mental health and risk for psychopathology.

In May 2023, the Office of the U.S. Surgeon General released a new Advisory on Social Media and Youth Mental Health. The advisory calls for swift, multi-sector action to maximize the benefits and reduce the risk of harm posed by social media to children and adolescents. This report followed the US Surgeon General’s issuance of the Advisory on Youth Mental Health (released in December 2021), which highlighted the urgent need to address the nation’s youth mental health crisis. Both advisories call special attention to the need for rigorous research on how youth engage with social media, gaming, and a wide variety of online images and content.

The conversation about the impact of social media on adolescent development has continued to evolve. More recently, in 2024, the National Academies of Sciences, Engineering, and Medicine (NASEM) published a report on Social Media and Adolescent Health which detailed the state of the research in this area and provided recommendations to policymakers, regulators, and industry, among others. Additionally, in April 2024, the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development hosted a workshop entitled “Impact of Technology and Digital Media on Child and Adolescent Development and Mental Health.” This workshop convened experts from around the country to engage in discussions about the current state of and future directions for research on how social media and adolescent mental health interact in both positive and negative ways.

Research Scope and Objectives

This Notice of Funding Opportunity (NOFO) focuses on understanding relationships between social media use and adolescent mental health, psychiatric symptoms, and risk or resilience for psychopathology. For the purposes of this NOFO, social media are defined as internet-based communication platforms and applications that enable interactions between users by sharing or consuming information. Importantly, adolescents (broadly defined here as 10-20 years of age) have increasing access to social media and greater autonomy in their use of digital platforms.

Adolescence is a period of significant social, behavioral, physiological, and neural development. The brain undergoes significant reorganization during this time. Adolescents also begin to re-orient from families to peers, develop more complex identities, and function more independently across a range of social contexts. These social changes occur in conjunction with developing neural circuits associated with executive function, emotion regulation, and reward processing, among others. Adolescence is also a period of increased risk for the onset of mental disorders and symptoms. Social media expands and potentially magnifies the sphere of social interactions that adolescents have available to them, both in terms of negative influences (e.g. bullying, harassment, and discrimination) and in terms of positive influences (e.g. social support from friends and virtual communities).

Bidirectional effects of social media and adolescent mental health

Research submitted to this NOFO is expected to focus on the impacts of social media on adolescent mental health and/or how adolescent psychopathology influences social media use. Interactions via social media play an increasingly important role in adolescent development, but little is known about the mechanisms by which social media use may impact risk or resilience for psychopathology, which may also include understanding the roles of social and structural determinants of health. Identifying individual and contextual factors that may serve as modifiable targets for intervention is a high priority.

This NOFO prioritizes rigorous research studies that utilize sophisticated and fine-grained approaches to assess social media use and that move beyond simple assessments of time spent on social media. Applications are expected to define and justify the social media platforms examined, social media data collection methods (e.g., content type, exposure levels, mode of use, etc.), and age range of participants in the proposed research. For example, projects may quantify social behavior and social media use across one or more avenues of social media (e.g., platforms, texting, gaming, chats, videos) and across hardware platforms (e.g., phones, computers, gaming systems with social interaction) as needed to fit a project’s conceptual framework and hypotheses. Collection of passive digital trace data, such as text analysis or movement and GPS data, is encouraged, as it offers an opportunity to study social media use by adolescents in their usage context and enrich our understanding of how they are utilizing social media.

Some adolescent participants may currently have, or have a history of, a mental illness diagnosis, like ADHD, anxiety, depression, and/or an eating disorder. Diagnostic documentation and current symptomatology are important factors to consider for studies examining issues of risk/resilience. Research that provides insight into clinical and societal interventions that might mitigate potential harms of social media are particularly encouraged.

Applications are encouraged to include a youth advisory board consistent with participant age to provide input on research design, interpretation of findings, and best avenues for dissemination of findings to adolescents and their communities. Applications may also consider incorporating an ethical research component or collaborations with ethics consultants to advance understanding of the ethical considerations and implications of social media research in adolescents, such as privacy of participants and their peers, parental consent vs. waiver, and reporting requirements for researchers, among others.

Potential applicants are strongly encouraged to consult with NIMH staff as early as possible when developing plans for an application. This early contact will provide an opportunity to clarify NIH policies and guidelines and help to identify whether the proposed project is consistent with NIMH program priorities and NOFO goals.

For the NIMH, areas of high priority include, but are not limited to:

• Understanding developmental influences on interactions between social media behavior and risk for psychopathology, including identification and exploration of sensitive periods.
• Potential neurodevelopmental mechanisms underlying social media experiences and their positive and/or negative associations with adolescent mental illness.
• Understanding social media behaviors and disparities in the mental health outcomes of rural, minoritized, and other underserved youth.
• Exposure to discrimination through social media use and its impact on mental health for youth of minoritized groups.
• Identification of neurobiological and psychological risk and protective factors that may serve as modifiable targets in future mental illness intervention development.
• Identification of positive attributes of social media environments that strengthen protective factors and create positive social experiences, particularly for minoritized and marginalized youth.
• Influence of parent and peer behaviors on social media use and risk or resilience for psychopathology.
• The role of algorithmic bias on adolescent mental health, which may include the impact of exposure to violent, racist, discriminatory, or other traumatic content via social media.
• Methods development to advance the study of social media behavior, including methods for capturing cross-platform and cross-device behavior, video or language content, algorithmic exposure to content, and/or passive vs. active uses.
• Studies investigating the role of social comparison and risk for psychopathology, including but not limited to, peer social processes, body image comparison, and comparison with influencers and peers from dominant cultural groups with non-minoritized identities.
• Studies of novel technologies and their intersection with mental health, including artificial intelligence, virtual reality, smart glasses, and novel smartphone and wearable technologies.
• Comparison of in-person vs. digital social interactions to understand unique contributions of social media to social connectedness, social isolation, anxiety, and/or other psychopathology symptoms.
• Proximal impacts of adolescent social media engagement with mental illness symptoms and/or emotional regulation, reward processes, attention, and/or executive function.
• Experimental paradigms that test neurocognitive mechanisms through which social media platforms impact behavior and/or risk for psychopathology.
• Identifying mechanisms through which social media behaviors interact with symptoms of disordered eating.
• Mechanisms underlying the interaction of social media behaviors with attention, impulsivity, and/or other symptoms of ADHD. 

Services and intervention

Increasingly, social media represents a primary source of information about mental health and related interventions and services for adolescents and their families.  Given well-documented challenges related to accessing mental health services, social media also represents a potential delivery approach for facilitating access to care.  This NOFO also encourages research focused on social media as a platform for facilitating the identification of adolescents with or at risk for mental illness, for encouraging appropriate mental health service use, and for delivering preventive and therapeutic interventions. Such research includes but is not limited to:

• Research using social media data to develop and validate algorithms for identifying youth who are exposed to negative online experiences or content or who might otherwise benefit from mental health evaluation or interventions. This could include developing and testing real-time interventions based on the risk characteristics.
• Research that leverages partnerships with purveyors of mental health related information aimed at providing accurate content (i.e., psychoeducation) and embedding tools for online screening for early detection and strategies to promote referral, help-seeking, and treatment engagement.
• Studies focused on optimizing and testing preventive or therapeutic interventions for youth who are exposed to rejection/exclusion, discrimination, harassment, or other negative online messages and experiences (e.g., through cyberbullying), including interventions to promote digital citizenship (e.g., online safety, healthy social media use) and to facilitate coping and other adaptive behavior among adolescents with or at risk for mental illness (e.g., depression, anxiety, conduct problems, suicidal thoughts and behavior).
• Projects that test technology-based approaches to manage problematic social media use or exposure in adolescents, such as app wrappers, phone- or computer-based timers, use of cookies or other meta data to redirect to useful social media sites, content or time warnings, or post exposure interventions.
• Studies that leverage social media to augment existing evidence-based preventive or therapeutic interventions (e.g., through moderated online communities or support groups, mobile health apps, etc.).
• Research that tests strategies for managing social media use and screen time (e.g., family-based interventions) that can be used to augment preventive and therapeutic interventions for youth with or at-risk for mental illness.
• Studies that examine social media platforms to deliver scalable, research-informed preventive and therapeutic interventions that might be offered as first-line interventions to help mitigate provider shortages and limitations in available mental health services.   
• Studies that leverage social media to address disparities in access, use, engagement, and retention, or that improve quality or outcomes of care among adolescents from diverse cultural, racial, and ethnic backgrounds, and other underserved groups.

Scope of research for R21 exploratory/developmental research projects: For this NOFO, R21 projects focused on intervention/services research should focus on examining the feasibility, acceptability, and preliminary utility of social-media focused interventions and services. As such, early intervention development might focus on understanding engagement and usability challenges with an intervention or on creating a wireframe-based tool that is tested locally to inform a wireframe that will be tested in a subsequent larger trial.

For all interventions and services research, the NIMH encourages deployment-focused design and testing that systematically assesses and incorporates the perspectives of end-users (e.g., adolescent- and family service users, providers, administrators, social media companies) and attends to the resource needs to sustainably utilize social media as a platform for mental health services and interventions. The NIMH encourages iterative intervention development that systematically considers end-user perspectives and workflows using Human Centered Design methods or other similar approaches. These approaches help ensure that the resultant interventions and services are feasible, acceptable, scalable, and ultimately sustainable (e.g., taking into account the ultimate system of care, payment, a sustainable staffing model).

For applications that involve optimizing and testing interventions for prevention, treatment or for promoting help-seeking and engagement in services, research designs must be consistent with the NIMH experimental therapeutics approach. Trial designs should include an evaluation of at least one hypothesized mechanism of action that is presumed to account for intervention effectiveness. Applications must specify (1) at least one hypothesized mechanism of action for the intervention and/or implementation strategy, (2) measurement plans to feasibly assess the mechanism of action and primary outcomes, and (3) an analytic plan designed to evaluate both changes in the mechanism of action and the association between changes in the mechanism of action and the primary outcome(s). The nature of the proposed mechanism will vary depending on the nature of the intervention (e.g., for preventive and therapeutic interventions, mechanisms include factors that have been empirically associated with mental disorder risk, etiology, maintenance, or severity). 

Applications Not Responsive to this NOFO.

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

• Applications that are not focused on adolescence, defined broadly as 10-20 years of age.
• Applications without theoretical and methodological considerations of mental illness.
• Applications that only measure duration of time spent on screens or digital communications.
• Applications that rely solely on self-reported social media usage without other objective methods.
• Applications proposing animal research.
• Applications that propose preventive, therapeutic, or services interventions without a preliminary evaluation of the mechanism of action and its impact on the primary outcomes, including the following components: (1) specified mechanisms of action, (2) measurement plans designed to assess the mechanism of action and clinical outcomes in the intervention setting, and (3) an analytic plan for a preliminary evaluation of whether intervention-induced mechanisms of action are associated with outcomes.
• Applications that propose psychoeducation, health literacy, and referral interventions without explicitly examining the impact on service access, engagement, quality and/or outcomes of care.

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.

In accordance with the NIMH Strategic Framework for Addressing Youth Mental Health Disparities, the NIMH is committed to supporting research that reduces disparities and advances equity in youth mental health interventions, services, and outcomes. As such, this NOFO encourages research that seeks to reduce disparities in outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, and other underserved groups. This NOFO strongly encourages both research on bidirectional influences of social media on adolescent mental health and intervention and services research that includes plans to address drivers of disparities in mental health outcomes and test research-informed strategies that are relevant across diverse individuals.

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.

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: nimhpeerreview@mail.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:

Applications must detail the following in the Research Strategy.

Factor 1. Importance of the Research

Significance

• Describe how the proposed project will advance our understanding of relationships between social media and adolescent mental illness, psychiatric symptoms, and/or risk or resilience for psychopathology.

Factor 2. Rigor and Feasibility 

Approach

• Provide sufficient detail to assess a) the rigor and reproducibility of social media measures and b) the rationale for how social media behaviors will be measured across time and/or platforms.
• Provide evidence that the proposed approaches are feasible and appropriate for capturing social media use beyond assessments of time spent on social media.
• Provide a scientific rationale for the proposed age(s) of participants and incorporate developmental variables into the research plan as appropriate.
• If proposing a youth advisory board, describe how the board will contribute to project measures of adolescent social media use, analysis and interpretation, and dissemination of findings.
• If proposing an ethics component, describe how this component will advance understanding of the ethical considerations and implications of social media research in adolescents.

For applications that involve testing interventions and services:

• Detail plans to preliminarily examine whether the intervention engages the one or more hypothesized mechanisms of action. Include the following:
  • A conceptual framework that clearly identifies the mechanism(s) of action and the empirical evidence linking the mechanism(s) to the primary outcomes of interest (e.g., clinical symptoms and functioning; improved access and engagement in mental health services) that the intervention seeks to improve.
  • Plans for assessing engagement of the mechanism(s), including the specific measures, the assessment schedule, and evidence regarding the validity and feasibility of the proposed measures in the effectiveness context.
  • An analysis plan that will be used to preliminarily examine whether the intervention engages the mechanism(s) and whether intervention-induced changes in the mechanism(s) are associated with and account for clinical benefit.
• Detail plans for deployment-focused development and testing that systematically assesses and incorporates the perspective of end-users (e.g., adolescent- and family service users, providers, administrators, social media companies) and attends to the resource needs to sustainably utilize social media as a platform for mental health services and interventions.  Describe how the proposed interventions and services are feasible, acceptable, scalable, and ultimately sustainable (e.g., taking into account the ultimate system of care, financing/payment considerations, provisions for a sustainable staffing model). 

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 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.

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 non-responsive 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 grantdisclosures@oig.hhs.gov.

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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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 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 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: GrantsInfo@nih.gov (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: support@grants.gov

Laura Thomas, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-480-1624
Email: laura.thomas@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: 301-443-8811
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.