Part 1. Overview Information

Key Dates

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

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

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

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

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Suicide rates among youth in the United States are a significant public health concern. For youth ages 10-14, suicide is the second leading cause of death. Although age-specific suicide rates for youth ages 10-14 are low relative to adults, suicide deaths in this age range tripled between 2007 and 2020, and girls ages 10-14 continued to have increasing rates during 2018-2020. For the first time, suicide was the 10th leading cause of death in children ages 5-9 in 2020. Youth suicide rates are highest among American Indian and Alaska Native youth, and the rate of suicide deaths over time has continued to trend upward for other racial and ethnic minority youth. In order to understand the concerning increases in suicide deaths among children and pre-teen youth and to understand why some groups are of greater risk, in 2021 NIMH convened a four-part virtual research roundtable series, Risk, Resilience, & Trajectories in Preteen Suicide. The roundtables highlighted the need for research to identify risk and protective factors, develop risk prediction tools, and inform targets/timing for intervening, for both proximal and distal risk/protection models. Prior to embarking on such studies, however, there is a clear need for preliminary work to refine approaches for sampling youth who are at increased risk of suicidal thoughts and behaviors (STB), including sub-populations that experience health disparities, for characterizing risk/protective factors across multiple domains, and for operationalizing STBs and non-suicidal self-injury (NSSI) among pre-teen youth. Such work will serve to define the scope, general approach, specific methods, and goals of subsequent studies.

Research Scope and Objectives

This initiative supports 4-year longitudinal studies that seek to refine protocols for the assessment of pre-teen STBs and associated risk and protective factors and/or define risk trajectories in pre-teen youth, with consideration for identification of novel targets for future development of prevention and intervention efforts. For the purposes of this announcement, pre-teen is defined as ages 8-12. An emphasis is placed on efforts that will enhance our knowledge of suicide risk among youth from sub-populations at higher risk for STBs or in which suicide death rates have been rising at significant rates, particularly those typically underrepresented in suicide research. Applications are expected to define and justify the sampling strategy of the proposed research in terms of risk and associated burden (e.g., the number of affected individuals, the associated level of suicide risk, and/or overall burden associated with unmet mental health needs) and anchor the assessment of risk and protective factors in the relevant developmental and cultural context.?

The scope of the proposed research may include optimizing existing assessment instruments to ensure that they are developmentally and culturally appropriate, developing and validating new or adapted measures to assess STBs and risk or resilience constructs that may have high predictive value for risk in pre-teens, examining the acceptability and utility of new or existing assessment methods, and/or developing and testing methods for characterizing risk trajectories.

Awarded R01 projects will be expected to create a Consortium that will work to identify and incorporate common data elements and develop a core assessment battery. This will include optimizing assessment protocols and examining the feasibility, acceptability, psychometric properties (reliability and validity), safety, and predictive utility of assessment approaches for use with diverse youth and families. This NOFO is intended to work in conjunction with a companion NOFO (RFA-MH- 24-322) that will facilitate data coordination support and the harmonization of study datasets. Harmonized datasets are intended to support the examination of measures across a diverse pool of participants, provide the statistical power needed to examine various types of measurement validity (e.g., concurrent; predictive) in diverse samples, and test approaches for modeling risk-factor trajectories.

This NOFO is centered around three core objectives:

1. To leverage the capacity of multiple, multidisciplinary teams to refine developmentally and culturally relevant assessment approaches, sampling strategies, and methods for longitudinal assessment of risk and risk trajectories in diverse samples.
2. To establish a community of practice, comprised of a Consortium of individual research projects and a Data Coordination Center, to identify and administer core common measures that could be integrated into future research and validate their utility for understanding risk and risk trajectories.
3. To leverage the power of combined cohorts to better understand mental health and suicide risk disparities among sub-populations and identify unique and common risk and protective factors in service of a long-term goal of improved screening, prevention, and treatment.

To address these objectives, this NOFO is specifically intended to inform:

• the selection of common data elements that will be included in a best practice core assessment battery for future use by investigators and clinicians working with pre-teen youth at risk for STBs.
• optimized stakeholder-informed and community-engaged strategies for sampling and engaging sub-populations of youth that experience health disparities are at increased risk for STBs, and/or are typically underrepresented in youth suicide research.
• multi-level, multi-domain and mixed method (I.e. qualitative and quantitative) approaches to characterizing relevant risk and protective factors, including behavioral, neurocognitive, physiological and clinical assessments. An emphasis is placed on mutable factors, across domains, that might represent potential targets for intervening on risk.
• inclusion of state-of-the-science measures of social determinants of health, with a focus on strategies for identifying key constructs that may be most relevant to pre-teen suicide risk, operationalizing these constructs, and testing low-burden assessment approaches for capturing the relevant data.
• scalable developmentally and culturally informed assessment approaches that have clinical utility for characterizing both risk/protective factors, identifying potential intervention targets, differentiating between self-harm and suicide-related behaviors, and suicide risk and outcomes.
• methods and model specifications for longitudinal assessments that can be used to identify risk and protective factors, characterize risk-factor trajectories, and understand imminent risk and the transition from ideation to behavior in diverse pre-teen youth.
• developmentally informed schedules of assessment to capture the timing and unfolding of risk (e.g., interactions among risk/protective factors, intersectionality).

Approaches Encouraged

NIMH encourages multi-level, translational assessment approaches to characterize core constructs, domains of functioning, and relevant cognitive/affective processes associated with pre-teen suicide risk. Applicants should provide the empirical justification for the selection of constructs, measures, and assessment schedules. Consideration should also be given to the environmental/social/developmental factors that have been empirically linked with suicide risk states and are relevant to the project’s empirically grounded assessment strategy (e.g., exposure to early adversity or economic hardship; geographic location/neighborhood context; familial/social context and support; developmental stage; victimization/bullying; experience of discrimination; digital media exposure). For constructs related to social determinants of health, including systemic, structural, and interpersonal racism, referencing the National Institute on Minority Health and Health Disparities Research Framework is recommended. Rigorous mixed method approaches are strongly encouraged. Studies that employ only qualitative methods will not be considered responsive to this announcement.

Translational assessment approaches that are developmentally and culturally informed are encouraged and may include, but are not limited to, multi-level assessment of Research Domain Criteria (RDoC)-like domains and constructs, such as negative valence, cognitive control, arousal and regulatory systems, and social processes that can be feasibly measured via low-burden approaches that go beyond self-report (e.g., mobile- or sensor-based assessments, computerized or task-based assessments, exposure to social media and other digital content). While translational assessment approaches including measures of neurobiology are allowed, applicants are also encouraged to consider including surrogate measures that are feasible and practical for use in larger scale research studies and clinical practice. Applicants are also encouraged to consider measures that might be included across linked sites as part of a core common assessment battery as part of a consensus process facilitated by the Data Coordinating Center as outlined in RFA-MH-24-322.

A variety of longitudinal study designs are of interest, including cohort and accelerated longitudinal studies that facilitate the examination of risk and protective factors, and their interaction over time. Given the low mean base rate of STBs in pre-teen youth, an emphasis is placed on the use of risk-based sampling to construct cohorts that are enriched for rates of STBs and exposure to suicide risk factors. Risk inclusion groups may include but are not limited to youth with a lifetime diagnosis of a psychiatric disorder or history of STBs/NSSI, youth from sub-populations with higher population rates or higher increase in rates over time of suicide (e.g., Black, American Indian and Alaska Native, sexual and gender minorities), youth with increased exposure to adversity, and youth with a family history of suicide, mental illness, and/or substance abuse. The inclusion criteria, sampling strategy, longitudinal design, and observational period should be justified in terms of the relevant empirical literature regarding risk and protective factors, the developmental time course of suicide risk, and epidemiological findings.

This NOFO strongly encourages applications that assemble an interdisciplinary, collaborative research team comprised of experts in the fields of mental health research and clinical practice, suicide research, developmental psychopathology, minority mental health and health disparities, and community-engaged research, as well as investigators with expertise relevant to the project’s focal area and/or methodological approach (e.g., digital health, translational assessment, measurement development, biostatistics/computational approaches, risk-factor modeling). Inclusion of community stakeholders is also encouraged to ensure the outcomes and interpretation of the research reflect the priorities of the populations being studied.

There are a number of outstanding questions in the assessment and characterization of suicidal thoughts and behaviors among younger children, as discussed in the Risk, Resilience, & Trajectories in Preteen Suicide roundtable series. Research supported under this R01 is intended to address fundamental questions and methodological challenges to inform future research. The research projects funded through this announcement will have the opportunity to network and communicate with other RFA recipients to:

• discuss safe and ethical approaches to data collection, management, and sharing.
• discuss inclusion of measures to promote consistency with other projects.
• participate in collaborative interim analyses.

Technical Assistance Potential applicants are strongly encouraged to consult with NIMH program staff when developing plans for an application (see Agency Contacts, Section VII).

In addition to any individual consultation with program staff, NIMH intends to hold a web-based pre-application webinar for applicants to RFA-MH-24-320 and RFA-MH-24-322. Information on how to attend the optional webinar will be published through a Guide Notice.

Applications with data collection plans that involve 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, including special provisions for the participation of minors.

Applications Not Responsive to this NOFO

Applications proposing the following will be considered non-responsive to this NOFO and will not be reviewed:

• Applications that are not designed to examine STBs during the pre-teen age range (e.g. ages 8-12);
• Applications that do not include racially and ethnically diverse samples and planned analyses of disparities in suicide thoughts and behaviors;
• Applications that focus on developing or testing preventive, therapeutic, or services interventions;
• Applications using animal research;
• Applications that are not primarily designed to examine STBs and focus only on NSSI, depression, anxiety, or PTSD;
• Applications that involve qualitative methods exclusively;
• Applications that involve use of existing data without plans to prospectively collect data.

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 Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, 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 SF424 Application Guide and the Table of Page Limits must be followed.

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Investigators' effort should include time for regular virtual meetings of the Consortium and with the Coordinating Center over the course of the project period.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Applicants must provide all items discussed below:

Significance:

• Justify how the proposed approach will yield developmentally and culturally informed and valid methods for operationalizing STBs and NSSI and characterizing suicide risk and protective factors across multiple domains and in preteen youth.
• As appropriate, describe the proposed stakeholder-informed risk-based sampling strategy, and how the strategy will facilitate the enrollment of high-risk participants from sub-populations typically underrepresented in suicide risk research.
• Describe how the proposed research will aid in the developmentally and culturally informed assessment and/or identification of mutable factors that could represent potential targets for intervening on risk.

Investigators:

• Detail how the research team includes expertise on suicide research, developmental psychopathology, minority mental health and health disparities, and community-engaged research, as well as expertise relevant to the project’s methodological approach. Describe plans for the inclusion of community stakeholders.

Innovation:

• As appropriate, highlight how the proposed methods overcome existing barriers to the developmentally and culturally appropriate assessment of STBs, NSSI, and/or suicide risk and protective factors, particularly in sub-populations that experience health disparities.
• As relevant, describe the use of innovative approaches for assessing social determinants of health that may interact with biological or behavioral factors to uniquely confer or mitigate risk for suicide.

Approach:

• Describe how the constructs being assessed, as well as the proposed assessment battery, assessment schedule, longitudinal design, and inclusion criteria, are justified in terms of the relevant empirical literature regarding suicide risk and protective factors. Include relevant literature relating to the developmental time course of suicide risk, minority mental health and health disparities, and epidemiological findings.
• As appropriate, describe the methods and model specifications for longitudinal assessments that will be used to identify risk and protective factors, characterize risk-factor trajectories, and understand imminent risk and the transition from ideation to behavior in diverse preteen youth.
• As relevant, when translational assessment approaches are proposed, describe the inclusion of surrogate measures that are feasible and practical for use in larger scale research studies and clinical practice.
• For studies proposing the use of mixed methods:
  • Provide the rationale for the use of mixed methods and the selected design, including an explanation for why alternative designs would be inappropriate or inadequate.
  • Describe the quantitative and qualitative components, procedures, and sequence of activities that will be used to achieve the study aims. For each method, specify and justify the sampling approach, sample size, and analysis plans.
  • Describe plans for integrating the proposed quantitative and qualitative methods. Indicate how they will work in tandem and how the qualitative data will complement and inform the quantitative approach.

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

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

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

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

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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 SF424 (R&R) 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.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following 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 National Advisory Mental Health Council. 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.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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:

• Federal-wide 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

The research projects funded through this announcement will participate in a research Consortium with other R01 recipients to share and analyze data, recommend candidate measures that will be included as common data elements in future research and practice contexts, identify optimal approaches for sampling individuals from underrepresented backgrounds, and disseminate project findings. This will include efforts to collate and coordinate common measurement approaches and identify a candidate core assessment battery, as well as to explore opportunities for the harmonization of study data and joint data analyses (I.e., analyses to examine psychometric properties and predictive utility of candidate measures).

Key objectives of the Consortium:

• tracking and facilitating progress across funded research sites, including but not limited to, providing assistance with monitoring study timelines, recruitment progress, and data collection progress and problem-solving challenges.
• facilitating communications among the research projects to ensure ongoing discussion, consultation, and troubleshooting related to individual study activities and progress, as well as cross-project activities related to the development of best practice guidelines, common data elements, and data harmonization.
• coordinating periodic conference calls that will facilitate cross-project discussions regarding technological hurdles, generating resolutions, and information sharing.
• organizing and hosting periodic scientific webinars with funded investigators and outside experts (e.g., webinars with /for experts in the field of suicide research, within and outside R01 network, to discuss latest research findings and possible solutions to measurement/protocol challenges.
• disseminating the best practice guidelines to make them available for use by the broader scientific community.

Each R01 site will have an independent relationship with the U24 Data Coordinating Center for the purposes of data management and sharing. The Consortium can also meet with the Data Coordinating Center as a group for purposes of consistency and optimizing data formatting to ensure data integrity and interoperability in the NDA.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 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: 301-480-7075

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

Eric R. Murphy, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-9230
Email: eric.murphy@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 45 CFR Part 75 and 2 CFR Part 200.