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 SF424 (R&R) 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

Purpose 

The purpose of this Notice of Funding Opportunity Announcement (NOFO) is to encourage formative research and pilot testing of culturally appropriate innovative preventive, therapeutic, and service interventions to reduce the risk of suicide, suicide ideation and behavior (SIB), and/or non-suicidal self-injury (NSSI), and promote resilience for people across the life span in low- and middle-income countries (LMIC).  During the development and testing of interventions, attention to implementation factors is strongly encouraged. Research resulting from this NOFO is expected to contribute to the long-term goals of strengthening the sustainable research capacity in LMICs and enhancing the potential for multidirectional knowledge and the exchange of research advancements.

Background

Suicide is a significant global public health problem and a major contributor to the global burden of disease. Around 700,000 people die by suicide annually, with a global age-standardized suicide rate of 9.0 per 100,000. Suicide occurs throughout the lifespan. Nearly one-third of all suicides occur among young people, and suicide is the fourth leading cause of death among 15–19 years old. However, suicide rates are higher globally among individuals aged 50-69 (16.2 per 100.000) and those aged 70 and over (27.4 per 100.000).

It is estimated that 77% of the world's suicides occur in LMICs, where most of the world's population lives. However, the overall suicide rate in LMICs is likely substantially underestimated since many LMICs lack a national suicide surveillance system and a systematic reporting system. Local and cultural factors may also contribute to under-reported suicide and suicidal behavior statistics, such as stigma, religious beliefs, and judicial and legal practices. In addition, mental illnesses are associated with suicide attempts. However, there are significant gaps in our understanding of the factors that contribute to suicide in LMICs, such as health system barriers (e.g., access to care), economic (e.g., financial insecurity), societal (e.g., discrimination), community (e.g., social isolation), relationship (e.g., sexual violence), and individual risk factors (e.g., abuse and trauma). Understanding protective and risk factors for suicide is critical to identify effective preventive and intervention targets and implementation strategies that should be prioritized and implemented in different contexts.

Gaps and Opportunities to Advance Suicide Prevention, Therapeutic and Service Interventions Applying Implementation Science Approach

A vital gap in advancing suicide prevention globally is the lack of reliable data on suicide rates. For most LMICs, suicide rate estimates are modeled, and national reports may not be accurate. Therefore, there is a need to create and/or strengthen community and/or national suicide surveillance systems in many LMIC settings. While NIMH expects projects to pilot-test culturally appropriate preventive, therapeutic, and/ or service interventions, it is also expected to enhance research capacity and country-led efforts to address the lack of reliable data on suicide rates.

Globally, there is a critical need to implement and evaluate a combination of 1) culturally adapted multilevel preventive approaches at the population level (universal prevention) and the individual level (selective and indicated prevention), and 2) therapeutic and service interventions with a focus on multiple risk factors and protective factors across various settings, such as primary care, education, employment, social welfare, and justice settings. 

This is critical in order to develop and implement a comprehensive national strategy for suicide prevention that include culturally appropriate multilevel prevention approaches at the community and/or the system level. Therefore, this NOFO encourages applications that aim to refine and test scalable and sustainable approaches that could be part of a national strategy to inform future research on testing and implementation of multi-level approaches.

Key Definitions for This NOFO

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

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

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

HIC and LMIC: Defined according to the fiscal year 2023 World Bank designations (see World Bank Data Helpdesk webpage.)

Research Objectives

This NOFO aims to stimulate research that will refine and test culturally scalable and sustainable approaches and interventions to reduce the risk of suicide, SIB, and/or NSSI and promote resilience for people across the life span in LMICs. This NOFO is also expected to contribute to the long-term goals of strengthening the sustainable research capacity in LMICs and enhancing the potential for multidirectional knowledge and the exchange of research advancements. 

All projects must propose a research pilot study and a research capacity element. Research projects must be conducted in the LMIC where the single PD/PI or at least one PD/PI has a primary appointment. For applications proposing a single PD/PI, the PD/PI will be required to have a primary academic appointment in an LMIC institution. Applications proposing MPIs must include at least one PD/PI who has primarily academic work in an LMIC institution where the projects will occur. The project's other PD/PI(s) can have an appointment at an LMICs- or HICs-based institution.

All projects must describe the extent of researchers' significant involvement in LMIC settings. It will be essential for the applicants to describe how the proposed research is relevant to the local context and aligns with NIMH's scientific priorities of transforming the prevention and treatment of mental illnesses and translating evidence into practice and policy.

All projects must propose an Advisory Board (AB) and an appropriate plan (e.g., advisory board structure, roles, and budget justification). The goal of the AB is to ensure the engagement of relevant stakeholders throughout the project - from design to dissemination-  (a) to inform research; (2) to advance mental health equity, and (c) to ensure that findings will benefit end-users in a particular context, setting, and population.

 The AB is expected to provide an ongoing assessment of the research's progress, discuss future research goals, aims, and ideas, and provide research career guidance to the awardee during the five years of the grant. During the project period, the PD/PI will be expected to describe the proceedings of the AB in annual progress reports. A schedule for the AB meetings should be included in the timeline.

Advisory Board members could include but are not limited to patients, family, community members, advocates, peers, healthcare providers, policymakers, and members of the research partnership. The Advisory Board is expected to provide an ongoing assessment of the research's progress, discuss future research goals, aims, and ideas during the five years of the grant.

Pilot studies submitted to this NOFO should be structured to inform future studies on whether and how the intervention strategy reduces SIB and/or NSSI in LMICs. For example, relevant pilot work might include and combine the following:

• Pilot testing of interventions, including formative mixed-methods research. Regarding pilot testing of interventions, the Center for Global Mental Health Research (CGMHR) strongly encourages strategies that leverage innovative mHealth technology, social media, and approaches that optimize early identification and treatment of individuals at high risk through modifications in systems and structures to ensure full access and effective use of prevention, therapeutic and service interventions.
• Adaptation and/or pilot testing of interventions with demonstrated efficacy for use in broader scale effectiveness trials. Research aiming to adapt efficacious interventions should be justified in terms of (a) Theoretical and empirical support for the adaptation target (e.g., the adaptation changes a factor that has been associated with non-response, partial response, and participant non-engagement); (b) Clear explication of the mechanism by which a moderator variable functions to disadvantage or advantage a subgroup; and/or (c) Evidence to suggest that the adapted intervention will result in a substantial improvement in an aspect of care, or uptake in community/practice settings when compared to existing intervention approaches.
• Pilot test implementation science and services research methodologies. This NOFO is also intended to support pilot implementation science and services research to identify factors that impact access, utilization, quality, and outcomes of service provision. Such research could inform or pilot-test patient-, family-, community-, provider-, organizational-, or policy-level services interventions that target empirically-supported factors to improve care quality, coordination, and/or delivery.

NIMH strongly encourages the collection of preliminary data regarding feasibility, acceptability, adoption, fidelity and implementation cost, and target outcomes such as:

• measuring change in the targeted proximal factors (e.g., consumer- or provider-behaviors and or organizational-/system level factors);
• measuring fidelity in the delivery of the intervention;
• measuring improvement in the intended outcomes in the populations served, and
• any other factors that will strengthen the success of a future larger-scale study and determine the mechanisms of action of the intervention.

Opportunities for the detection and prevention of SIB and /or NSSI in people across the lifespan may occur at various points of contact across an array of health and non-health settings. Given the importance of cultural, social, and contextual factors, the intervention should consider the individual-, family-, community-, provider-, and organizational-level factors to optimize effectiveness, feasibility, acceptability, rapid uptake, and sustained delivery. The intervention should also improve connections to preventive and treatment interventions with proven effectiveness in reducing SIB or NSSI. 

The pilot work should be designed to support the anticipated future study design. A variety of methodologically rigorous approaches may be used such as randomized controlled trials (RCTs), quasi-experimental designs with non-randomized comparison groups, time series designs, and other designs of equivalent rigor and relevance. Pilot studies should be designed to inform and test the feasibility of the research design for a subsequent, adequately powered test of the intervention strategy (e.g., determining whether randomization is feasible), taking into account practical and local constraints, ethical issues, and the trade-off between maximizing internal and external validity. Of specific interest is research that uses task-sharing, competency-based training approaches, and innovative digital health technologies, where appropriate.

NIMH will consider supporting up to eight R34 applications with multidisciplinary research teams that establish and/or expand meaningful collaborations (e.g., active involvement in the research process, and sharing decision-making, mutual benefits, and resource-sharing) with at least one or more key stakeholders, such as multisectoral collaborations across government (e.g., health, finance, education, labor, agriculture), international development agencies (e.g., United States Agency for International Development (USAID), United Nations Children's Fund (UNICEF), and World Health Organization (WHO)), non-government partners, and/or other key stakeholders (e.g., health systems, provider, communities, advocates and users). In addition, collaborations should consider current local strategic plans and infrastructure investments.

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

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

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

Examples of Relevant Research Topics:

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

• Studies pilot testing and adapting universal prevention interventions such as safe storage of lethal means, media coverage for responsible suicide reporting, addressing social determinants of health, and implementing effective mental health policies.
• Studies pilot testing and adapting media guidance curricula and policies in multiple settings to reduce the risk of suicide and SIB and/or NSSI and promote resilience for people across the lifespan.
• Studies pilot testing and adapting effective suicide prevention selective and indicative efforts (e.g., safety planning and follow-up contacts after an attempt; community-based prevention programs; crisis intervention and management of SIB)
• Studies pilot testing and adapting effective youth and adult resilience socio-emotional life skills building programs, such as problem-solving, coping with stress, anti-bullying programs, and strengthening links to support services. The interventions and programs can be delivered across many different settings, such as the school, juvenile services, employment, training programs, worksite, and other community settings.
• Studies testing and adapting a chain of care (universal screening for high-risk groups, assessment, engagement, referral, and tracking of individual outcomes) in the healthcare system (primary care centers; pediatric and perinatal clinics) and community-level platforms (e.g., community services; school system, work-sites, juvenile services, and adult detention). Such research could inform or pilot-test patient-, provider-, organizational-, or policy-level services interventions to improve care quality, coordination, or delivery.
• Studies to develop innovative models of integrated prevention and treatment services to health systems and community platforms.
• Studies pilot testing and adapting scalable and sustainable strategies for training, supervising, and supporting providers, including technology-assisted training and competency assessments to improve reach (accurate detection) and quality of care in delivering research-supported suicide prevention and treatment interventions.
• Acceptability or feasibility studies that complement an ongoing effectiveness trial of preventive, treatment, and /or service intervention.

Applicants are also encouraged to consider one or more of the topics below: 

• Pilot work that would build the evidence for approaches described in the World Health Organization LIVE LIFE and /or Zero Suicide.
• Employ the United Nations Human Rights and intersectional lens when designing interventions and strategies.
• Engage with stakeholders and propose a multisectoral partnership to collaboratively address the research questions, study designs, and dissemination.
• Employ a multidisciplinary research approach, which may also be reflected in the composition of the study team.
• Consider innovations from conventional means of service delivery, especially conventional approaches that are not effectively addressing the needs of the highest-burden communities.
• Consider the policy context in the design of the project.
• Utilize methods to optimize intervention components.
• Develop broad, generalizable knowledge that will extend beyond the specific implementation sites included in the application.

Research Capacity Element

Applicants are expected to describe a plan and one or more activities to strengthen research capacity in LMICs and enhance the potential for exchange of multidirectional knowledge and research advancements. Applicants should describe how the research capacity activity component could strengthen significant country-led efforts to prevent suicide.

Activities may include but are not limited to: Training for community/ hospital surveillance systems, civil registration and vital statistics; training and strengthening the media professionals on best practices to report suicide; training for improving communication between researchers and policymakers, developing and disseminating implementation science programs to support the development of future studies and others.

Applications Not Responsive to This NOFO

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

•  Applications that propose research to be conducted primarily in HICs, including but not limited to the United States.
• Studies examining the efficacy and effectiveness of new pharmacologic therapies.
• Studies are limited to descriptive analyses of suicide prevalence and health systems.
• Studies conducted exclusively in academic research laboratories as opposed to effectiveness studies in community practice clinics/settings (e.g., studies in research clinics that involve research therapists or other features that are not representative of typical practice settings and substantially impact generalizability).
• Applications that do not propose an advisory board, which should include one or more members from the community and the collaborator organization
• Studies focus only on developing new screening/assessment instruments
• Studies that do not propose a capacity-building element
• Studies that do not include collaboration with a community partner(s)
• Studies that do not have an implementing partner on the investigative team
• Applications whose scope of work involves examining intervention effectiveness without studying whether the intervention engages the target(s) presumed to underlie benefits and without examining whether intervention/implementation strategy-induced changes in targets are associated with clinical or service benefits.

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

The NIMH has published updated policies and guidance for investigators regarding human research protection, clinical research data, and safety monitoring (NOT-MH-19-027). The 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. The NIMH will review plans to protect research participants and data and monitor safety for consistency with NIMH and NIH policies and federal regulations.

Technical Assistance Teleconference

A Technical Assistance teleconference will be held via Zoom (Webinar ID 161 812 3252) for potential applicants on April 21, 2023, at 9:00 AM ET. Click here to register. Please check the NIMH Center for Global Mental Health website for webinar updates.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

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

• 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 registration; 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.

For institutions/organizations proposing a single PD/PI, the PD/PI must have a primary academic appointment in an LMIC institution.

Applications proposing MPIs are required to include at least one PD/PI who has a primary academic appointment in an LMIC institution where the projects occur.

The applicant organization (contact PI) can be located in an LMIC or HIC. Research projects must be conducted in the LMIC where the single PD/PI or at least one PD/PI has a primary appointment. 

A single PI should devote at least 6 person-months per year of their professional effort to research. In the case of MPI, a combined effort should devote 6- person-months per year of their professional effort to research. The strength of the institutional support will be considered a factor in the review of the application.

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 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 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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Email: [email protected]

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.

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

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

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

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.

R&R Subaward Budget

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

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

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

The following elements must be included in the application:

Significance

• Address the degree to which the proposed study is relevant to the local context and could be disseminated into practice and policy.
• Detail how the proposed research will lead to new knowledge about an optimal and effective intervention to reduce the risk of suicide and SIB and NSSI and promote resilience for people across the life span in LMICs.
• Indicate the project's relevance to the partnering LMICs and how it will leverage and strengthen existing research capacities at the LMICs institutions.
• Describe how the pilot work will inform subsequent studies testing the effectiveness of intervention strategies.

Investigator 

• Provide details on how the research team includes necessary expertise in suicide preventive, therapeutic, and service interventions research, health disparities, community-engaged research and other relevant disciplines and how they will each contribute to the overarching goals of the proposal
• Describe the expertise and track record of the members of the investigative team in suicide preventive, therapeutic, and service interventions research, implementation science, social sciences, community engagement, and other relevant disciplines, and how they will each contribute to the overarching goals of the proposal.
• Describe the extent of involvement of researchers and key stakeholders.
• Describe plans to involve inputs from  relevant key stakeholders in a manner that informs the research (e.g., to help ensure the intervention approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility.

Innovation

• As relevant and appropriate, describe how the application of digital technologies, big data, or other innovative approaches or frameworks to pilot test preventive, therapeutic and service interventions ultimately reduce suicide risk (suicide ideation and behavior, including acts of self-harm/suicide) and promote resilience for people across the life span in LMICs.

Approach

 As appropriate, describe design features

• Propose a research project and a research capacity element that enhance the potential for multidirectional knowledge and the exchange of research advancements.
• Propose a formative research and /or pilot testing of culturally appropriate innovative preventive, therapeutic, and/or service interventions for suicide prevention in LMIC.
• Provide a rationale for the selection of suicide-related constructs and corresponding assessment instruments for the proposed population(s); and, if relevant, the time periods assessed and the schedule for assessments.
• Provide a clear justification for the experimental design chosen, a rationale for the choice of methods proposed, and describe how the results will inform the next stages of research.
• For studies proposing adaptations of existing interventions, provide the empirical justification for the proposed adaptation.
• If indicated, describe how the pilot work will preliminary assess the feasibility, usability, and acceptability of 1) measuring the change in the targeted proximal factors; 2) measuring fidelity in intervention delivery; 3) measuring improvement in intended outcomes, and 4) any other factors that will strengthen the success of a future larger scale study.
• Describe how the pilot work will support and strengthen the methodology anticipated in the future study (e.g., determining a schedule for data collection, whether randomization is feasible, etc.).
• As appropriate, describe design features that will be incorporated to ensure that the approach can be feasibly implemented in practice, that it is scalable, and that it is robust against implementation drift (e.g., using technology as scaffolding or expert consultation via existing resources/ other sustainable means to support delivery).
• Describe plans to establish meaningful collaborations with at least one or more key stakeholders such as multisectoral government (e.g., health, finance, education, labor, agriculture), international development agencies (USAID, UNICEF, WHO, and World Bank), non-government partners, and other key stakeholders (e.g., health systems, provider, communities, advocates and users).
• Describe plans for community engagement and Advisory Board, including a description of the activities or processes that will facilitate equitable and engaged decision-making and consensus building.

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

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

Advisory Board:

Propose an Advisory Board (AB) and an appropriate plan to ensure engagement of relevant stakeholders, including the collaborator organization, community members, throughout the project - from design to dissemination- to inform research and ensure findings will have utility for end-users. AB members could include but are not limited to patients, family, community members, advocates, peers, health care providers, policymakers, and members of the research partnership. An appropriate plan with a description of the advisory board structure, roles, and budget justification to secure the members to complete the research aims and support regular meetings should be provided.  AB  meetings should be included in the timeline. Potential AB members are not to be contacted, recruited, or identified in advance (i.e., in the application) to minimize conflicts during the review process. The application should indicate the areas of  expertise, anticipated input, and any critical considerations in selecting potential members. AB members cannot be collaborators or consultants on the proposed project. 

Letters of Support: 

The chair of the department where the PD/PI holds the primary academic appointment must provide a letter describing any tangible research support committed to the PD/PI. This may include start-up packages supplied to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities made available without charge-back, specialized training, mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protecting research time for the applicant. The department is encouraged to provide release time, so the applicant (s) can devote  their professional effort to research. The strength of the institutional support will be considered a factor in the review of the application.

The applicant also must provide letters of support from the community partners and local administrators or regulators from where the study will be taken place.

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 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 the 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 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.

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.

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.

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

Foreign Institutions

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at {[email protected]} when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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. Applicants who do not plan to collect the expected CDEs should explain the rationale in the Data Management and Sharing Plan attached in the Other Plans attachment of the application or potentially when Just in Time information is submitted. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Sharing for Applicants and Awardees.

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

• To what extent is the proposed study relevant to the local context and could it be disseminated into practice and policy?
• How well does  the proposed pilot work contribute to future studies testing models, theories, and conceptual frameworks of the intervention process that consider the local context and available resources of the target care settings?
• How likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility of an R01 research project or full-scale clinical trial?
• How well does the study propose to leverage and strengthen existing research capacities at the LMICs institutions?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

• How adequate is the research team's expertise in the areas of suicide prevention, therapeutic, and /or service interventions research, health disparities, and community-engaged research?
• To what extent does the research team describe plans to involve collaborations and/or input from community practice partners/providers, consumers, policymakers, and relevant key stakeholders in a manner that informs the research (e.g., to help ensure the intervention approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

• How well does the application propose a research project and a research capacity element that enhance the potential for multidirectional knowledge and the exchange of research advancements?
• How well does the application propose formative research and /or pilot testing of culturally appropriate innovative preventive, therapeutic, and/or service interventions for suicide prevention in LMIC?
• As appropriate, to what extent does the application provide the rationale for selecting suicide-related constructs and corresponding assessment instruments for the proposed population (s); the time periods assessed, and the assessment schedule? How well does the application address provisions for clinical management when suicidal behavior is reported?
• To what degree is the experimental design well-justified given this phase of research? Assess the rationale for the methods proposed and how the results will inform the next stages of research.
• For studies proposing adaptations of existing interventions for broader use, to what degree is the justification for the proposed adaptation is based on relevant empirical data?
• If indicated, how well does the pilot work preliminarily assess the feasibility, usability, and acceptability of 1) measuring change in the targeted proximal factors; 2) measuring delivery fidelity; 3) measuring change in the intended outcomes; and 4) any other factors that strengthen the success of a future larger scale study?
• How the pilot work will support and strengthen the methodology anticipated in the future study (e.g., determining a schedule for data collection, whether randomization is feasible, etc.).
• As appropriate, to what degree, does the approach or intervention can be feasibly implemented in practice, and is it scalable and robust against implementation drift (e.g., using technology as scaffolding can be or expert consultation via existing resources/ other sustainable means to support delivery)?
• To what degree does the proposed study include plans to involve significant collaborations, at least with one or more key stakeholders? How well does the proposed study include plans for an advisory board, including a description of the activities or processes that will facilitate equitable engagement?
• To what degree the application describe plans for the assessment of suicidal behavior and related outcomes using strategies that can facilitate integration and sharing of data?
• Does the study design preliminarily assess whether the intervention engages the mechanism(s) presumed to underlie the intervention effects as appropriate to a pilot study? How well are the plans for assessing target engagement/mechanism well-justified? Will data analysis preliminarily explore whether intervention-induced changes in the target(s) are associated with intended outcomes?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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.

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

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 Research Terms and Conditions
• 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 condition of receiving the grant, to administer 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. 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.htmlandhttps://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.”

Not Applicable

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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

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

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

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

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

Andrea Horvath Marques, M.D., Ph.D., MPH 
National Institute of Mental Health (NIMH)
Telephone: 301-646-7320
Email: [email protected]

Elizabeth L. Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone: 301-827-5578
Email: [email protected] 

Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

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

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.