Part 1. Overview Information

Key Dates

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

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

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

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Letter of Intent
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This Notice of Funding Announcement (NOFO) solicits exploratory/developmental research applications within the learning health care framework to support adoption, implementation, sustainability, and continuous improvement of evidence-based practices in outpatient mental health and substance use treatment systems. These settings could include, but are not limited to, Certified Community Behavioral Health Clinics (CCBHCs) funded through the Substance Abuse and Mental Health Services Administration (SAMHSA) expansion grant program and CCBHCs participating in their states’ Section 223 CCBHC Medicaid demonstration program, or as a part of independent state programs where the CCBHCs are meeting the federal CCBHC certification criteria. This NOFO requires active collaboration between behavioral health researchers and community behavioral health partners across all phases of the research process. Studies that are co-designed between community clinic staff/service users and health services researchers may focus on (1) identifying subgroups within the population of individuals served by CCBHCs with unique needs, including health disparities experienced by people from racial and ethnic minority groups or underserved communities; (2) workforce development strategies, including new approaches to train providers who vary in terms of prior experience, expertise and skills; (3) developing and testing tools to promote measurement-based treatment; (4) hybrid effectiveness-implementation trials aimed at implementing and improving evidence-based prevention, treatment, or services delivery approaches in real-world settings; and (5) research to establish and/or expand 988 crisis response services within CCBHC settings.

Background

The 2023 White House Report on Mental Health Research Priorities highlights learning health care as a promising methodology for sustaining and improving evidence-based services in mental health treatment systems. Likewise, the National Institute of Mental Health (NIMH) Strategic Plan for Research encourages practice-oriented research to study implementation and refinement of evidence-based approaches in real-world treatment settings. Strategic Objectives 3.3 and 4.1 – 4.3 outline strategies for comparative effectiveness, implementation science, and learning health care research to improve access, quality, and outcomes of mental health services for all Americans. The National Institute on Drug Abuse (NIDA) also emphasizes studying the implementation of evidence-based practices in real world setting in NIDA's Strategic Plan Priority Scientific Area #4. To broaden the dissemination and impact of this research, NIMH and NIDA collaborate with other federal agencies to promote adoption of evidence-based treatments in service delivery programs, including those supported by SAMHSA, the Health Resources and Services Administration, and the Centers for Medicare and Medicaid Services. Prior federal collaborations have supported science-to-service initiatives in early intervention for psychosis, testing zero suicide treatment and prevention models in health systems, and using implementation science to support delivery of evidence-based practices in community-based mental or general medical healthcare settings.

Research Objectives

This R34 funding opportunity extends NIMH and NIDA support for practice-oriented research that aims to advance implementation, sustainability, continuous improvement, and equity of evidence-based practices, which may include adaptations of established evidence-based practices, in community-based mental or general medical health care settings. SAMHSA encourages such studies in  Certified Community Behavioral Health Clinics established though recent CCBHC expansion grant initiatives, CCBHCs participating in their states’ Section 223 CCBHC Medicaid demonstration program, or CCBHCs that are part of independent state programs where the CCBHCs are meeting the federal CCBHC certification criteria. The purpose of the CCBHC initiative is to increase access to comprehensive, coordinated, and person-centered behavioral health care for all persons seeking mental health and/or substance uses services, including individuals with serious mental illness (SMI) or substance use disorders; children and adolescents with serious emotional disturbance (SED); and individuals with co-occurring mental and substance disorders. Elements required in CCBHCs include 24/7 crisis intervention and stabilization services; screening, assessment, and diagnosis, including risk assessment; outpatient mental health and substance use treatment; outpatient primary care screening and monitoring of key health indicators; targeted case management; psychiatric rehabilitation; peer support and peer counselor services; and intensive community-based mental health care for military service members and veterans. CCBHC certification criteria encourage participating clinics to (1) deliver evidence-based practices; (2) collect data on clinical encounters, quality of services, and patient outcomes; and (3) evaluate program effectiveness regarding access to care, scope and quality of services, and behavioral health care costs. These requirements align with the Institute of Medicine vision of learning health care in which health systems provide effective treatments, evaluate care processes and outcomes systematically, strive for continuous improvement and innovation in care delivery, and utilize data collected in clinical practice to drive the process of scientific discovery.

This NOFO encourages practice-oriented research to advance data-driven learning health care in community-based mental health and substance use treatment settings, including CCBHCs, leading to better knowledge and tools that are informed by clinical teams and patients for implementing, sustaining, and optimizing evidence-based, high quality, and equitable services. NIMH Strategic Objective 4.2.A advocates strong science-practice partnerships in the development of research projects that produce generalizable findings that can improve care for all people with mental illness, including those with SMI, SED, substance use disorders, and other co-occurring conditions, throughout the United States. To be responsive to this NOFO, applicants must partner with healthcare delivery organizations and/or organizations charged to deliver implementation support to healthcare delivery organizations. Examples of healthcare delivery organizations include current CCBHC expansion grant awardees and Federally Qualified Health Centers that provide comprehensive mental health and substance use services. An example of an organization charged to deliver implementation support is the SAMHSA-funded Technical Assistance (TA) Center.

Examples of high priority research topics include, but are not limited to the following:

• Projects that seek to identify mutable patient, provider, organization, or community-level factors that impact access, initial and sustained engagement, continuity, utilization, quality, and outcomes of evidence-based services offered in outpatient mental health and substance use treatment settings and represent potential targets for intervention.
• Studies that test novel strategies that can be used to reduce disparities, address social determinants of health, and advance equity in availability, quality, and outcomes of mental health and substance use services for racial and ethnic minority groups, individuals impacted  by language or cultural barriers, sexual and gender minorities, persons with disabilities, individuals living in rural areas, socioeconomically disadvantaged persons, and members of other underserved groups.
• Projects that seek to adapt established evidence-based practices to improve care for specific populations served by CCBHCs, including people from racial and ethnic minority groups or historically underserved communities or those who experience challenges related to underlying structural factors within communities that affect health, such as access to safe spaces, housing, healthy food, employment opportunities, transportation, and quality health care.
• Projects that seek to test novel strategies or to adapt established evidence-based practices for outpatient mental health and substance use treatment settings to improve behavioral health care for vulnerable populations across the lifespan such as children, adolescents, older adults, and pregnant and postpartum people. For example, CCBHC-supported behavioral health services including early childhood initiatives, school-based supports, disability and aging services, and perinatal/postpartum services.
• Research that seeks to test novel strategies or to adapt established evidence-based practices for outpatient mental health and substance use treatment settings to improve care for justice-involved populations (e.g., CCBHC-supported behavioral health services including juvenile justice programs and re-entry services).
• Research that evaluates whether intervention effectiveness, or successful implementation of evidence-based services, is mediated by individuals’ health-related social needs or other environmental conditions that affect mental health, functioning, or quality of life. Projects are encouraged that test approaches for addressing health-related social needs such as employment, housing, transportation, food security, or other social determinants of health. For example, targeted case management, supported employment, psychiatric rehabilitation, or other social services that are integrated with behavioral health interventions.
• Projects that seek to streamline evidence-based service delivery interventions for people with mental illness and other medical or behavioral health needs (e.g., opioid use disorder) to improve adoption, contextual fit, scalability, affordability, and sustainability of integrated care.
• Projects that test/compare sustainable staff training and supervision approaches (e.g., technology-assisted training, expert telephone consultation, training approaches for alternate or extender staff) that can be used to train providers to initial competence in evidence-based practices, to monitor intervention quality, turnover, and to promote sustained fidelity in the delivery of research-supported services, across a range of clinical modalities, including telehealth, for people with mental illness and/or substance use disorders. Cost-effectiveness of various approaches can also be considered.
• Projects that examine the mechanisms by which peer service providers may improve access, continuity, utilization, quality, and outcomes of evidence-based services in outpatient mental health and substance use treatment settings.
• Projects that examine the mechanisms by which recovery support services and/or psychiatric rehabilitation services may improve engagement, continuity, utilization, quality, and outcomes of evidence-based services in outpatient mental health and substance use treatment settings. 
• Studies that identify barriers to implementing measurement-based care (MBC) in community-based mental health and substance use treatment settings that represent potential targets for intervention and/or studies that test targeted strategies to support implementation of MBC with fidelity and maintain MBC over time.
• Projects focused on developing, refining, and/or testing the utility of screening, clinical assessment, and data reporting tools that support MBC (e.g., measures of risk, symptoms, and functioning, electronic health record documentation, paper-pencil questionnaires, mobile health technology, telephone monitoring), that can be used to assist providers and empower patients to track their progress.
• Projects that implement and evaluate data-driven quality improvement approaches to suicide care in health systems, which may include adoption of zero suicide common data elements, monitoring key metrics for high quality suicide care, and using data visualization tools to track and communicate progress on effective care practices and patient outcomes. 
• Projects that employ Hybrid Type 2 and 3 Effectiveness-Implementation Trial designs to test the effectiveness of implementation strategies and measure clinical outcomes for prevention, treatment, or services interventions. Type 2 designs simultaneously test the effectiveness of (a) implementation strategies and (b) promising prevention, treatment, or services interventions with some empirical support, but lacking sufficient evidence for inclusion in clinical practice guidelines. Type 3 designs test strategies to implement prevention, treatment, or services interventions with strong extant evidence of effectiveness (e.g., recommended in a clinical practice guideline).
• Projects that develop and test practical shared decision-making strategies for children and adolescents with serious emotional disturbance and adults with serious mental illness.
• Projects to develop and optimize care models that integrate primary care services into mental health treatment settings to reduce modifiable health risks associated with premature mortality in people with SMI, e.g., smoking, overweight and obesity, dyslipidemia, and other common cardiovascular disease risk factors.
• Projects that test financing and payment strategies, including alternative payment models, that incentivize the implementation and sustainment of evidence-based practices and their effects on clinical, functional, and health services (e.g., access, continuity, and equity of care) outcomes.
• Projects focused on refining and testing the feasibility and utility of patient and provider facing technologies (e.g., SMS reminders, digital tracking, and action plan/workflow support) to support decision-making, evidence-based practices and interventions, treatment fidelity, and care integration.
• Projects that seek to understand circumstances and test strategies to stop or reduce (i.e., “de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful in efforts to demonstrably free up resources and then implement a high-value EBP.
• Projects to develop new components or unbundle or test the unique contributions of existing components (and/or combinations of components) of multi-component service delivery interventions using designs such as the following: factorial designs and their derivatives (e.g., fractional factorial); Multiphase Optimization STrategy (MOST); Sequential, Multiple Assignment, Randomized Trials (SMART); randomized encouragement; and interrupted time series designs or other quasi-experimental approaches, where randomization may not be possible.
• Projects that optimize interventions and implementation approaches by testing implementation strategies and their alignment with school programs, medical facilities (e.g., primary care, emergency departments), the criminal justice system and/or employment settings for people with mental illness and other co-occurring conditions.
• Studies that are designed to identify the specific components or underlying mechanisms that account for the effectiveness of best practices in the delivery of crisis services in community-based mental health and substance use care settings, where a wide range of clinical presentations, psychosocial factors, age-related (e.g., child; youth; adult; older adult), geographic (rural/remote settings), cultural considerations, and health disparities influence the types of crisis care provided.
• Projects that address research topics listed in NOT-MH-23-140, Notice of Special Interest: Priority Research Opportunities in Crisis Response Services.

Scope of Research

This R34 NOFO supports projects designed to (1) examine the feasibility of learning health research approaches, (e.g., ability to recruit and retain participants); (2) refine and pilot test experimental protocols, including assessment protocols and experimental intervention protocols, as relevant; and (3) yield pilot data necessary for informing next steps and for enhancing the probability of obtaining meaningful results in subsequent, well-powered R01-level studies. The scope of research for such pilot research projects is generally analogous to the scope of research described in the NIMH R34 Research Mechanisms for Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (PAR-21-131) or for Pilot Services Research Not Involving Clinical Trials (PAR-23-105).

Depending on the research question, a variety of methodologically rigorous approaches may be indicated for proposed studies. These may include randomized controlled trials, natural experiments, quasi-experimental designs with non-randomized comparison groups (including propensity score matching and instrumental variables designs), time-series designs, difference-in-difference, stepped wedge, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the trade-off between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

Guidance Regarding Clinical Trials 

Consistent with the NIMH experimental therapeutics approach, all R34 projects that focus primarily on mental health and involve clinical trials, including projects that involve testing preventive, therapeutic, or services interventions, should be designed to not only examine the intervention effects on outcomes of interest, but to also inform understanding of the intervention’s mechanisms of action. As such, applications are expected to pre-specify intervention targets and measure the impact of the intervention on both the hypothesized targets and more distal clinical or service outcomes. For example, an application that targets clinicians’ beliefs about their capacity to deliver an evidence-based practice could assess changes in clinicians perceived self-efficacy (proximal outcome) as well as the number of clinicians who deliver the evidence-based treatment following training (distal outcome). Thus, the scope of work for effectiveness and implementation trials must (1) specify intervention target(s); (2) include measures that assess the target(s) before and after exposure to an experimental intervention; and (3) propose a data analysis plan that that will be used to examine whether the intervention leads to changes in the target(s) and to conduct a preliminary examination of whether changes in the target(s) are associated with changes in the distal clinical our services outcomes, as appropriate in the context of the pilot trial (see Support for Clinical Trials at NIMH). Furthermore, projects seeking to adapt established evidence-based practices are required to provide an empirical rationale for the adaptation; a clear hypothesis and plan to address the mechanism by which the adapted intervention will enhance outcomes; and evidence to suggest that the adapted intervention will result in a substantial improvement in outcomes (e.g., an adaptation or augmentation might target a factor that has been previously shown to be associated with non-response, partial response, poor engagement, or relapse).

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

Applications Not Responsive to this NOFO

The following applications will be considered non-responsive and will not be reviewed:

• Applications that do not include a clinical partner advisory board and/or involvement of clinical practice partners as key personnel (e.g., community behavioral health practitioners, clinic leaders, service user advocates, and/or policymakers). Clinical practice partners must be involved in the scientific development of the project and have institutional support for applying study findings to influence clinical practice within the outpatient mental health treatment setting.
• Applications that focus primarily on mental health and propose clinical trials that do not align with the NIMH experimental therapeutics framework (see above). For example, clinical trial applications that fail to (1) prespecify intervention target(s); (2) include measures that assess the target(s) before and after exposure to the experimental intervention; and (3) propose a data analysis plan that evaluates relationships between changes in proximal outcomes and changes in distal clinical or services outcomes.
• Applications that propose adaptations of existing interventions in the absence of a compelling justification.
•  Applications that propose adaptations of existing interventions without a clear experimental therapeutics approach to examining how the intervention engages the adaptation target (see above).

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

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 Organizations) 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Email: nimhpeerreview@mail.nih.gov

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

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

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 Research Strategy must include the following information:

Significance

• Describe the overall significance and potential impact of the proposed research on data-driven learning health care in community-based mental health treatment settings in relation to the state-of-the-art of the field.
• Describe the likelihood that the project will generate knowledge and practices that advance implementation, sustainability, continuous improvement, and equity of evidence-based practices in community-based mental health systems.
• Detail how the proposed research will generate data that will lead to a conclusion about the feasibility of a regular research project grant or full-scale clinical trial and provide information about the anticipated scope and goals of intended future work.

Investigators

• In the biosketches, provide evidence that the investigative team has expertise in conducting comparative effectiveness, implementation science, or learning health care research studies in community-based mental health treatment settings. Describe prior collaborations between behavioral health scientists and community behavioral health partners in conducting practice-oriented mental health research in real-world settings.
• In the biosketches, identify community behavioral health partners (e.g., service users, practitioners, CCBHC administrators, and/or policymakers) to be included among key personnel. Describe each individual’s specific role in the project and document their qualifications and experience related to the proposed research.    

Innovation

• Projects should propose novel solutions to challenges in implementing and sustaining data-driven learning health care in community-based mental health treatment settings.

Approach

• Describe how input from community behavioral health partners (e.g., service users, practitioners, CCBHC administrators, and/or policymakers) has contributed to the development and design of the research project.  
• Describe the methods by which community and research partners will collaborate, including but not limited to state-of-the-art team building methods, such as Team Science Approaches, Lean business methodology, Plan-Do-Study-Act (PDSA) cycles and interactive design teams.
• Describe how the research project employs state-of-the-art methods in health services research, comparative effectiveness trials, implementation science, hybrid effectiveness-implementation designs, and/or learning health care research to study adoption, implementation, sustainability, continuous improvement, and outcomes of evidence-based practices in outpatient mental health treatment systems.
• Justify the choice of research design in terms of practical constraints, ethical issues, and trade-offs between maximizing internal and external validity.
• Explain how prior research informs the approach, including any preliminary data that may be available, that supports the feasibility, tolerability, acceptability and safety and preliminary effectiveness of approaches to improve mental health/functional outcomes, to modify risk factors, or to improve service delivery (e.g., improve access, continuity, quality, equity, and value of care).
• Discuss plans for rapid implementation of research findings to improve clinical practices in community-based mental health treatment settings.
• For effectiveness and implementation trials, specify an intervention target(s); include measures that assess the target(s) before and after exposure to an experimental intervention; and propose a data analysis plan that that will be used to (1) examine whether the intervention leads to changes in the target(s) and (2) conduct a preliminary examination of whether changes in the target(s) are associated with changes in the distal clinical our services outcomes, as appropriate in the context of the pilot trial
• For projects that plan to adapt established evidence-based practices, provide an empirical rationale for the adaptation; a clear hypothesis and plan to address the mechanism by which the adapted intervention will enhance outcomes; and evidence to suggest that the adapted intervention will result in a substantial improvement in outcomes.

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 by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA. The NIMH Data Archive (NDA) Data Submission Agreement requires applicants to acknowledge that data submitted to the NDA are collected in a manner consistent with all applicable laws and regulations, institutional policies, and/or with the approval of an Institutional Review Board.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID or Pseudo 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.&nnbsp;

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

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.

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

For studies involving human subjects, applications must provide a clear description of:

• Recruitment and Referral sources, including detailed descriptions of the census/rate of new cases and anticipated yield of eligible participants from each source;
• Procedures that will be used to monitor enrollment and track/retain participants for follow-up assessments;
• Strategies that will be used to ensure a diverse, representative sample;
• Potential recruitment/enrollment challenges and strategies that can be implemented in the event of enrollment shortfalls (e.g., additional outreach procedures, alternate/back-up referral sources);
• Evidence to support the feasibility of enrollment, including descriptions of prior experiences and yield from research efforts employing similar referral sources and/or strategies.

2.7 Study Timeline

Applications must provide a timeline for reaching important study benchmarks. Benchmarks should be objective, quantifiable, and justifiable. Benchmarks may include but are not limited to the following:

• Finalizing the study procedures and training participating clinical site staff;
• Developing the intervention manual and assessment protocols, including fidelity measures/procedures, where applicable;
• Establishing data use agreements accessing data sets, data cleaning, and linking data sets where applicable;
• Enrollment benchmarks;
• Completing all subject assessments and data collection activities, including data quality checks;
• Analyzing and interpreting results;
• Preparing de-identified data and relevant documentation to facilitate data sharing, as appropriate.

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.

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the 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 the National Institute of Mental Health (NIMH), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Not Applicable

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. 

NIDA strongly encourages investigators involved in human-subjects studies, including those who respond to this funding announcement, to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 for further details.

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

This NIMH R34 NOFO supports pilot research designed to (1) examine the feasibility of learning health research approaches, (e.g., ability to recruit and retain participants); (2) refine and pilot test experimental protocols, including assessment protocols and experimental intervention protocols, as relevant; and (3) yield pilot data necessary for informing next steps and for enhancing the probability of obtaining meaningful results in subsequent, well-powered R01-level studies. Because this NOFO supports exploratory/developmental research, applications need not have extensive background material or preliminary information as one might normally expect in an R01 application. Preliminary data are not required for R34 applications but may be included if available. Adequate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, investigator-generated data. Therefore, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance scientific knowledge or understanding related to mental health and substance use services.

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:

• How likely is it that the proposed research will lead to advances in data-driven learning health care in community-based mental health and/or substance use treatment settings? To what extent will the research generate knowledge and practices that advance implementation, sustainability, continuous improvement, and equity of evidence-based practices in community-based mental health and/or substance use treatment systems? How likely is it that the proposed research will generate data that will lead to a conclusion about the feasibility of a regular research project grant or full-scale clinical trial and provide information about the anticipated scope and goals of intended future work?

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 strong is the evidence that the investigative team has adequate expertise for conducting comparative effectiveness, implementation science, or learning health care research studies in community-based mental health and/or substance use treatment settings? How strong is the evidence that the community behavioral health partners have the qualifications and experience necessary to fulfill their specific roles in the project?  How strong is the evidence that named behavioral health scientists and community behavioral health partners have prior experience in conducting collaborative practice-oriented research in real world settings?     

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?

Specific to this NOFO:

• To what extent does the project propose novel solutions to challenges in implementing and sustaining data-driven learning health care in community-based mental health and/or substance use treatment settings?

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 strong is the evidence that mental health and/or substance use researchers and community behavioral health partners have collaborated in defining the study’s aims and methods? To what extent are state-of-the-art team building methods such as Team Science approaches, Lean business methodology, Plan-Do-Study-Act (PDSA) cycles, or interactive design teams employed to ensure a collaborative feedback loop across all phases of the research project?
• To what extent does the project employ state-of-the-art methods in health services research, comparative effectiveness trials, implementation science, hybrid effectiveness-implementation designs, and/or learning health care research to study adoption, implementation, sustainability, continuous improvement, and outcomes of evidence-based practices in outpatient mental health and/or substance use treatment systems? How strong is evidence from prior research (i.e., literature citations, data from other sources, or, when available, investigator-generated data) regarding the feasibility, tolerability, acceptability, safety, and preliminary effectiveness of approaches to improve mental health/functional outcomes, to modify risk factors, or to improve service delivery, including access to and/or continuity, quality, equity, and value of care? How strong are proposed strategies for rapid implementation of research findings to improve clinical practices in community-based mental health and/or substance use treatment settings?
• For applications that test preventive, therapeutic, or services interventions, to what extent does the study design (1) specify proximal intervention target(s) that are hypothesized to account for improvement in clinical or service outcomes; and (2) describe the plan for assessing intervention-related changes in the target(s), including the specific measures and assessment schedule?
• For projects that plan to adapt established evidence-based practices, how strong is (1) the empirical rationale for the adaptation; (2) the plan to address the hypothesized mechanism by which the adapted intervention will enhance outcomes; and (3) prior evidence that suggests that the adapted intervention will result in a substantial improvement in outcomes?
• For applications that test preventive, therapeutic, or services interventions, to what extent does the data analysis plan (1) employ strategies that will examine whether the intervention leads to changes in the target(s); and (2) examine the relation between changes in the target(s) and changes in clinical or service outcomes, as appropriate in the pilot trial?

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Not Applicable.

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 the National Institute of Mental Health (NIMH), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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.

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

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (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 2 CFR Part 200 – 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: 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

Michael Freed, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3747
Email: michael.freed@nih.gov

Sean Lynch, PhD, LCSW
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-4596
Email: sean.lynch@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

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Section VIII. Other Information

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

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