Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)

Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) is sponsored by National Institute of Mental Health (NIMH). Supports innovative pilot studies in mental health services research, including those focusing on disability policy and public opinion.

PAR-25-284: Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose Proposed research should seek to: 1) Identify mutable factors that impact access, continuity, utilization, quality, value, and outcomes, including disparities in outcomes, or scalability of mental health services, which may serve as targets in future service delivery intervention development, 2) Develop and test new research tools, technologies, measures, or methods and statistical approaches to study these issues, and 3) Test the feasibility of integrating and analyzing large data sets to understand factors affecting mental health services outcomes using advanced computational and predictive analytic approaches.

4) Wherever possible, leverage existing infrastructure and partnerships to accomplish these goals. Funding Opportunity Goal(s) The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The healthcare landscape in the United States and globally is constantly changing, creating new challenges to the delivery of high-quality treatments and services to children, youth, adults, and older adults with unmet or under-met mental health needs.

Epidemiological findings suggest that approximately one-half of the United States population meets lifetime criteria for a mental illness, and approximately one-fifth of people over 18 years old meet criteria in any given year. However, only one-half of people with any mental health disorders and only two-thirds of adults with a serious mental health disorder received mental health services in the previous year.

Among young adults with serious mental illness, approximately half received mental health services in the previous year. Of those who find their way into mental health care, many quickly fall out of care and/or do not receive guideline-concordant treatment. Statistics for low- and middle-income countries ( LMICs) show even lower rates of treatment.

Health disparities among certain populations (e.g., members of racial, ethnic, and rural communities), a fragmented healthcare system, provider shortages, healthcare affordability, and other factors moderate these findings.

Innovative mental health services research is needed to improve access, continuity, effectiveness, efficiency, and value of mental health services, and to bring effective strategies to scale to maximize public health impact.

Research Scope and Opportunities This notice of funding opportunity (NOFO) is intended to foster pilot mental health services research in strategic but understudied areas where new knowledge has the potential for high public health impact.

This NOFO supports non-clinical trials research, including but not limited to natural experiments (that are not clinical trials), survey or mixed methods research, clinical epidemiology, and development and refinement of new research methods, measures, financing approaches, or statistical approaches related to mental health services research.

Services research can target patients, providers, healthcare leaders and administrators, and/or healthcare systems or other organizations that provide services to persons with mental disorders, including those with early psychosis or autism spectrum disorders across the lifespan.

NIMH encourages investigators to design their applications to maximize the likelihood that findings will meaningfully inform future research and/or be translated rapidly into practice, whether at the patient, clinical, healthcare/other system, or policy level. Studies involving providers, technologies, and workflows that generate results that can inform future studies of implementation in routine care settings are encouraged.

Studies (using non trial designs) that are seeking to develop, refine, or evaluate services or system interventions, should employ methods that seek to understand how, why, for whom, and/or in what circumstances the intervention may be effective. That is, methodology should go beyond evaluating simply whether an intervention is effective.

Studies that evaluate interventions must not employ NIH-defined clinical trial designs (e.g., must not prospectively assign participants to one or more interventions). NIMH encourages investigators to develop and leverage strong research-practice partnerships with public and private stakeholders, so that the research follows a deployment-focused model of services design and testing.

Deployment-focused studies consider the perspective of relevant stakeholders and key characteristics of settings intended to implement optimized mental health interventions.

This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure that resultant interventions and service delivery strategies are feasible and scalable, and to ensure that the research results will have utility for end users.

Such stakeholders include, but are not limited to, federal agencies (e.g., Centers for Medicare and Medicaid Services , Substance Abuse and Mental Health Services Administration , Health Resources and Services Administration , U.S. Department of Defense , Department of Veterans Affairs ); state agencies, including state Medicaid leadership; commercial health insurers and/or funders; public and commercial disability insurers; employers and other payers; delivery systems; professional and/or trade associations; accrediting and licensing organizations; medical education and other clinician training programs; clinicians; vendors of information technology and other relevant products and/or services; service users; family members; and community organizations or comparable institutions and stakeholders in LMICs.

Such communication and collaboration will ensure findings are relevant and practical, create opportunities for research that is not otherwise feasible, and enable stakeholders to anticipate relevant research initiatives in their planning and activities.

Given the critical need for practice-relevant research in community and practice settings, collaborations between academic investigators and clinical or community practice partners or networks are encouraged.

When possible, studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN) and the Early Psychosis Intervention Network ( EPINET ); NIMH-sponsored ALACRITY Research Centers ; NIMH-sponsored suicide research centers NIMH-sponsored Scale-Up Hubs ; electronic medical records, administrative databases, patient registries, institutions with Clinical and Translational Science Awards) to increase the efficiency of participant recruitment, data collection and management.

NIMH is committed to supporting research that reduces disparities in mental health interventions, services, and outcomes.

Accordingly, this NOFO encourages pilot research on innovative service delivery models that seek to reduce disparities in service access, quality, and outcomes for underserved groups, for example, racial and ethnic minority groups, individuals limited by language or cultural barriers, and individuals living in rural areas.

Research improving the efficiency, reach, and clinical impact of existing mental health services: Developing and evaluating performance feedback systems, decision support tools, and quality improvement processes, which can be utilized across a range of systems (e.g., primary care, schools, criminal justice system, child welfare agencies) or levels within a single system to optimize the delivery of effective mental health interventions.

Developing pragmatic, valid, and reliable measures of intervention fidelity, quality, and treatment outcomes, including outcome-focused quality measures, that can be applied at the patient, clinician, clinic, system, and/or population levels.

Identifying mutable factors, including patient, provider, organizational, and policy-level factors, to include social determinants of health, that are likely to influence disparities in healthcare access, continuity, quality, and mental health outcomes for racial and ethnic minorities and other underserved groups.

Social determinants of health include, but are not limited to, housing, food security, employment, social contact, and education. Social determinants of health may be operationalized in multi-level terms. These identified factors should serve as targets for future intervention development and testing.

Investigating alternative financing mechanisms, service purchasing mechanisms, inclusion in publicly funded benefit baskets, policies, regulations, and healthcare system rules, to include provider- or payer-level incentives, that promote high value (e.g., clinically effective and efficient) care, including integrated medical and psychosocial treatment approaches, and discourage low-value services.

Evaluating existing strategies to enhance treatment engagement and adherence (e.g., shared decision-making or behavioral economic approaches to behavior change).

Research that informs the expeditious adoption, scaling, sustained implementation, and continuous quality improvement of evidence-based mental health or autism services as part of a learning healthcare system: Improving the dissemination, implementation, and delivery of evidence-based prevention and treatment practices in community mental health centers and non-specialty care settings (e.g., primary medical care, schools, online and virtual communities).

Examining mutable patient-, provider-, organizational-, and policy-level factors that influence the degree to which evidence-based interventions are implemented with fidelity, and sustained over time, to include mutable factors that influence sustainment after the research project period has ended.

Systematic, data-guided quality improvement activities that rigorously examine mental health care processes and outcomes within healthcare systems, to inform potential strategies that could lead to rapid, durable, and generalizable improvements in access and continuity of services, quality of care, and mental health outcomes at the individual and population-level.

Designing and/or validating instruments to measure dissemination, implementation, or sustainability processes; changes in service user functioning or provider practice over time; or organizational or systems processes related to access and continuity of services, quality of care, and mental health outcomes at the individual and population levels.

Employing studies (with quasi-experimental or quality improvement designs and methodologies that are not clinical trials) that simultaneously evaluate the effectiveness and implementation of mental health services to enhance the delivery of evidence-based mental health practices and improve implementation of mental health services to enhance the delivery of evidence-based mental health practices and improve implementation outcomes (e.g., fidelity, acceptability, feasibility, appropriateness, penetration, and sustainability of services).

Research on innovative service delivery models to reduce or eliminate known health disparities, to dramatically improve outcomes in understudied populations in theUnited States and global communities, and to ensure high value mental health services are readily accessible to those in need: Using innovative technologies (e.g., mobile devices, health information systems, social networking platforms) to improve early detection of mental illnesses, engaging and connecting service users to evidence-based care, and increasing the reach, clinical impact, and scalability of services for underserved populations in a variety of settings.

Developing and examining strategies for delivering evidence-based mental health services in non-specialty settings (e.g., primary care, criminal justice system, community-based programs providing mental health services to military or veteran populations, colleges or other academic settings, the child welfare system, or geriatric service settings), and leveraging those strategies to bolster the delivery of high-quality evidence-based care in specialty care settings.

Investigating the role of peer specialists to improve access, engagement, and effectiveness of services for people with mental illnesses, with or without co-occurring medical and other conditions. This research may address related issues such as optimal integration of peer specialist staff in service delivery systems and financing of such services.

Studying service delivery models that fully integrate treatment for mental illnesses with primary medical care, including medical decision models for treating mental illnesses and multiple chronic conditions.

Using non-clinical trial methodology (e.g., natural experiments) to evaluate service delivery models for comorbid conditions, such as care decision models that integrate treatment for mental illness and medical conditions, including service delivery interventions to identify, prevent, and reduce modifiable health risks associated with premature mortality in people with serious mental illnesses.

Research to evaluate the public health impact of mental health services or autism services innovation using large representative data sets and novel computational approaches: Using electronic health record data to examine the clinical epidemiology, service utilization, response to treatment, and health state transitions of people with mental health needs within or across large systems responsible for mental health service delivery.

Monitoring real-time trends in suicidal behavior, serious mental illness, and other mental illnesses that generally go unrecognized in health care and other settings (e.g., school, work, and home) and promoting effective data-driven planning to improve detection and help seeking in these populations.

Developing and using big data and commensurate analytic approaches (e.g., predictive analytics, machine learning, artificial intelligence, large language models, etc.) for the purposes of understanding concentrations of risk and optimizing mental health care.

Developing, refining, or applying new methodological and computational approaches for the analysis of complex and dynamic systems affecting mental health outcomes, with the goal of demonstrating the impact of such factors on client outcomes. Developing sampling frames and leveraging/enhancing existing epidemiological datasets to understand mental health needs in treatment seeking and general populations.

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

Applications that do not include mental health services research. Applications whose scope of work primarily involves the provision of direct services (e.g., the creation of a clinic or center). Applications that have no clearly articulated relevance to people with or who are at risk for mental illness or autism spectrum disorder.

Studies focused on stigma or health literacy that examine knowledge about or attitudes towards mental health and mental health care without also examining mental health policy, actual service access, engagement, quality and/or outcomes of care. Applications that propose a clinical trial.

Mental health services research questions that require a clinical trial design must be submitted via the appropriate NIMH Clinical Trials Funding Opportunity Announcement (see Support for Clinical Trials at NIMH ).

Applicants considering research studies where participants are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related outcomes are encouraged to review the NIMH clinical trials website and contact NIMH Program Officials regarding the match between a potential application and current priorities.

Applications proposing definitive studies consistent with NIMH priorities for mental health services research not involving interventions should be submitted via PAR-25-283 , Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed).

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

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to $450,000 in direct costs over the R34 project period, with no more than $225,000 in direct costs allowed in any one year.

The total project period for an application submitted in response to this funding opportunity may not exceed three years. 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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. 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 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission 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 How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Within the Research Strategy, include the following information: Factor 1.

IMPORTANCE OF THE RESEARCH (SIGNIFICANCE) Detail how the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant (e.g., an R01 application) and provide information about the anticipated scope and goals of intended future work.

For projects involving methods development and testing, describe the potential for broad use of results in studies of other target populations and/or outcomes. Describe collaborations and/or input from community partners and relevant policymakers/health leaders.

Discuss how information gleaned from these relationships influenced the development of the research, ensure it is deployment-focused (as defined above) and/or deployed and sustained if study is successful, and/or will help ensure that the results will have utility to community practice and/or other relevant stakeholders or end users of the research.

Address the potential public health impact of the proposed work in terms of a) reach and effect on the target populations, and/or b) meaningfulness of the anticipated outcome(s) compared to existing approaches and/or current state of science in the topic area.

For studies involving services interventions (e.g., research with quasi-experimental or quality improvement designs and methodologies that are not clinical trials), address the degree to which the proposed services intervention is scalable and could be broadly implemented using typically available resources, staff, and service structures, including financing mechanisms.

IMPORTANCE OF THE RESEARCH (INNOVATION) Highlight any innovative research strategies and design or analytic elements that are being used and describe the potential of these to enhance the relevance and usefulness of study findings. Describe how any use of information technology contributes to new knowledge and/or research efficiency, and/or has the potential to contribute significantly to improved outcomes. Factor 2.

RIGOR AND FEASIBILITY (APPROACH) Describe factors that are mutable and have the potential to serve as targets in future intervention development that impact access, continuity, utilization, quality, value, financing, effectiveness, outcomes, or scalability of mental health or autism services.

For applications that propose to develop and test new research tools, measures, or methods, describe how the research will lead to validated and deployable products, services, and/or methodologies that are broadly and efficiently usable in community practice settings.

For applications that propose to integrate and/or analyze existing data sets, discuss how results will enhance and extend our understanding of factors affecting access, continuity, quality, delivery, efficiency, financing, value, effectiveness, or outcomes of care. Describe any planned collaboration or input from stakeholders and describe how these will contribute to the utility of study results.

Beyond providing letters of support, consider proposing an advisory board that includes relevant stakeholders and decision makers (e.g., local, state, or federal policymakers; health system executives) or strategically including such decision makers as part of the study team. Provide evidence that outcomes measures are valid and reliable, including measures of outcomes that are meaningful to the stakeholders involved.

For studies that involve the assessment of patient-level outcomes, describe plans for the detection of suicidal behavior/ideation and non-suicidal self-harm, and for clinical management to reduce subject risk when these factors are identified. Factor 3.

EXPERTISE AND RESOURCES (ENVIRONMENT) Describe how the study will leverage resources and expertise from existing infrastructure (e.g., CTSAs; practice-based research networks; other NIMH investments like the Mental Health Research Network, ALACRITY Research Centers, and EPINET; electronic medical records; administrative databases; patient registries) or utilize other available resources to increase the efficiency of participant recruitment and data collection.

Or, provide a justification in the event that such efficiencies cannot be incorporated. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100 ).

Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission.

The NDA website provides two tools to help investigators develop appropriate strategies: 1) t he 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