It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

Rationale

The healthcare landscape in the United States 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 disorder, and approximately one quarter of the population meets criteria in any given year. However, only one half of people with any mental health disorder and only two thirds of people with a serious mental health disorder received mental health services in the previous year. Of those that find their way into mental health care, many fall out of care and/or do not receive guideline concordant treatment. Disparities in population status (e.g., members of racial, ethnic, sexual, and gender minority 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, quality, equity, efficiency, and value of mental health services, and to bring effective strategies to scale to maximize public health impact.

Research Scope and Objectives

This program announcement uses the R01 and is intended to foster mental health services research in strategic but understudied areas where new knowledge has the potential for high public health impact. This announcement supports non-clinical trials research, including quasi-experimental studies, survey or qualitative research methods, clinical epidemiology, and development and testing of new research methods, measures, 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. 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, clinic, healthcare/other system, or policy level.

Pilot studies consistent with NIMH priorities for mental health services research not involving interventions should be submitted via PAR-15-323, Pilot Services Research Grants Not Involving Interventions (R34).

Investigators are strongly encouraged to review NOT-OD-15-015 for guidance concerning the NIH definition of clinical trial research, which includes diagnostic, treatment, and preventive strategies as well as interventions involving delivery systems. Mental health services research questions that require a clinical trial design must be submitted via the appropriate NIMH Clinical Trials Funding Opportunity Announcement (see https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml). Applications submitted in response to the current Funding Opportunity Announcement (FOA) may not include a clinical trial within the aims; such applications will not be accepted by NIMH. Applicants considering clinical trials are encouraged to review the NIMH clinical trials website and contact NIMH Program Officials regarding the match between a potential application and current priorities.

NIMH strongly encourages investigators to develop and leverage partnerships with public and private stakeholders, so that the research follows a deployment-focused model of services design and testing. Deployment-focused studies take into account 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, Department of Defense, Department of Veterans Affairs); commercial health insurers/funders; public and commercial disability insurers; employers and other payers; delivery systems; professional/trade associations; accrediting and licensing organizations; medical education and other training programs; clinicians; vendors of information technology and other relevant products/services; service users; family members; and community organizations. 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, electronic medical records, administrative data bases, patient registries, institutions with Clinical and Translational Science Awards) to increase the efficiency of participant recruitment, data collection and management, and securing stakeholder support.

Under this FOA NIMH seeks mental health services research applications in the following areas:

Research to improve the efficiency and clinical impact of existing mental health services:

1) 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) to optimize the delivery of effective mental health interventions.

2) Developing pragmatic, valid, and reliable measures of intervention fidelity, quality, and treatment outcomes that can be applied at the person, clinic, system, and/or population levels.

3) Identifying mutable factors that are likely to contribute to documented healthcare disparities in care access, continuity, quality, and outcomes for racial and ethnic minorities and other underserved groups and which can serve as targets for future intervention development and testing.

4) Investigating alternative financing mechanisms that promote high quality, clinically effective, and efficient community-based care, including integrated medical and psychosocial treatment approaches and discourage low-value services.

Research to improve dissemination, implementation, and sustainability of evidence-based mental health services as part of a learning healthcare system:

1) Improving the dissemination, implementation, and delivery of evidence-based prevention and treatment practices in community mental health centers and other non-specialty care settings (e.g., primary medical care, schools, online and virtual communities).

2) 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.

3) Systematic, data-guided quality improvement activities that rigorously examine mental health care processes and outcomes within healthcare systems, leading 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.

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

Research on innovative service delivery models to reduce or eliminate known health disparities related to race, ethnicity, geography, sexual and gender minority status and/or socio-economic status, to dramatically improve outcomes in understudied populations in diverse United States communities, and to ensure high value mental health services are readily accessible to those in need;

1) Utilizing 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 unserved populations in diverse settings.

2) Developing and examining strategies for delivering evidence-based mental health services in non-specialty settings (e.g., 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.

3) Investigating the role of peer support 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 support staff in service delivery systems and financing of such services.

4) 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 medical conditions.

Research to evaluate the public health impact of mental health services innovations in target populations using large representative data sets and novel computational approaches:

1) Utilizing 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.

2) Monitoring real-time trends in suicidal behavior in health care and other settings and promoting effective data-driven planning to improve detection and prevention of suicide in defined populations.

3) Using big data and commensurate analytic approaches (e.g., predictive analytics, machine learning, etc.) for the purposes of understanding concentrations of risk and optimizing mental health care.

4) 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.

HUMAN SUBJECTS PROTECTIONS

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

2) Human subject protections and consent procedures should be described for all study participants, who may include, clients, families, providers, supervisors, administrators, etc.

3) Updated NIMH policies and guidance regarding human research protection and data and safety monitoring are published in NOT-MH-15-025, which should be used as a guide in the development of the application's Protection of Human Subjects section. Compliance with these and all federal regulations for human subject research will be a part of the application review. The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects 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.

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

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

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. 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 NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

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.

Other Attachments: For studies involving human subjects, applicants must upload a single attachment with the title, "Recruitment, Retention, Milestones, and Timeline." The attachment must contain following information in no more than 4 pages:

I. Participant Recruitment and Retention Procedures: Applications must provide a description of:

• Recruitment and referral sources, including the anticipated rate of subject/data accrual from each source;
• Procedures that will be used to monitor enrollment and ensure that data is obtained at all data collection points, including follow-up;
• Strategies to ensure a diverse, representative sample;
• Potential recruitment challenges and planned strategies to overcome enrollment shortfalls (e.g., additional outreach procedures, alternate referral sources, etc.)
• Evidence to support the feasibility and likely success of enrollment (e.g., rate at which potential subjects/data should become available at recruitment sites

II. Study Milestones and Timeline: Applications must provide a description of:

• Objective, quantifiable, and justifiable study milestones; and
• A proposed timeline for important study milestones, including: a) finalizing the study protocol and staff training; b) finalizing the assessment protocols, fidelity measures, and data collection strategies; c) enrolling 25%, 50%, 75%, and 100% of the sample; d) completing all data collection and data quality checks; e) analyzing the data and interpreting the results; and, f) preparing de-identified data and materials for data sharing, as appropriate. The proposed milestones should outline the projected measureable progress throughout the project period, and can be used as an indicator of when corrective action is needed to achieve success

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.

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

Research Strategy:

As appropriate for the proposed study, sections should cover the following topics:

SIGNIFICANCE

1) Discuss how the results of the proposed work lead to a firm conclusion about the tested hypothesis. Applications are expected to maximize efficiencies (e.g., by utilizing existing infrastructure such as practice-based research networks like the NIMH-sponsored Mental Health Research Network, electronic medical records, administrative data bases, patient registries, or other available resources) and should explicitly address how efficiencies are incorporated.

2) Describe collaborations and/or input from community partners and relevant policy makers/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.

3) Address the potential public health impact of the proposed work in terms of 1) reach and effect on the target population and/or 2) meaningfulness of the anticipated outcome(s) compared to existing approaches and/or current state of science in the topic area.

4) 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 structures.

INNOVATION

1) 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.

2) 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.

APPROACH

1) 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, outcomes, or scalability of mental health services.

2) 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.

3) Applications that propose to integrate and/or analyze existing data sets should produce results that enhance and extend our understanding of factors affecting access, continuity, quality, delivery, efficiency, financing, value, or outcomes of care.

4) Describe any planned collaborations or input from stakeholders, and describe how these will contribute to the utility of study results.

5) Provide evidence that outcome measures are valid and reliable, including measures of outcomes that are meaningful to the stakeholders involved.

6) 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.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan, in order to advance the goal of advancing research through widespread data sharing among researchers. Data collected from human subjects should follow data sharing plans from the NIMH Data Archive (NDA, http://ndar.nih.gov).

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

NIH encourages 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.

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

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

1) How well does the application discuss how the results of the proposed work lead to a firm conclusion about the tested hypothesis? How well does the application maximize efficiencies (e.g., by utilizing existing infrastructure such as practice-based research networks like the NIMH-sponsored Mental Health Research Network, electronic medical records, administrative data bases, patient registries, or other available resources) and explicitly address how efficiencies are incorporated?

2) How well does the application describe collaborations and/or input from community partners and relevant policy makers/health leaders? How well does the application 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?

3) How well does the application address the potential public health impact of the proposed work in terms of 1) reach and effect on the target population and/or 2) meaningfulness of the anticipated outcome(s) compared to existing approaches and/or current state of science in the topic area?

4) For studies involving services interventions (e.g., research with quasi-experimental or quality improvement designs and methodologies that are not clinical trials), how well does the application 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 structures?

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?

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?

1) How well does the application 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?

2) How well does the application 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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

1) If appropriate, how well does the application describe factors that are mutable and have the potential to serve as targets in future intervention development that impact access, continuity, utilization, quality, financing, outcomes, or scalability of mental health services?

2) For applications that propose to develop and test new research tools, measures, or methods, how well does it 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?

3) For applications that propose to integrate and/or analyze existing data sets, how well should the research produce results that enhance and extend our understanding of factors affecting access, continuity, quality, delivery, efficiency, value, or outcomes of care?

4) How well does the application describe any planned collaborations or input from stakeholders and how these will contribute to the utility of study results?

5) If appropriate, how well does the application provide evidence that outcome measures are valid and reliable, including measures of outcomes that are meaningful to the stakeholders involved?

6) For studies that involve the assessment of patient-level outcomes, how well does the application 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?

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 children, justified in terms of the scientific goals and research strategy proposed?

Are human subject protections and consent procedures adequately described for all study participants, who may include, clients, families, providers, supervisors, administrators, etc.?

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?

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.

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

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

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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

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.

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

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Mental Health, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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.
• Will receive a written critique.

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

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.

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 grantee’s business official.

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

Any application awarded in response to this FOA 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees 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 progress report, 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.

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

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Michael C. Freed, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3747
Email: [email protected]

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

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail,nih.gov

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

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