NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

This Funding Opportunity Announcement (FOA) invites applications for center grants to support Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Centers. The purpose of these research Centers is to support transdisciplinary teams of clinical and mental health services researchers, behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in high-impact studies that will significantly advance clinical practice and generate knowledge that will fuel transformation of mental health care in the United States. Successful ALACRITY Centers will address major mental health problems observed among children, youth, and/or adults (including older adults), and foster innovative research aimed at increasing the effectiveness of existing interventions, improving delivery and quality of evidence-based services, and accelerating the diffusion, implementation, and continuous improvement of new practices in diverse settings. Centers proposed should reflect a deployment-focused model of intervention and services design and testing, i.e., studies that take into account key characteristics of the settings and providers where optimized mental health interventions and services will be implemented.

The ALACRITY Centers program is intended to support research that demonstrates an extraordinary level of synergy across disciplines and has a high potential for increasing the public health impact of existing and emerging mental health interventions and service delivery strategies. The Centers are intended for transdisciplinary projects that could not be achieved using standard research project grant mechanisms. Support is provided both for individual research projects and for cores that are critical for the integration across ALACRITY components. Centers are expected to provide plans for rapid, widespread sharing of relevant data, methods, and resources that will promote near-term improvements in clinical practice, as well as plans that further advance research in treatment effectiveness and/or services research. A strong vision of how the ALACRITY Center will advance the field beyond the goals of the individual projects is essential for successful applications.

ALACRITY Centers also provide opportunities for graduate students, postdoctoral researchers, and investigators in early stages of independent careers to participate in interdisciplinary research.

Mental disorders affect approximately 15-20 percent of the U.S. population annually. According to recent estimates, mental illnesses account for 21.3 percent of all years lived with disability in the United States. An estimated 9.6 million American adults suffer from a serious mental illness (SMI) in which the ability to function in daily life is significantly impaired. Those with SMI die 10 years earlier than individuals in the general population, on average. Furthermore, over 40,000 Americans die each year from suicide, more than twice the annual mortality from homicide. Suicide attempts and ideation far exceed these numbers. Beyond the morbidity and mortality, a conservative estimate places the direct and indirect financial costs associated with mental illnesses in the United States at well over $300 billion annually. Mental illnesses rank as the third most costly medical conditions in terms of overall health care expenditure, behind heart conditions and traumatic injury. In addition, between two and four hundred thousand men and women with SMI are incarcerated in U.S. jails and prisons, where they receive inadequate treatment and often no aftercare following release to the community. This public health burden demands that we combine current knowledge about effective mental disorder treatments with emerging health information and communication technologies, health care informatics, data science tools, and novel organizational structures for delivering health care to achieve significantly better outcomes for these disabling conditions.

The primary purpose of each ALACRITY Center is to support rapid development, testing, and refinement of innovative approaches for (1) optimizing the effectiveness of therapeutic or preventive interventions for mental disorders within well-defined target populations; (2) organizing and delivering optimized mental health services within real world treatment settings; and (3) continuously improving the quality, impact, and sustainability of optimized interventions and service delivery strategies within diverse care systems. To achieve these ambitious goals, each ALACRITY Center aims to support multidisciplinary teams of leading clinical and mental health services researchers, and experts from allied disciplines such as behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in studies focused on selected populations for whom existing interventions or services do not adequately address urgent, unmet mental health needs.

The NIMH Strategic Plan for Research (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) was developed to inspire and support research that takes advantage of recent technological advances and opportunities, and to bring into sharper focus questions and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders. Strategic Research Objectives 3.2, 3.3, and 4.1 4.4, which focus on optimizing existing and new interventions, translating effective interventions to community practice settings, and strengthening the public health impact of NIMH-supported research, are particularly relevant to ALACRITY Centers. Specific research priorities recently identified for Strategic Research Objectives can be found at http://www.nimh.nih.gov/about/strategic-planning-reports/strategic-research-priorities/index.shtml.

The ALACRITY Centers program provides a mechanism for maximizing synthesis and potential synergies across various components of the mental health research ecosystem, including new discoveries in basic and clinical research, transformative health care technologies, advances in information science, behavioral economic strategies for influencing health behaviors, and new federal and state mechanisms for organizing and financing mental health care. ALACRITY Centers provide a unique opportunity for addressing T2 translational priorities outlined in the NIMH Strategic Plan, i.e., effective transfer of findings from clinical studies to practice settings and communities, where research findings can be applied to improve public health.

Some general characteristics of ALACRITY Centers are listed below:

• ALACRITY Centers are intended to support a program of science that is defined in terms of (a) a target population for whom existing interventions or services do not adequately address mental health needs; (b) the therapeutic or preventive interventions or service delivery strategies to be studied and optimized; and (c) the service settings intended to implement optimized interventions and/or services.
• The scope of science for ALACRITY Centers spans interventions science (optimizing the effectiveness of therapeutic or preventive interventions for mental illness within well-defined target populations) through services research (innovative strategies to improve access, engagement, coordination and quality of service delivery). It is not necessary for an individual Center to emphasize intervention refinement and health services research activities equally. An ALACRITY Center may include (a) intervention enhancement projects only, (b) a combined program of interventions and services research, or (c) mental health services research projects only. In all cases, however, research studies should address necessary features for rapid dissemination, adoption, and implementation of new approaches in clinical and community settings, thus facilitating T2 translation from research to practice.
• Regardless of where the Center’s focus falls on the continuum of research spanning optimization of therapeutic/preventive interventions through services research, ALACRITY Centers are intended to support research that reflects a deployment-focused model of intervention and 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 the resultant interventions and service delivery strategies are feasible and scalable, and to ensure that the research results will have utility for end users.
• The goal of ALACRITY Centers is to support transdisciplinary research that brings together diverse teams of clinical scientists, mental health services researchers, and experts from allied disciplines that bring new perspectives and tools relevant to enhancing the effectiveness, delivery, reach, and continuous improvement of mental health interventions for children, youth, and adults (including older adults) with unmet mental health needs. ALACRITY teams should also include members with real world experience of care within target clinical and/or community practice settings, including service users, family members, mental health care providers, program administrators, and payers.
• Given the explicit goal of encouraging synergies across diverse areas of science and technology, and in partnership with relevant stakeholders and end-users, ALACRITY Centers are intended to provide research infrastructure and coordination in the form of Cores that provide support for overall organization, administration, and collaboration with stakeholders (Administrative Core), and support for implementing the Center’s transdisciplinary research projects and additional pilot studies, as well as support for methodological development and consultation (Methods Core). Each Core should also facilitate the development of new collaborative research opportunities and future directions that extend the Center’s activities.
• The scope of science should comprise three exploratory planning research projects modeled on the NIMH R34 grant program. These projects should propose innovative, transdisciplinary approaches that address ALACRITY Center goals of optimizing the effectiveness of therapeutic or preventive interventions for well-defined target populations; organizing and delivering optimized mental health services within real world treatment settings; and/or continuously improving the quality, impact, and durability of optimized interventions within diverse care systems. (Funding Opportunity Announcements RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34) and PAR-18-267, Pilot Services Research Grants Not Involving Interventions (R34) provide examples regarding the focus and scope of potential pilot projects).
• ALACRITY Centers are intended to facilitate emerging opportunities for additional pilot research through a process for soliciting, reviewing, and selecting promising pilot feasibility projects of 1-2 years duration similar in scope to the NIH R03 grant mechanism that can be launched within the project period. Accordingly, the scope of science should include such pilot feasibility projects that can be proposed by new or established investigators to address innovative, interdisciplinary research that is consistent the Center’s focus, in order to position the investigator(s) for subsequent research that aligns with the Center’s program of research.
• ALACRITY Centers are intended to support transdisciplinary science through research projects and cores at a single institution or across multiple institutions. Collaborations among mental health interventions research programs, services research programs, behavioral and social science programs, and healthcare technology research programs are encouraged, even if this means that investigators are geographically distributed.
• ALACRITY Centers are expected to provide opportunities for graduate students, postdoctoral researchers, and investigators in early stages of independent careers to participate in T2 translational mental health research.

Potential applicants are strongly encouraged to discuss their research concept and approach, and alignment of planned Center goals with the NIMH Strategic Plan for Research, with appropriate NIMH contacts before developing their application [see section VII Agency Contacts].

For additional information about ALACRITY Awards, see "Frequently Asked Questions about Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional) Funding Opportunities Announcement

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section 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 from 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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core (Use for Administrative Core)	6
Core (use for Methods Core)	12
Project (use for Research Projects)	6 for each project

Additional page limits 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 a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; maximum one
• Methods Core: required; maximum one
• Research Projects: required; minimum of 3; maximum 3

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

It is expected that a Center Director (PD/PI) will have a demonstrated capability to organize, administer, and direct the Center. Center Director must demonstrate leadership in the area of science proposed, have a strong record of high impact scientific achievements.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Provide a concise description of the overall ALACRITY Center focus and aims. Outline how the research projects and Cores will contribute to attaining the Center objectives.

Research Strategy: The Research Strategy should begin with an overview of the Center describing the target population for whom existing interventions or services do not adequately address mental health needs, the therapeutic or preventive interventions or service delivery strategies to be studied and optimized, the service settings intended to implement optimized interventions and/or services, the integration of the ALACRITY Center components, and why these components are essential for accomplishing the goals of the overall Center. The overview should be targeted to a broad audience and be concise. The overview should include:

1.Goals, relevant background, significance and a description of the impact of the proposed research in relation to the state-of-the-art of the field. This section should also include an explanation of how the work proposed is both innovative and potentially impactful for advancing clinical practice and clinical outcomes with members of the target population. The focus of the ALACRITY Center should be justified in terms of the potential impact of research, vis- -vis the:

• target population (e.g., the number of affected individuals, the associated severity of symptoms or disability, and/or overall burden associated with unmet mental health needs);
• therapeutic/preventive interventions or services that will be studied, including the potential for optimized intervention or service delivery strategies to substantially improve outcomes beyond existing approaches;
• potential reach and overall impact of embedding optimized approaches in target clinical and/or community practice settings; and
• anticipated dissemination, adoption and sustained use of new approaches that can be achieved through partnerships with identified mental health stakeholders.

ALACRITY Centers may include technology development as an element, but not as the main focus, of the Center. When technology development is an integral part of the scientific goals, it should be proposed as a project. When technology development is part of a standard service provided to support Center projects, it should be proposed as an element of the Methods Core.

2.Value added by an interdisciplinary Centers approach. This section should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Center’s major objectives, a description of how the Center as a whole will benefit from interdisciplinary interactions, an explanation of why this work cannot be accomplished by a cluster of individual research project grants (e.g., R01s), and why the whole is significantly better than the sum of its parts. The application should describe how Center resources and Investigator support will be leveraged to create efficiencies within other projects beyond the Center-supported exploratory research projects and 1-2 year pilot feasibility projects.

3.An explanation of the potential importance and relevance of the proposed research for increasing the effectiveness of existing interventions for a target population with unmet mental health needs, improving delivery and quality of optimized evidence-based services, and/or accelerating the diffusion, implementation, and continuous improvement of new practices in diverse settings. NIMH is particularly interested in programs of research that will lead to near-term improvements in clinical practice for mental disorders.

The Research Strategy should also include:

1. Preliminary Data: This section should include evidence for feasibility and preliminary findings. This section should also present very clear evidence that the research team has been/will be able to work together effectively to accomplish the research proposed in the projects.

2. Center Approach: This section should describe the working scientific and logistical design, as well as the resource support necessary to implement the research. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. (Documentation of these arrangements should be included in the Letters of Support section.)

Letters of Support: Include letters of support relevant to the overall center here. Letters detailing contributions to individual components are to be placed in their respective individual Research Project and Core components.

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.

To advance the goal of facilitating research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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, there must be 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 within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

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.

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.

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Admin Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• It is expected that the Center Director will be the primary leader of the Administrative Core. Multiple leads are allowed for the Administrative Core.

Budget forms appropriate for the specific component will be included in the application package.

Each proposed Center Director must commit a minimum effort of 3 person months per year overall to the Center and be a leader of one of the projects and of the Administrative Core. The 3 person months should be a total of the Center Director's efforts on his/her project(s) and core(s). The 3 person month requirement applies to each individual listed as a Center PD/PI in a multiple PD/PI Center.

The Leadership of the Administrative Core must commit a cumulative minimum effort of 1 person month per year to the Administrative Core. Multiple leaders are allowed for the Administrative Core. If there are multiple leaders for this Core, the combined effort of the identified Administrative Core Leaders must total at least 1 person month per year.

The Administrative Core budget should include costs for:

• Center Director must commit a minimum effort of 3 person months per year serving as the overall center director as well as the leader of one research project and the Admin core.
• For each year of the award, support for soliciting, reviewing, selecting, and executing 2 or more pilot feasibility projects of 1-2 years duration, proposed by early-stage investigators or established investigators, that will inform the development of larger, peer-reviewed research applications that can compete successfully for NIH or other funding. Funding for these pilot feasibility projects is limited to no more than $100,000 total for all projects per year.
• Data and resource sharing (e.g., personnel, assessment and intervention protocols, software and/or programming for technology assisted approaches, data analytic strategies, etc.) as appropriate. For data sharing, the NDCT web site provides a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing (http://ndct.nimh.nih.gov/preplanning/budget).
• Investigator and advisory board travel
• Website and Training

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a concise description of the goals of the Administrative Core.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to (a) facilitate innovative and nimble transdisciplinary T2 translational research in mental health, (b) foster synergy among research disciplines and cores, (c) oversee the solicitation, review, and selection of additional innovative pilot studies that capitalize on center resources and extend the research program, (d) support training opportunities, (e) communicate the Centers aims and activities, (f) oversee evaluation activities, and (g) carry out future planning.

Highlight features of the Administrative Core that will enhance the collaborative effort, including optimizing communication, decision-making and sharing between the Research Projects and the Methods Core.

Describe how each Research Project and Methods Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Research Project or Methods Core needs. The description of the Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be effected in a coherent manner.

For each year of the award, the Administrative Core should include provisions for 2 or more pilot feasibility studies of 1-2 years duration that can be proposed by new or established investigators, including projects that are proposed by or involve trainees preparing for independent research careers. These pilot projects should be similar in purpose and scope to small research project grants (R03), and address innovative, interdisciplinary research consistent with the Center's focus. Pilot feasibility studies should serve as a mechanism for conducting nimble proof-of-concept studies (e.g., to rapidly refine/optimize intervention and service delivery approaches) that will position the investigator(s) for subsequent research that aligns with the Center's scientific goals. The application should detail a systematic approach for soliciting, reviewing, selecting, and monitoring the progress of the pilot studies. All pilot projects must comply with applicable NIH policies and the evidence that proposed plans for protection of human subjects; inclusion of women, minorities, and children; and assurance of animal welfare must be submitted to the NIMH Program Official prior to study initiation.

Additional information required in the Administrative Core Research Strategy:

• Stakeholder Component: Describe plans for establishing partnerships with key mental health stakeholders e.g., service users, family members, clinicians, payers who will help identify unmet mental health needs within the target population, develop and refine strategies for optimizing interventions and services, inform research topics, and maximize the external validity of ALACRITY research findings.
• Website: Describe plans for establishing and maintaining a website. The website should target a broad audience, convey the aims and activities of the ALACRITY Center in plain language, and describe the implications of research supported by the Center for increasing the effectiveness of existing mental health interventions and promoting near-term improvements in clinical practice. The website should also include information pertaining to the sharing of resources with the scientific community. This website is intended to be distributed to a variety of educated audiences with broad backgrounds and interests, such as the NIMH Outreach Partners (see: http://www.nimh.nih.gov/outreach/partnership-program/index.shtml).
• Training Opportunities: Describe how the ALACRITY Center will promote opportunities for graduate students, postdoctoral researchers, and investigators in early stages of independent careers to participate in interdisciplinary research, including opportunities to work with and learn from participating investigators (e.g., in-house lecture series, webinars, visiting scholars series, meetings with potential practice partners from new community settings), opportunities for investigator-initiated pilot projects by trainees and junior faculty, and opportunities that capitalize on other unique institutional resources and contribute to substantive research experiences.
• Evaluation Plan: Describe plans for coordinating the evaluation of the Center's research activities and public health impact, with input from the Methods Core. Describe how the evaluation plan will be used to iteratively refine the Center's ongoing activities and inform plans for future collaborative research.
• Timeline, Milestones, and Advisory Board: A graphic Timeline and a descriptive Milestones section must be included for the Administrative Core. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include alternative strategies should any component efforts fail to perform as expected. The timeline should include the establishment of a to-be-named advisory board to be convened annually to assess progress and accomplishments, and to advise the Center. It is very important that potential advisory board members not be identified in the application in order to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration by NIMH review staff for the peer review panel that evaluates ALACRITY Center applications. Advisory board members should only be identified and convened after an application is funded. During the project period, the Center Director will be expected to refer to these milestones in annual progress reports.

Letters of Support: Include letters of support relevant to the Administrative Core (e.g., letters from stakeholder who will partner to inform research topics, conduct research, and help ensure the research has external validity and utility).

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. To advance the goal of facilitating research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Information on the sharing of all resources generated by Center activities should be consolidated and detailed in this section, and include the following elements as appropriate:

• Project management of resource sharing.
• Description of what specific resources will be shared (e.g., assessment and intervention protocols, software and/or programming for technology assisted approaches, data analytic strategies, de-identified data collected in research studies, etc.).
• Schedule/timeline for availability of resources to other users.
• Persons who will have access to the resources (written as broadly as possible to the extent consistent with applicable laws, regulations, rules, and policies).
• Plan for post award disposition of resources.

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Methods Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Core
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Methods Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Methods Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Methods Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Methods Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Methods Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• It is expected that Methods Core Leaders demonstrate competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere.

Budget (Methods Core)

Budget forms appropriate for the specific component will be included in the application package.

The Leadership of the Methods Cores must commit a cumulative minimum effort of 3 person months per year to the Methods Core. Multiple leaders are allowed for Methods Cores. If there are multiple leaders for this core, the efforts of the identified leaders must total at least 3 person months per year.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Methods Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide a concise description of the goals of the Methods Core. Explain how the Methods Core will contribute to individual Research Projects and to attaining ALACRITY Center objectives.

Research Strategy: Describe how the Methods Core will function as an incubator for innovative approaches to optimizing and enhancing the effectiveness of interventions/service delivery models for selected mental disorders. Describe how the Methods Core will facilitate novel and convergent solutions to intractable mental health problems by integrating input from clinical and services researchers, insights from key mental health stakeholders, and contributions from diverse experts in complementary fields, as relevant (e.g., behavioral and social science, health information and communications technology, health system engineering, decision science, bioinformatics, and/or data modeling). Describe how the Methods Core will stimulate additional research collaborations, identify future research directions, and ultimately boost the clinical impact, delivery, reach, and continuous improvement of mental health interventions. Detail how the Core's collective expertise will function to facilitate each of the following:

Development of Research Projects: Detail how the Methods Core will facilitate the development and design of the Center's three exploratory research projects. Describe how the Core will identify and apply scientific, technological, and methodological innovations and tools to facilitate the research enterprise (e.g., identify opportunities to rapidly refine/optimize intervention content and delivery; apply innovative approaches to study design, participant selection/engagement, ecologically valid assessment, and monitoring of study progress). Describe how the Core's efforts will accelerate delivery of convergent interventions and services in clinical and community settings (e.g., identify and test novel applications of emerging technologies, information science, systems engineering, and other approaches that can be used to seamlessly integrate research-supported strategies into routine practice).

Operational Support to Research Projects: Describe how the Methods Core will provide expert conceptual, methodological, technical, and analytic statistical support to the Center's investigators. Describe the facilities and resources that will be available for conducting research projects of the Center, including (a) laboratories, research clinics, and/or community practice settings, (b) a Central Institutional Review Board (IRB), and (c) centralized clinical assessment and data management services. Present the plan for data collection, data quality assurance, and data management for exploratory studies presented in the Research Projects section, together with the plans for statistical analyses. If the research activities of the ALACRITY Center include clinical trials, describe the operational structures that will ensure good clinical practice as well as human subject protections.

Generate Innovative Research Methods and Chart Future Directions: Describe the Core's role in generating new research opportunities that capitalize on the Center's transdisciplinary nature. Detail the Core's role in catalyzing, selecting, and rapidly implementing pilot studies proposed by Center collaborators, including trainees, junior faculty, and new investigators, during the 4-year project period. Describe strategies that will be used to monitor and incorporate emerging scientific, technological, methodological, and analytic innovations and to identify and engage new collaborators working in allied areas, such as adult learning, machine learning, artificial intelligence, bioinformatics, etc. Describe how collaborative activities among Core investigators and stakeholders will culminate in future projects and grant applications that build off of the three exploratory research projects.

Dissemination of Methodological Advances and other Center-generated Resources: Describe how the Core will function as a national consultation resource beyond the Center collaborations. Detail the Core's role in facilitating the development and dissemination of research resources (e.g., new data collection/assessment approaches and analytic methods; web-based platforms for identifying and recruiting participants and accelerating research; data sets that can be shared for re-analysis/meta-analysis; other common-source materials (e.g., new methods and analytic strategies for mining and analyzing "big data" from large-scale data collection efforts, programming for technology-assisted approaches).

Evaluation of the Center's Research Productivity and Impact: Describe how methodological and analytic expertise within the Methods Core's will contribute to a comprehensive and valid evaluation of the Center's progress, including evaluation of the Center's:

• Research progress and impact (e.g., progress on the three exploratory projects and other pilot studies that may be proposed during the project period as well as success at disseminating research results; developing and disseminating technological, methodological, and analytic innovations; identifying, integrating, and mentoring junior investigators; generating new interdisciplinary collaborations and new R01 research projects and grant applications).
• Public health benefit (e.g., modeling the incremental benefit and potential public health impact of optimized interventions and service delivery approaches; quantifying the uptake of Center-generated prevention, treatment, and service delivery approaches; engaging new end-users and forming academic-stakeholder partnerships to implement research-supported strategies in clinical and community practice settings).

Letters of Support: Include letters of support relevant to the Methods Core (e.g., letters from stakeholder who will partner to inform research topics, conduct research, and help ensure the research has external validity and utility).

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. All information on the sharing of resources should be consolidated in the Administrative Core.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Methods Core)

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.

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

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.

Delayed Onset Study

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

When preparing your application in ASSIST, use Component Type Project .

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Facilities & Other Resources:

This section should also explain how available resources will contribute to the success of the project in the context of the overall goals of the Center.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• It is expected that each Research Project leader be at the forefront in the area of science proposed and have a successful record of bringing novel and significant projects to fruition as the principal investigator.
• The Center Director must be a Project Lead of one of the projects.

Budget (Research Projects)

Budget forms appropriate for the specific component will be included in the application package.

The Project Lead(s) must commit a total minimum effort of 1.8 person months per year to each project. Multiple project leads are allowed for Projects. If there are multiple leads on a Project, the combined efforts of the identified project leads must total 1.8 person months per year. Do not include costs for staffing that are already included in the Administrative or Methods Cores.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Projects)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: The specific aims should provide a concise description of the aims the project.

Research Strategy: This section of the application can be organized with the headers below for ease and clarity of review.

Significance: Describe overall goals and the impact of the science proposed in the project in relation to the state-of-the-art of the field. This section should also explain the contribution of the project to the overall goals of the Center, how the project will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment.

Innovation: Describe the unique and innovative contributions that will be made by the research project. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project. Research projects should propose novel, transdisciplinary, convergent solutions to intractable mental health problems by integrating input from the diverse experts brought together in the ALACRITY Center.

Approach: Research projects proposed for ALACRITY Centers should be designed to yield preliminary data of sufficient quality to guide the design of future, more definitive investigations centered on optimizing the effectiveness of therapeutic or preventive interventions for mental disorders within well-defined target populations; organizing and delivering optimized mental health services within clinical or community practice settings; or continuously improving the quality, impact, and durability of optimized interventions and service delivery strategies within diverse care systems.

The exploratory research project might involve 1) effectiveness research aimed at refining and optimizing preventive and therapeutic interventions, for use with the target population(s) in the identified community practice settings, or 2) research on the development and preliminary testing of innovative services interventions that target patient-, provider-, or systems-level factors in order to improve care quality, coordination, delivery, or scalability of mental health services. Such exploratory clinical trials projects should include provisions for evaluating the feasibility, tolerability, acceptability and safety of approaches to improve mental health or functional outcomes, or modify risk factors, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale intervention trial (e.g., comparative effectiveness study, practical trial). Consistent with the NIMH experimental therapeutics approach (http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml ), pilot tests of intervention effectiveness or service delivery approaches should explicitly address whether the intervention engages the proximal target(s)/mechanism(s) presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/functional outcomes, changes in provider behavior, etc.) and preliminarily examine whether intervention-induced changes in the presumed targets are associated with clinical benefit. In this manner, the results of the pilot effectiveness trial will advance knowledge regarding therapeutic change mechanisms and inform decisions about whether further effectiveness testing is warranted (see NIMH web page on Clinical Trials).

Other potential pilot projects might include services research that is consistent with NIMH's Strategic Plan and the Center s focus,but is not immediately focused on development and testing of services interventions. Such research might include: 1) studies to identify and elucidate mutable factors that impact access, utilization, quality, financing, outcomes including disparities in outcomes, or scalability of mental health services, which may serve as targets in future intervention development; 2) development and testing of new research tools, measures, or methods; or 3) testing the feasibility of integrating existing data sets to understand factors affecting access, quality, delivery or outcomes of care, and 4) pilot work on the learning mental health care system model as a means to enable practical studies of the value and effectiveness of services and treatments.

All exploratory research projects should be to designed to examine the feasibility of the research approach, (e.g., feasibility of recruiting and retaining participants); should provide an opportunity to refine and pilot test the experimental protocols, including assessment protocols and the experimental intervention protocol (e.g., the manual for a psychosocial intervention, the dosing schedule for a psychosocial or pharmacological approach, the comparison intervention protocol and randomization procedures), as relevant; and should yield pilot data necessary for informing next steps and enhancing the probability of obtaining meaningful results in subsequent, well-powered studies.

The content of the exploratory Research Project should be directly linked to the Center’s primary problem focus and should follow the deployment-focused model of intervention and services design and testing that characterizes the overall ALACRITY center. It is expected that these projects will have highly innovative cross-disciplinary linkages and high-risk/high-pay-off components designed to address the identified unmet mental health needs of the target population. Describe the feasibility of the proposed research study, the advantages of any new methodologies, potential pitfalls, and alternative approaches for the project and how these might impact on progress in the overall Center.

Describe the anticipated interactions between this project and other components of the Center and anticipated progress in the overall Center.

Letters of Support: Include letters of support relevant to the project.

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. All information on the sharing of resources should be consolidated in the Administrative Core.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

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.

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Applications must include a single attachment, with no more than 3 pages, that clearly describes the following information:

Participant Recruitment and Retention Procedures:

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

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

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.

Delayed Onset Study

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

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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.

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

In addition, for applications involving clinical trials:

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center 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 Center 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?

How compelling is the justification for the Center s focus and the overall significance of the program of research in terms of:

• the target population (e.g., the number of affected individuals, the associated severity of symptoms or disability, and/or overall burden associated with unmet mental health needs);
• the therapeutic/preventive interventions or services that will be studied, including the potential for optimized intervention or service delivery strategies to substantially improve outcomes beyond existing approaches;
• the potential reach and overall effect of embedding optimized approaches in the target clinical and/or community practice settings;
• the anticipated dissemination, adoption and sustained use of new approaches that can be achieved through partnerships with identified mental health stakeholders; and
• the description of how the center-based, interdisciplinary approach will facilitate T2 translational research in a manner that cannot be accomplished by a collection of individual research project grants (i.e., how the whole is significantly better than the sum of its parts)?

In addition, for applications involving clinical trials

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

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

Evaluate the proposed Center Director's record of leadership in the area of science and the Director's record of scientific achievements. To what extent does the Center Director have a proven record that demonstrates his/her ability to organize, direct, and administer complex projects?

Is (are) the proposed Research Project Leader(s) at the forefront in the proposed scientific area; to what extent do the Research Project Leaders have a successful record of bringing novel and potentially high-risk projects to fruition? To what extent do the Research Project Leaders bring complementary and integrated expertise to the overall Center?

To what extent do the Core Leaders have demonstrated competence in the area of science and do they have a record of interacting and working well with other investigators at their institution and elsewhere?

In addition, for applications involving clinical trials

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

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

In addition, for applications involving clinical trials

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

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

If the Center 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?

How compelling is the justification for an interdisciplinary Center approach as necessary and suitable for the proposed work? How likely is it that an integrated Center approach will add significantly to what could be accomplished through other modes of research support? To what extent will synergy between projects contribute to the overall Center objectives?

How will the proposed research designs maximize the reliability and replicability of the findings?

Evaluate the quality of the plans for managing the Center's research and administration, fostering synergy, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution. How likely are these plans to contribute to the effective, productive management of the Center as a whole? How will the organizational structure facilitate coordination and integration of Center activities and progress?

To what extent does the overall approach take into account the perspective of relevant stakeholders/end-users and key characteristics of the settings that will implement optimized mental health interventions in order to ensure that the resultant interventions and service delivery strategies are feasible and scalable and to ensure that the research results will have utility for end users?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

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

In addition, for applications involving clinical trials

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

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

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

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

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.

Milestones

To what extent are the proposed milestones feasible, well developed, and quantifiable with regard to the specific aims for each project and core, and for the goals of the Center as a whole? Are there other intermediate and overall goals that should be monitored?

Administrative Core

To what extent is the Administrative Core leader(s) qualified and experienced in the administration of a large, multi-component research program?

Evaluate the strength of plans to incorporate opportunities for trainees and early-career investigators. How will the plans for developing new research training opportunities and integrating them with ongoing training at the participating institution(s) benefit trainees and new investigators? How likely is it that the specific strategies that are proposed will promote cross-fertilization of ideas and facilitate new investigators and trainees exposure to potential consultants and collaborators (e.g., in-house lecture series, webinars, visiting scholars series, meetings with potential practice partners from new community settings)?

Evaluate the provisions for pilot feasibility studies of 1-2 years duration that can be proposed by new or established investigators and the strength of the plans for soliciting, reviewing, and selecting pilot feasibility projects. How likely is it that the proposed plan will yield pilot projects that will position the Center investigators for subsequent research that advances and extends the Center’s overall program of research?

How likely is it that the plans for establishing partnerships with key mental health stakeholders e.g., service users, family members, clinicians, payers will help Center investigators identify unmet mental health needs within the target population, develop and refine strategies for optimizing interventions and services, inform research topics, and maximize the external validity of ALACRITY research findings?

How strong are the plans for coordinating the evaluation of the Center’s research activities and public health impact, with input from the Methods Core? To what extent will the evaluation plan be useful for iteratively refining the Center’s ongoing activities and informing plans for future collaborative research?

Evaluate the quality of the dissemination plan and the potential to reach a broad and diverse audience and increase science literacy.

Methods Core

To what extent will the qualifications, past performance (if applicable), and time commitments of the Methods Core Leader(s) contribute to the likely success of the Center? Evaluate the appropriateness of the expertise for carrying out the functions proposed for the core.

Evaluate the Methods Core's potential to:

• Function as an incubator for innovative approaches and facilitate novel and convergent solutions to intractable mental health problems by integrating input from clinical and services researchers, insights from key mental health stakeholders, and contributions from diverse experts in complementary fields, as relevant (e.g., behavioral and social science, health information and communications technology, health system engineering, decision science, bioinformatics, data modeling, research design, and/or biostatistics);
• Facilitate development and design the Center’s three exploratory research projects and how the Core will identify and apply scientific, technological, and methodological innovations and tools to facilitate both the research enterprise and accelerate delivery of interventions and services in clinical and community settings?
• Provide expert conceptual, methodological, technical, and analytic statistical support to the Center’s investigators;
• Offer facilities and resources that are appropriate and optimal for conducting exploratory research projects, given the goals of the Center;
• Facilitate research via centralized functions (e.g., IRB, clinical assessment, data collection/management, quality assurance, data analysis);
• Ensure good clinical practice as well as human subject protections if the research activities of the Center include clinical trials;
• Help generate research methods and future directions, including pilot feasibility projects of 1-2 years duration proposed by center collaborators;
• Monitor and incorporate emerging scientific, technological, methodological, and analytic innovations and identify and engage new collaborators working in allied areas;
• Function as a national consultation resource beyond the Center collaborations in order to disseminate methodological advances and other Center-generated resources;
• Contribute to the Administrative Core’s efforts to evaluate Center progress by providing methodological and analytic expertise that informs a more comprehensive and valid evaluation of the Center’s research progress and public health impact.

Research Projects

How does the project complement and contribute to the Center as a whole?

How well is the project integrated with the scientific objectives of the Center?

How qualified is the Project Leader; is the Project leader at the forefront of the area of science proposed?

To what extent is the project original and innovative?

Evaluate the appropriateness and quality of the conceptual design, methods, and analyses.

If the project involves a clinical trial, to what extent does it follow the experimental therapeutics approach to intervention development and testing and specify plans to assess whether the intervention engages the proximal target that is presumed to underlie clinical benefit?

How likely is it that the project will yield preliminary data of sufficient scope and quality to guide the design of future, more definitive studies and to inform support the development of future research applications consistent with the Center’s research focus?

Study Timeline - Overall

Specific to applications proposing clinical trials

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

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

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 Center 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.

Not Applicable

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.

Not Applicable

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 Center 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.

Not Applicable

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 .

Evaluate the quality of the plans for effective sharing of resources. How adequate are the plans for sharing research resources (e.g., assessment and intervention protocols, software and/or programming for technology assisted approaches, data analytic strategies, de-identified data collected in research studies, etc.) with the scientific community?

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 NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Joel Sherrill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2477
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: [email protected]

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.