Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Early Psychosis Intervention Network (EPINET) Data Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects Cooperative Agreements

Announcement Type
New
Related Notices
  • February 23, 2024-Notice of Pre-Application and Technical Assistance Webinar for RFA-MH-24-105 and RFA-MH-24-106. See Notice NOT-MH-24-180.
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-MH-24-106
Companion Funding Opportunity
RFA-MH-24-105 , P01 Research Program Projects
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.242
Funding Opportunity Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit Resource-Related Research (U24) applications for an Early Psychosis Intervention Network (EPINET) National Data Coordinating Center (ENDCC). The ENDCC will develop infrastructure to facilitate large-scale, practice-oriented research across clinics offering evidence-based Coordinated Specialty Care (CSC) to persons experiencing a first episode of psychosis. This NOFO focuses on research tools and resources directed at (1) optimizing the EPINET Core Assessment Battery (CAB) to support learning health care studies within and across CSC research networks; (2) adapting and implementing the CAB for use in publicly funded CSC programs that aspire to measurement-based care; (3) developing the informatics infrastructure and pipelines necessary to gather, store, and upload de-identified, person-level data collected across participating research networks to the NIMH Data Archive (NDA); and (4) assembling individual network datasets into a national repository of early psychosis clinical features, interventions, and treatment outcomes to be shared with qualified investigators via the NDA. In addition, the ENDCC will provide operational and technical support to the EPINET research consortium described in companion announcement RFA-MH-24-105.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Applicants should carefully read the NOFO instructions and review the available PEDP guidance material.

Key Dates

Posted Date
November 28, 2023
Open Date (Earliest Submission Date)
February 29, 2024
Letter of Intent Due Date(s)

February 29, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
March 29, 2024 Not Applicable Not Applicable July 2024 August 2024 December 2024

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

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date
March 30, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

In 2019 the National Institute of Mental Health (NIMH) established the Early Psychosis Intervention Network (EPINET) to advance learning health methods in treatment programs that offer evidence-based Coordinated Specialty Care (CSC) to persons in the early stages of psychotic illness. Several clinical research networks and the EPINET National Data Coordinating Center have established infrastructure to support data sharing across connected CSC programs and to aid the networks' program evaluation and quality improvement activities, as well as embedded research projects aimed at advancing knowledge about first episode psychosis populations, interventions, and recovery outcomes. These complementary activities align with the Institute of Medicine vision of learning health care in which health systems provide effective treatments, evaluate care processes and outcomes systematically, strive for continuous improvement and innovations in care delivery, and utilize data collected in clinical practice to drive the process of scientific discovery.

This Notice of Funding Opportunity (NOFO), along with companion announcement RFA-MH-24-105, will continue NIMH support for practice-oriented research in early psychosis that aims to (1) promote measurement-based care in real-world settings; (2) improve service delivery, intervention effectiveness, and long-term outcomes for youth and young adults experiencing an initial episode of psychosis; and (3) test new approaches to eliminate disparities in early psychosis diagnosis and intervention for populations with health disparities as defined by the National Institute on Minority Health and Health Disparities. This agenda is consistent with Research Strategies 3.3 and 4.1 4.3 from the NIMH Strategic Plan for Research, which focus on testing interventions for effectiveness in community practice settings and improving access, quality, and impact of mental health services for all Americans. It also addresses mental health equity and implementation research goals outlined in the 2023 White House Report on Mental Health Research Priorities.

Purpose

The purpose of this NOFO is to solicit Resource-Related Research (U24) applications for an EPINET National Data Coordinating Center (ENDCC). The ENDCC will develop infrastructure to facilitate large-scale, practice-oriented research across clinics offering evidence-based Coordinated Specialty Care (CSC) to persons experiencing a first episode of psychosis. This NOFO focuses on research tools and resources directed at (1) optimizing the EPINET Core Assessment Battery (CAB) to support learning health care studies within and across CSC research networks; (2) adapting and implementing the CAB for use in publicly funded CSC programs that aspire to measurement-based care; (3) developing the informatics infrastructure and pipelines necessary to gather, store, and upload de-identified, person-level data collected across participating research networks to the NIMH Data Archive (NDA); and (4) assembling individual network datasets into a national repository of early psychosis clinical features, interventions, and treatment outcomes to be shared with qualified investigators via the NDA. In addition, the ENDCC will provide operational and technical support to the EPINET research consortium described in companion announcement RFA-MH-24-105.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Research Objectives

The companion funding opportunity RFA-MH-24-105 supports multiple hub and spoke early psychosis networks that include a coordinating scientific hub and connected CSC programs. Scientific hubs selected for funding will implement (1) the EPINET Core Assessment Battery (CAB) of early psychosis clinical features, CSC services, and treatment outcomes; and (2) the Program Level Core Assessment Battery (PL-CAB) of CSC program characteristics across participating early psychosis clinics. CAB measures are administered to newly enrolled CSC participants at admission and subsequent 6-month evaluations; PL-CAB data are collected annually. Scientific hubs will provide informatics support to participating clinics to facilitate data collection at the local level and to create combined datasets that contain de-identified, person-level CAB data from individuals receiving CSC services across the network. Aggregated CAB and PL-CAB data are expected to facilitate rigorous program evaluation and quality improvement efforts within each network and to support mental health services and intervention research that advances learning health care in early psychosis. In addition, scientific hubs will utilize CAB and PL-CAB data in research projects that explore questions related to data-driven learning health care in first episode psychosis (FEP) treatment systems.

The ENDCC will support EPINET scientific hubs' data collection, data processing, and data sharing efforts through the following activities:

  • Creating informatics and data management infrastructure. The ENDCC will build and maintain informatics infrastructure and pipelines to gather and store de-identified CAB and PL-CAB data submitted by scientific hubs, and raw and analyzed data from learning health research projects, including data dictionaries, validation tools, and quality metrics to ensure data completeness and integrity. The ENDCC will establish secure processes for combining scientific hubs CAB and PL-CAB data into integrated longitudinal datasets and submitting aggregated data to the NIMH Data Archive (NDA; https://data-archive.nimh.nih.gov/) every six months. The ENDCC will propose a strategy for making aggregated CAB, PL-CAB, and research project data Findable, Accessible, Interoperable, and Reusable (FAIR) to enable secondary analyses by the scientific community.
  • Developing data analysis, data presentation and data reporting tools. The ENDCC will develop data processing and visualization tools that leverage CAB information collected from large numbers of patients treated across CSC networks; support measurement-based care; and advance generalizable approaches for CSC fidelity monitoring and program evaluation/quality improvement activities that will benefit multiple CSC networks.
  • Supporting the EPINET Research Consortium. The ENDCC will provide logistical and technical support to aid the Research Consortium's efforts to share research expertise, tools, and methods across the scientific hubs, and to promote cross-network communication and sharing about learning health care principles, gaps in knowledge, and common challenges in conducting practice-oriented research in early psychosis treatment systems. At the behest of Consortium members, the ENDCC will support the organization of annual research investigators meetings and recurring conference calls to allow Consortium investigators to discuss new or emerging methods and techniques for data capture and analysis based on aggregated CAB data.
  • Assisting efforts to optimize the EPINET Core Assessment Battery. The ENDCC will assist Research Consortium members in identifying strategies for optimizing the CAB for use in community CSC programs, including approaches for increasing participants willingness to complete longitudinal clinical assessments. As requested, the ENDCC will aid the Consortium’s examination of the feasibility, acceptability, and clinical utility of refinements to the CAB.
  • Disseminating CSC clinical assessment, data management, and performance monitoring tools. The ENDCC will develop web-based versions of the CAB and PL-CAB, including data visualization tools, CSC fidelity/quality readouts, and performance reports that meet the requirements of state and local mental health authorities. The ENDCC will propose plans for disseminating web-based clinical assessment infrastructure broadly, including technical assistance to support adoption of measurement-based care in publicly funded CSC programs.

Research Team Responsibilities

The PD/PI (or multiple PDs/PIs) of the U24 application is responsible for the operational, administrative, and budgetary leadership of the data coordinating center. This individual will lead efforts to (1) develop, implement, and maintain data collection, data processing, and data sharing infrastructure for CSC networks; (2) provide technical and logistical support to the EPINET Research Consortium for organizing annual in person consortium meetings and recurring conference calls between annual meetings; and (3) manage ENDCC workflows, oversee timelines, and monitor overall progress of the project.

ENDCC team members will provide expertise in bioinformatics and data processing for establishing procedures for collecting, processing, and sharing clinical practice data from scientific hubs.

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV).

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in and benefit from research, and enhancing public trust. See Notice of NIH's Interest in Diversity (NOT-OD-20-031).

To support the best science, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include, but are not limited to:

  • Transdisciplinary research projects and collaborations among investigators from different fields.
  • Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Individual applications and partnerships that enhance geographic and regional heterogeneity.
  • Investigators and teams composed of researchers at different career stages.
  • Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
  • Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

Applications Not Responsive to this NOFO

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

  • Applications that do not contain a Plan for Enhancing Diverse Perspectives (PEDP).
  • Applications that fail to include annual milestones.

Technical Assistance

Potential applicants are strongly encouraged to contact NIMH Program Officials before the application due date to discuss a potential U24 application [see section VII Agency Contacts].

In addition to any individual consultation with program staff, NIMH intends to hold a web-based pre-application webinar for applicants to RFA-MH-24-105 and RFA-MH-24-106. Information on how to attend the optional webinar will be published through a Guide Notice.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIMH intends to commit a total of $9.5 million FY 2024 for this NOFO and its companion, RFA-MH-24-105, to fund one U24 National Data Coordinating Center and up to five P01 EPINET scientific hubs.

Award Budget

Direct costs are limited to no more than $1,000,000 in any one year.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:


Email: nimhpeerreview@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments:

Environment:

If applicable, describe how the ENDCC will benefit from any special features in the environment or distinctive resources that will enhance the overall research program. For example, collaborations with federal, state, or local mental health authorities around implementation of data-driven learning health care in public health systems, or access to other forms of patient-linked data such as state-level all payer administrative databases, Medicaid/Medicare claims data, commercial insurance claims data, social media data, and/or National Death Index-acquired data.

Plan for Enhancing Diverse Perspectives (PEDP)

  • In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
  • The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate.
  • Where possible, applicant(s) should align their description with these required elements within the research strategy section.
  • The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
  • The PEDP should be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Description of any planned partnerships that may enhance geographic and regional diversity.
  • Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce.
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks.
  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
  • Publication plan that enumerates planned manuscripts and proposed lead authorship.
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

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

  • Within the biosketches, highlight the PD(s)/PI(s)' experience in organizing, directing, and managing multi-site clinical research studies, as well as success in meeting milestones and timelines.

R&R Budget

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

EPINET Research Consortium Meetings

  • Include costs for logistical support for annual in-person EPINET Research Consortium meetings and recurring virtual conference calls.

PEDP implementation costs

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Include the following information:

Significance: Describe how the proposed activities of the ENDCC will facilitate large-scale, practice-oriented research to advance data-driven learning health care in FEP treatment systems.

Investigators: Within the biosketches, describe study team members expertise and experience in bioinformatics and data processing methods appropriate for establishing and carrying out procedures for collecting, processing, and analyzing clinical practice data.

Approach: Provide information about the following:

ENDCC management plan

  • Describe the leadership structure, organization, and data coordination capabilities of the ENDCC, including novel data processing methodologies and/or instrumentation that will support individual scientific hubs as well as the overall EPINET research consortium.
  • Describe the workflow and timeline for ENDCC activities, a detailed set of milestones, and metrics that will document annual progress towards the achievement of the ultimate goals. Include plans for critically evaluating and revising milestones on a regular basis.

Creating informatics and data management infrastructure

  • Describe plans for building and maintaining informatics infrastructure and pipelines to gather and store de-identified CAB and PL-CAB data, and raw and analyzed data from learning health research projects, submitted by scientific hubs, including Global Universal Identifiers (GUIDs) or Pseudo GUIDs, data dictionaries, validation tools, and quality metrics to ensure data completeness and integrity.
  • Describe data management tools and practices that will assist scientific hubs in achieving high standards for CAB, PL-CAB, and research project data completeness, integrity, and timely transmission of data to the ENDCC.
  • Describe processes for combining scientific hubs CAB and PL-CAB data into secure and integrated longitudinal datasets and submitting aggregated data to the NIMH Data Archive (NDA; https://data-archive.nimh.nih.gov/) every six months.
  • Describe the strategy for making aggregated CAB and PL-CAB data, and research project data, Findable, Accessible, Interoperable, and Reusable (FAIR) to enable secondary analyses by the scientific community.
  • Describe plans for a secure interface that will permit scientific hub investigators to access aggregated de-identified patient-level data for the purposes of multi-network analyses. Include features that support data exploration and analysis of pooled data, such as an interactive dashboard with visualization and search capabilities as well as data analytic tools in a cloud-based environment.

Developing data analysis, presentation and reporting tools

  • Describe plans for data processing and visualization tools that leverage CAB information collected from large numbers of patients treated across CSC networks; support measurement-based care; and advance generalizable approaches for CSC fidelity monitoring and program evaluation/quality improvement activities that will benefit multiple CSC networks.

Supporting the EPINET Research Consortium

  • Describe the logistical support and technical assistance that will facilitate cross-network communication, including exchange of views about (a) learning health care principles; (b) gaps in knowledge; (c) common challenges in conducting practice-oriented research in early psychosis treatment systems; and (d) new or emerging methods and techniques for data capture and analysis based on aggregated CAB and PL-CAB data.
  • Describe how the ENDCC will support the organization of annual in person Consortium meetings and recurring conference calls among Research Consortium investigators.

Optimizing CAB and PL-CAB assessment batteries

  • Describe how the ENDCC will assist Research Consortium members in identifying strategies for optimizing the CAB and PL-CAB for use in community CSC programs, including approaches for increasing participants willingness to complete longitudinal clinical assessments.
  • Describe data coordination and data processing capabilities that will aid Research Consortium members examination of the feasibility, efficiency, acceptability, and clinical utility of refinements to the CAB and PL-CAB.

Disseminating CSC clinical assessment, data management, and performance monitoring tools

  • Describe plans for developing an ENDCC website that will disseminate learning health research findings and clinical data management tools to a broad audience of early psychosis practice-research partners, including FEP patients and relatives, CSC clinicians and program administrators, health care policymakers, and members of the scientific community.
  • Present a plan for developing web-based versions of the CAB and PL-CAB, including data visualization tools, CSC fidelity/quality readouts, and performance reports, that meet the requirements of state and local mental health authorities.
  • Describe plans for disseminating web-based clinical assessment infrastructure broadly, including technical assistance to support adoption of measurement-based care in publicly funded CSC programs.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. For more guidance on submitting data to NDA, refer to the NDA Data Management and Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

Appendix:

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Management and Sharing for Applicants and Awardees.

Post Submission Materials

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

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed ENDCC address the needs of the research consortium that it will serve? Is the scope of activities proposed for the ENDCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Specific to this NOFO:

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the ENDCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing learning health care research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the ENDCC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the ENDCC? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO:

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the ENDCC will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Specific to this NOFO:

  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the ENDCC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

Specific to this NOFO:

  • How well do the ENDCC facilities, resources, services, and professional skills align with the support functions that will be provided to the scientific hubs?
  • Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
  • To what extent is the overall strategy for building and maintaining informatics infrastructure, pipelines, validation tools, quality assurance procedures, and privacy and security safeguards well-reasoned and appropriate to accomplish the goals of the ENDCC?
  • Are proposed plans and activities for (a) promoting high standards for clinical data completeness and integrity; and (b) curating integrated longitudinal datasets for secure bi-annual submission to the NIMH Data Archive logical, feasible, and likely to aid scientific hubs efforts to contribute high quality clinical data?
  • How strong is the plan to make aggregated CAB, PL-CAB, and research project data Findable, Accessible, Interoperable, and Reusable (FAIR)?
  • How likely is it that plans for a secure interface within the ENDCC informatics infrastructure will permit scientific hub investigators to access aggregated de-identified patient-level data for the purposes of multi-network analyses? How likely is it that proposed features support data exploration and analysis of pooled data?
  • How strong are the plans for data analysis and visualization tools that will support measurement-based care in CSC programs and advance generalizable approaches for CSC fidelity monitoring, program evaluation/quality improvement activities, and other program management functions that benefit multiple CSC networks?
  • To what extent will the ENDCC’s expertise in data coordination and data processing methods support the scientific hubs' efforts to optimize the CAB and PL-CAB for use in community CSC programs, and to examine the feasibility, efficiency, acceptability, and clinical utility of refinements to the CAB and PL-CAB?
  • How likely is it that plans for the ENDCC website will effectively disseminate learning health research findings and clinical data management tools to a broad audience of FEP patients and relatives, CSC clinicians and program administrators, health care policymakers, and members of the scientific community?
  • How strong are plans for developing web-based versions of the CAB and PL-CAB that include data visualization tools, CSC fidelity/quality readouts, and performance reports, that meet the requirements of state and local mental health authorities?
  • How strong are the plans for disseminating the web-based clinical assessment infrastructure broadly? How sufficient is the technical assistance to support adoption of measurement-based care in publicly funded CSC programs?

Environment

Will the institutional environment in which the ENDCC will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the ENDCC proposed? Will the ENDCC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO:

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the 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, including the PEDP.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Define the details of the project within the guidelines of this NOFO.
  • Assume responsibility and accountability to the applicant organization and to NIH for performance and proper conduct of all research in accordance with the Terms and Conditions of Award.
  • Accept close coordination, cooperation, and participation of NIH program staff in the scientific, technical, and administrative management of the grant.
  • Provide milestones for the grant to NIH program staff as requested (usually at the onset of the award and annually thereafter, but also at other times as requested).
  • Adhere to NIMH policies regarding intellectual property and other policies that might be established during the course of this project activity.
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
  • Deposit all novel subject-level data generated by the ENDCC, as well as data collected at EPINET research network project sites, in the NIMH Data Archive (NDA; https://data-archive.nimh.nih.gov/). All data will be deposited into NDA biannually.
  • Acknowledge NIMH support in publications or oral presentations of work done under this agreement, including the assigned cooperative agreement award number.
  • Share data and resources according to the Data Management and Sharing and R esource’s haring policies developed for and by this project as appropriate and consistent with achieving the goals of the project.
  • Fully disclose algorithms and software source code to the EPINET scientific hubs for the purpose of scientific evaluation.
  • Not disclose confidential information obtained from the EPINET scientific hubs.
  • Submit data for quality assessment and/or validation in any manner specified by the EPINET Research Consortium scientific hubs, and/or the NIMH program staff to ensure scientific rigor.
  • Accept and implement the common guidelines and procedures approved by the EPINET Research Consortium and NIMH.
  • Coordinate and collaborate with other U.S. and international groups that may be generating relevant early psychosis treatment datasets.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • An NIMH Program Officer will be named on the award notice. The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring and assistance in the coordination of the overall project and implementation of the Data Management and Sharing and the Resource Sharing plans, and will be named in the award notice.
  • The NIMH Program Officer will facilitate interactions between the ENDCC and P01 projects funded under companion notice RFA-MH-24-105.
  • One or more extramural NIMH Program Officer(s) will be assigned as the Project Scientist(s) for this award. The role of the NIMH Project Scientist(s) is one of substantial involvement above and beyond the normal program stewardship role of a Program Official. The Project Scientist(s) will interact scientifically with the PDs/PIs and other named personnel of the ENDCC award, as a partner in the research, including providing technical assistance, advice, and assistance to the ENDCC in interactions with the P01 research consortium.
  • The participation of the NIMH Project Scientist(s) is intended to ensure that the broad scientific goals of NIMH are reflected in the final design, implementation, and reporting of results from the ENDCC. However, the role of the NIMH Project Scientist(s) is to assist, participate in deliberations, and facilitate discussion, but not to direct activities. The NIMH Project Scientist’s level of involvement does not alter the recipient's dominant role and prime authority in conducting the activities of the ENDCC (see NIH Manual 1820). The NIMH Project Scientist(s) may cooperate with the recipient as author or co-author of resulting publications in accordance with publication policies developed by the Executive Committee. Publications involving NIMH staff must follow NIH and NIMH publication policies.

Areas of Joint Responsibility include:

  • The PD(s)/PI(s) will establish an organizational structure for the ENDCC that ensures that individual scientific hubs and the overall EPINET research consortium receives necessary support for data coordination, data collection, data management, and data sharing activities. The ENDCC organizational structure will include the PD(s)/PI(s), key personnel, and the NIMH Project Scientist(s).
  • The PD(s)/PI(s) and key personnel of the ENDCC will meet periodically with the NIMH Project Scientist(s), but not fewer than twice per year, to plan research activities, review study progress, and establish priorities, policies, and procedures.
  • The ENDCC will facilitate the efforts of the EPINET Research Consortium, made up of individual P01 projects funded under the companion announcement RFA-MH-24-105, to exchange views about learning health care principles, gaps in knowledge, and common challenges in conducting practice-oriented research in early psychosis treatment systems. The ENDCC’s role will be to (1) work with individual P01 programs to implement informatics infrastructure and pipelines necessary to gather, process, and transmit de-identified CAB and PL-CAB data to the NDA; and (2) assist the Research Consortium’s discussions of new methods for clinical data capture and analysis based on aggregated CAB data.
  • Research Consortium members will establish a schedule of annual in person meetings and recurring conference calls; the ENDCC will provide technical and logistical support for organizing annual and recurring meetings of the Research Consortium.
  • NIMH Program Officials and Project Scientists may attend Research Consortium annual meetings and recurring conference calls as non-participant observers.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the ENDCC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

Progress Reviews

Progress of the project will be reviewed annually by the NIMH Project Officer at the time of each non-competing continuation application to assure that satisfactory progress is being made in achieving the project objectives.

By acceptance of this award, the recipient agrees to abide by the terms and conditions listed above or referenced in the Notice of Grant Award.

3. Data Management and Sharing

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

4. Reporting

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

  • Recipients will provide updates at least annually on implementation of the PEDP.

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

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Robert K. Heinssen, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0371
Email:rheinsse@mail.nih.gov

Peer Review Contact(s)

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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

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