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
Funding Opportunity Announcement (FOA) Number
RFA-MH-19-151
Companion Funding Opportunity
RFA-MH-19-150, R01 Research Project Grant
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.242
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for an Early Psychosis Intervention Network (EPINET) National Data Coordinating Center (ENDCC) to support and extend the work of regional scientific hubs described in companion announcement RFA-MH-19-150. The ENDCC will lead efforts to (a) harmonize early psychosis common data elements, standard measures, and uniform data collection procedures across multiple early psychosis Coordinated Specialty Care (CSC) clinics within regional networks; (b) build informatics infrastructure and pipelines necessary to gather and store de-identified, patient-level data collected across all regional clinics; (c) develop data analysis, presentation, and reporting tools to facilitate timely quality improvement and program evaluation efforts across regional networks; (d) identify innovative CSC assessment, intervention, and quality improvement practices for broad dissemination; and (e) make national CSC data available for practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery and health outcomes in early psychosis. The ENDCC will combine regional datasets into a national repository of early psychosis common data elements, clinical measures, assessment and intervention strategies, and de-identified person-level data from patients receiving CSC services. Data assembled by the ENDCC will facilitate large-scale, practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, and health outcomes in clinics offering evidence-based care to persons in the early stages of psychotic illness.

 
Posted Date
July 30, 2018
Open Date (Earliest Submission Date)
October 02, 2018
Letter of Intent Due Date(s)
October 2, 2018
Application Due Date(s)
November 2, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)
Not Applicable
Scientific Merit Review
March 2019
Advisory Council Review
May 2019
Earliest Start Date
July 2019
Expiration Date
November 03, 2018
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 SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

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

Purpose

This Funding Opportunity Announcement (FOA) invites applications for an Early Psychosis Intervention Network (EPINET) National Data Coordinating Center (ENDCC) to support and extend the work of regional scientific hubs described in companion announcement RFA-MH-19- 150 . The ENDCC will lead efforts to (a) harmonize early psychosis common data elements, standard measures, and uniform data collection procedures across multiple early psychosis Coordinated Specialty Care (CSC) clinics within regional networks; (b) build informatics infrastructure and pipelines necessary to gather and store de-identified, patient-level data collected across all regional clinics; (c) develop data analysis, presentation, and reporting tools to facilitate timely quality improvement and program evaluation efforts across regional networks; (d) identify innovative CSC assessment, intervention, and quality improvement practices for broad dissemination; and (e) make national CSC data available for practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery and health outcomes in early psychosis. The ENDCC will combine regional datasets into a national repository of early psychosis common data elements, clinical measures, assessment and intervention strategies, and de-identified person-level data from patients receiving CSC services. Data assembled by the ENDCC will facilitate large-scale, practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, and health outcomes in clinics offering evidence-based care to persons in the early stages of psychotic illness.

Background

In 2008, the National Institute of Mental Health (NIMH) announced the Recovery After an Initial Schizophrenia Episode (RAISE) initiative, which called for research to investigate the feasibility and effectiveness of early intervention services for first episode non-affective psychosis (FEP) in the United States. The RAISE Early Treatment Program randomized controlled trial demonstrated the superiority of team-based, multi-component treatment for improving quality of life, symptoms, and functioning among persons with FEP, compared to usual care. The RAISE Connection Program implementation study reported similar outcomes for treated individuals and produced practical tools for introducing and maintaining research-based practices in community settings. Today, over 200 specialty care programs for FEP operate in 49 states, many based on the CSC model tested in RAISE. These programs share several common features, including a collaborative, recovery-oriented treatment philosophy, multidisciplinary team structure, and commitment to high quality, evidence-based services that address the needs of youth and young adults experiencing FEP.

In 2015, the National Institute of Mental Health (NIMH) introduced the concept of an Early Psychosis Intervention Network (EPINET) among treatment centers that offer evidence-based specialty care to persons experiencing early symptoms of psychosis. EPINET is expected to link clinical sites through standard clinical measures, uniform data collection methods, data sharing agreements, and integration of participant-level data across service users and settings. Systematic analysis of pooled data will inform clinics’ quality improvement and program evaluation efforts, and will accelerate research into psychosis risk factors, indicated prevention, service delivery models, and personalization of care. These goals are consistent with the Institute of Medicine's vision of learning health care in which health systems provide effective treatments, evaluate care processes and outcomes systematically, strive for continuous improvement and innovation in care delivery, and utilize data collected in clinical practice to drive the process of scientific discovery.

The companion FOA RFA-MH-19-1 50 supports development of 5 regional CSC networks in the United States. Each regional network will include a coordinating hub and 4 or more connected CSC programs that endorse the principles of measurement-based treatment and continuously learning health care for early psychosis. Participating clinics will implement standard measures that capture key aspects of early psychosis symptoms, clinical features, functioning, and treatment outcomes. Regional coordinating hubs will provide informatics support necessary to create large, interactive datasets that contain de-identified, person-level information from individuals receiving CSC services across settings. Aggregated data are expected to facilitate rigorous quality improvement and program evaluation efforts within regional networks, and to support mental health services and intervention research to advance the learning health care goals of measurement-based treatment, continuous improvement and innovation in care delivery, and practice-based research to drive the process of scientific discovery.

Research Objectives

Regional scientific hubs selected for funding under the companion FOA (RFA-MH-19-150 ) are expected to collaborate with the ENDCC on activities that support a national approach to learning health care in early psychosis. The ENDCC will work closely with regional scientific hubs to optimize data collection, processing, and analytic methods across regional networks, and to combine regional datasets into a national repository of early psychosis common data elements, clinical measures, assessment strategies, and de-identified person-level data from patients receiving CSC services. The ENDCC will develop the infrastructure necessary to support secure data sharing and quality improvement and program evaluation studies across regional networks, and to accelerate practice-based intervention and services research in early psychosis. The role of the ENDCC will encompass:

1. Coordinating regional EPINET activities

The principal goal of the ENDCC is to support and enhance the learning health care efforts of regional CSC networks funded under the companion FOA (RFA-MH-19-150). The ENDCC will serve as a clearing house of early psychosis measures, clinical assessment procedures, informed consent practices, informatics approaches, quality improvement strategies, and research ideas proposed by regional scientific hubs. The ENDCC will (i) identify common and unique early psychosis data collection, data processing, and data reporting methods employed across the regional networks; (ii) facilitate partnerships among scientific hubs to exploit standard measures, common data elements, and integrated datasets for quality assessment and research purposes; (iii) promote fidelity monitoring and performance improvement activities across regional networks; and (iv) disseminate data-driven “best practices” for clinical assessment, service delivery, quantitative evaluation, and intervention refinement throughout the national CSC consortium.

The ENDCC will establish an EPINET Steering Committee to oversee cross-network learning health care activities. The ENDCC Steering Committee will consider an ethics framework for learning health care that allows practice and research activities to be seamlessly integrated to achieve rapid, systematic learning. Applicants to the current FOA should describe a process that results in ethically defensible strategies for streamlining informed consent requirements in learning health care settings. For example, opt-out methods to cover observational, quality improvement, and program evaluation studies that utilize de-identified patient-level information to foster learning from routine care. In contrast, written, prospective informed consent to cover research activities that fall outside standard clinical practice. ENDCC Steering Committee members should be included in these deliberations, along with experts in clinical and research ethics and representatives from learning health care systems with relevant expertise.

The ENDCC will be responsible for organizing, providing logistical support, and running EPINET Steering Committee meetings. This includes a 2-day kickoff meeting in Bethesda, MD within the first 6 months of the award and annual progress reviews thereafter. In-person meetings will include all Steering Committee members, representatives from CSC clinics connected to the regional scientific hubs, and external advisors, as required. The ENDCC will organize monthly phone and/or web-based teleconferences to maintain communication and collaboration among Steering Committee members between annual EPINET Steering Committee meetings. Annual meetings and monthly teleconferences should be factored in the ENDCC budget.

2. Curating standard measures, common data elements, and clinical assessment strategies

The companion FOA (RFA-MH-19-150) requires regional scientific hubs to present a conceptual model of early psychosis clinical features, course of illness, intervention targets, CSC services, and key outcomes. Based on this model, regional hubs will propose a feasible, multi-purpose core assessment battery to cover key domains of early psychosis psychopathology, intervention, and treatment response. To be responsive to this FOA, ENDCC applicants should propose a process for (i) curating early psychosis measures and common data elements recommended by regional scientific hubs; (ii) comparing early psychosis assessment procedures utilized in CSC clinics; (iii) summarizing common and unique strategies for obtaining clinical encounter data; and (iv) identifying opportunities for harmonizing early psychosis measures, data elements, and assessment methods to increase concordance among clinical batteries. This analysis should be completed within the first 6 months of the award, with results presented at the ENDCC kickoff meeting. Responsive applications will outline a consensus process directed at maximizing the clinical, administrative, and scientific value of common and divergent assessment and intervention practices observed among regional scientific hubs.

In addition, the ENDCC will consult with regional hub PD(s)/PI(s) regarding relevant data that might feasibly be obtained from sources outside of the regional networks, such as commercial insurance companies, public insurance providers, or other private or government sources. For example, state-level all payer administrative databases, Medicaid/Medicare claims data, social media data, and National Death Index-acquired data. The ENDCC will have primary responsibility for obtaining, linking, and analyzing exogenous data of significant value for advancing EPINET objectives.

3. Optimizing health informatics within and across regional hubs

Each regional scientific hub funded through the companion FOA (RFA-MH-19-150) will propose a health informatics approach for collecting, aggregating, and manipulating clinical encounter data from 4 or more CSC clinics. Each regional hub is expected to maintain high standards for data completeness and integrity, with data quality metrics and data validation tools to ensure appropriate quality control. Each regional hub will maintain privacy procedures and security processes for safely storing and accessing de-identified data from 100 or more early psychosis patients enrolled and receiving services each year within the regional CSC network.

Applications in response to this FOA are encouraged to engage thought leaders in health care informatics when developing the ENDCC data processing system. The resulting plan should describe:

  • the informatics infrastructure and pipelines necessary to gather, combine, store, and manipulate de-identified clinical encounter data provided by the 5 regional scientific hubs;
  • submission procedures, validation tools, and quality metrics to ensure data completeness and integrity;
  • technical assistance made available to regional hub investigators for optimizing regional health informatics systems and linking these with the ENDCC;
  • staffing resources for help desk activities.

The ENDCC will create a data dictionary for all variables included in the regional hubs’ core clinical assessment batteries, along with validation tools to ensure that data submitted by regional hubs are consistent with the allowable values in the data dictionary. The ENDCC and the regional hubs will use the NIMH Globally Unique Identifier (GUID) infrastructure to create de-identified subject and clinic codes. The GUID number represents a unique identifier that protects the anonymity of the individual-level patient data as well as the CSC clinic. Staff at the NIMH Data Archive will be responsible for helping the ENDCC export the GUID infrastructure to all the CSC clinics across the regional networks. The ENDCC will maintain privacy procedures and security processes for safely storing and accessing de-identified data from 400-1000 early psychosis patients enrolled each year across the regional CSC networks.

4. Data analysis, presentation, and reporting tools

Applicants to this FOA should propose analytic methods and data visualization tools that (i) leverage clinical information collected from several hundred patients treated in multiple CSC clinics; (ii) explore variations in patient characteristics, CSC service delivery, treatment fidelity and quality, and early psychosis treatment response; and (iii) plot individual clinics’ performance against outcomes observed across all regional networks. The ENDCC is expected to rapidly translate large amounts of clinical service data into usable information that is informative to regional network stakeholders. Responsive applications will recommend “big data” reporting tools that support measurement-based care, CSC fidelity monitoring, quality improvement and program evaluation analyses, along with other program management functions. As needed, the ENDCC will provide computational support to the regional hubs to facilitate quality improvement, program evaluation, and practice-based research efforts within and across regional networks (see below).

5. Supporting practice-based research

To promote scientific investigation across the regional scientific hubs, ENDCC informatics infrastructure should include a secure interface that allows network hub investigators to access aggregated de-identified patient-level data for the purposes of practice-based research. Over the course of the award, the ENDCC will collaborate with PD(s)/PI(s) from the regional scientific hubs to develop a secure method of contact between investigators and individual patients, moderated by clinical care staff at participating clinics, regarding voluntary research participation. The ENDCC will support data processing and analyses for research projects proposed by each of the 5 regional hubs, as well as efforts that might arise from emerging network collaborations.

In addition, the ENDCC will develop a secure, web-based portal to allow extramural scientists to query de-identified EPINET data for research purposes. The ENDCC will also develop the capacity to allow EPINET data users to bring their own analysis tools to the data. Responsive applications will describe a data access policy that will promote large-scale, practice-based research to improve diagnosis, clinical assessment, intervention effectiveness, service delivery, and health outcomes in clinics offering evidence-based specialty care for early psychosis.

NIMH envisions future translational research efforts that utilize the EPINET platform to explore early psychosis risk factors, mechanisms of illness progression, and novel treatment targets/interventions. While the ENDCC will mainly hold de-identified data, this query system may be useful in recruiting patients to participate in translational studies. Such recruitment would be mediated by the regional hubs and their partners rather than directly with the patients.

To facilitate EPINET data use by the extramural scientific community, the ENDCC will be responsible for coordinating education and outreach efforts to the scientific community. This outreach could include, for example, the development of tutorials, conducting user workshops, use of social media outlets, or other activities not specifically named here.

6. Disseminating CSC resources to clinical practice and scientific communities

Responsive applications will describe the ENDCC’s role in disseminating innovative (i) clinical assessment approaches, (ii) data collection methods, (iii) service delivery models, (iv) program evaluation strategies, and (v) quality improvement practices generated by the regional scientific hubs. The application should describe plans for establishing and maintaining a website that conveys the aims and activities of the ENDCC in plain language and includes information pertaining to the sharing of EPINET resources with patients and relatives, CSC clinicians and program administrators, health care policy makers, and members of 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 Partnership Program.

Archiving data

The Data Coordinating Center will have responsibility for depositing data collected under this award, including patient-level data, in the NIMH Data Archive (see NDA; https://data-archive.nimh.nih.gov/). All data collected will be deposited into NDA every 6 months.

Technical Assistance

Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NIMH policies and guidelines, identify whether the proposed project is consistent with NIMH program priorities, and to discuss how to develop an appropriate project timeline, which is subject to peer review.

A web-based Technical Assistance Teleconference will be held for potential applicants on August 15, 2018 from 3:30 pm to 5:00 pm EST, when NIMH staff will be available to answer questions related to this funding announcement. Prospective applicants can participate in the teleconference by calling 646-558-8656  or 669-900-6833   and are encouraged to submit their questions or comments in advance to RFA4EPINETDCC@mail.nih.gov. Participation in the teleconference is neither required nor necessary for a successful application. A recording of the teleconference will be available at  https://www.nimh.nih.gov/funding/grant-writing-and-application-process/early-psychosis-intervention-network-epinet-teleconferences-for-potential-applicants.shtml

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

Cooperative Agreement: A support 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 FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards
NIMH intends to commit $6 million in direct costs in fiscal year 2019 for this and companion FOA RFA-MH-19-150 fund one U24 National Data Coordinating Center and five R01 EPINET regional hubs per fiscal year. Future year amounts will depend on annual appropriations.
Award Budget
Direct costs are limited to $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 FOA.

1. Eligible Applicants

Eligible Organizations

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
Foreign Institutions

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 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. 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.
  • 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.

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 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.

3. Additional Information on Eligibility

 

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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)

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

 

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

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

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

The letter of intent should be sent to:

Email: nimhpeerreview@nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
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.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
Describe the PD(s)/PI(s), collaborators, and other researchers’ expertise in study coordination, health informatics, data management, and using robust analytic platforms and tools to rapidly translate large amounts of pooled data from community clinics into usable information for diverse stakeholders.
 

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

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
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: The Research Strategy should include the following information:

Significance

Explain how the proposed ENDCC and the scope of its proposed activities will facilitate large-scale, practice-based research to improve early psychosis care in CSC clinics.

Innovation

Highlight innovative strategies for (i) identifying opportunities for harmonizing early psychosis measures, data elements, and assessment methods to increase concordance among early psychosis clinical assessment batteries; (ii) optimizing health informatics within and across the regional scientific hubs; (iii) rapidly translating large amounts of clinical service data into usable information that is informative to regional CSC network stakeholders; (iv) promoting access to aggregated de-identified patient-level data to support practice-based research both within EPINET and among extramural scientists broadly; and (v) disseminating CSC resources to clinical practice and scientific communities.

Highlight innovative strategies for adapting and leveraging existing functioning infrastructure to create the ENDCC informatics infrastructure, where applicable.

Approach

Coordinating regional EPINET activities

  • Describe how the ENDCC will coordinate with the regional scientific hubs funded under companion FOA RFA-MH-19-150 to enhance their learning healthcare efforts and accomplish key tasks. Include the following: (i) how the ENDCC will establish, organize, and provide logistical support for an EPINET Steering Committee to oversee cross-network learning health care activities; (ii) ethically defensible strategies for streamlining informed consent requirements in learning health care settings; and (iii) a process for written, prospective informed consent for research activities falling outside of clinical practice. Describe how often the Steering Committee will meet and the specific activities it will perform. The Steering Committee should include Program Directors/Principal Investigators (PD(s)/PI(s)) from each regional scientific hub, and additional members that reflect the diversity of early psychosis stakeholders. These members may include patients and relatives, clinicians, administrators, and health care policy makers from regional CSC networks. Experts in learning health care, measurement-based treatment, health information technology, health informatics, computational modeling, and other areas may be included, as appropriate. However, applicants should not contact potential Steering Committee members prior to the review of the application, nor should potential Steering Committee members be named in the application to avoid conflict of interest in the review process.  

Curating standard measures, common data elements, and clinical assessment strategies

  • Propose a process for (i) curating early psychosis measures and common data elements recommended by the regional scientific hubs; (ii) comparing early psychosis assessment procedures utilized in CSC clinics; (iii) summarizing common and unique strategies for obtaining clinical encounter data; and (iv) identifying opportunities for harmonizing early psychosis measures, data elements, and assessment methods to increase concordance among clinical batteries.
  • Outline a consensus process directed at maximizing the clinical, administrative, and scientific value of common and divergent assessment and intervention practices observed among regional scientific hubs.
  • Propose a process for identifying relevant data that might feasibly be obtained from sources outside of the regional network.
  • Identify potential challenges to standardized data collection in the regional hub early psychosis clinics and propose strategies to address those challenges.

Optimizing health informatics within and across regional hubs

  • Propose a health informatics approach for collecting, aggregating, and manipulating clinical encounter data from 20 or more CSC clinics.
  • Outline a plan, including incentives, for maintaining data completeness and quality.
  • Describe how technical assistance will be made available to regional hub investigators for optimizing regional health informatics systems and linking these with the ENDCC, including help desk activities.
  • Outline a strategy for maintaining appropriate data security processes and privacy procedures to store and analyze data from patients enrolled in the regional CSC networks, including (i) establishing a GUID for each patient, and (ii) establishing a clinic-level GUID for each CSC clinic within the regional hubs.
  • Describe the creation of a validation tool to ensure that all data reported by the regional hubs is consistent with the allowable values in the data dictionary. 

Data analysis, presentation, and reporting tools

  • Propose analytic methods and data visualization tools that (i) leverage clinical information collected from several hundred patients treated in multiple CSC clinics; (ii) explore variations in patient characteristics, CSC service delivery, treatment fidelity and quality, and early psychosis treatment response; and (iii) plot individual clinics’ performance against outcomes observed across the 5 regional CSC networks.
  • Recommend “big data” reporting tools that support measurement-based care, CSC fidelity monitoring, quality improvement and program evaluation analyses, along with other program management functions.

Supporting practice-based research

  • Describe how the ENDCC informatics infrastructure will support a secure interface that allows network hub investigators to access aggregated de-identified patient-level data for the purposes of practice-based research.
  • Describe how the ENDCC will collaborate with PD(s)/PI(s) from the regional scientific hubs to develop a secure method of contact between investigators and individual patients, moderated by clinical care staff at participating clinics, regarding voluntary research participation.
  • Describe how the ENDCC will support data processing and analyses for research projects proposed by each of the 5 regional hubs, as well as efforts that might arise from emerging network collaborations.
  • Propose a plan to develop a secure, web-based portal to allow extramural scientists to query de-identified EPINET data for research purposes.
  • Propose a plan for developing the capacity to allow EPINET data users to bring their own analysis tools to the data.
  • Propose a plan for coordinating education and outreach efforts to the extramural scientific community in order to facilitate their EPINET data use.

Disseminating CSC resources to clinical practice and scientific communities

  • Describe how the ENDCC will disseminate innovative (i) clinical assessment approaches, (ii) data collection methods, (iii) service delivery models, (iv) program evaluation strategies, and (v) quality improvement practices generated by the regional scientific hubs.
  • Describe plans for establishing, maintaining and promoting a website that conveys the aims and activities of the ENDCC in plain language and includes information pertaining to the sharing of EPINET resources with diverse stakeholders.

ENDCC Management

Present a Management Plan that describes the following:

  • How the PD(s)/PI(s) will manage the proposed project and who will oversee the day-to-day activities (e.g., a project manager if not a PD/PI).
  • How the management will support achievement of the proposed goals and milestones. Describe the organization of the proposed ENDCC, including its coordination and communication functions, key personnel, reporting relationships, and a management plan for fiscal accountability and communication. Recruitment and training of personnel may also be discussed.
  • How the proposed multiple efforts of the ENDCC will be integrated.
  • How to enhance the collaborative effort with and among the regional scientific hubs to ensure efficient cooperation, communication and coordination, and resource sharing.
Present a detailed set of milestones and a timeline covering all aspects of ENDCC’s activities. Include annual milestones with metrics that will document progress towards the achievement of the ultimate goals. Applications should include plans for critically evaluating and revising these milestones on a regular basis.
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.

The following modifications also apply:

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 NIH-defined human subjects research, clinical research, and/or 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 with the following additional instructions:

Delayed Onset Study

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 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.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIMHReferral Office by email at nimhreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Use of Common Data Elements in NIH-Funded Research

NIMH 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 "Common Data Element (CDE) Resource Portal"  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 responding to this funding opportunity announcement are strongly encouraged to incorporate CDEs available in the PhenX Toolkit of mental health research measures, especially the PhenX Toolkit Early Psychosis Clinical Services Specialty Collection. In addition to CDEs for demographic features, substance use, and suicidal ideation and behaviors, the PhenX Toolkit contains clinical service measures and translational research measures selected for use by scientists who are collecting data from human subjects in the early stages of psychotic illness. These CDEs, along with selected measures from the  NIH Toolbox, the National Outcome Measures (NOMs), and the Patient-Reported Outcomes Measurement Information System (PROMIS), may also be appropriate for the early psychosis core assessment battery that the regional scientific hubs will implement, as solicited in companion FOA RFA-MH-19-150.

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.

1. Criteria

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.

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.

 

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed ENDCC and its proposed activities facilitate large-scale, practice-based research to improve early psychosis care in CSC clinics? 

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the PD(s)/PI(s), collaborators, and other researchers’ have appropriate expertise in study coordination, health informatics, data management, and using robust analytic platforms and tools to rapidly translate large amounts of pooled data from community clinics into usable information for diverse stakeholders?

Do the PD(s)/PI(s) and other personnel have demonstrated experience and an ongoing record of accomplishments in managing research data from community mental health clinics and applying big data analytic methods? 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?

Do the PD/PI(s) and key personnel have the appropriate expertise and experience in study coordination, data management, and using robust analytic platforms and tools to rapidly translate large amounts of pooled data into usable information?

Is the organizational structure appropriate for the proposed ENDCC? 

 

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?

Are innovative strategies proposed for (i) identifying opportunities for harmonizing early psychosis measures, data elements, and assessment methods to increase concordance among early psychosis clinical assessment batteries; (ii) optimizing health informatics within and across the regional scientific hubs; (iii) rapidly translating large amounts of clinical service data into usable information that is informative to regional network stakeholders; (iv) promoting access to aggregated de-identified patient-level data to support practice-based research both within EPINET and among extramural scientists broadly; or (v) disseminating CSC resources to clinical practice and scientific communities?

Are innovative strategies proposed for adapting and leveraging existing functioning infrastructure to create the ENDCC informatics infrastructure, where applicable?

 

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

Is the plan for coordinating EPINET activities with the regional scientific hubs feasible and appropriate for accomplishing the ENDCC’s key tasks?

Are the processes proposed for curating standard early psychosis measures, common data elements, and clinical assessment strategies feasible and appropriate? Is the consensus process proposed for maximizing the clinical, administrative, and scientific value of common and divergent assessment and intervention practices observed among regional scientific hubs feasible and appropriate? Does the application identify potential challenges to standardized data collection in the regional hub early psychosis clinics and propose strategies to address those challenges?

Is the proposed health informatics approach for collecting, aggregating, and manipulating clinical encounter data from 20 or more CSC clinics feasible and appropriate? Is the plan for maintaining data completeness and quality feasible and appropriate? Is the plan for providing regional hub investigators technical assistance feasible and appropriate? Is the plan to create a data validation tool feasible and appropriate? 

Is the strategy for maintaining appropriate data security processes and privacy procedures, including establishing patient and clinic-level GUIDs sufficient?

Are the proposed data analysis, presentation, and reporting methods and tools feasible and appropriate?

Is the plan for supporting a secure interface that allows network hub investigators to access aggregated de-identified patient-level data for the purposes of practice-based research feasible and appropriate?

Is the plan for collaborating with the regional hubs to develop a secure method of contact between investigators and individual patients regarding voluntary research participation feasible and appropriate?

Is the plan for supporting data processing and analyses for research projects proposed by each of the 5 regional hubs, as well as efforts that might arise from emerging network collaborations, sufficient?

Is the plan for developing a secure, web-based portal to allow extramural researchers to query the de-identified EPINET data feasible and appropriate?

Is the plan for developing the capacity to allow EPINET data users to bring their own analysis tools to the data sufficient?

Is the plan for coordinating education and outreach efforts to the extramural scientific community in order to facilitate their EPINET data use sufficient?

Is the plan for disseminating CSC resources to clinical practice and scientific communities and feasible and appropriate?

Does the Management Plan adequately describe (i) how the PD(s)/PI(s) will manage the proposed project; (ii) who will oversee the day-to-day activities; (iii) the ENDCC's organizational structure and individual responsibilities; (iv) how management will support the achievement of the proposed goals and milestones; (v) how multiple efforts will be integrated; and (vi) how collaborative efforts with and among the regional hubs will be enhanced to ensure efficient cooperation, communication and coordination, and resource sharing?

Are the proposed project milestones, timeline and metrics to document project achievement adequate?

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

 

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?

Will the institutional environment in which the ENDCC will operate contribute to the probability of success in facilitating the ENDCC’s goals and objectives? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed ENDCC? 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?

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.

 

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

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

 

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

 

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

 

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

 

Not Applicable

 

Not Applicable

 

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.

 

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 (GDS).

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by the 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.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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 FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council . The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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.

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 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.

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, 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.

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.

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.

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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Define the details of the project within the guidelines of this FOA.
  • 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 and cost 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).
  • Chair and coordinate the activities of the ENDCC Steering Committee. The Chair is responsible for preparing meeting agendas, scheduling and chairing meetings, and preparing concise minutes which will be delivered to Steering Committee members within 2 weeks of the meeting. Virtual meetings are appropriate.
  • Serve as a member of the Steering Committee and fulfill related duties outlined below in Areas of Joint Responsibility; inform the NIMH Program Official of all major interactions with other members of the Steering Committee.
  • Adhere to NIMH policies regarding intellectual property and other policies that might be established during the course of this project activity. Awardees 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 DHHS, PHS, and NIH policies.
  • A data sharing plan is required; investigators funded under this FOA are expected to share data via the National Database for Clinical Trials related to Mental Illness (NDCT; http://ndct.nimh.nih.gov/; see NOT-MH-14-015 and  NOT-MH-15-012).
  • The ENDCC will have responsibility for depositing all data collected under this award, including de-identified patient-level data, in the NIMH Data Archive (see NDA; https://data-archive.nimh.nih.gov/). All data collected will be deposited into NDA every 6 months.
  • Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIMH support, including the assigned cooperative agreement award number.
  • Share data and resources according to the data release and resource sharing 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 regional scientific hubs for the purpose of scientific evaluation.
  • Not disclose confidential information obtained from the regional scientific hubs.
  • Submit data for quality assessment and/or validation in any manner specified by the Steering Committee, regional hubs, and/or the NIMH program staff to ensure scientific rigor.
  • Accept and implement the common guidelines and procedures approved by the Steering Committee 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 Official 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 and research resource sharing plans, and will be named in the award notice.
  • The NIMH Program Official will facilitate interactions between the ENDCC, the Steering Committee and awardees of NIMH FOA RFA-MH-19-150, Early Psychosis Intervention Network (EPINET): Practice-Based Research to Improve Treatment Outcomes (R01 Clinical Trial Optional).
  • In addition to the Program Official, an NIMH Project Scientist(s) will be named to the Steering Committee as a voting member. 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 participation of the NIMH Project Scientist(s) is intended to assist the Steering Committee in its efforts to ensure that the broad scientific goals of NIMH are reflected in the final design, implementation, and reporting of results from the ENDCC. 
  • The role of the NIMH Project Scientist(s) is to assist, participate in deliberations, and facilitate discussion, but not to direct activities. This level of staff involvement does not alter the awardee’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 awardee as author or co-author of resulting publications in accordance with publication policies developed by the Steering Committee. Publications involving NIMH staff must follow NIH and NIMH publication policies.

Areas of Joint Responsibility include:

  • A governing Steering Committee will be established to assist in ensuring that the ENDCC provides the necessary support for practice-based research to improve early psychosis care and to monitor progress over time. The Steering Committee will be composed of the PD(s)/PI(s); key personnel; the NIMH Project Scientist(s); PD(s)/PI(s) of the regional scientific hubs that will be funded under the companion announcement RFA-MH-19-150; and additional members that reflect the diversity of early psychosis stakeholders, such as patients and relatives, clinicians, administrators, and health care policy makers from regional CSC networks. Experts in learning health care, measurement-based treatment, health information technology, health informatics, computational modeling, bioethics, and other areas may also be included, as appropriate.
  • Steering Committee members will meet periodically, but not fewer than twice per year, to plan research activities, review study progress, and establish priorities, policies, and procedures. Each member will have one vote in any decision to be made by the Steering Committee with respect to study policies and procedures. The NIMH Project Scientist(s) will be a voting member of the Steering Committee. Adoption of policies and procedures will require a majority vote. 
  • NIMH Program Officials may attend Steering Committee meetings as non-voting participants.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS 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 and to ensure that all policies and procedures recommended and approved by the project Steering Committee are followed.

By acceptance of this award, the awardee agrees to abide by decisions and policies of the project Steering Committee and the other terms and conditions listed above or referenced in the Notice of Grant Award.

3. Reporting

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.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and 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)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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)

There must be a contact for all participating ICs.

Susan Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3267
Email: azrinst@mail.nih.gov

Peer Review Contact(s)

Nick Gaiano Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301- 827-3420
Email: NIMHPeerReview@mail.nih.gov

Financial/Grants Management Contact(s)
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 45 CFR Part 75.


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