Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Mental Health (NIMH)
This Funding Opportunity Announcement (FOA) invites applications for Early Psychosis Intervention Network (EPINET) regional scientific hubs to support practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery, and health outcomes in clinics offering evidence-based specialty care to persons in the early stages of psychotic illness. For this FOA, early psychosis is defined as the period spanning the onset of an affective or non-affective psychotic disorder and up to 5 years following the first episode of psychosis (FEP). Each EPINET regional scientific hub will link multiple early psychosis clinical service programs through (a) standard measures of early psychosis clinical features, services, and treatment outcomes; (b) informatics tools to collect de-identified, person-level data across sites; and (c) a unified approach for aggregating and analyzing pooled data. Large, integrated datasets are expected to facilitate rigorous quality improvement and program evaluation efforts within regional networks. In addition, each regional scientific hub will propose one or more mental health services and intervention research projects 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. Regional scientific hubs selected for funding will collaborate closely with the EPINET National Data Coordinating Center, which is described in companion announcement RFA-MH-19-151 .
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.
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.
Purpose
This Funding Opportunity Announcement (FOA) invites applications for Early Psychosis Intervention Network (EPINET) regional scientific hubs to support practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery, and health outcomes in clinics offering evidence-based specialty care to persons in the early stages of psychotic illness. For this FOA, early psychosis is defined as the period spanning the onset of an affective or non-affective psychotic disorder and up to 5 years following the first episode of psychosis (FEP). Each EPINET regional scientific hub will link multiple early psychosis clinical service programs through (a) standard measures of early psychosis clinical features, services, and treatment outcomes; (b) informatics tools to collect de-identified, person-level data across sites; and (c) a unified approach for aggregating and analyzing pooled data. Large, integrated datasets are expected to facilitate rigorous quality improvement and program evaluation efforts within regional networks. In addition, each regional scientific hub will propose one or more mental health services and intervention research projects 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. Regional scientific hubs selected for funding will collaborate closely with the EPINET National Data Coordinating Center, which is described in companion announcement RFA-MH-19-151.
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 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 Coordinated Specialty Care (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 experiencing FEP. While most programs restrict eligibility to recent-onset, non-affective psychosis (i.e., less than 2 years of illness), other clinics extend eligibility to persons with affective psychosis and/or up to 5 years illness duration.
In 2015, 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 will 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 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.
EPINET presents a unique opportunity for accelerating practice-based research into treatment approaches for early psychosis in the U.S., i.e., encouraging collaborations among service users, front-line clinicians, health care administrators, and scientific content experts to conduct high-quality clinical research in real-world settings. This perspective is consistent with Research Strategies 3.3 and 4.2 from the NIMH Strategic Plan for Research, which focus on testing interventions for effectiveness in community practice settings and establishing research-practice partnerships to improve implementation of evidence-based mental health services, respectively.
In 2017, NIMH convened a meeting to understand stakeholders perspectives on opportunities and barriers to adopting a harmonized approach to early psychosis clinical assessment and data collection across community-based CSC programs. Participants voiced strong support for a national early psychosis learning health care system as envisioned in EPINET and recommended strategies to facilitate data collection, data management, and quality improvement efforts in real world settings. This FOA aims to support research that will advance these goals. Anticipated outcomes of this program of research should include, but are not limited to:
Regional early psychosis networks selected for funding will collaborate closely with the EPINET National Data Coordinating Center (ENDCC), which is described in companion announcement RFA-MH-19-151 and is referenced below.
Research Objectives
This FOA supports development of several regional hub and spoke CSC networks across the United States. For this initiative, a hub is the anchor site of CSC services delivered within a region and provides scientific and technical expertise to support uniform assessment and data collection, data integration, data analysis, and data presentation across connected sites. Region refers to political or geographic subdivisions of the United States (e.g., cities, counties, Congressional districts, states, census divisions, etc.) or to integrated health systems which may cross geographic areas. Spokes are clinical programs that provide evidence-based care within the CSC framework and are connected to the central hub through common data elements, information technology, and a uniform operating system. NIMH expects applications to be submitted by PDs/PIs from regional hubs, with input from clinical and scientific partners in connected clinics.
To be responsive to this FOA, regional hubs will partner with four or more early psychosis intervention programs that endorse the principles of (1) measurement-based care (i.e., standardized clinical assessment, systematic monitoring of key outcomes, and timely feedback to clinicians about patients progress); (2) data-guided fidelity monitoring and quality improvement; and (3) participation in practice-based research to advance understanding of early psychosis characteristics, interventions, and outcomes. In aggregate, clinical programs within the regional network should collect assessment and treatment data from a minimum of 100 persons with early psychosis each year who are receiving CSC specialty services. The regional hub is expected to establish an Executive Committee with representatives from each CSC program and to include a diverse set of stakeholders, e.g., patients, family members, clinicians, administrators, and researchers. The purpose of the Executive Committee is to assure alignment of clinical and scientific goals among network stakeholders and to facilitate meaningful innovation in clinical assessment, data management, data sharing, and performance reporting across the network.
Core Early Psychosis Clinical Assessment Battery
Responsive applications will present a conceptual model of early psychosis clinical features, course of illness, intervention targets, CSC services, and key outcomes. Measures proposed for the core clinical assessment battery by the regional hub should be justified in terms of the early psychosis conceptual model, clinical utility, feasibility for community clinics, and value for quality improvement, program evaluation, and practice-based research purposes. Information derived from core assessment measures should be relevant to clinicians, program administrators, policy makers, and scientists, and address care processes and outcomes valued by patients and family members. Core measures should also consider the racial, ethnic, and cultural diversity of populations served.
Applicants are encouraged to incorporate instruments from the PhenX Toolkit of mental health research measures, which have been selected on the basis of validity, feasibility for real-world treatment settings, and low burden for patients and clinicians. The PhenX Toolkit includes standard measures of demographic features, substance use, suicidal ideation and behaviors, and 19 promising clinical service measures for community CSC programs. Responsive applications will propose suitable assessments to cover early psychosis domains absent from the PhenX collection, like duration of untreated psychosis, hospital episodes, utilization of crisis services, and school and work participation. Selected measures from the NIH Toolbox may also be appropriate for the core assessment battery. In addition, existing data collection systems such as the National Outcome Measures (NOMs) and the Patient-Reported Outcomes Measurement Information System (PROMIS) could be leveraged to standardize clinical data collection across CSC programs.
Informatics Infrastructure
Each regional hub will propose an informatics platform to collect, aggregate, and manipulate clinical encounter data collected from 4 or more early psychosis treatment programs. Whenever possible, hubs should leverage health information technology systems already present in CSC clinics to achieve feasible and efficient data collection across the network.
The hub is expected to maintain appropriate security processes and privacy procedures to store and analyze data from one hundred or more early psychosis patients enrolled each year across the regional network. These procedures will include establishing a Global Universal Identifier (GUID) for each patient to de-identify and protect the anonymity of individual-level patient data. Regional hubs should use the NIMH Globally Unique Identifier (GUID) infrastructure as the subject identifier
. Staff at the NIMH Data Archive will be responsible for helping regional hubs to export GUID infrastructure to all early psychosis clinics within the regional network. The regional hub will maintain high standards for data completeness and integrity, and in collaboration with participating clinics, will establish data quality metrics and data submission procedures to ensure appropriate quality control.The regional hub is encouraged to utilize analytic platforms and data visualization tools that rapidly translate large amounts of clinical service data into usable information that is informative to regional network stakeholders. Responsive applications will propose data reporting tools that support measurement-based care, CSC fidelity monitoring, quality improvement and program evaluation analyses, along with other program management functions. Examples of reports include, but are not limited to, patients clinical characteristics at initial evaluation, CSC services delivered over time, clinician variables, variations in treatment fidelity and quality, and patient outcomes.
To promote scientific investigation within the regional networks, the informatics infrastructure should include a secure interface that allows network investigators to access de-identified patient-level data for the purposes of practice-based research projects. This infrastructure should also make it possible for patients to be re-contacted through the CSC program that shared the data with the regional hub.
Practice-Based Research to Advance Early Psychosis Care
EPINET regional hubs are encouraged to conduct mental health services and intervention research projects directed at (1) optimizing the effectiveness of therapeutic or preventive interventions for early psychosis; (2) organizing and delivering optimized services within community early psychosis clinics; and (3) continuously improving the quality, impact, and durability of optimized interventions and services. Translational research projects that explore early psychosis risk factors, mechanisms of illness progression, and novel treatment targets/interventions are allowed but are not required at this initial stage of EPINET development. NIMH expects applicants to propose a research project that addresses a substantial gap in knowledge regarding early psychosis treatment and generates findings that can be incorporated rapidly within participating regional network clinics. The research project should reflect the input of the network’s diverse stakeholders, including patients, family members, clinicians, administrators, and scientists.
The scope of science should comprise at least one exploratory or pilot research project modeled on the NIMH R34 grant mechanism. Funding Opportunity Announcements PAR-18-267, Pilot Services Research Grants Not Involving Interventions (R34 Clinical Trials Optional), and RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trials Required), provide examples regarding the focus and scope of exploratory and pilot projects for NIMH R34 grant mechanisms. This project may be observational in nature; test new tools, measures, or methods to advance the learning health care model; employ a quasi-experimental design; or include a randomized control trial. To the greatest extent possible, the research project should leverage data to be collected in the core early psychosis clinical assessment battery. Additional measures are permissible but should be justified based on the research question and the scientific and public health significance of the proposed study.
Examples of possible topics for EPINET research projects include, but are not limited to, the following:
Clinical assessment of individuals with early psychosis
Treatment fidelity and quality improvement
Optimizing early psychosis treatment outcomes
Maintaining early psychosis treatment gains after initial CSC
Collaboration with the EPINET National Data Coordinating Center (ENDCC)
Each regional hub will establish a large, interactive dataset that contains de-identified, person-level information from one hundred or more patients enrolled and receiving services in regional CSC clinics. The companion funding opportunity announcement RFA-MH-19-151 describes the EPINET National Data Coordinating Center (ENDCC), which aims to develop infrastructure necessary for combining regional datasets into a national repository of early psychosis common data elements, clinical measures, and data processing tools. The ENDCC will develop an integrated national database to hold de-identified person-level data from many thousands of patients who receive CSC services each year across the United States, along with secure mechanisms to facilitate practice-based research with this large sample.
By responding to the this FOA (EPINET: Practice-Based Research to Improve Treatment Outcomes (R01), applicants agree to cooperate with all proposed ENDCC activities, including:
De-identified, patient-level data submitted to the ENDCC by regional hubs will become part of a readily accessible early psychosis data resource that can be widely used by the extramural research community.
Clinical High Risk for Psychosis in EPINET
NIMH understands that some CSC clinics have expanded early psychosis services to include individuals at Clinical High Risk (CHR) for psychosis. Applicants may include individuals at CHR in their response to this FOA but should provide a scientific and/or clinical rationale for doing so. The inclusion of individuals with CHR would be in addition to the required minimum of 100 persons with early psychosis served annually in the regional network.
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 12:00 pm 1:30 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 [email protected]. 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 .
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Need help determining whether you are doing a clinical trial?
NIMH intends to commit $6 million in fiscal year 2019 for this and companion FOA RFA-MH-19-151 to fund one U24 National Data Coordinating Center and up to five R01 EPINET regional hubs per fiscal year. Future year amounts will depend on annual appropriations.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Email: [email protected]
Document the experience of the PD(s)/PI(s) and co-investigators in working successfully with community mental health providers and administrators to integrate standardized assessment methods and health information technology into routine clinical care and in establishing collaborations across diverse mental health care stakeholders, such as patients, families, clinicians, researchers, administrators and payors to create organizational and/or cultural change in mental healthcare delivery.
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: Applications should describe a feasible mechanism for scientific integration of research procedures and overall managerial and administrative responsibilities across participating clinic sites. The common research protocol should specify mechanisms for cross-site coordination of clinical assessment, data collection, and database management to assure reliability and quality control. The research grant application should include a data management hub, central data coordination, and statistical analysis support for the overall project. In addition, the Research Strategy should include the following information:
Significance
Applicants should explain how the proposed regional scientific hub and the scope of its proposed activities will address the goals of (1) measurement-based treatment, (2) continuous improvement and innovation in early psychosis care delivery, and (3) practice-based research to drive the process of scientific discovery in early psychosis.
Applicants should explain how the project addresses an important problem or a critical barrier to progress in early psychosis care and provide the scientific premise for the project. Indicate how scientific knowledge, technical capability, and/or clinical practice in early psychosis could be improved if the aims of the project are achieved. Applicants should indicate how successful completion of the project aims could change the concepts, methods, technologies, treatments, services, or preventative interventions that drive the early psychosis care field.
In addition, for applications involving clinical trials:
Applicants should justify the practical impact of the intervention or service approach in terms of the estimated hypothesized effect size (in terms of key outcomes, such as clinical benefit, safety/tolerability, value and efficiency, or scalability), compared with already available approaches. Applications should address the potential impact of the intervention/service delivery approach in terms of both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches.
Applicants should address the degree to which the proposed intervention/service delivery approach is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service structures (including mental health financing), and typical service use patterns.
Innovation
Applicants should highlight how innovative strategies are incorporated within the regional network hub and clinics to advance the learning health care goals of measurement-based treatment, continuous quality improvement and innovation in care delivery, and practice-based research.
Applicants should highlight innovative strategies for establishing and implementing a core early psychosis clinical assessment battery that is practical and feasible to administer in a uniform manner across regional network clinics, and minimizes data collection burden on clinicians, administrators, patients, and family members to the greatest extent possible. Applicants should also highlight innovative health information technology applications that increase the efficiency, security, and meaningful use of clinical encounter data collected across participating early psychosis clinics.
In addition, for applications involving clinical trials:
Applicants should highlight how innovative research strategies and design/analytic elements are incorporated, as appropriate, to enhance the study’s potential for yielding practice-relevant information.
Applicants should describe innovative elements of the clinical trial(s) design/research plan that enhance its sensitivity, potential for information or potential to advance early psychosis scientific knowledge or clinical practice.
Approach
Management plan
Applicants should present a Management Plan that describes the following:
Applicants should present a detailed set of milestones and a timeline covering all aspects of the regional hub’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.
Core early psychosis clinical assessment battery
The application should describe how the core assessment battery is integrated into routine clinical care and how assessment methods and data collection procedures are standardized across clinics. If new measures are to be integrated within existing assessment procedures, the application should anticipate implementation challenges, including clinical work flows, staff expertise and time available, and assessment training needs. The application should propose strategies to overcome any anticipated difficulties. Whenever feasible, applicants could consider innovative assessment approaches, such as remote centralized assessment, web-based assessment, assessment portals that talk to electronic health records, or hiring, training, and retaining CSC personnel for data collection duties across multiple early psychosis clinics.
Informatics infrastructure
Applicants should propose an informatics platform to collect, aggregate, and manipulate clinical encounter data collected from the 4 or more early psychosis treatment programs connected to the hub. The applications should indicate how the hub will leverage health information technology systems already present in regional network clinics to achieve feasible and efficient data collection across the network. If health technology systems are not present in regional network clinics, feasible workarounds should be proposed.
Applicants should describe the security processes and privacy procedures to store and analyze data from one hundred or more early psychosis patients enrolled and receiving services each year across the regional network, including establishing a Global Universal Identifier number (GUID) for each patient to de-identify and protect the anonymity of individual-level patient data. Regional hubs should use the NIMH Globally Unique Identifier (GUID) infrastructure as the subject identifier. Staff at the NIMH Data Archive will be responsible for helping regional hubs to export GUID infrastructure to all early psychosis clinics within the regional network.
Applicants should present a plan for maintaining high standards for data completeness and integrity, including establishing data quality metrics and data submission procedures to ensure appropriate quality control.
The application should indicate how the regional hub will utilize analytic platforms and data visualization tools to rapidly translate large amounts of clinical service data into usable information that is informative to network stakeholders. Applicants should propose data reporting tools that support measurement-based care, early psychosis care fidelity monitoring, quality improvement and program evaluation analyses, and other program management functions, as appropriate.
Applicants should propose a secure interface that allows network investigators to access de-identified patient-level data for the purpose of conducting practice-based research within the regional network.
Early psychosis care research projects
Applicants should propose at least one mental health services or intervention research project that addresses a substantial knowledge gap regarding early psychosis treatment, reflects the input of diverse scientific regional hub stakeholders, and will generate findings that can be incorporated rapidly within participating clinics to improve the effectiveness of services. The application should describe how the project(s) will inform our understanding of and improve the quality of early psychosis care.
The research project(s) should be similar in scope to an NIMH R34 pilot study, e.g., PAR-18-267, Pilot Services Research Grants Not Involving Interventions (R34 Clinical Trials Optional, or RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trials Required). This project(s) may be observational in nature; test new tools, measures, or methods to advance the learning health care model; employ quasi-experimental designs; or include a randomized control trial.
Each early psychosis research project description should include the following: brief summary of the project; knowledge gap addressed; rationale for the proposed project; research question(s); research design, including justification for the design chosen; primary and secondary outcomes; analytic approach; and potential for public health impact in the practice of early psychosis care, including relevance to community-based early psychosis clinics broadly.
Applicants should indicate how the proposed project(s) will leverage the data to be collected in the core early psychosis clinical assessment battery and justify the collection of additional measures based on the particular research question and the potential scientific and public health impact of the proposed study.
Applications proposing a research project that is a clinical trial should incorporate NIMH’s experimental therapeutics approach to intervention development and testing, as described in RFA-MH-18-706 Pilot Effectiveness Trials for Treatment, Preventive, and Services Intervention (R34 Clinical Trial Required). (If you re unsure whether the proposed project is a clinical trial, see Need help determining whether you are doing a clinical trial?)
Collaboration with the EPINET National Data Coordinating Center
Applicants should outline a strategy for maintaining a high level of collaboration with the EPINET National Data Coordinating Center (ENDCC) on key tasks, including the following:
In addition, for applications involving clinical trials:
Environment
Describe features of the regional hub settings and its constituent early psychosis clinics that promote an early psychosis learning healthcare system.
Describe each early psychosis clinic (a minimum of four are required) that will comprise the regional network, including their patient flow and early psychosis services offered, and explain how the regional network as a whole will collect assessment and treatment data from a minimum of 100 persons with early psychosis per year who are receiving CSC specialty services.
In addition, for applications involving clinical trials:
Address the capability and ability to conduct the trial at the proposed site(s), including plans to add or drop enrollment centers, as needed.
For multi-site clinical trials, provide evidence of the ability of the sites to (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure.The following modifications also apply:
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:
2.5 Recruitment and Retention Plan
Applicants should indicate the availability of the eligible population for the proposed trial and describe plans for handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection.
Section 4 - Protocol Synopsis
4.2 Study Design
Applicants should describe how the trial study design is justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested. The application should indicate how the scientific rationale/premise of the study is based on previously well-designed preclinical and/or clinical research.
Applicants should indicate where the trial study design incorporates efficiencies and utilizes existing resources (e.g., data collected as part of the core early psychosis clinical assessment battery, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection. The application should discuss potential challenges to conducting the clinical trial and corresponding solutions (e.g., strategies that can be implemented in the event of enrollment shortfalls).
4.3 Outcome Measures
Applications should incorporate outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., functioning, health service use).
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
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 a "Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Applicants responding to this FOA 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 proposed core early psychosis clinical assessment battery solicited in this FOA.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.
A proposed Clinical Trial application may include study design, methods, and interventions that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or leads to new avenues of scientific investigation.
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 regional scientific hub and its activities significantly advance the principles of (1) measurement-based treatment in early psychosis, (2) continuous improvement and innovation in early psychosis care delivery, and (3) practice-based research to drive the process of scientific discovery in early psychosis?
In addition, for applications involving clinical trials:
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the 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 the appropriate expertise in early psychosis course of illness; standardized clinical assessment of early psychosis symptoms, functioning, and outcomes; measuring delivery of evidence-based early psychosis services; collecting and integrating de-identified, person-level data gathered across multiple specialty clinics; using standardized data to improve the quality of mental health services and individual patient outcomes; and conducting services and/or intervention research with individuals with early psychosis, including success in identifying and recruiting such participants into research studies?
Do the PD(s)/PI(s) and co-investigators have experience working successfully with community mental health providers and administrators to integrate standardized assessment methods and health information technology into routine clinical care and in establishing collaborations across diverse mental health care stakeholders, such as patients, families, clinicians, researchers, administrators and payors to create organizational and/or cultural change in mental healthcare delivery?
In addition, for applications involving clinical trials:
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are innovative strategies incorporated within the regional network hub and clinics to advance the learning health care goals of measurement-based treatment, continuous quality improvement and innovation in care delivery, and practice-based research?
Are innovative strategies proposed for establishing and implementing a core early psychosis clinical assessment battery that is practical and feasible to administer in a uniform manner across regional network clinics, and minimizes data collection burden on early psychosis care stakeholders? Are innovative health information technology applications proposed that will increase the efficiency, security, and meaningful use of clinical encounter data collected across participating early psychosis clinics?
In addition, for applications involving clinical trials:
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance early psychosis scientific knowledge or clinical practice?
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?
Does the application include an adequate Management Plan that describes how the PD(s)/PI(s) will manage the proposed project and who will oversee the day-to-day activities?
Does the management plan support the achievement of the proposed goals and initiatives?
Does the application adequately describe the regional hub’s organizational structure and individual responsibilities; how management will support the achievement of the proposed goals and milestones; how multiple efforts will be integrated across network clinics; how collaborations or subcontracts (if proposed) will be managed; and how to enhance the collaborative effort among the network clinics to ensure efficient cooperation, communication and coordination?
Does the application propose an adequate plan for how the Executive Committee will assure alignment of clinical and scientific goals among network stakeholders and facilitate meaningful innovation in clinical assessment, data management, data sharing, and performance reporting across the network?
Are the proposed project milestones and timeline reasonable for achieving the project aims?
Core early psychosis clinical assessment battery
Does the application propose an adequate conceptual model for early psychosis features, course of illness, intervention targets, CSC services, and key outcomes? Does the application propose a practical, low-burden early psychosis core clinical assessment battery that addresses key domains identified in the conceptual model?
Are standard measures of baseline characteristics and illness features, intervention targets, treatment fidelity and quality, services delivered, and important symptomatic and functional outcomes adequately described? Are the proposed measures justified in terms of clinical utility, importance to patient and family stakeholders, and value for quality improvement, program evaluation, and practice-based research purposes? Does the application adequately describe the frequency and method of assessment, training required to administer measures, and the cultural relevance of measure for diverse populations?
Is a feasible and efficient strategy proposed for collecting the early psychosis core clinical assessment battery data in a standardized fashion across clinics and integrating data collection as a component of routine care? Is a clear plan proposed for how the regional hub’s information technology systems will support this data collection and ensure interoperability among the regional network clinics?
Does the application identify possible challenges in implementing the core assessment battery, including clinical work flows, staff expertise and time available, and assessment training needs, and propose strategies to overcome these challenges?
Is the proposed informatics platform adequate to collect, aggregate, and manipulate clinical encounter data collected from the 4 or more early psychosis treatment programs connected to the hub? Does the application clearly indicate how the hub will leverage health information technology systems already present in regional network clinics to achieve feasible and efficient data collection across the network? Or propose sufficient workarounds if health technology systems are not already present in regional network clinics?
Are the proposed security processes and privacy procedures sufficient to store and analyze data from one hundred or more early psychosis patients enrolled each year across the regional network, including establishing a Global Universal Identifier number (GUID) for each patient to de-identify and protect the anonymity of individual-level patient data?
Is an adequate plan presented for maintaining high standards for data completeness and integrity, including establishing data quality metrics and data submission procedures to ensure appropriate quality control?
Is an adequate plan presented for how the regional hub will utilize analytic platforms and data visualization tools to rapidly translate large amounts of clinical service data into usable information that is informative to network stakeholders? Are the proposed data reporting tools sufficient?
Does the application propose an appropriate secure interface that allows network investigators to access de-identified patient-level data for the purpose of conducting practice-based research within the regional network?
Does the application propose at least one mental health services or intervention research project, similar in scope to an NIMH R34 pilot study, that addresses a substantial knowledge gap in early psychosis treatment, will generate findings that can be incorporated rapidly within participating clinics to improve the effectiveness of services, and reflects the input of diverse scientific regional hub stakeholders? Does the project have strong potential to produce data that will inform our understanding and improve the quality of early psychosis care and make a substantial public health impact on the practice of early psychosis care?
Does the proposed research project leverage data to be collected in the core early psychosis clinical assessment battery? If collection of additional data is proposed, is the collection of the additional measures justified by the particular research question and its potential scientific and public health importance?
Does the application include a feasible strategy for maintaining a high level of collaboration with the EPINET National Data Coordinating Center (ENDCC) on key tasks, including pubmitting de-identified, patient-level data to the ENDCC?
In addition, for applications involving clinical trials:
How well does the study design address whether the intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes, changes in provider behavior, etc.)? To what extent does the application include (1) clearly identified target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms, functional deficits, or patient-, provider- or system-level behaviors/processes that the intervention seeks to improve; (2) well justified plans for assessing engagement of the target(s)/mechanism(s), including the specific measures; and (3) an appropriate analytic strategy that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit (i.e., mediation)? In the case of interventions with multiple elements, does the application specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention element, as appropriate in the effectiveness context?
When appropriate, for studies that involve preventive or therapeutic interventions, does the study take into account RDoC or RDoC-like constructs when defining the subject eligibility (inclusion), intervention targets or mechanisms, and outcomes, as feasible in the effectiveness setting?
Does the application include provisions for the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid for use in community practice settings?
Where appropriate, are there plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research and helps to ensure the results will have utility?
Are proposed outcome measures validated and generally accepted by the field; are stakeholder-relevant outcomes included, as appropriate (e.g., functioning, health services use)?
Are the trial design and description of the research protocol consistent with CONSORT guidelines, as appropriate?
As appropriate, will the trial contribute to advancing the personalization of mental health care? Does it include collection of clinical predictors of treatment response at each stage of care and biological variables (e.g., blood or saliva for genetic analysis, imaging and other potential biomarkers), as appropriate, that might be used to inform or test algorithms for more prescriptive approaches? Will the study have either adequate statistical power to test for moderators or the potential to contribute information to larger databases for future use?
Does the application adequately address the following, if applicable?
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
Do the regional hub and its constituent early psychosis clinics have features that promote an early psychosis learning healthcare system?
Does the regional hub include a sufficient number of early psychosis clinics to collect assessment and treatment data from a minimum of 100 persons with early psychosis each year who are receiving CSC specialty services across the regional network?
In addition, for applications involving clinical trials:
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Study Timeline
Specific to applications proposing clinical trials:
If one or more of the early psychosis care research projects are clinical trials, then for each research project:
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed 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
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.
Information regarding the disposition of applications is available 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.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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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.
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.
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Nick Gaiano Ph.D.
National Institute of Mental Health (NIMH)
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