National Institute of Mental Health (NIMH)
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.
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.
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.
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.
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 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.
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.
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
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.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Higher Education Institutions
Nonprofits Other Than Institutions of Higher Education
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.
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.
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:
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: The Research Strategy should include the following information:
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.
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.
Coordinating regional EPINET activities
Curating standard measures, common data elements, and clinical assessment strategies
Optimizing health informatics within and across regional hubs
Data analysis, presentation, and reporting tools
Supporting practice-based research
Disseminating CSC resources to clinical practice and scientific communities
Present a Management Plan that describes the following:
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:
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.
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.
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.
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.
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.
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?
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.
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.
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.
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.
The PD(s)/PI(s) will have primary responsibility to:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
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 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.
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.
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)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
There must be a contact for all participating ICs.
Susan Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Nick Gaiano Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301- 827-3420