Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Reducing the Duration of Untreated Psychosis in the United States (R34)
R34 Planning Grant
Reissue of PAR-13-188
PAR-16-264
PAR-16-265, R01 Research Project Grant
93.242
Approximately 100,000 adolescents and young adults in the United States experience a first episode of psychosis (FEP) every year. The early phase of psychotic illness is widely viewed as a critical opportunity for indicated prevention, and a chance to alter the downward trajectory and poor outcomes associated with schizophrenia and related psychotic disorders. Compared to traditional treatment approaches, programs that integrate pharmacologic, psychological, and rehabilitation interventions for FEP, i.e., team-based Coordinated Specialty Care (CSC), have been found to produce a range of positive clinical and functional outcomes. However, the timing of treatment is critical; short and long-term outcomes are better when individuals begin treatment close to the onset of psychosis. Unfortunately, numerous studies find a substantial delay between the onset of psychotic symptoms and the initiation of FEP care; in the U.S. treatment is typically delayed between one and three years. Early identification of FEP, rapid referral to evidence-based services, and effective engagement in CSC are essential to shortening the duration of untreated psychosis (DUP) and pre-empting the functional deterioration common in psychotic disorders. The World Health Organization advocates reducing DUP to 3 months or less. Accordingly, this Funding Opportunity Announcement (FOA) seeks planning grant applications that (1) identify a baseline rate of DUP in community settings that include CSC programs; (2) map referral pathways to CSC care, (3) identify bottlenecks and gaps in the pathway to CSC care, and (4) develop and pilot test feasible strategies for substantially reducing DUP among persons with FEP.
May 17, 2016
June 19, 2016
Not Applicable
Any due dates on or after Jan 25, 2018 must use reissued FOA.
July 19, 2016; November 18, 2016; March 17, 2017; July 18, 2017; November 17, 2017; March 19, 2018; July 18, 2018; November 19, 2018; March 19, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
November 2016, March 2017, June 2017, November 2017, March 2018, June 2018, November 2018, March 2019, June 2019
January 2017, May 2017, October 2017, January 2018, May 2018, October 2018, January 2019, May 2019, October 2019
April 2017, July 2017, September 2017, April 2018, July 2018, September 2018, April 2019, July 2019, September 2019
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Approximately 100,000 adolescents and young adults in the United States experience a first episode of psychosis (FEP) every year. The early phase of psychotic illness is widely viewed as a critical opportunity for indicated prevention, and a chance to alter the downward trajectory and poor outcomes associated with schizophrenia and related psychotic disorders. Compared to traditional treatment approaches, programs that integrate pharmacologic, psychological, and rehabilitation interventions for FEP, i.e., team-based Coordinated Specialty care (CSC), have been found to produce a range of positive clinical and functional outcomes, including reduced symptoms, greater involvement in work or school, and improved quality of life. However, the timing of treatment is critical; short and long-term outcomes are better when individuals begin treatment close to the onset of psychosis.
International consensus statements from the World Health Organization recommend that specialty care for FEP start within 3 months of illness onset. However, more than two dozen studies conducted worldwide have observed a substantial delay (on average 2 years) between the appearance of psychotic symptoms and the initiation of treatment. Two influential meta-analyses clearly establish that the duration of untreated psychosis (DUP), the time between the onset of psychosis and initiation of treatment, is correlated with poor outcome. In the United States, DUP ranges between one and three years, suggesting that many people with FEP are missing a critical opportunity to benefit from early psychosis intervention.
Research suggests that DUP can be reduced by enhancing early detection, treatment referral, and clinical engagement mechanisms. Reducing DUP in the United States from current levels of 1-3 years to the international standard of no more than 3 months should be a major focus of applied research efforts. Research to improve FEP case identification and referral in the United States is a logical complement to other NIMH initiatives on improving outcomes for people with FEP, such as the Recovery After an Initial Schizophrenia Episode (RAISE) initiative, which found that CSC produced superior clinical and functional improvements compared to typical care, especially among clients with shorter DUP.
This FOA aims to support research that will (1) investigate early links in the FEP case identification and referral chain in the United States, and (2) develop feasible strategies for reducing delays in early detection, speedy referral, and rapid initiation of stage-specific treatment. The target population is not limited to first episode schizophrenia, but includes all persons experiencing a first episode of psychosis regardless of presenting DSM-IV diagnosis. Applicants are encouraged to base research activities in settings that link to treatment systems with CSC programs for FEP. A variety of configurations for FEP specialty care programs are possible, but evidence-based CSC treatment involves integrated, team-based care and typically feature use of single antipsychotic medications, prescribed in low doses; family psychoeducation; supported employment and/or education; cognitive-behavioral therapy oriented to recovery; coordination with primary care services; and continuity of care across inpatient and outpatient treatment settings.
Applications submitted to this FOA are encouraged to develop and test the feasibility of strategies for reducing contributors to DUP within the selected community setting, based on results of the benchmarking activities. It is expected that pilot data from feasibility tests will be used to support applications for subsequent R01 intervention studies that will compare alternative methods for reducing DUP in community service settings. The strategies proposed to reduce DUP should aim to remove significant bottlenecks as well as close gaps in the pathway to specialty FEP care. NIMH encourages applications that explore approaches for producing one or more of the following:
Applications submitted to this FOA should consider supply side approaches (e.g., targeting clinical and community systems), such as the development and testing of strategies for training primary care physicians and nurses, school and college counselors, emergency department staff, police, and mental health generalists to recognize signs of early psychosis, and the improvement of referral networks to fast-track the initiation of FEP care. This FOA is also intended to encourage demand side approaches (e.g., engaging people with FEP and their family members, friends, caregivers and others close to the affected individual) to improve recognition of early symptoms, help-seeking, access, and engagement in care for persons with FEP and/or youth at high clinical risk for psychosis, through education, decision-support systems, and other tools, including social marketing, social media and social networking.
Research to reduce DUP requires expertise on the characteristics of service delivery systems and community settings in which DUP reduction strategies would be embedded, as well as expertise on the needs, life circumstances, and diversity of the population of young people with FEP and/or at high clinical risk of psychosis. Investigators should convey knowledge of DUP assessment strategies and factors that may contribute to treatment delays in the U.S. health care system. Multi-disciplinary research teams with complementary areas of expertise are encouraged. NIMH encourages applications that involve collaboration with stakeholders from multiple clinical or community practice settings, as well as consumers of services and their family members and social contacts.
In addition, NIMH welcomes applications proposing to leverage existing practice research infrastructures such as the Mental Health Research Network (MHRN), the Clinical Translational Science Awards Program (CTSA) and other research and practice networks looking to conduct studies to reduce DUP. NIMH also welcomes coordination of DUP research with other public and private initiatives that specifically address early identification and treatment of young people at high risk for mental illness. For example, since 2014 the Substance Abuse and Mental Health Services Administration (SAMHSA) has supported the implementation of evidence-based treatment programs for FEP across the United States via a set-aside in the Community Mental Health Block Grant Program (CMHBG). The NIMH estimates that by 2017, over 100 CSC programs will be operating in 32 states, as a consequence of the CMHBG set-aside, representing a tremendous opportunity for advancing DUP reduction research.
This FOA, and the companion FOA, PAR-16-265, support experimental and quasi-experimental studies focused on designing, refining, and testing algorithms of practical and accurate case identification of persons with FEP and/or at high risk of psychosis within a myriad of possible clinical and community contexts, in combination with strategies that promote rapid referral to the appropriate stage-specific specialty care.
Applications to this FOA should focus on practical and reproducible strategies to achieve substantial DUP reduction for persons with FEP. The NIMH encourages applications in which referral to CSC programs is feasible. This FOA supports studies on the research topics listed below, which are intended to be illustrative, not exhaustive:
It is expected that applications submitted to this FOA will identify other important, innovative and impactful research topics. Investigators considering applying to this FOA are encouraged to contact the Scientific/Research Contact for this FOA for additional guidance prior to submitting an application. Investigators who have already completed significant developmental or pilot work in this area should consider an application to PAR-16-265.
The R34 should propose the developmental work to be performed that would enhance the probability of success in a larger study. Designs need not be reduced scope versions of the anticipated larger study, but should instead attempt to develop and refine the research strategies to be utilized in the subsequent large-scale study. NIMH recognizes that while the scope of interest for this FOA is consistent across both this and the companion FOA, PAR-16-265, there are specific research topics for which the field may not yet be ready for a large-scale trial. This FOA provides the opportunity for high risk, high reward studies that may be of high priority to the NIMH. Thus, appropriate research activities for this FOA might include:
Given the intended pilot nature of this FOA, conducting a formal test of outcomes is not required and obtaining an estimate of an effect size may not be possible.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
Revision
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIMH intends to commit approximately $3,000,000 in FY 2017 to fund between 4 and 6 grants submitted to this FOA and the companion FOA PAR-16-265.
Direct costs are limited to $450,000 over the R34 project period, with no more than $225,000 in direct costs allowed in any single year
The total project period for an application submitted in response to this FOA may not exceed 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketch Describe investigators' knowledge of DUP assessment strategies and factors that may contribute to treatment delays in the U.S. health care system. The biographical sketches should also describe the qualifications of the PD/PI and other senior investigators, including expertise in the identification and treatment of people with FEP and expertise in the service delivery systems or community settings in which the selected DUP reduction strategies would be embedded.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: For the initial benchmarking phase of the research, applications submitted to this FOA should (1) specify a scientifically acceptable operational definition of DUP; (2) use reliable measures to quantify overall DUP among persons who enroll in FEP specialty care; (3) map the various pathways that channel persons with FEP to CSC care programs; and (4) identify bottlenecks and gaps in these referral pathways, including barriers that impede the following:
Applications should propose a DUP reduction approach that has the potential to substantially reduce DUP in the target population of people with FEP. Applications should also describe novel strategies proposed for reducing DUP among people with FEP and/or measuring DUP in community treatment settings in the U.S. The application should describe a project that involves substantial DUP reduction for persons with FEP as a primary outcome.
Applications should describe appropriate study milestones that are clearly defined for all of the study aims. The milestones should be feasible and quantifiable and described in the context of the study timeline. Potential challenges that may result in enrollment shortfalls should be discussed, along with and corresponding solutions to address enrollment problems.
Applications should describe the multi-disciplinary features of the proposed research team, including team members' complementary areas of expertise.
The application should also describe collaborations with stakeholders from multiple clinical or community practice settings, as well as with consumers of services and their family members and social contacts, detailing stakeholders' engagement in the research process, including project design.
For projects involving a clinical trial:
Applications should identify the target(s) of the proposed services intervention to reduce DUP and provide evidence of the association between those targets and the outcomes of interest (e.g., DUP, symptoms, and functioning). The application should also provide evidence that: 1) the outcome measures have been validated or will be validated during the pilot work, 2) the outcomes measured include stakeholder relevant outcomes, 3) the intervention could be implemented in typical service settings using typically available personnel and resources, and 4) fidelity in intervention delivery will be monitored. Include the following:
(1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the reduction in DUP;
(2) plans for assessing whether the services intervention engages the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures);
(3) an analytic strategy for data analyses that will be used to examine whether the intervention engages the target(s) and whether intervention-induced changes in the target(s) are associated with reduction in DUP (i.e., mediation).
(4) justification for the sample size in terms of feasibility goals; and
(5) a clear rationale for the choice of methods proposed.
In the case of multi-element interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each DUP reduction intervention element.
Protections for Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly.
The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
To advance the goal of furthering research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables advancement of research through the effective communication of detailed research results, tools, and supporting documentation.
Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
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., mental illness), 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" (https://www.nlm.nih.gov/cde/) 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, in particular the Consensus Measures for Phenotypes and eXposures Mental Health Research Toolkit (https://www.phenxtoolkit.org/), and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Applicants are required to follow our Post Submission Application Materials policy.
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.
For this particular announcement, note the following:
This FOA supports the development and/or pilot testing of new or adapted interventions, pilot testing of interventions with demonstrated efficacy in broader scale effectiveness trials, or conducting pilot innovative services research that requires preliminary testing or development. Because this is a clinical exploratory/developmental grant application, it need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will be instructed to place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator generated data. Preliminary data are not required for R34 applications, but may be included if available.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the proposed approach have the potential to substantially reduce DUP in the target population of people with FEP?
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 qualifications of the PD/PI and other senior investigators include expertise in the identification and treatment of people with FEP and expertise in the service delivery systems or community settings in which the selected DUP reduction strategies would be embedded? Do research team members have complementary areas of expertise?
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 novel strategies proposed for reducing DUP among people with FEP and/or measuring DUP in community treatment settings in the U.S.?
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 project include a scientifically acceptable operational definition of DUP? Are methods described for obtaining reliable estimates of DUP in community programs? Does the project include substantial DUP reduction for persons with FEP as a primary outcome? If clinical, community or public health settings are involved, are stakeholders sufficiently engaged in the research process, including project design?
For projects involving a clinical trial, does the application provide evidence of the association between the intervention target(s) and the endpoint(s) of interest? Are the outcome measures validated and are stakeholder relevant outcomes included? Does the application describe the monitoring of fidelity in intervention delivery in community practice settings? Does the application provide justification for the sample size in terms of feasibility goals? Is there a clear rationale for the choice of methods proposed?
Does the application describe appropriate milestones that are clearly defined for all of the study aims?
Does the project involve collaborations with relevant stakeholders?
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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council . The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]
GrantsInfo
(Questions regarding application instructions and process, finding NIH grant
resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Susan T. Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3267
Email: [email protected]
David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.