Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Mental Health (NIMH)
New
March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128
August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
RFA-MH-20-401, R34 Exploratory/Developmental Grant
93.242
This Funding Opportunity Announcement (FOA) encourages studies that develop and test the effectiveness of strategies for implementation and sustainable delivery of evidence-based mental health treatments and services to improve mental health outcomes for underserved populations in under-resourced settings in the United States. Studies should identify and use innovative approaches to remediate barriers to provision, receipt, and/or benefit from evidence-based practices (EBPs) and generate new information about factors integral to achieving equity in mental health outcomes for underserved populations. Research generating new information about factors causing/reducing disparities are strongly encouraged, including due consideration of the needs of individuals across the life span.
This FOA is published in parallel to a companion R34 RFA-MH-20-401 that supports pilot studies in preparation for the larger-scale studies described here.
November 27, 2019
January 24, 2020 and July 25, 2020
February 24, 2020 and August 25, 2020
No late applications will be accepted for this Funding Opportunity Announcement
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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
June 2020 and October 2020
August 2020 and January 2021
September 2020 and April 2021
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
This Funding Opportunity Announcement (FOA) encourages studies that develop and test the effectiveness of strategies for implementation and sustainable delivery of evidence-based mental health interventions and services to improve clinical and functional outcomes for underserved populations in under-resourced settings in the United States. Studies should identify and use innovative approaches to remediate barriers to provision, receipt, and/or benefit from evidence-based practices (EBPs) and generate new information about factors integral to achieving equity in mental health outcomes for underserved populations. Research generating new information about factors causing/reducing disparities are strongly encouraged, including due consideration for the needs of individuals across the life span.
Background
Evidence-based mental health treatment and preventive interventions and services (EBPs) are effective in improving clinical and functional outcomes for a wide variety of people. Ample research suggests, however, that EBPs are often not delivered in low-resource settings and in settings where clients are predominantly from traditionally underserved populations. These populations are also more likely to have worse mental health outcomes, and more inpatient hospitalizations and emergency room use for psychiatric crises. While the prevalence of some mental disorders may be lower among racial and ethnic minorities, the course of illness is often more severe, persistent, and disabling. Recent research also suggests that disparities in receipt of mental health treatment and services may be increasing. Based on these findings, this announcement solicits research intended to improve access to evidence-based mental health care in low-resource areas and for underserved populations as a strategy for achieving greater equity in mental health and related functional outcomes and reducing disparities.
Research Objectives
This initiative is focused on developing and testing the effectiveness of strategies to deliver evidence-based mental health services, treatment interventions, and/or preventive interventions (EBPs) in low-resource mental health specialty and non specialty settings within the United States, where EBPs are not currently delivered or delivered with fidelity, such that there are disparities in mental health and related functional outcomes (e.g., employment, educational attainment, stable housing retention and integration in the community, treatment of comorbid substance use disorders, etc.) for the population(s) served. Of interest are settings where a significant number of children, youth, adults, or older adults with or at risk for mental illnesses can be found and evidence-based mental health treatments or services are not currently delivered. Studies should identify and use innovative approaches to remediate barriers to provision, receipt, or benefit from EBPs and generate new information about factors integral to achieving greater equity in mental health and related functional outcomes for underserved populations. Research generating new information about factors causing/reducing disparities is strongly encouraged.
The goal is to develop scalable implementation strategies that achieve delivery of EBPs with high fidelity in these settings and significantly improve clinical and functional outcomes toward greater equity with outcomes documented in non-disparity populations.
For the purposes of this FOA, NIMH uses the following definitions:
Strategies for achieving equity via implementation of EBPs might include those that focus on: access, quality/fidelity of care delivery, patient/family engagement, care management and coordination, or other innovative strategies as are empirically or theoretically justified. Implementation strategies might address EBP delivery barriers at one or more of the following: provider-, clinic-, organizational-, within- or cross-systems levels.
Studies submitted to this FOA should be structured to elucidate whether and how the implementation strategy achieves delivery of the EBP with fidelity, and measurement of whether receipt of EBP leads to improved mental health and related functional outcomes for the intended population(s).
Accordingly, studies should be designed to explicitly assess and investigate whether the strategy being tested leads to changes in the targeted consumer- or provider-behaviors, or organizational-/system-level factors that are intervened upon proximally in order to achieve implementation of EBPs, and in turn, ultimately improve clinical and functional outcomes. The goal is to inform how best to deliver and sustain EBPs in under-resourced settings and determine the mechanisms that contribute to achieving improved clinical and related functional outcomes to reduce disparities in such outcomes.
Proposed studies are expected to test models, theories, and conceptual frameworks of the implementation process that account for the available resources of the targeted care settings, the potential for cross-system collaboration(s), using a deployment-focused approach that takes into account the perspectives and needs of multiple stakeholders, including end-users (e.g., consumers, providers, administrators, payers). In other words, the tested approaches should be developed with consideration for the realistic constraints in organizational structure, provider availability and training, organizational or provider capacity and other relevant factors specific to the type of under-resourced setting being addressed. Studies should be formulated to contribute generalizable strategies that, if effective, can be rapidly disseminated and implemented across a broad range of real-world settings.
NIMH encourages research that utilizes novel technology to assist in the implementation, fidelity, delivery, and feedback of clinical and organizational processes in the implementation of EBPs (see NOT-MH-18-031; Notice of Information: NIMH High-Priority Areas for Research on Digital Health Technology to Advance Assessment, Detection, Prevention, Treatment, and Delivery of Services for Mental Health Conditions). When indicated, strategies should incorporate health information technology (HIT) and electronic health records (EHR) to coordinate care and monitor outcomes.
A variety of methodologically rigorous approaches may be indicated for testing the impact of the proposed implementation strategies. These approaches may include randomized controlled trials (RCTs), quasi-experimental designs with non-randomized comparison groups, time series designs, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity, and the design being used should be justified in the application.
Applicants are strongly encouraged to propose EBP implementation strategies that identify factors that facilitate sustainability (e.g., utilization of existing personnel or realignment of responsibilities to facilitation impementation, effective financing strategies, response to staff turnover, technological factors, etc.), scalability, and generalizability to other settings or geographic regions. NIMH anticipates that the studies supported by this FOA will substantially contribute to the development of new, generalizable knowledge regarding strategies to reduce or eliminate disparities in mental health outcomes. Accordingly, NIMH encourages studies that are designed to examine whether the proposed strategy has potential for addressing disparities in access to, or quality or outcomes of EBPs for underrepresented, underserved individuals (e.g., through comparisons among subgroups, or through a priori plans to benchmark outcomes/effect sizes against those achieved in prior research).
Areas of interest include, but are not limited to one or more of the following:
Proposed studies should be statistically powered to provide a definitive test of the implementation strategy's effectiveness incomparison to usual care practices in the setting. Support for pilot studies to promote the development of and evaluation of the initial feasibility, acceptability and preliminary effectiveness of implementation strategiesis provided viaRFA-MH-20-401.
Potential applicants are strongly encouraged to contact the Scientific/Research contact as far inadvance as possible to discuss the match between potential research applications and current NIMH priorities.
Examples of studies that are not responsive to this FOA and will not be reviewed include applications in which:
Protections for Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, families/caretakers/guardians, providers, supervisors, administrators, etc.) should address provisions for human subject protections and consenting procedures for all participant groups. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The applications's Protection of Human Subjects section plans 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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NIMH intends to commit $2,000,000 in FY 2020 to fund 3-4 awards.
The scope of the proposed project period should determine the project period. The maximum project period is 5 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
NIMH Peer Review Office
Email:[email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy
Significance
Describe how effective implementation strategies may optimize the delivery of evidence-based mental health services, improve receipt and quality of care, and foster measurable improvement in clinical and functional mental health outcomes among the identified populations, in the targeted settings.
Describe how the proposed project will facilitate sustainability, scalability, and enhance the potential for broader implementation and future uptake of the strategy in diverse settings.
Describe how the project will contribute to the development of an implementation strategy that improves clinical and functional mental health outcomes in the targeted setting and with the intended population.
Provide evidence that the implementation strategy is likely to lead to delivery of an EBP with fidelity and assess whether this leads to subsequent improvement in clinical and functional client outcomes.
Describe how the scientific rationale and need for a study to test the proposed hypothesis or implementation strategy is supported by preliminary data, clinical studies, or information in the literature or knowledge of behavior or systems change mechanisms. Provide the rationale for why this study could lead to a change in clinical practice, community behaviors or health care policy. Describe how this study is needed to advance scientific understanding related to improving clinical and functional outcomes for individuals in need of mental health interventions and services seen in low-resource settings.
Innovation
Describe any innovations in implementation strategy development, feasibility testing, research strategy, design or analytic approach, if they are employed, and how these may enhance the potential value of study results.
Describe any innovative technologies (e.g., use of dashboards, outcome tracking, and clinical or functional milestone measurement, incorporation of health information technology) that will contribute to the establishment of the implementation strategy and/or the delivery of an EBP with fidelity.
Describe any new approaches to promote delivery of and engagement in EBPs in low-resource settings for underserved populations.
Describe whether the design/research plan includes innovative elements related to interventions intended to change provider-, clinic-, organizational- or systems-level functioning in low-resource settings to improve individual and family clinical and functional outcomes, as appropriate, that offer potential for new information or advancement of scientific knowledge or clinical practice.
Approach
Describe how the study design will elucidate how components of the implementation strategy affect the change(s) that lead to delivery of an EBP with fidelity, and how those changes and the subsequent impact on mental health and related functional outcomes will be measured. Address: 1) the empirical and/or theoretical basis for the components of the implementation strategy and the corresponding proximal target(s), 2) the assessment of whether the strategy influences the intended proximal target(s) (e.g., change in provider behavior, improved client engagement, change in work flow, etc.) leading to delivery of an EBP with fidelity, 3) the analysis plan(s) to determine whether intervention-induced changes in the proximal target(s) mediate improvement in the distal outcomes or clinical endpoints of improved clinical and related functional outcome(s), and 4) how reduction of outcome disparities will be determined.
Provide evidence of the quality, feasibility, and validity of any measures used and how these will ensure reliable data appropriate to the planned analysis (See Clinical Trials FAQs at: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml#faq for more information on approach).
Include plans to foster long-term sustainability by incorporating stakeholder perspectives that will enhance collaboration across agencies, health care systems, and community programs, and consumers.
Describe the steps for implementation strategy development/refinement and a clear rationale for the choice of methods proposed.
Describe the provisions for the assessment and monitoring of the fidelity of EBP delivery via procedures that are feasible and valid for use in the identified delivery settings.
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.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
Not applicable
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
How compelling is the description regarding how effective implementation strategies may optimize the delivery of mental health services, improve receipt and quality of EBPs, and foster greater equity in clinical and functional mental health outcomes?
How well does the proposed project facilitate sustainability, scalability, and enhance the potential for broader implementation and future uptake of the strategy in diverse settings?
Does the application adequately describe how the project will contribute to the development of an implementation strategy that accomplishes the delivery of an EBP with fidelity, and specify the research strategies and instruments that will be used to measure: the active attributes of the strategy, the fidelity of EBP delivery, the indicators of clinical and functional impact on clients, and the magnitude of improvements in clinical, functional and behavioral outcomes for clients served in the targeted setting(s)?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
What innovations, if any, are proposed relevant to implementation strategy development, feasibility testing, research strategy, design or analytic approach, and can these enhance the potential value of study results?
How well will innovative technologies (e.g., use of dashboards, outcome tracking, and clinical or functional milestone measurement, incorporation of health information technology) contribute to the establishment of the implementation strategy and/or the delivery of an EBP with fidelity?
Does the application identify new approaches to promote delivery of and engagement in EBPs in low-resource settings for underserved populations?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 study design likely to elucidate how components of the implementation strategy affect the change(s) that lead to delivery of and EBP with fidelity, and how those changes and the subsequent impact on clinical and functional mental health outcomes will be measured? Are the following addressed: 1) the empirical and/or theoretical basis for the components of the implementation strategy and the corresponding proximal target(s), 2) the assessment of whether the strategy influences the intended proximal target(s )(e.g., change in provider behavior, improved client engagement, change in client flow, etc.) leading to delivery of an EBP with fidelity, 3) the analysis plan to determine whether intervention-induced changes in the proximal target(s) mediates the distal outcomes of improved clinical and functional outcome(s) and 4) how reduction of outcome disparities will be determined? See Clinical Trials FAQs at: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml#faq for more information on approach.
Is there evidence of the quality, feasibility, and validity of all measures used and a description of how these will ensure reliable data for analysis?
How adequate are the plans to foster long-term sustainability by incorporating stakeholder perspectives that will enhance collaboration across agencies, health care systems, and community programs, and consumers?
How comprehensive and logical are the steps for implementation strategy development/refinement and is the rationale for the choice of methods proposed sufficient?
How adequate is the description of the provisions for assessment and fidelity monitoring of EBP delivery via procedures and what is the likelihood of their feasibility and validity for use in the identified delivery settings?
How adequate is the evidence that the implementation strategy is likely to produce the proximal and distal outcomes?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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
Not applicable
Not applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://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 https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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 instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Denise Juliano-Bult
National Institute of Mental Health (NIMH)
Telephone: 301-443-1638
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]