Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Research on Women's Health (ORWH)
Funding Opportunity Title
Secondary Data Analysis to Examine Long-Term and/or Potential Cross-Over Effects of Prevention Interventions: What are the Benefits for Preventing Mental Health Disorders? (R01 Clinical Trial Not Allowed)
Activity Code
R01 Research Project Grant
Announcement Type
New
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-MH-20-110
Companion Funding Opportunity
None
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.242, 93.213, 93.313
Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to encourage research to integrate/harmonize existing data sets from preventive intervention trials implemented early in life to: 1) examine risk and protective factors relevant to later mental health outcomes in childhood, adolescence and young adulthood; and 2) determine whether preventive interventions delivered earlier in life have long-term effects, and/or cross-over effects (e.g., unanticipated beneficial effects), on important mental health outcomes, including serious mental illness (e.g., depression, anxiety, suicide ideation and behaviors, psychosis behaviors).

Key Dates

Posted Date

February 6, 2019

Open Date (Earliest Submission Date)
April 02, 2019
Letter of Intent Due Date(s)

April 2, 2019 and December 2, 2019.

Application Due Date(s)

May 2, 2019; January 2, 2020, 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.

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2019 and March 2020

Advisory Council Review

October 2019 and May 2020

Earliest Start Date

December 2019 and July 2020

Expiration Date
January 03, 2020
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

There is a growing body of literature reporting on the benefits of preventive interventions for substance abuse and internalizing/externalizing behaviors, delivered in childhood, on the long-term outcomes of mental health and reduced substance use. Findings from this research demonstrate that (1) intervening early in development and targeting proximal risk and protective factors can have an impact on a broad array of distal outcomes; and (2) preventive interventions can have unanticipated beneficial effects on outcomes not specifically targeted by the intervention (cross-over effects). Indeed, there is a small body of evidence providing proof of concept that preventive interventions aimed at reducing a number of risk factors for suicide (e.g., substance use, externalizing, and internalizing behavior) can prevent suicidal ideation and behaviors. New technological and analytic approaches for harmonizing/integrating data sets hold potential for increasing statistical power and facilitating the detection of the impact of prevention interventions, in general, among important subgroups (e.g., sexual gender minority youth, racial/ethnic minority youth), and in the case of low base rate behaviors (e.g., psychosis, suicide ideation and behaviors). 

 

Purpose/Research Objectives:

The purpose of this funding opportunity announcement (FOA) is to encourage research to integrate/harmonize existing data sets from preventive intervention trials implemented early in life to: 1) examine risk and protective factors relevant to later mental health outcomes in childhood, adolescence and young adulthood; and 2) determine whether preventive interventions delivered earlier in life have long-term effects, and/or cross-over effects (e.g., unanticipated beneficial effects), on important mental health outcomes, including serious mental illness that typically emerges in adolescence or young adulthood (e.g., depression, anxiety, suicide ideation and behaviors, psychosis behaviors, violence/aggression).

Scientific knowledge to be achieved through research supported by this FOA, including information regarding which prevention interventions have an impact on which mental health outcomes, for which populations, and under what conditions, could provide a foundation for future research on and for more targeted deployment of interventions. Information about intervention targets and strategies that are most strongly associated with preventive effects could be used to refine preventive interventions to enhance their potency and efficiency. It would potentially provide evidence for beginning earlier in the life course to intervene on proximal risk factors that are likely to have effects on multiple mental health outcomes later in life (e.g., suicide ideation and behaviors, psychosis behaviors). Information regarding important moderators of intervention effects and data regarding the impact of interventions among important subgroups could be used to identify opportunities for refining interventions for refractory groups and to inform the development and deployment of more targeted, personalized approaches.  Ultimately, results of this research will contribute to an evidence base that can be used by communities to guide their efforts to reduce risk for mental health disorders. 

 

NIMH Specific Areas of Research Interest: 

Appropriate topics include, but are not limited to studies that: 

  • harmonize data from prevention studies targeting common child conditions (e.g., disruptive behavior disorders, internalizing disorders) to determine whether interventions lead to reduced risk for mental health disorders that typically emerge later in life, including serious mental illnesses that typically emerge in adolescence/early adulthood, and aggression/violence)
  • combine data from trials for larger samples to examine cross-over effects on low base rate behaviors (e.g., suicide ideation and behaviors, psychosis behaviors)
  • utilize novel approaches to harmonize and analyze data from multiple trials (e.g., integrate data from trials that used different measures to assess the same construct, derive latent variables for key constructs of interest that were not directly assessed)
  • combine data from prevention trials with other extant data to examine the impact of intervention on longer-term outcomes mental health outcomes (e.g., health-care claims data to examine health outcomes and related service utilization, death index data to examine suicide and mental-health related all-cause mortality)
  • explore whether changes in key intervention targets or change mechanisms originally targeted by preventive interventions mediate and account for sustained benefit in long-term outcomes
  • examine core common mediators (e.g., improvements in self-regulation, family processes) that might account for cross-over effects and the impact of prevention interventions on a broad array of outcomes (including aggression/violence)
  • examine how parameters of intervention delivery (e.g., implementation fidelity, dose) impact the magnitude of longer-term crossover effects
  • capitalize on larger samples in integrated data sets to examine moderators of response and examine the impact of prevention interventions on mental health outcomes in racial/ethnic minority populations (e.g., American Indian/Alaskan Natives and African Americans), sexual and gender minority populations, and rural youth
  • examine the effects of different levels of intervention (e.g., universal, selected, indicated, tiered) on reducing mental health symptoms and disorders for populations and various subgroups, including violence/aggression
  • test whether interventions focused on preventing substance use, misuse and disorder lead to reduced risk for mental health symptoms and disorders (e.g., suicide ideation and behaviors, psychosis behaviors, depression, etc.)
  • examine whether early preventive interventions (e.g., family- or school-based prevention interventions) that address known risk factors (child abuse and neglect, growing up in early adverse circumstances, bullying) reduce risk for mental health difficulties in later childhood, adolescence, and adulthood

NCCIH Specific Areas of Research Interest:

Appropriate topics include, but are not limited to studies that:

  • harmonize prevention data sets focused on complementary approaches
  • harmonize prevention data sets that have long-term outcomes on pain comorbid with mental health conditions

ORWH Specific Areas of Research Interest:

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. In particular, ORWH is interested in co funding applications that include adequate plans to address sex as a biological variable (SABV) including plans to disaggregate data by sex/gender with a focus on examining sex and gender influences on health and disease and their impact on the health of women. Applicants are encouraged to discuss applications with the ORWH contact listed under Agency Contacts. The 2019 – 2023 Trans-NIH strategic plan for Women's Health Research:  "Advancing Science for the Health of Women” highlights research priorities to improve the health of women. The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 - 2023 is available on the ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.

Scale and Scope of Studies Covered Under this Announcement

This FOA is intended to support integration and re-analysis of existing data sets from trials of preventive interventions.  For purposes of this announcement, it is essential that prevention data sets be integrated (applications that propose analysis of data from a single trial or parallel analyses of separate trials are not considered responsive). The use of existing administrative data, such as electronic medical records, health care claims data, social media, criminal justice data, can be integrated with prevention data sets to examine outcomes of interest (provided original consent allows for such data access and provisions are in place for safeguarding personally identifiable information).  However, primary data collection (re-assessment of original trial participants) is beyond the scope of FOA, and applications that include plans for primary data collection will be considered non-responsive.
Applications that address questions using integrated prevention data sets are particularly encouraged to include: 1) examination of risk and protective factors relevant to outcomes of interest (i.e., factors that mediate and/or moderate outcomes); 2) analyses to better understand common mediators of intervention effects across trials  (e.g., sustained improvement in self-regulation, family communication); 3) analyses to test whether the intervention engages the proximal target(s)/mechanism(s) that were specifically targeted by the original intervention and to examine whether changes in the original target(s)/mechanism(s) account for cross-over- and/or longer-term- effects; and 4) examination of subgroups of populations (e.g., age, gender, racial/ethnic, and sexual orientation) to better understand “what works, for whom, and under what conditions.”  
 

For the purposes of this FOA, levels of preventive interventions can include universal, selective, and indicated interventions, as well as tiered approaches (using more than one level of prevention intervention). The period of the life span in which the prevention interventions were implemented can include prenatal through adolescence. Long-term and/or cross-over effects can be examined. Projects that examine the long-term impact of prevention interventions delivered earlier in life (e.g., in early childhood or adolescence) on longer-term outcomes (e.g., the emergence of serious mental illnesses such as depression, bipolar disorder, psychosis, or suicidal behavior in adolescence or young adulthood) are especially encouraged. Projects that examine the potential of cross-over effects (unanticipated beneficial effects on outcomes that were not the primary focus of the prevention intervention being studied) should propose analyses that were not included as part of the original study. The observation period for long-term and/or cross-over effects will depend on the age and developmental period at the time of the initial intervention and on the nature of and typical age of onset for the outcomes of interest.  For long-term effects we encourage age and developmentally appropriate outcomes beyond the original study period of the trial. Justification for length of follow-up is needed.
 

We encourage harmonization of databases where data can be publically shared.  When possible, investigators funded under this FOA are encouraged to share data via the NIMH Data Archive (https://data-archive.nimh.nih.gov/ndct/about ). The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., electronic medical record data; National Death Index acquired data). The NIMH Data Archive can also provide a private cloud-based storage site that will facilitate the proposed work. Applicants who are interested in exploring this possibility should contact the NIMH Data Archive help desk (ndahelp@mail.nih.gov) .
 

Effective prevention and treatment of mental illness have the potential to reduce morbidity and mortality associated with intentional injury (i.e., suicide attempts and deaths, see: www.suicide-research-agenda.org). Integration of extant data from prevention trials can facilitate examination of the impact of interventions on low base-rate events, including suicidal behavior.  Accordingly, under this FOA, NIMH strongly encourages examination of the impact of preventive interventions on suicidal behavior in order to advance understanding of how effective prevention and treatment of mental disorders might impact suicide relevant outcomes.
 

This FOA is one of several FOAs participating in a program called, “Ending Disparities in Mental Health” (EDify-MH) (https://www.nimh.nih.gov/about/organization/gmh/ending-disparities-in-mental-health-edify-mh.shtml). The EDIfy-MH program stimulates and encourages mental health disparities research that spans the NIMH strategic research priorities , from basic science to services research, and across the lifespan, in the United States and worldwide.  EDIfy-MH aims to generate research to identify and better understand the genetic, neurobiological, psychosocial, and other environmental mechanisms/ factors that underlie disparities in order to address and eliminate mental health disparities domestically and globally.  
 

Each FOA under the EDIfy-MH program addresses a particular aspect of disparities in mental health. Specifically, this FOA focuses on the integration of prevention data sets to better understand the long-term and/or cross-over effects of prevention interventions and  encourages, but is not limited to, projects that focus on examination of outcomes of preventive interventions among  racial/ethnic minority groups, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, or any other subgroup with documented disparities in prevalence of mental illnesses, mental illness trajectories, access to preventive and treatment intervention services, and quality and outcomes of mental health care.
 

Potential applicants are strongly encouraged to consult with NIH staff as early as possible when developing plans for an application (see Scientific/Research Contacts, Section VII ). This early contact will provide an opportunity to clarify NIH policies and guidelines and help to identify whether the proposed project is consistent with NIMH program priorities and the goals of this FOA.

 

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission
Revision

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

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2020:

NIMH intends to commit $3 million total costs in FY 2020 to fund 4-6 awards.

NCCIH intends to commit $500,000 total costs in FY 2020 to fund 1 award.

Award Budget
Application budgets are limited to $500,000 direct costs (not including consortium F&A) in any project year and need to reflect the actual needs of the proposed project.
Award Project Period
The scope of the proposed project should determine the project period. The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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

 

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

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

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

The letter of intent should be sent to:

Email:  NIMHpeerreview@mail.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
 

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

Applicants should request funds for one trip per year by the PI for an annual meeting to be held at NIH in Bethesda, MD. The purpose of these meetings is to discuss ‘lessons learned’ among other grantees, in operational and scientific challenges and advances.  Budget should include cost of integrating the data and preparing it for submission to the NIMH National Data Archive.

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Research supported through this FOA should focus on novel, transformative approaches that leverage and aggregate existing prevention datasets to advance our understanding of the long-term and/or cross-over effects (unanticipated beneficial effects) of prevention interventions on important mental health outcomes.

 

Significance:

  • Detail how the proposed research addresses a research gap and how it will inform understanding of the long-term outcomes and/or cross-over effects of prevention interventions on mental health.
  • Describe how the proposed research substantially advances understanding above and beyond the original analyses and results of the prevention trials that are included as part of the current project (how does the proposed research substantially extend beyond current and previous federally and privately supported activities?).
  • Detail how the results will advance understanding regarding key targets or change mechanisms that account for broad and sustained outcomes and moderators of response, and accordingly, how the results might be used to guide future efforts at intervention refinement and/or deployment.


Investigators:

  • Detail how the proposed research includes the needed expertise for integrating prevention data sets and other proposed (e.g., administrative) data.
  • Describe how the proposed research includes the appropriate methodological and statistical expertise.
  • Address how the project has the appropriate scientific expertise for examining cross-over effects (unanticipated beneficial effects).

Innovation:

  • Describe how the proposed research utilizes novel, transformative approaches that leverage and aggregate existing prevention datasets to advance our understanding of the long-term and cross-over effects of prevention interventions on important mental health outcomes.
  • Detail the use of novel approaches to harmonizing data across trials or novel informatic strategies that will be used to integrate data from other extant sources (e.g., claims data, publicly available data sources), as relevant.

Approach:

  • Specify the cross-over and long-term outcomes that will be examined, describe how these key outcomes were originally assessed in the original prevention trials, and detail plans for how these outcomes will be operationalized for the current analyses.
  • Describe strategies that will be used to harmonize data across trials, including plans that will be used to integrate data from trials that used different measures to assess the same construct and/or to derive latent variables for key constructs of interest that were not directly assessed.
  • Detail plans to examine change mechanisms and mediators that might account for broad outcomes (including outcomes not originally targeted by the intervention) and sustained effects.
  • Address plans for examining moderators of response and for examining differential impact of the intervention across subgroups, as appropriate.
  • Provide detailed power analyses for key aims, including power for analyses that address cross-over- and long-term- outcomes, analyses to identify key change mechanisms (e.g., changes in targeted self-regulatory skills, family processes) or other mediators of effects (e.g., implementation fidelity, dose), and analyses to identify moderators of response and/or explore subgroup analyses.
  • Describe the characteristics of the samples with regards to gender, race, ethnicity and children

Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes operationally-defined indicators of progress at critical junctures. This timeline might include, for example, data acquisition, integration, and application of various statistical approaches, and interpretation. These milestones should be tailored to the unique scope of each project and written concretely enough to evaluate exactly what will have been achieved during the course of the project.

Letters of Support:

When multiple datasets are proposed to be aggregated, a clearly documented commitment by the data owners must be provided in the application and documentation that the informed consent documents permit such aggregation. Likewise, if the application includes leveraging healthcare or other types of data, appropriate permissions for using these data for research purposes must be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Where possible (e.g., permitted by appropriate consent), harmonized data sets should be submitted to the NIMH National Data Archive and serve as a resource to the research community.   
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
 

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit 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.

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Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at nimhreferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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.

Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is 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 well does the project inform a research gap in understanding the long-term and/or cross over effects of prevention interventions on mental health?
  • To what extent does the project substantially advance understanding above and beyond analyses and results of individual prevention trials included as part of the current application?
  • Will the project results advance understanding regarding key targets or change mechanisms that account for broad and sustained outcomes and moderators of response?
  • How well does the application describe how the results might be used to guide future efforts at intervention refinement and /or deployment?

 

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?

  • Does the application include the needed expertise for integrating prevention data sets and other proposed (e.g., administrative) data?  Is the appropriate methodological and statistical expertise included?
  • Does the project have the appropriate scientific expertise for examining cross-over effects (unanticipated beneficial effects)?

 

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?

  • Does the application utilize novel, transformative approaches that leverage and aggregate existing prevention datasets to advance understanding of the long-term and/or cross-over effects of prevention interventions on important mental health outcomes?
  • To what extent does the application detail the use of novel approaches to harmonize data across trials or novel informatic strategies that will be used to integrate data from other extant sources (e.g., publicly available data sources), as relevant?

 

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?

  • How well have the investigators described the long-term and/or cross-over effects to be examined, how these key outcomes were assessed in the original prevention trials, and how they will be operationalized for the current analyses? 
  • To what extent does the application provide strategies for the harmonization of data across trials, including plans to integrate data from trials that used different measures to assess the same construct and/or to derive latent variables for key constructs of interest that were not directly assessed?
  • To what extent does the project provide plans to examine change mechanisms and mediators that might account for broad outcomes (and if relevant, including outcomes not originally targeted by the intervention) and sustained effects? 
  • Evaluate the plans for evaluating moderators of response and differential impact of the intervention across subgroups, as appropriate? 
  • Is power sufficient for primary analyses (e.g., detection of long-term- and/or cross-over- effects)?  For exploratory analyses, is there a well justified plan for examining and interpreting observed effects??

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?

Because this FOA requests the use of existing data sets, does the application describe the characteristics of the samples with regard to gender, race, ethnicity and children?  

 

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?

Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

 

For research that involves human subjects but does not involve one of the 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

 

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.

Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by the National Institute of Mental Health in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by appropriate National Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see 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.

Cooperative Agreement Terms and Conditions of Award
Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Eve Reider, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-4045
Email: ereider@mail.nih.gov

Della White, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-827-6358
Email: whitede@mail.nih.gov

Rebecca DelCarmen-Wiggins, Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-8689
Email: rdelcarm@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov  

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: Carows@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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