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)

Funding Opportunity Title
Addressing Suicide Research Gaps: Understanding Mortality Outcomes (R01 Clinical Trial Not Allowed )
Activity Code
R01 Research Project Grant
Announcement Type

Reissue of RFA-MH-18-410

Related Notices
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

Funding Opportunity Announcement (FOA) Number
RFA-MH-20-305
Companion Funding Opportunity

RFA-MH-20-307, R01 Research Project Grant

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) seeks to support efforts focused on linking pertinent data from healthcare system records (e.g., suicide attempt events) to mortality data so that a more accurate understanding of the risk factors for, and the burden of, suicide among those seen in structured healthcare settings can be discerned. Specifically, data are needed on the type, severity, and timing of suicide predictors in the U.S. In addition to improving our national knowledge of the burden of suicide, these data offer the hope of yielding essential benchmarks for both public and private care providers/insurers, who increasingly will be seeking improvements to reduce the frequency of suicide events in their systems. Projects supported by this FOA will help address gaps identified in the 2014 Prioritized Research Agenda for Suicide Prevention. Applicants seeking to integrate data sets from existing basic, clinical, and intervention research on suicide risk and behaviors to conduct novel secondary analyses aimed at identifying potential biological, experiential, and other predictors, moderators, and mitigators of suicide risk should apply to the companion NIMH Funding Annoucement - RFA-MH-20-307  

Key Dates

Posted Date

November 20, 2019

Open Date (Earliest Submission Date)
January 10, 2020
Letter of Intent Due Date(s)

January 10, 2020

Application Due Date(s)

February 10, 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.

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

May 2020

Advisory Council Review

August 2020  

Earliest Start Date

December 2020

Expiration Date
February 11, 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

In 2017, the Centers for Disease Control and Prevention   reported that there were more than 47,000 suicide deaths in the United States, which is more than two times the number of homicide deaths in the same year. The annual suicide rate in the U.S. has continued to climb over the past sixteen years and suicide is one of the 10 leading causes of death. Reports of a reduction in men’s longevity due to overdose and suicide deaths and a 56% increase in the suicide rate among young people ages 10 to 24 years old have put U.S. mortality data in the spotlight. Compounding the impact of this preventable loss of life, the rate of nonfatal suicide attempts is many times higher than the rate of suicide death and the economic impact of suicidal behaviors has been estimated to exceed more than $50 billion annually in the U.S. Suicide decedents are not unknown to health care settings. A significant proportion of U.S. suicide decedents have accessed health care within the year of their death, with estimates ranging from 30% to 80%, mirroring the broader population access to health care. Approximately one-quarter of suicide decedents had treatment for psychiatric issues prior to their death.

The primary goal of this Funding Opportunity Announcement (FOA) is to solicit applications that propose to directly inform our understanding of mortality outcomes subsequent to healthcare visits. This effort is consistent with NIMH Strategic Research Objective 4, which calls for strengthening the public health impact of NIMH-supported research. This FOA also speaks to goals in the 2014 Prioritized Research Agenda for Suicide Prevention that estimated the number of suicidal individuals who had been seen in boundaried systems (e.g., health care, education, workplaces, incarceration, etc.), who could have been reached by improved detection and intervention, and how many suicide attempts (fatal and nonfatal) could have been prevented. Through that effort, multiple gaps in data linkages were noted. This FOA is also responsive to a 2016 NIH Office of Disease Prevention workshop, Advancing Research to Prevent Youth Suicide, where experts recommended expansion of surveillance of suicide and suicide attempts by linking data from multiple sources (e.g., state all-payer databases, syndromic emergency room data, electronic health records data, health information exchanges, accountable care organizations, research data).

Since 1995 the Joint Commission (JC) has consistently listed suicide among the top five sentinel events, i.e., unexpected occurrences involving death or serious physical or psychological injury, taking place in health care settings. The JC issued a Sentinel Alert in February 2016 that includes recommendations for appropriate discharge planning that keeps patients safe. This means that as patients transition to home and/or across care settings, health care services should work to keep patients safe. Of the 1.3 million individuals in the U.S. who reported making a suicide attempt within the past 12 months, about 6% also reported receiving treatment in an outpatient mental health clinic (estimated 206,000 cases). Rates of individuals reporting attempts within the year have also been estimated for those receiving care in other settings that include: those receiving substance use treatment (5%, estimated 122,000 cases); and those having accessed emergency care in the same year (1%, estimated 728,000 cases). Despite the large number of suicide events among persons receiving healthcare, not all states require health care systems to report adverse events that include suicide deaths and attempts, that occur during or following receipt of services. Lack of information about the rate and nature of suicide events within and between care systems hinders efforts to eliminate these adverse events through quality improvement initiatives.

The U.S. military and Veterans Health Administration have reported on suicide mortality outcomes among those seen in their respective health care systems. This information spurred actions in those systems to improve care aimed at preventing suicide. In the absence of U.S. civilian healthcare data linked to mortality outcomes, researchers rely on Canadian and European estimates of mortality risk for civilians seen in health care settings. There is a clear need to better understand the real burden of suicidal behavior for individuals seen in U.S. healthcare settings.   Such data might then serve as essential benchmarks for both public and private care providers/insurers who are seeking care improvements to reduce suicide events in their systems. Incentives to support the development of teams with appropriate expertise that can link relevant healthcare data sources with mortality data might serve to both facilitate an empirical understanding of the scope of the issues in this area, as well as the development of novel interventions and/or strategic implementation of existing treatment options. In addition to improving our national knowledge of the burden of suicide, these are essential ‘metrics’ for both public and private care providers/insurers, who increasingly will be seeking improvements to drive down suicide events in their systems.

Responses received to a recent Request for Information from the NIMH (NOT-MH-16-027) support the field’s converging interest in linking healthcare data with mortality data as a critical step to better understand the relationship between healthcare utilization patterns and mortality outcomes. The primary goal of this FOA is to solicit applications that propose to directly inform our understanding of mortality outcomes subsequent to healthcare visits. To accomplish this goal, we seek to support efforts that link data from healthcare systems to mortality data. While not an exhaustive list, applications that focus on the following areas would be considered of particular interest to the goals of this FOA:

  • Among the largest public data sources (e.g., Medicaid and Medicare/CMS; Agency for Healthcare Research and Quality‘s Healthcare Cost and Utilization Project [HCUP]), seek proximal as well as longer term precursors of mortality outcomes among various cohorts (e.g., defined by care access patterns; demographic characteristics)
  • Examine mortality-linked CMS and HCUP data at both the state and national level to track state and federal quality improvement progress in reducing suicide burden
  • Facilitate linkage of private/commercial insurance health care data with mortality outcomes to enable research on patterns and predictors of suicide and other mortality in this population
  • Examine precursors and their association to suicide and other mortality outcomes to probe whether targeting particular precursors would reduce suicide as well as other types of mortality
  • Explore suicide risk factors and mortality within specific health disparity populations (e.g., across Asian or Hispanic subgroups)
  • Examine patterns of suicide risk and mortality related to the intersection of multiple health disparity populations (e.g., mortality in rural vs. urban African Americans, race/ethnicity and sexual/gender minority status)
  • Identify protective factors related to lower suicide mortality in particular health disparity populations, including African Americans, Hispanics/Latinos, and Asian Americans
  • Develop and test methods to generate more accurate estimates of probable suicide mortality for causes of death that are more prevalent in certain health disparity populations (e.g., firearm deaths, accidents, poisonings).

Applications that address questions using these combined/large datasets are strongly encouraged to consider: 1) work flow in healthcare systems that enhance efficiencies in timely, and sustained linkage processes of health care data to vital statistics; and 2) subgroups of populations (e.g., age, economic status, racial/ethnic, rurality, sexual minority status) that may reveal differing healthcare utilization and mortality patterns, with implications for health care improvements.

In developing projects, applicants should consider which linked data in their application can be publicly shared. When possible, investigators funded by NIMH under this FOA are expected to share data via the NIMH Data Archive (https://nda.nih.gov). 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).

Pilot data are not required, but if a project is high-risk with limited preliminary results, it should be supported by a sound rationale as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful.

Non-responsive applications

Applications that do not focus on specific, primary variables of relevance to understanding suicidal behavior and mortality outcomes will be deemed non-responsive and will not be reviewed. In addition, collection of new data is not allowed for this initiative and applications will be deemed non-responsive if new data collection is proposed. It is essential that data sets be integrated: applications that propose analysis of data from a single trial or parallel analyses of separate trials are not considered responsive.

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.

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

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.

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

NIMH intends to commit $3 million in FY 2021   to fund 4-6 awards.

Award Budget

Application budgets are limited to $500,000 in directs 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 4 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)
  • 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:

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.

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: The Research Strategy should include the following information:

Significance

  • Research supported through this FOA should focus on theory-based, novel, transformative approaches that leverage and aggregate existing healthcare datasets with that of mortality data to advance our understanding of suicidal behaviors.
  • Applications should make a compelling case as to how the proposed research might yield insight regarding risk factors, the etiology of suicidal behaviors as well as predictors and precursors of suicidal behavior.
  • The application should describe the potential implications of how the proposed research might extend beyond the purview of existing federal and private-supported research.
  • As relevant, applications should describe how results will be used to inform future phases of research and development, particularly if these findings inform

    Research Domain Criteria (RDoC) approaches in this area.

Investigators

  • Without duplicating information in the biosketches,     the application should describe the study team’s expertise regarding: 1) Electronic health records (EHR) and health care systems, 2) mortality data, 3) state-of-the art methodology and statistical/computational approaches for integrating/harmonizing and analyzing data sets, and 4) suicide ideation and behaviors.

Innovation:

  • The application should describe how state-of-the art approaches to integrating/harmonizing data sets and statistical/computational approaches that maximize the information yield and interpretability of the results have been incorporated.

Approach

  • Sufficient detail should be provided regarding the methodological approach and discussion of how this line of research will be beneficial to continued investigations focused on suicide. The specific goals of the application should be clearly delineated.
  • The application should describe how the proposed research will yield informative benchmark data regarding mortality outcomes following medical treatment or other care patterns. The application should describe how the approach will advance knowledge beyond the current state-of-the-science and how it will facilitate additional research avenues that might follow from the proposed project.
  • Appropriate methodological and statistical/computational approaches to analyze the combined data should be described in detail.
  • A clear description of strategies that will be used to harmonize data across datasets should be provided. A clear plan to integrate data from datasets 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 should be described. Detail clear milestones for integrating healthcare datasets with measures of mortality outcomes.
  • If the project is high-risk with limited preliminary results, justify the proposed approach and how it will lead to high impact results if successful.
  • When possible, the application should propose to identify composite suicide risk and protective factors.
  • Moderators and mediators for suicide risk factor research should be considered. Applications should consider if there are unique circumstances for particular subgroups (e.g., age, gender, cultural and sexual orientation differences) as they pertain to suicidal behaviors and outcomes, and detail analyses to examine subgroup differences, accordingly.
  • If the application proposes to link multiple datasets, document the commitment from the data owners and/or provide evidence to support the feasibility of obtaining publicly available data. If linkage requires informed consent, provide documentation that the plan is feasible.

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. These junctions include the translation from pilot research, if needed, the plan for integrating healthcare datasets with measures or mortality outcomes, any statistical approaches that will be used to analyze the combined data, and any translational efforts to systematically evaluate and implement findings from this study. 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.  . Investigators should describe how results will be used to inform future phases of research and development, particularly if these findings inform RDoC approaches.

Letters of Support: When multiple datasets are proposed to be aggregated, a clearly documented commitment by the data owners and/or documented feasibility to obtain publicly available data must be provided in the application. If linkage requires informed consent, documentation that such is permitted 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:

Sharing Data via the NIMH Data Archive: To advance research through widespread data sharing among researchers, investigators funded under this FOA are encouraged to share human subjects data via the NIMH Data Archive (NDA) (NOT-MH-19-033, Notice of Data Sharing Policy for the National Institute of Mental Health). Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation.

Where possible, investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://nda.nih.gov/contribute/sharing-regimen.html. A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the grant application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies. Investigators funded under this FOA should use these technologies to submit and share their research data and results at the appropriate times. The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget (http://nda.nih.gov/contribute_cost_estimation.html).

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 human subjects research, clinical research, and/or NIH-defined 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.

Section 3 - Protection and Monitoring Plans

Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s Protection of Human Subjects section and Data and Safety Monitoring 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.

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 Institutions

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.

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.

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?

  • Is the application theory-based? Where relevant, has a compelling case been made regarding the significant added value for linking pertinent data from healthcare system records (e.g., suicide attempt events) to mortality data so that a more accurate understanding of the risk factors for, and the burden of, suicide among those seen in structured healthcare settings can be discerned?
  • How well does the application address how the proposed study(ies) might yield insight regarding the etiology of suicidal behaviors?
  • Does the application describe the potential implications of how the proposed research might extend beyond the purview of existing federal- and private-supported research?  
  • How well does the application describe how results will be used to inform future phases of research and development, particularly if these findings inform RDoC approaches?

 

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 study team have the appropriate expertise regarding: 1) EHR records and health care systems, 2) mortality data, 3) state-of-the art methodology and statistical/computational approaches for integrating/harmonizing and analyzing data sets, and 4) suicide ideation and behaviors?

 

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 incorporate state-of-the art approaches to integrating/harmonizing data sets and statistical/computational approaches that maximize the information yield and interpretability of the results?

 

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?

  • Are sufficient details provided regarding the methodological approach and discussion of how this line of research will be beneficial to understanding suicide etiology? Have the specific goals of the application been delineated?
  • Has the state of the art been accurately provided as a benchmark against which the proposed research will be measured? Does the proposed research plan describe a compelling advancement that will yield informative benchmark data regarding mortality outcomes following medical treatment or other care patterns? Has the application provided an assessment of how the approach will advance knowledge beyond the current state-of-the-science?      
  • Are the statistical/computational approaches that will be used to analyze the combined data appropriate?
  • Does the application adequately describe the strategies that will be used to harmonize data across datasets, including plans that will be used to integrate data from datasets 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? Does the application include clear milestones for integrating healthcare datasets with measures of mortality outcomes?
  • If the project is high-risk with limited preliminary results, has a sound rationale been provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful?
  • Does the application propose to identify composite suicide risk and protective factors?
  • Does the application propose to evaluate moderators and mediators for suicide risk factor research? Is the application designed to consider subgroups of populations (e.g., age, gender, cultural and sexual orientation differences) as they pertain to suicidal behaviors and outcomes?
  • If the application proposes to link multiple datasets, is there a clearly documented commitment by the data owners and/or documentation for the feasibility to obtain publicly available data? If linkage requires informed consent, is documentation included that supports linkage?
  • Are the proposed milestones operationally-defined and appropriate indicators of progress at critical junctions? Are these milestones tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project?

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?

 

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

 

Not Applicable

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). If applicable, has the applicant adequately addressed approaches to use common data elements? Has the applicant described what linked data in their application can be publicly shared and how this will occur?

 

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(s) convened by NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:
  • 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 to the appropriate NIH Institute or Center.  Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:
  • 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.

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.

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)

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email: haima@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

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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