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
Pilot Practice-based Research for Primary Care Suicide Prevention (R34 Clinical Trial Optional)
Activity Code

R34 Planning Grant

Announcement Type
New
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • January 25, 2022 - Notice of Change to Application Types Allowed for RFA-MH-22-120, "Pilot Practice-based Research for Primary Care Suicide Prevention (R34 Clinical Trial Optional)". See Notice NOT-MH-22-150
  • January 12, 2022 - Notice of change to key dates for RFA-MH-22-120: Pilot Practice-based Research for Primary Care Suicide Prevention (R34 Clinical Trial Optional). See Notice NOT-MH-22-130
  • October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
  • September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
  • August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
  • August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
  • April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109
  • November 10, 2021 - Notice of Pre-Application Webinar for RFA-MH-22-120, "Pilot Practice-based Research for Primary Care Suicide Prevention (R34 Clinical Trial Optional)". See Notice NOT-MH-22-070
Funding Opportunity Announcement (FOA) Number
RFA-MH-22-120
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.242
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages primary care practice-based research focused on rigorous evaluations of factors that impact or account for the effectiveness of existing suicide prevention practices and/or pilot clinical trials aimed at optimizing and pilot testing patient-, provider-, or systems-level suicide prevention strategies. Applications of interest include those that refine and test scalable strategies for use in primary care across different intercepts in the chain-of-care, including strategies for identifying individuals at risk, assessing and stratifying risk, providing brief interventions, promoting initial and ongoing engagement in indicated services, continued outcome monitoring and follow-up, and tracking patient outcomes. For purposes of this FOA, primary care is defined as pediatric practice, family practice, obstetrics/gynecology, internal medicine, and geriatric practice. Primary care practices range in size, resources and patient health needs; proposed strategies should meet the practice needs to be feasible, scalable, sustainable, and practice-ready. NIMH encourages prevention approaches that incorporate the use of mHealth (the use of mobile and wireless devices [cell phones, tablets, etc.]) and other design features that can facilitate scalability and sustainability, and deployment-focused research approaches that take into account the perspectives of key stakeholders (e.g., patients, providers, administrators) and system-level factors such as setting resources, workforce capacity, and training needs. This FOA also encourages studies that examine suicide prevention strategies that have broad reach, including potential for addressing risk among individuals who experience mental health service disparities (e.g., racial/ethnic minority groups; sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons), and studies that explore how the proposed strategies can reduce health disparities and promote health equity.

Key Dates

Posted Date
October 08, 2021
Open Date (Earliest Submission Date)
May 20, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date.

Dates in bold italics in the following table were modified per issuance of NOT-MH-22-150.

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 21, 2022 Not Applicable Not Applicable November 2022 January 2023 April 2023
February 21, 2023 February 21, 2023 Not Applicable June 2023 October 2023 January 2024

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.

Expiration Date
New Date - February 22, 2023 per issuance of NOT-MH-22-130
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

Rationale

NIMH, as a federal partner of the National Action Alliance for Suicide Prevention, seeks to reduce suicide by building evidence-based suicide prevention in healthcare systems. Previous research has found that over 90% of suicide decedents accessed care within the 12 months of their death, and they averaged 17 healthcare visits during the year. Nearly a third of individuals had a healthcare visit in the 7-days before suicide. Within that week, nearly 1 in 10 had been seen in primary care. These data suggest healthcare visits, and in particular, a healthcare visit in primary care, offer crucially important opportunities to identify and intervene with at-risk individuals. This FOA is consistent with NIMH Strategic Research Objective 4.2.B, which calls for practice-based research partnerships in health care systems, and addresses the ‘practice-to-science’ needs identified by the National Action Alliance for Suicide Prevention. This FOA also speaks to objectives in the Prioritized Research Agenda for Suicide Prevention that focus on increasing the effectiveness of suicide risk detection and screening, and interventions and services, and is relevant to questions posed by the United States Preventive Services Task Force (USPSTF) regarding the risks and benefits of suicide risk screening in primary care for children, adolescents, and adults (including perinatal women.

Improving suicide prevention services in primary care is also essential to overall healthcare system safe and effective suicide care capabilities. Beyond screening and initial identification of at-risk individuals, depending on the goals and the capacity within the setting, primary care can potentially play a role in advancing suicide prevention at additional intercepts in the chain of care, including stratifying risk through additional assessment, delivering brief interventions, promoting initial and ongoing engagement in appropriate services, and determining the benefit of services and need for additional services through ongoing measurement of patient outcomes. Systems-level improvements, such as collaborative care for depression, have repeatedly resulted in lower suicide ideation in primary care. Moreover, large health care organizations, like the Veterans Health Administration, have identified evidence-based, multi-tiered suicide prevention approaches across healthcare settings. Resources for best practices that can be used to help achieve goals relevant to Zero Suicide — a commitment to suicide reduction strategies in healthcare settings — have been developed, including approaches to measurement-based primary care and sample clinical workflows. Given the diversity of primary care settings, additional research is needed to test existing strategies, and/or develop new strategies for implementing measurement-based care for suicide prevention.

Research Scope and Objectives

This FOA encourages research focused on refining and pilot testing scalable strategies for suicide prevention in primary care across different intercepts in the chain-of-care, including strategies for: identifying individuals at risk; assessing and stratifying risk; providing brief interventions; promoting initial and facilitating ongoing engagement in indicated services, continued outcome monitoring and follow-up, and tracking of patient outcomes. Applications can address multi-component clinical workflows (the delivery of clinical services as a series of tasks, in what order, by whom, and how) and/or optimize and test specific components that will advance practice effectiveness and efficiency. For purposes of this FOA, primary care is defined as pediatric practice, family practice, obstetrics/gynecology, internal medicine, and geriatric practice.

The pathway to effective suicide prevention in primary care is multilevel and complex. It can include multiple types of providers within and beyond the primary care setting, and it requires buy-in from practice leadership that supports suicide prevention infrastructure, including provisions for monitoring and feedback systems to ensure practices are effective and support for suicide prevention training for providers and other staff. Moreover, comprehensive suicide prevention is typically comprised of multicomponent workflows that include screening, brief interventions for immediate safety needs (e.g., safety planning; means safety counseling) and/or for prevention; processes for obtaining behavioral health consultations (in person or telehealth) or for referral (e.g., to mental health specialty care); and ongoing assessment and monitoring (e.g., using medical records) to facilitate measurement based care (MBC; i.e., systematic evaluation of patient symptoms before or during each clinical encounter to inform behavioral health treatment ) and promote continuity of care, over time.

NIMH encourages applicants to consider existing resources on evidence-based and best practices (e.g., National Action Alliance - Zero Suicide;  Zero Suicide; The Joint Commission National Patient Safety Goal on Suicide Prevention) and electronic medical records and billing codes that can currently be used to support service delivery, in order to expedite the development and testing of service-ready approaches.

Research Objectives

This FOA is intended to support rigorous evaluations of factors that impact or account for the effectiveness of existing suicide prevention practices and/or pilot clinical trials aimed at developing, optimizing, and pilot testing scalable patient-, provider-, and systems- level interventions and service delivery approaches for intervening at key intercepts in the chain of care. Suicide prevention services in primary care might involve a variety of strategies, depending on the goals and capacity within the setting.

Depending on the research question, a variety of methodologically rigorous approaches may be indicated for proposed pilot studies. These may include pilot randomized controlled trials (RCTs), quasi-experimental designs with non-randomized comparison groups, time-series designs, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

Applications in response to this FOA can address multi-component clinical workflows and/or optimize and test specific components that will advance practice effectiveness and efficiency. In the context of care pathways and clinical workflows that can include multiple intercepts with multiple opportunities and options for the delivery of services at each of these intercepts, as well as wide variation among practice settings, it is critical to identify effective, efficient, and generalizable services that will contribute to overall suicide risk reduction. Accordingly, for studies that evaluate multi-component approaches, the project must be designed to examine the unique contribution of the components (and/or combinations of components) in a manner that will facilitate interpretation of results and identification of the specific elements that account for observed benefit.

The following research areas are examples of responsive application topics. Combinations of the strategies outlined, below, and other proposed aims may be appropriate, depending on the circumstances and suicide prevention goals for the primary care setting. Examples of responsive applications include, but are not limited to studies focused on:

Risk identification, screening, and assessment, including applications that focus on:

  • Testing clinical care approaches that can inform USPSTF reviews (youth; adults) on suicide screening (e.g., alone or in combination with screening for other behavioral health problems) and/or subsequent steps in the chain of care (e.g., assessment, referral), to determine if relevant outcomes are improved (e.g., rates of engagement in evidence-based care, initial patient outcomes).
  • Identifying the optimal timing and frequency of suicide screening approaches in the context of proximal outcomes and appropriate follow-up (e.g., engagement in evidence-based care; reduced use of emergency services). Screening frequency questions can vary depending on the nature, goals, and capabilities of the primary care practice setting (e.g., base rate of suicide events in patients; access to behavioral health consultation), as well as the nature of the patient contact and patient characteristics (e.g., an annual visit screen; intake of a new patient; a patient with a known history of risk factors such as a mental disorder; or a patient returning from acute suicide care).
  • Testing innovative approaches to the identification of individuals at elevated risk, such as item response theory-based assessment strategies and algorithm informed approaches to screening and risk stratification across demographically diverse patients, with provisions for appropriate follow-up (e.g., assessment, brief interventions, referral).
  • Developing and validating clinical decision-support tools for risk stratification that incorporate data from risk algorithms (e.g., EHR data, other routinely collected information, or screening responses) and can be used to match individuals to the appropriate services (e.g., type, intensity, duration) across service settings.

Preventive and therapeutic interventions, including studies that develop and pilot test:

  • Scalable prevention strategies that reduce suicide risk factors and enhance protective factors for subgroups known to be at risk (e.g., risk related to family or health history, current comorbidities, adverse experiences, developmental transitions), that can be delivered with fidelity within the primary care setting.
  • Relapse prevention approaches which include defining suicide attempt relapse risk (e.g., recent discharge from inpatient care or ED visit; clinical worsening) and implementing practices aimed at reducing relapse (e.g., increased monitoring; coordination with behavioral health; caregiver support).
  • Safety planning and other brief interventions in the context of practice workflows for diverse demographic groups, including approaches that incorporate training for primary care staff implementing the safety planning.
  • Approaches that leverage mHealth to encourage monitoring and promote sustained behavior change (e.g., to facilitate cognitive behavioral skills practice, periodic symptom/ functioning checks, social support contacts (e.g., caring contacts)).
  • Currently billable and feasible family- and/or peer- education and support strategies to encourage appropriate and sustained engagement in primary care suicide prevention services or interventions to educate and involve family members in interventions (e.g., education in safety planning activities).

Strategies to promote service engagement/continuity, appropriate referral, and quality of care, including studies focused on:

  • Refining and testing the utility of measurement-based care (MBC) tools (e.g., paper-pencil questionnaires, mobile health technology, telephone monitoring), that can be used to assist providers and empower patients to track their progress in reducing suicide risk.
  • Testing provider-, patient-, or system-level strategies to facilitate referral to and connection with appropriate follow-up specialty care, including approaches to promote access to specialists when needed (e.g., telehealth), and continuity over high-risk transitions and across care settings (e.g., referral to outpatient specialty care, monitoring post-discharge from inpatient care).
  • Developing and testing system-level strategies for ongoing monitoring and for detecting risk of relapse following discharge from the Emergency Department or acute care.
  • Refining and evaluating/comparing research-informed implementation strategies, including infrastructure support (e.g., practice alerts, clinical dashboards, provider incentives) for promoting sustained delivery and implementation fidelity of evidence-based approaches to assessment and intervention
  • Testing sustainable staff training approaches (e.g., technology-assisted training, expert telephone consultation) that can be used to train providers to initial competence, to monitor quality, and to promote sustained fidelity in the delivery of research-supported suicide prevention services across a range of clinical modalities, including telehealth and collaborative care.
  • Evaluating the ‘return on investment’ for infrastructure and training investments that facilitate successful identification and management of suicide among the practice registry, including collecting estimates of the initial and ongoing costs of implemented suicide prevention care, preliminary cost effectiveness or cost benefit analysis, or other economic analyses used to optimize service organization/delivery, facilitate decisions to adopt new best practices, or inform policy.

Consistent with the NIMH experimental therapeutics approach, for applications that test the preliminary effectiveness of preventive, therapeutic, or services interventions, or components of a suicide prevention clinical workflow, NIMH seeks to understand the mechanisms of action that account for changes in outcomes of interest. Consistent with the NIMH experimental therapeutics approach, the scope of work must include specification and assessment of the proximal intervention/service delivery targets/mechanisms and examination of whether changes can in the presumed targets/mechanisms account for the changes in outcomes (see Support for Clinical Trials at NIMH). In this manner, the results of the trial will advance knowledge regarding therapeutic change mechanisms and can be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the clinical workflow components were successful at engaging its targets can facilitate interpretation).

Given the focus on scalable, sustainable approaches, NIMH encourages community-partnered and deployment-focused approaches that systematically consider the perspective of key stakeholders (e.g., service users, providers, administrators, payers) and the characteristics of the primary care settings (e.g., available resources, including workforce capacity; existing clinical workflows) where optimized prevention strategies are intended to be implemented. Accordingly, collaborations between academic researchers and clinical or community practice partners or networks are encouraged. When possible, studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), electronic medical records, access to administrative databases, patient registries, institutions with Clinical and Translational Science Awards) to facilitate the identification and collection of relevant clinician actions (e.g., CPT and billing codes; clinician notes) and potential measurement based outcomes, such as injury codes; patient utilization of care (emergency care; inpatient care; outpatient specialty care) and access to mortality outcomes.

NIMH encourages studies that test intervention and service delivery strategies that incorporate features that are specifically designed to prevent threats to implementation fidelity, as appropriate. Strategies that might be used to enhance scalability and sustained implementation include but are not limited to: consumer-facing technology (e.g., self-administered content) and provider-facing technology (e.g., technology to support provider training and sustained implementation fidelity); expert consultation via existing resources or other sustainable means (e.g., telehealth, collaborative care approaches); or other robust design features that promote provider competence and sustained implementation fidelity.

In addition to testing the effectiveness of the suicide prevention strategy under study, studies that test interventions should be designed to examine patient-, provider- and setting- level factors that might be associated with implementation fidelity or might be designed specifically test strategies to facilitate successful implementation. In this manner, research funded in response to this FOA will contribute to a better understanding of what will be needed to successfully implement suicide preventive interventions more broadly in primary care settings.

Because patients with mental health problems often access primary care settings more frequently than mental health specialty care, suicide prevention implemented in primary care is likely to have a broader reach of individuals at risk, including those who experience mental health service disparities (e.g., racial/ethnic minority groups; sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons). NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes. This FOA encourages pilot interventions and evaluations that seek to reduce disparities in outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, and other underserved groups. Thus, evaluations/pilot studies in response to this FOA should explore how the proposed suicide prevention practices can also reduce health disparities.

Scale and Scope of Studies Covered Under this Announcement

This FOA seeks primary care practice-based research aimed at rigorously evaluating existing and/or developing and pilot testing suicide prevention strategies. With appropriate justification, effectiveness testing of preventive and therapeutic interventions might be warranted in the absence of extensive efficacy data (e.g., when the intervention is primarily comprised of research-informed strategies, but the specific strategies that haven't been extensively tested in combination or with a specific target population; when there is strong pilot data and the goal is to conduct further testing in a deployment-focused manner to expedite the translation into practice). Pilot efforts in effectiveness research should be designed to evaluate the feasibility (including identifying resources necessary to implement suicide prevention efforts), acceptability, and to obtain preliminary data regarding the effectiveness of the approach, and data regarding putative targets/mechanisms for preventive, therapeutic, and services interventions, per NIMH’s experimental therapeutics approach. The pilot study should be designed to yield data that are needed as a pre-requisite to a larger-scale, definitive study (e.g., effectiveness trial) that can be supported by other research mechanisms (e.g., R01; SBIR/STTR).

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. Given the nature of suicide research, applications should include plans for operationalizing/measuring patient suicide risk and safety, including monitoring of current care approaches (i.e. treatment as usual) as well as monitoring of patient suicide risk during implementation of clinical workflows. 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 and Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in the NIMH notice and website. 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.

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.

Applications Not Responsive to this FOA

Studies that are not responsive to this FOA and will not be reviewed include the following:

  • Applications whose scope of work involves examining intervention effectiveness without studying whether the intervention engages the target(s) presumed to underlie benefits and without examining whether intervention-induced changes in targets are associated with and account for clinical benefit.
  • Studies not conducted in primary care settings.
  • Studies that do not focus on suicidal thoughts and/or behaviors as the primary clinical outcome.
  • Studies that test multicomponent approaches without examining elements that might account for benefit.
  • Studies that use research support to introduce interventionists or provide services that would not otherwise be feasible in the context of typical resources/workflows.
  • Studies that involve testing screening/identification approaches without describing plans for ensuring referral to appropriate follow-up services.

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 PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIMH intends to commit up to $2 million in FY 2023 to fund up to 8 awards.

Award Budget

Direct costs are limited to $450,000 over the R34 project period, with no more than $225,000 in direct costs allowed in any single year.

Award Project Period

The Total project period for an application submitted in response to this funding opportunity may not exceed 3 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made 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)

Local 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)

Federal Government

  • 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

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

Number of Applications

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

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.

Letter of Intent

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.

Applications should address the following additional instructions:

Biographical Sketch:

Without duplicating information in biosketches, describe the investigator team’s expertise in primary care settings, measurement-based care, incorporating stakeholder input, mixed methods (if applicable), addressing health disparities, suicide preventive services, and methodology/statistics.

R&R or Modular Budget

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: Applicants should include the following sections as part of the Research Strategy. Applications should not duplicate information provided in the attachment described in the PHS Human Subjects Clinical Trial Information form but may reference it to provide context as needed.

Significance:

  • Justify the practical effects of the suicide prevention strategy being evaluated/pilot tested in terms of the estimated hypothesized effect (e.g., improved risk identification/stratification, engagement in follow-up care, prevention/treatment outcomes for at-risk individuals), compared with already available approaches. Address the potential impact in terms of both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches.
  • Address the degree to which the proposed suicide prevention services are scalable and could be disseminated into practice, given typically available resources (e.g., level of provider training and skill), typical service structures (including mental health financing), and typical service use patterns.
  • Detal how the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant or full-scale clinical trial and provide information about the anticipated scope and goals of intended future work.

Innovation:

  • Highlight how innovative research strategies and design/analytic elements (e.g., stakeholder-engaged research) are incorporated, as appropriate, in order to enhance the study's potential for yielding practice-relevant information.
  • As relevant, highlight how applications of information technology are leveraged to increase the reach, efficiency, or effectiveness of strategies for identifying and reducing suicide risk (e.g., use of predictive analytics or other decision science approaches for risk identification and stratification, use of mHealth and other technology-assisted approaches to promote staff training and/or services).

Approach:

  • Describe how the strategy or clinical workflow approach being evaluated/pilot-tested is aligned with the goals and capacity within the primary care setting (e.g., pediatrics, family practice, etc.) of interest, with regard to patient characteristics/needs, setting capability, and likelihood that the workflow could be feasibly implemented in similar practice settings and describe plans to quanitify the resources that are required (e.g., provider qualitifications, training and supervision requirments, therapist administration/delivery time and burden).
  • Detail plans for operationalizing/measuring patient suicide risk and plans for assessing the delivery of suicide prevention approaches (e.g., plans for monitoring fidelity of study interventions; plans for operationalizing usual care, as appropriate), as well as monitoring of patient suicide risk during implementation of clinical workflows.
  • Describe plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policymakers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility.
  • Detail plans to assess and examine patient-, provider- and setting- level factors that might be associated with uptake, implementation fidelity, and sustained use of the approach that is being developed and tested. Describe the patient-, provider- and setting- level characteristics that will be assessed and the measures that will be used (e.g., standardized measures of provider attitudes/experience, clinic-/organizational characteristics).
  • Describe plans for the collection of sociodemographic, clinical, and other variables that might be used to explore moderators of effects.
  • As appropriate, describe design features that are incorporated to help ensure the approach can be feasibly delivered in primary care and is robust against implementation drift (e.g., using technology as scaffolding or expert consultation via existing resources/ other sustainable means to support delivery).

For applications involving clinical trials

  • Provide the scientific rationale and need for a clinical trial to test the proposed hypothesis supported by preliminary data, clinical and/or preclinical studies, or information in the literature. Provide a rationale for the clinical trial as a necessary design for testing the safety, efficacy, or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors, or health care policy.
  • Consistent with NIMH's experimental therapeutics approach, detail plans to explicitly address whether the preventive, therapeutic, or services interventions engage the mechanism(s) presumed to underlie the intervention effects (the mechanism(s) that accounts for changes in clinical/ functional outcomes, changes inpatient or provider behavior, etc.). Include the following: (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms, functional deficits, or patient-, provider- or system-level behaviors/processes that the intervention seeks to improve; (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and (3) analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in the pilot trial. In the case of multi-component approaches, the application should specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each component, as appropriate in the effectiveness context.
  • Describe the research team’s expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines, including appropriate expertise in study coordination, data management, and statistics. If the pilot work includes multiple sites, describe the organizational structure and staffing that coordinate and manage multiple sites.

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, must address a Data Sharing Plan

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-19-033). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA web site provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. The NDA Data Sharing Plan is available for review on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

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.

The following additional instructions must also be followed.

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Applications must provide a clear description of:

1. Recruitment and Referral sources, including detailed descriptions of the census/rate of new cases and anticipated yield of eligible participants from each source;

2. Procedures that will be used to monitor enrollment and track/retain participants for follow-up assessments;

3. Strategies that will be used to ensure a diverse, representative sample;

4. Potential recruitment/enrollment challenges and strategies that can be implemented in the event of enrollment shortfalls (e.g., additional outreach procedures, alternate/back-up referral sources);

5. Evidence to support the feasibility of enrollment, including descriptions of prior experiences and yield from research efforts employing similar referral sources and/or strategies.

2.7 Study Timeline

Applications must provide a timeline for reaching important study benchmarks such as (1) finalizing the study procedures and training participating clinical site staff; (2) finalizing the intervention manual and assessment protocols, including fidelity measures/procedures, where applicable; (3) enrollment benchmarks; (4) completing all subject assessments and data collection activities, including data quality checks; (5) analyzing and interpreting results; and (6) preparing de-identified data and relevant documentation to facilitate data sharing, as appropriate.

Section 4 - Protocol Synopsis

4.2 Outcome Measures

Incorporate outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., functioning, health services use), as appropriate.

4.3 Statistical Design and Power

Address statistical power to test for moderators and/or the potential to contribute information regarding potential moderators to larger databases for future use.

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments

Applicants must upload the attachments for Intervention Manual/Materials, as applicable. If more than one set of Intervention Manual/Materials are used, they should be combined in this attachment. Applicants must use the “Intervention Manual/Materials” to name this other attachments file. As appropriate, this may include screenshots of mobile interventions, technological specifications, training manuals or treatment algorithms.

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.

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

NIMH has released expectations for collecting common data elements when an application involves human research participants. Details can be found at NOT-MH-20-067 and the NIMH webpage on Data Sharing for Applicants and Awardees.

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.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

Significance

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 likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant or full-scale clinical trial? To what extent will the results inform the next stages of research (e.g., a well-powered study to definitively test the approach)?

How well does the application justify the practical effect of the clinical services being evaluated/pilot tested in terms of the estimated hypothesized effect size (e.g., improved risk identification/stratification, facilitating follow-up care, prevention/treatment for at-risk individuals), compared with already available approaches? How well does the application address both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches?

Assess the potential of the proposed approach to be scalable and the potential for dissemination into practice given typically available resources (e.g., trained, skilled providers), typical service structures (including health care financing), and typical service use patterns.

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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?

As appropriate, how well does the study involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure that the intervention/service delivery approach is acceptable, practical, and scalable) and helps to ensure the results will have utility for end-users?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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?

 

If applicable, to what extent are innovative research strategies and design/analytic elements incorporated in order to enhance the study's potential for yielding practice-relevant information?

As relevant and appropriate, how well does the application leverage innovative applications of information technology to increase the reach, efficiency, or effectiveness for identification, prevention, and treatment of individuals at risk for suicide (e.g., use of predictive analytics or other decision science approaches for risk identification and stratification, use of mHealth and other technology-assisted approaches to promote intervention delivery or provider training)?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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?

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?

Evaluate the degree to which the application provides a clear rationale and compelling empirical basis for the approach to enhancing suicide prevention in primary care in terms of the intended target population, and the clinical workflow. Are the associated resource demands (e.g., in terms of patient/consumer burden, provider/system demands) and required resources (e.g., provider qualitifcations, training and supervision requirements, administration/delivery time) considered and assessed?

To what extent does the application include plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility?

How well does the application describe the consumer-, provider- and setting- level characteristics that will be assessed and the measures that will be used (e.g., standardized measures of provider attitudes/experience, clinic-/organizational characteristics) to examine factors that might be associated with uptake, implementation fidelity, and sustained use of the approach that is being tested? Are proposed outcome measures validated and generally accepted by the field? What is the rationale for plans for the assessment of suicidal behavior and related outcomes?

Evaluate plans to include collection of sociodemographic, clinical, and other variables that might be used to explore moderators of effects.

To what extent does the approach incorporate design features that will help ensure that the intervention can be feasibly implemented in practice, that it is scalable, and that it is robust against implementation drift (e.g., using technology as scaffolding or expert consultation via existing resources/ other sustainable means to support delivery)?

Evaluate the provisions for collecting data in a manner that will facilitate data sharing. To what extent does the application utilize an enrollment and data collection strategy that will facilitate collection of de-identified, sharable data and include plans to use standard assessments and collection of common data elements, as appropriate)?

How well does the study design address whether the preventive-, therapeutic-, or services- intervention engages the mechanism(s) presumed to underlie the intervention effects (the mechanism(s) that accounts for changes in clinical/ functional outcomes, changes inpatient or provider behavior, etc.)? To what extent does the application include: (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms, functional deficits, or patient-, provider- or system-level behaviors/processes that the intervention seeks to improve; (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context; and (3) analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in the pilot trial?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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?

To what extent does the study utilize other available resources (e.g., practice networks) to increase the efficiency of primary care practice collaboration and data collection?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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.

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

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

 

 

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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 will receive a written critique.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 the 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 recipient's business official.

Recipients 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.

The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial’s data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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)

Stephen O'Connor, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-480-8366
Email: stephen.o'connor2@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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