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
Safety and Feasibility Trials for Rapid-Acting Interventions for Severe Suicide Risk (R01 Clinical Trial Required)
Activity Code
R01 Research Project Grant
Announcement Type

New

Related Notices
July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128

August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137

Funding Opportunity Announcement (FOA) Number
RFA-MH-20-345
Companion Funding Opportunity

None

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

93.242

Funding Opportunity Purpose

The goal of this Funding Opportunity Announcement (FOA) is to test the feasibility and safety of treatment protocols for rapid-acting interventions that have the potential to reduce severe suicide risk. Approaches considered should be feasibly integrated into existing appropriate healthcare settings, such as emergency departments (ED), psychiatric inpatient units, and/or settings that may need to meet Risk Evaluation and Mitigation Strategy (REMS) approaches. Of interest are promising, existing interventions that include pharmacological, psychosocial/behavioral, and device-based approaches, alone or in combination. Approaches should build upon extant intervention findings regarding efficacy, dosing, durability of effects, patient selection/matching, and safety. Principal outcomes of interest are the reduction of suicide events, including ideation, attempts, death, and the potential decrease in high resource utilization (e.g., ED visits, hospitalization). This FOA uses the R01 grant mechanism and invites clinical research applications that will build foundational work for larger trials that could expand the evidence base for rapid-acting treatments for youth and adults with severe suicide risk.

Key Dates

Posted Date

November 25, 2019

Open Date (Earliest Submission Date)
January 26, 2020
Letter of Intent Due Date(s)

January 26, 2020

Application Due Date(s)

February 26, 2020

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

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
May, 2020
Advisory Council Review

August, 2020

Earliest Start Date

September, 2020

Expiration Date
February 27, 2020
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

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

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

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

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Purpose

    The goal of this FOA is to test the feasibility and safety of treatment protocols for rapid-acting interventions that have the potential to reduce severe suicide risk. Approaches considered should be feasibly integrated into existing appropriate healthcare settings, such as emergency departments (ED), psychiatric inpatient units, and/or settings that may need to meet Risk Evaluation and Mitigation Strategy (REMS) approaches. Of interest are promising, existing interventions that include pharmacological, psychosocial/behavioral, and device-based approaches, alone or in combination. Approaches should build upon extant intervention findings regarding efficacy, dosing, durability of effects, patient selection/matching, and safety. Principal outcomes of interest are the reduction of suicide events, including ideation, attempts, death, and the potential decrease in high resource utilization (e.g., ED visits, hospitalization). This FOA uses the R01 grant mechanism and invites clinical research applications that will build foundational work for larger trials that could expand the evidence base for rapid-acting treatments for youth and adults with severe suicide risk.

    Rationale

    The continuing rise in rates of suicide deaths and nonlethal suicide attempts, often associated with underlying psychiatric disturbances, remain pressing public health challenges. Up to 80% of suicide decedents visit healthcare settings in the year before death, and about a fifth of decedents are seen in healthcare within the week of death, making the delivery of effective interventions a top priority. Despite advances in psychiatric treatments over the past several decades, and effective psychosocial interventions that reduce repeat suicide attempts, there remain few evidence-based interventions that have been tested for their rapid-onset benefits for reducing suicide risk. The lack of widely used rapid-acting interventions often necessitates managing individuals at high risk for suicide in resource-intensive healthcare services (e.g., emergency department boarding; inpatient care), while other treatments take time to become effective. Building the evidence base for the use of rapid-acting treatments has the potential to reduce or pre-empt hospitalization, and ‘jumpstart’ the recovery trajectory. However, given the limited evidence base, there are a number of safety, effectiveness and practical issues to address, such as identifying potential clinical contraindications, defining non-responders, testing strategies for initial non-responders, defining duration of response, identifying indicators of durability of response, developing safety monitoring of side effects during acute and follow-up interventions, and clinician team and setting qualifications, including practical and logistical challenges in accessing appropriate interventions and services on an urgent basis. Rapid treatments may need to be accompanied by interventions (co-administered; sequenced with) with evidence of more durable recovery (e.g., cognitive behavior therapy, SSRIs), and may require longer treatment periods.

    The ultimate goal of this FOA is to build foundational work for larger trials that could build a strong evidence base for rapid-acting treatments for youth and adults with severe suicide risk. Protocols to be tested should be scalable and integrated into care for potential near-term impact. Accordingly, NIMH encourages research on strategies that involve targeted use of existing, promising interventions (including psychosocial/behavioral, pharmacological, and device-based approaches), alone or in combination/ sequence. Potential strategies include, but are not limited to the following:

    • Fast Acting Cognitive-Behavioral, and Neurocognitive Interventions. Advances in smart phone ecological momentary assessment methods and passive monitoring of physiological changes associated with suicide distress, have led to opportunities to identify suicide distress states in real time. Through smart phone technology, ecological momentary interventions can be delivered to mitigate suicide risk in real time. Some of these interventions are cognitive-behavioral, while others are based on neurocognitive (e.g., changing cognitive biases; enhancing executive functioning) and physiological (relaxation; meditative) skills that can interrupt suicide risk trajectories. The degree to which these approaches could be used effectively with other rapid-acting pharmacological and device interventions (concurrent; sequential) remains to be explored.
    • Ketamine. The off-label intravenous (IV) administration of ketamine for severe, and/or treatment resistant depression is already available in outpatient clinics across the country. It is not known to what degree patients receiving this care seek relief for suicide risk. A 2017 consensus statement on the Use of Ketamine in the Treatment of Mood Disorders by the American Psychiatric Association noted that there are no postmarketing surveillance data on the  safety and effectiveness of ketamine for any psychiatric indication. This broad use could speak to feasibility of outpatient care delivery, but many questions regarding safety and durability of effects for individuals with suicide risk remain. Because of the IV administration, feasibility testing of the delivery of ketamine intervention in acute care setting requires further research.
    • Recently Approved Rapid-acting Medications that Require REMS. Recent FDA approvals of rapid-acting pharmacological interventions such as esketamine and brexanalone have been breakthrough interventions for treatment resistant depression and postpartum depression, respectively. Esketamine is delivered intranasally, and brexanalone by infusion, and both require a Risk Evaluation and Mitigation Strategy (REMS) by the U.S. Food and Drug Administration (FDA), to ensure that the benefits of the medication outweigh its risks. Several studies by the manufacturer of esketamine indicate that suicide ideation is rapidly reduced after administration; brexanalone has not been tested for its benefits to reduce suicide events or self-harm for post-partum women. Because of the REMS requirements for the administration of these medications, the feasibility of delivery for acutely suicidal individuals remains to be explored.
    • Neuromodulation Devices. Potential existing neuromodulation device interventions that could be used as rapid onset include electroconvulsive therapy (ECT), with large studies showing clearing of suicidal ideation within a week. Despite evidence that ECT can work quickly, other aspects of treatment delivery have impeded ECT reaching its full potential in the service of suicide prevention, including limited availability in some locations and misunderstandings about treatment delivery and side effects among patients, families, and some providers. The logistics of ECT administration, as well as newer neurostimulation approaches, such as transcranial magnetic stimulation (TMS), and deep brain stimulation (DBS), can involve specific types of equipment and multiple healthcare professions. This FOA encourages investigators to consider how to overcome these possible logistical barriers to pilot test the potential of these device-based interventions in care settings to reduce acute suicide risk.

    Research Scope and Objectives

    The goal of this FOA is to test the feasibility and safety of treatment protocols for rapid-acting interventions that have the potential to reduce severe suicide risk, as foundational work for larger effectiveness trials. Depending on the stage of science and existing evidence for the intervention(s) being tested, conducting a fully powered test of outcomes or attempting to obtain an estimate of a stable effect size may not be feasible in the context of these protocol tests. Trials should be designed to yield data regarding feasibility, safety, and preliminary effectiveness and lead to a conclusion about the potential of larger trials to expand the evidence base for rapid-acting treatments for youth and adults with severe suicide risk.

    Consistent with the NIMH experimental therapeutics approach (http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml), this FOA encourages tests of intervention effectiveness that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism presumed to account for changes in clinical/functional outcomes). Accordingly, applications that propose the use of existing interventions for which intervention targets and the associated change mechanisms have been previously identified (e.g., variants of CBT strategies) should be designed to measure and confirm whether the previously identified change targets are operative in the proposed context. In this manner, the results of the pilot effectiveness trial will advance knowledge regarding therapeutic change mechanisms and inform decisions about whether further larger-scale effectiveness testing is warranted (see NIMH web page on Clinical Trials). Acknowledging that specific targets and their assessment are not always available for all agents (e.g., in the case of certain pharmacological approaches), and given the pressing need for treatment to rapidly reduce acute risk, this FOA also encourages research to test promising interventions, absent prior evidence regarding target engagement, under the following prerequisite conditions:

    • There are prior data suggesting a promising efficacy signal (e.g., independent case studies and/or pilot trials suggest the intervention has potential to lead to meaningful, rapid reductions in acute suicide risk);
    • Existing data are available to inform dosing (i.e., clear data exist regarding a dose range that can safely be administered with potential for efficacy); and
    • The application includes plans to assess a well-justified proximal indicator that can be used as a surrogate endpoint or early marker of response. Such indicators might include, for example:
    • changes in an empirically established risk/etiological/maintaining factor (e.g., cognitive biases) that has been associated with suicide risk or intervention response; or
    • an early response indicator that is operationalized in terms of minimum change in key symptoms (e.g., hopelessness) or outcomes following a pre-determined exposure to the intervention (e.g., x percent reduction in severity by y weeks), based on prior data regarding treatment-related change trajectories.

    For purposes of this announcement, “rapid-acting” interventions are those that are associated, in the majority of treatment responders, with a clinically-significant reduction in suicidality-related symptoms [as assessed with a validated rating instrument, within 2-3 days of initial dosing.

    A range of research approaches might be appropriate, depending on the stage of science and existing evidence for the intervention(s) being tested. Studies of treatment approaches applied in a novel way might employ more efficacy-type aims and designs. Studies of existing interventions–-those that have already shown promise for providing fast-acting relief of severe suicide risk-–could focus more on feasibility of delivery in acute care settings (emergency departments, inpatient units, REMS, crisis outpatient settings), and protocols for follow-up. Testing sequences/combinations of effective interventions to accelerate initial response and to maintain the acute gains from fast-acting treatments is also of interest. Given the overall goal of identifying approaches that can feasibly be integrated into practice, across all stages of intervention refinement and testing, NIMH encourages a deployment-focused approach that takes into account the perspective of relevant stakeholders (patients, parents/family members, providers, and key administrators), to yield interventions and service strategies that are relevant and can be more rapidly integrated into practice.

    NIMH encourages the use of technology to facilitate assessment and intervention and to facilitate the conduct of clinical research (see NOT-MH-18-031; Notice of Information: NIMH High-Priority Areas for Research on Digital Health Technology to Advance Assessment, Detection, Prevention, Treatment, and Delivery of Services for Mental Health Conditions). Technology-based assessments may be particularly useful for evaluating initial intervention response, target engagement, and treatment response over time. Applications of technology might include: technology-assisted self-report (e.g., ecological momentary assessment) and self-monitoring or passive monitoring to detect changes in symptom severity, functional impairments, or treatment adherence. Therapeutic applications of technology might include patient-facing mobile health approaches to promote between-session skills-use or deliver ecological momentary interventions, and clinician-facing applications to monitor status over time, to promote measurement-based care, and to facilitate the implementation of research-informed interventions.

    NIMH encourages effectiveness research that includes assessment of suicidal behavior using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009 and https://www.phenxtoolkit.org/ for constructs and corresponding assessment strategies).

    Examples of therapeutic strategies that might be studied under this announcement could include, but are not limited to:

    • Single- or multiple-dose ketamine/ esketamine or related N-methyl-D-aspartate (NMDA) receptor antagonists, or scopolamine or related muscarinic cholinergic receptor antagonists (via intravenous infusion, nasal spray, or other route of administration), followed–if successful acutely–by an active intervention that can maintain gains and provide relapse protection
    • Device-based treatments, such as ECT, magnetic seizure therapy (MST), and accelerated TMS, alone or in combination with medications that target comorbid symptoms, such as depression and anxiety; attention should be paid to logistical adaptations required to permit rapid implementation in acute-care settings
    • Neurocognitive interventions to enhance executive functioning (reducing cognitive constriction; enhancing reward delays)
    • Just-in-time app-based cognitive skills (e.g., enhanced problem solving) and physiological (e.g., relaxation) interventions to change the distress trajectory
    • Brexanolone infusion for women with severe post-partum depression with suicide risk, and follow-up relapse prevention strategies
    • Pharmacotherapy or psychotherapy augmentations or sequences in conjunction with experimental rapid-acting interventions, to accelerate and sustain clinical response

    Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, parents/family members, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly.

    NIMH has published policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

    Scale and Scope of Studies Covered Under this Announcement

    The goal of this FOA is to test the feasibility and safety of treatment protocols for rapid-acting interventions that have the potential to reduce severe suicide risk, as foundational work for larger effectiveness trials. Applicants are encouraged to visit the NIMH Clinical Trial web page for a list of alternative FOAs that support other stages of intervention development and testing, including FOAs that are intended to support the translation of emerging basic science findings of mechanisms and processes underlying mental disorders into novel pharmacological or device-based (https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-702.html; https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-703.html). Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NIMH policies and guidelines, and discuss whether the proposed project is consistent with NIMH program priorities.

    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

    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?
    Required: Only accepting applications that 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 a total of $5 million in FY 2020 to fund up to 6 awards.  

    Award Budget
    Application budgets are limited to no more than $400,000 in direct costs in any single year.    
    Award Project Period

     Project periods are limited to no more than 4 years.

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • U.S. Territory or Possession
    Other
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility

     

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

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

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

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

     

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

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

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

    The letter of intent should be sent to:  

    Email: NIMHpeerreview@mail.nih.gov

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

    The Research Strategy should include the following information:

    Significance

    • Identify how the proposed feasibility research addresses gaps in suicide prevention. Describe how the proposed intervention strategy can potentially alleviate the need for more resource-intensive care. Explain how the proposed study will contribute to the evidence base for the use of rapid-acting treatments for immediate reduction of risk and/or to ‘jumpstart’ for recovery.
    • Justify the practical effect of the proposed intervention approach in terms of the estimated hypothesized effect size (e.g., in terms of the magnitude of and/or timeframe for reductions in acute suicide risk), compared with currently available approaches. Address the potential impact of the intervention 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.
    • Detail 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.

    Innovation

    • Highlight how state-of-the-art or innovative research strategies and design/analytic elements are incorporated into the feasibility study, as appropriate, to enhance the study's potential for yielding practice-relevant information
    • As relevant, detail applications of technology that will be leveraged to facilitate the collection of data and/or increase the reach, efficiency, or effectiveness of interventions and/or to promote rapid and/or sustained improvement in reduced suicide risk over time.

    Approach

    • Detail the rationale and empirical basis for the intervention approach in terms of the intended target population, stage of intervention refinement, corresponding goals and focus of the intervention (e.g., rapidly reducing acute risk, promoting sustained recovery), and the key window or timeframe over which the intervention should be administered.
    • Describe the plan for assessing whether the intervention leads to intended proximal changes and subsequent clinical benefit:
    • For applications that test existing interventions for which proximal targets/mechanisms have been identified: Detail the plan to explicitly assess whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (the mechanism(s) that accounts for changes in clinical/functional outcomes). Include: (1) the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms or functional deficits, and (2) the plans for assessing engagement of the target(s)/mechanism(s), 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).
    • For applications that test interventions for which proximal targets/mechanisms are unknown: Detail plans to assess a proximal indicator that can be used as a surrogate endpoint or early marker of response. Include: (1) the justification for the selection of a surrogate proximal indicator (e.g., an empirically established risk/etiological/maintaining factor (e.g., cognitive biases) that has been associated with suicide risk or intervention response; an early response indicator that is operationalized in terms of minimum change in key symptoms (e.g., hopelessness) or severity following a pre-determined exposure to the intervention, based on prior data regarding treatment-related change trajectories); and (2) the plans for assessing the proximal indicator, 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).
    • For all applications: Detail the analytic strategies that will be used: (1) to examine whether the intervention leads to changes in the target(s)/mechanism(s) or the surrogate proximal indicator, and (2) to conduct a preliminary examination of whether intervention-induced changes in the target(s)/mechanism(s) or surrogate indicator are associated with clinical benefit.
    • ustify the choice of methods proposed and describe how the results will inform the next stages of research.
    • As relevant, describe 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 intervention(s)/ is acceptable, feasible, and scalable) and helps to ensure the results will have utility for end-users.
    • Explain the provisions for the assessment and monitoring of fidelity of intervention delivery via procedures that are practical and valid.
    • Justify the assessment schedule and the proposed period of observation/follow-up, in terms of the intent of the intervention (e.g., rapid reduction of acute risk) and in the context of the project period.
    • Describe how the trial will inform personalization of mental health care. Detail plans to include collection of clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers), as appropriate, that might be used to inform or test algorithms for more prescriptive approaches. Describe preliminary plans to examine moderators and/or the potential to contribute information regarding potential moderators to larger databases for future use.
    • Detail plans to incorporate outcome measures that are valid and generally accepted by the field, including the use of stakeholder-relevant outcomes, as appropriate (e.g., functioning, health services use).
    • Detail the rationale and empirical basis for the intervention approach in terms of the intended target population, stage of intervention refinement, corresponding goals and focus of the intervention (e.g., rapidly reducing acute risk, promoting sustained recovery), and the key window or timeframe over which the intervention should be administered. Describe the plan for assessing whether the intervention leads to intended proximal changes and subsequent clinical benefit:
    • Describe how the assessment of suicidal behavior and related outcomes uses strategies that can facilitate integration and sharing of data as appropriate (see NOT-MH-15-009 and the PhenX Toolkit website for constructs and corresponding assessment strategies). Provide the rationale for the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during intervention, post-intervention, follow-up), taking into account the nature of the target population, participant burden, etc. Address provisions for clinical management when suicidal behavior is reported. (This NIMH document provides resources on the conduct of research with participants at elevated risk for suicide with regard to safety and study design: https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml).
    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan
    • To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share human subjects data via the NIMH Data Archive (NDA) ( https://ndar.nih.gov/ ; see NOT-MH-19-033). Established by the NIMH, and supported by other Institutes of NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation. Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html . A resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.
    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.

    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..

    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.

    For this particular announcement, note the following: This FOA solicits feasibility and safety studies. As such, data for the study interventions in the proposed context (i.e., for rapidly addressing suicide risk) might be limited, and fully-powered formal analysis at this stage of testing may not be feasible or warranted.

    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.

     

    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?

    • To what extent does the proposed feasibility research address gaps in suicide prevention? If successful, does the proposed intervention strategy have the potential to alleviate the need for more resource-intensive care? Will the results of the proposed study contribute to the evidence base regarding rapid-acting treatments that can lead to immediate reductions in risk or ‘jumpstart’ recovery?
    • How compelling is the justification regarding the practical effect of the intervention in terms of the estimated hypothesized effect size (e.g., in terms of the magnitude of and/or timeframe for reductions in acute suicide risk), compared with currently available approaches? Does the application address the potential impact of the intervention 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?
    • How likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility of a full scale clinical trial?

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

     

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

     

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

    • 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?
    • As appropriate, does the application incorporate state-of-the-art or innovative research strategies and design/analytic elements, to enhance the study's potential for yielding practice-relevant information?
    • As relevant, does the application incorporate applications of technology that will be leveraged to facilitate the collection of data and/or increase the reach, efficiency, or effectiveness of interventions and/or to promote sustained improvement in reduced suicide risk over time?

     

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    • How compelling are the rationale and empirical basis for the intervention approach in terms of the intended target population, stage of intervention refinement, corresponding goals and focus of the intervention (e.g., rapidly reducing acute risk, promoting sustained recovery), and the key window or timeframe over which the intervention should be administered?
    • Evaluate the appropriateness and strength of the plans for assessing whether the intervention leads to intended proximal changes and subsequent clinical benefit:
    • For applications that test existing interventions for which proximal targets/mechanisms have been identified: Evaluate the plan to explicitly assess whether the intervention engages the target(s)mechanism(s) presumed to underlie the intervention effects (the mechanism(s) that accounts for changes in clinical/functional outcomes), including: (1) the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms or functional deficits, and (2) the plans for assessing engagement of the target(s)/mechanism(s), 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).
    • For applications that test interventions for which proximal targets/mechanisms are unknown: Does the application include plans to assess a proximal indicator that can be used as a surrogate endpoint or early marker of response? Evaluate: (1) the justification for the selection of a surrogate proximal indicator (e.g., an empirically established risk/etiological/maintaining factor (e.g., cognitive biases) that has been associated with suicide risk or intervention response; an early response indicator that is operationalized in terms of minimum change in key symptoms (e.g., hopelessness) or severity following a pre-determined exposure to the intervention, based on prior data regarding treatment-related change trajectories); and (2) the plans for assessing the proximal indicator, 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)?
    • For all applications: Evaluate the proposed analytic strategies that will be used: (1) to examine whether the intervention leads to changes in the target(s)/mechanism(s) or the surrogate proximal indicator, and (2) to conduct a preliminary examination of whether intervention-induced changes in the target(s)/mechanism(s) or surrogate indicator are associated with clinical benefit.
    • How well does the application justify the choice of methods proposed and describe how the results will inform the next stages of research?
    • Evaluate the provisions for the assessment and monitoring the fidelity of intervention delivery via procedures that are practical and valid.
    • Does the application appropriately justify the assessment schedule and the proposed period of observation/follow-up, in terms of the intent of the intervention (e.g., rapid reduction of acute risk) and in the context of the project period?
    • As appropriate at this pilot stage, does the research have potential to inform personalization of mental health care?
    • As relevant, 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 intervention(s)/ is acceptable, feasible, and scalable) and helps to ensure the results will have utility for end-users?
    • Does the assessment plan incorporate outcome measures that are valid and generally accepted by the field, including the use of stakeholder-relevant outcomes, as appropriate (e.g., functioning, health services use)? Does the assessment of suicidal behavior and related outcomes use strategies that can facilitate integration and sharing of data as appropriate? Does the application justify the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during intervention, post-intervention, follow up), taking into account the nature of the target population, participant burden, etc.?
    • Are there appropriate provisions for managing safety among participants at risk for suicide?

    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?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

     

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    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
    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

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

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

     

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

     

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

     

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

     

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

     

    Not Applicable

     

    Not Applicable

     

    Not Applicable

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

     

    Not Applicable

     

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

     

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). Researchers funded by NIMH are required to comply with data sharing policies detailed in NOT-19-033.

     

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

     

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

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:
    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.
    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by 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 grantee’s business official.

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

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

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

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

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

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

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

    2. Administrative and National Policy Requirements

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

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

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    Cooperative Agreement Terms and Conditions of Award
    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    Recruitment Reporting and Trial Registration  

    NIMH requires reporting of recruitment milestones for participants in clinical trials as noted at http://grants.nih.gov/grants/guide/notice-files/NOT-MH-05-013.html. While trials in response to this FOA may not seek 150 subjects or more (the level at which this reporting has been required), we expect reporting for all trials, even those with less than 150 subjects.

    The NIMH expects the registration and results reporting for all NIMH-supported clinical trials in ClinicalTrials.gov, regardless of whether or not they are subject to FDAAA (see http://grants.nih.gov/ClinicalTrials_fdaaa/at-a-glance.htm). We plan to include language regarding this expectation in the notice of grant award.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
    Application Submission Contacts
    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues) Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

    Scientific/Research Contact(s)

    Matthew Rudorfer, M.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-1111
    Email: mrudorfe@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Tamara Kees
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-8811
    Email: tamara.kees@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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