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
Enhancing Suicide Prevention in Emergency Care via Telehealth (R01 Clinical Trial Optional)
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-20-226
Companion Funding Opportunity

None

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

93.242

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit research to develop, optimize and test mental health telehealth methods to help evaluate and treat emergency department (ED) patients with suicide risk, compared to usual care of such patients in emergency departments without adequate on-site mental health specialty consultation. Primary research questions include whether the use of telehealth methods (i.e., without involving in-person interaction between a mental health clinician and the patient or ED staff) affects the proportion of ED patients who: (1) are considered at imminent risk for suicide, (2) are boarded in the ED due to suicide risk, and/or (3) are required to be hospitalized for suicide risk. Other questions address: whether use of telehealth methods affects the rate of within-encounter provision of evidence-based suicide prevention interventions; and whether use of telehealth methods affects the rates of suicide ideation, suicide attempts and deaths, as well as health care use and costs in the year after an “index” ED visit in which a patient was identified with suicide risk. To inform future implementation of telehealth enabled suicide prevention practices in the ED, this FOA encourages research on patient-, provider- and setting- level factors that may facilitate or impede telehealth provision and outcomes, as well as patient and provider views of telehealth provision of suicide prevention practices (feasibility and acceptability of clinical decision making; clinical workflows; ease of use of technology).

Key Dates

Posted Date

November 19, 2019

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

January 10, 2020; September 15, 2020

Application Due Date(s)

February 10, 2020; October 15, 2020

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

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

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2020; February 2021

Advisory Council Review

August 2020; May 2021

Earliest Start Date

September 1, 2020; July 1, 2021

Expiration Date
October 16, 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 purpose of this Funding Opportunity Announcement (FOA) is to solicit research to develop, optimize and test mental health telehealth methods to help evaluate and treat emergency department (ED) patients with suicide risk, compared to usual care of such patients in emergency departments without adequate on-site mental health specialty consultation. Primary research questions include if the use of telehealth methods (i.e., without involving in-person interaction between a mental health clinician and the patient or ED staff) affects the proportion of ED patients who: (1) are considered at imminent risk for suicide (2) are boarded in the ED due to suicide risk, and/or (3) are required to be hospitalized for suicide risk. Other questions address whether use of telehealth methods affects the rate of within-encounter provision of evidence-based suicide prevention interventions; and whether use of telehealth methods affects the rates of suicide ideation, suicide attempts and deaths, as well as health care use and costs in the year after an “index” ED visit in which a patient was identified with suicide risk. To inform future implementation of telehealth enabled suicide prevention practices in the ED, this FOA encourages research on patient-, provider- and setting- level factors that may facilitate or impede telehealth provision and outcomes, as well as patient and provider views of telehealth provision of suicide prevention practices (feasibility and acceptability of clinical decision making; clinical workflows; ease of use of technology).

    Rationale

    The continuing rise in rates of suicide deaths and nonlethal suicide attempts remain pressing public health challenges. Nearly half of suicide decedents visit emergency care in the year before death, and around one-fifth in the month before death. These rates are substantially higher than for the general population and help underscore the importance and potential value of improving identification and treatment of suicide risk in emergency departments (EDs). A growing body of evidence documents the feasibility and effectiveness of ED-based suicide prevention practices, including universal suicide risk screening; brief within-encounter interventions such as safety planning; and post-discharge interventions such as written caring contacts, telephone follow-up, and referral to indicated psychotherapy. Universal screening of ED patients for suicide risk can double the number of individuals identified as warranting treatment for suicide risk, versus usual ED practices. At-risk patients seen in VA EDs, who received the Safety Planning Intervention with follow-up telephone contact were half as likely to exhibit suicidal behavior and more than twice as likely to attend mental health treatment during the 6-month follow-up period, versus usual care. ED patients who screened positive for suicide risk were provided with further screening, a safety plan intervention, and a series of supportive phone calls upon discharge, which resulted in 30% fewer suicide attempts in the following year, versus usual care. ED-initiated follow-up of patients identified with suicide risk, via telephone or via written caring contacts, has also been found to be highly cost-effective and in some cases cost-saving. However, uptake of these practices remains insufficient, and none of them are a part of standard ED practice.

    One key barrier consistently identified by the emergency medicine community to implementing universal suicide screening—which would increase the identification of known suicidal patients—is that many ED settings have limited access to mental health specialty consultation. Patients who screen positive should be further evaluated, be provided a brief safety intervention, and appropriate triage and discharge. Absent such access, many EDs report a default care path of hospitalizing individuals with suicide risk, due to a combination of limited clinical expertise and a related concern about potential legal liability. Yet the clinical benefits of such hospitalization are unclear, and the economic and logistical burdens–often including ED boarding until an appropriate hospital bed becomes available–are considerable. Moreover, some patients fear hospitalization as the default treatment, and it has been reported that fear of this limited treatment option deters patients’ reporting of suicidal ideation and/or help seeking altogether. As such, methods to provide mental health specialty consultation to EDs may benefit patients who are identified with suicide risk under current practice. Moreover, mental health specialty consultation could also enable EDs to expand suicide risk identification efforts and provide intervention options that are less restrictive.

    Given widespread shortages of local mental health specialty clinicians, telehealth represents a promising way to increase access for EDs to mental health and suicide prevention consultation. Use of telehealth is expanding in many areas, including in EDs. For example, the Emergency Medicine Network conducted a 2017 survey of all (N=5,375) US EDs with 4,507 EDs responding to questions about their use of telehealth (https://doi.org/10.1177/1357633X18816112). Nearly half (48%) of responding EDs reported using telehealth, most commonly for stroke/neurology (77% of telehealth-using EDs, or 38% of responding EDs overall) The next most common use was “psychiatry” (38% of users, or 18% overall), but the study did not assess whether or how telehealth for psychiatry addressed suicide risk.

    In this context, NIMH partnered with several other Institutes and agencies in a request for information on the use of telehealth consultation in the ED for suicide prevention (NOT-MH-19-030, Request for Information [RFI]: Guidance on Current Clinical Experience in the Use of Telemental Health for Suicide Prevention in Emergency Department Settings). Responses to the RFI indicated that, overall, there was general provider satisfaction with telehealth use for mental health issues, but less experience with suicide risk consultation. ED providers also saw the potential of telehealth benefits for suicide risk consultation, specifically with regard to reductions in patient boarding (keeping patients in the ED until an inpatient bed is available). These responses indicated that research should examine whether telehealth-enabled suicide prevention practices in the ED do indeed enable EDs to strengthen suicide risk identification and treatment, and improve patient outcomes.

    Thus, the primary research questions for this initiative are to determine if ED access to telehealth mental health services affects the proportion of ED patients who: (1) are considered at imminent risk for suicide (2) are boarded in the ED due to suicide risk, and/or (3) are required to be hospitalized for suicide risk. Other questions address whether use of telehealth methods affects the rate of within-encounter provision of evidence-based suicide prevention interventions; and whether use of telehealth methods affects the rates of suicide ideation, suicide attempts and deaths, as well as health care use and costs in the year after an “index” ED visit in which a patient was identified with suicide risk. To inform future implementation of telehealth enabled suicide prevention practices in the ED, this FOA encourages attention to patient-, provider- and setting- level factors that may facilitate or impede telehealth provision and outcomes, as well as patient and provider views of telehealth provision of suicide prevention practices (feasibility and acceptability of clinical decision making; clinical workflows; ease of use of technology).

    Other research questions that could be addressed under this FOA include, but are not limited to the following:

    • Does use of telehealth mental health consultation increase the duration of ED visits for at-risk individuals, but ‘pay off’ with less patient boarding time?
    • How do family members/significant others, who may accompany the patient in the ED visit, view the application of telehealth enabled suicide prevention practices in the ED?
    • Are there particular subgroups of patients (e.g., pediatric; geriatric; patients with comorbid conditions such as substance use disorders) that telehealth services are more frequently engaged, and/or for whom the consultation is more likely to improve clinical workflow?
    • How often are patients whose suicide care was facilitated by telehealth able to be discharged to community outpatient care (e.g., specialty and/or primary care) compared to patients in practices that were not receiving telehealth consultation for suicide risk?

    Research Scope and Objectives

    The goal of this FOA is to support research to assess the effects of telehealth services to general hospital emergency departments (EDs) regarding the care of ED patients identified with suicide risk. NIMH anticipates that research in response to this FOA will involve trials with prospective data collection in which patients are exposed to specific intervention conditions. While random allocation to intervention conditions is feasible in some cases, depending on the study question, practical constraints, and ethical considerations might justify the use of quasi-experimental designs with non-randomized comparison groups, that could be responsive with adequate justification.

    ED Setting and Patient Characteristics of Interest

    This FOA focuses on assessing the feasibility and effects of using telehealth methods to enhance suicide prevention practices in general hospital EDs that currently lack on-site access to mental health specialty consultation. General hospital EDs with existing telehealth services for urgent and/or chronic medical issues are eligible if they propose to add telehealth support to address psychiatric and substance use disorders, including assessment and management of suicide risk. Research studies in psychiatric EDs or general EDs that are part of hospitals with inpatient psychiatric wards with in-house ED mental health expertise will not be considered responsive to this FOA. Similarly, an application focused on quality improvement by a general hospital ED that already uses telehealth mental health for patients with suicide risk as part of their standard practice is also beyond the scope of this FOA.

    This FOA focuses on care for individuals in general hospital EDs who are identified with suicide risk, via self-identification, positive primary screening for suicide risk, or clinician judgement based on patient presentation. Reflecting current evidence regarding effective screening and treatment of suicide risk, studies under this FOA can focus on individuals aged 10 years and over. Consistent with increasing suicide rates in the US across essentially all demographic groups, responsive applications should have limited patient exclusion criteria. Study designs that focus on a narrower scope of patients should provide compelling clinical and logistical rationale for doing so.

    Suicide Prevention Practices of Interest

    Telehealth methods could focus on enhancing ED care for individuals with suicide risk for any combination of the following components: suicide risk screening, assessment/evaluation (including consideration of co-occurring mental health and substance use issues), within-encounter brief interventions, recommendations/decisions about disposition, and recommendations and arrangements for post-discharge and follow-up care. Study designs that focus on a narrower scope of suicide prevention practices should provide compelling clinical and logistical rationale for doing so. This FOA focuses on services that are furnished within the ED, during an index ED visit in which the patient is identified with (or confirmed to have) suicide risk. Study protocols may also include intervention components that are furnished after the patient leaves the ED, but the specific focus of this announcement is on assessing the effects of telehealth services provided during the ED visit. Telehealth services might include support/consultation provided to ED clinicians regarding a given patient, without direct contact between the telehealth provider and the patient, and/or telehealth services can involve direct contact between the telehealth provider and the patient (e.g., telehealth-enabled provision of brief within-encounter intervention such as safety planning). NIMH encourages researchers to focus on synchronous telehealth methods during the ED visit/encounter (e.g., telephone, video). Studies that seek to focus on asynchronous telehealth methods (e.g., email, voice mail, faxed recommendations, text messages), in whole or in part, could be considered, but these services should be provided while the patient is still in the ED. Applicants should provide compelling clinical and logistical rationale for the specific telehealth support that is included.

    Design Considerations

    This FOA seeks to support studies that can assess the safety and potential patient benefits of telehealth enabled suicide prevention practices. Studies that test telehealth versus on-site mental health services will be deemed nonresponsive to this FOA. As above, the comparison of interest is to care provided in general hospital EDs that currently lack adequate on-site access to mental health specialty consultation (and that also do not currently utilize the types of telehealth mental health services to which this announcement refers).

    NIMH anticipates that research in response to this FOA will involve trials with prospective data collection in which patients are exposed to specific intervention conditions. While random allocation to intervention conditions is feasible in some cases, depending on the study question, practical constraints, and ethical considerations might justify the use of quasi-experimental designs with non-randomized comparison groups, time series designs, or other designs of equivalent rigor and relevance, that could be responsive with adequate justification.

    Due to the nature of the FOA research questions, study designs should take into account practical aspects of telehealth implementation, clinical workflows, and assessment of patient outcomes. NIMH encourages assessment and examination of patient-, provider-, and setting- factors that facilitate or impede implementation of outcomes of telehealth interventions. For example, mixed methods approaches that incorporate qualitative research strategies to complement quantitative methods of the clinical trial could be used to examine the perspectives of providers and patients (those exposed and those not exposed to telehealth enhanced suicide care) and to characterize changes in ED provider attitudes and beliefs about implementing suicide preventive practices; responses to practices implemented; and views on clinical work flows for suicidal patients, with and without telehealth enhanced care.

    Design aspects for proposed clinical trials should be consistent with the NIMH experimental therapeutics approach (http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml; https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml). Under this approach, studies should be designed to explicitly examine whether the intervention engages the proximal 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 changes in practice and service delivery for which intervention targets and the associated change mechanisms have been previously identified should be designed to measure and re-confirm whether the previously identified change targets are operative in the proposed context.

    NIMH encourages a deployment-focused model of intervention refinement and testing that considers the perspectives of relevant stakeholders (e.g., patients, providers, administrators, payers) and the key characteristics of the settings that are intended to implement optimized mental health interventions. This attention to end-user perspectives and characteristics of the ED setting is intended to ensure that the resultant interventions and service delivery strategies are acceptable to patients and providers, to ensure that the approaches are feasible and scalable in the settings where individuals are typically served, and to ensure that the research results will have utility for end users.

    Studies under the announcement are encouraged to implement telehealth services as naturalistically as possible, in order to increase the generalizability of research findings as well as to minimize barriers to translating any positive research findings into real-world practice. Ideally, findings generated by supported studies will be implementable within the EDs involved in research under this announcement as well as to the wider population of general hospital EDs that currently lack adequate on-site or telehealth mental health specialty consultation. NIMH encourages studies that furnish telehealth services through existing providers/vendors of such services, versus developing telehealth services specifically for this research. Similarly, NIMH encourages studies to rely as much as possible on existing financing mechanisms for telehealth and other services. In any case, studies under this announcement should assess the adequacy of existing financing models to support the implementation of relevant telehealth services.

    Outcomes of Interest

    EDs without adequate mental health consultation report the difficulty with triage decisions related to hospitalization (and related wait times for available beds), and telehealth consultation could, in theory, provide consultation that is better matched to patient needs within the ED visit, as well as disposition decisions. Therefore, studies conducted under this announcement are expected to have adequate statistical power to evaluate the effects of access to telehealth mental health specialty consultation on the proportion of ED patients identified with suicide risk who are determined to be at imminent risk, such that they warrant safety measures and constant observation, and the proportion who are determined to require hospitalization. With regard to patient suicide-relevant outcomes, the rate of suicide behavior (e.g., attempts and deaths) proximal to the index ED visit (e.g., within a week of ED discharge; or, for individuals who are hospitalized from an ED visit in which they were identified with suicide risk, within a week of discharge from that hospitalization), and during the year following the ED encounter (e.g., 30 days; 90 days, 6 and 12 months from the index ED/hospital discharge) are secondary outcomes of particular interest.

    In addition to patient suicide attempts and deaths, research under this announcement should assess effects on other relevant non-fatal and fatal injury outcomes, particularly those due to unintentional injuries (which include, but are not limited to, unintentional overdose via opioids, alcohol, or other substances with high abuse potential). Studies are expected to track patient mortality systematically for at least one year after an index ED visit in which a patient is identified with suicide risk. Mortality tracking may be done through primary data collection and/or linkage to appropriate state or national mortality data systems, but should not be limited to ad hoc observation of deaths that occur in, or happen to be reported to, participating EDs and hospitals. Additional patient outcomes of interest include suicidal ideation, and health care use and costs in the year after an index ED visit. As noted above, gathering outcome information that represents the perspectives of relevant stakeholders (e.g., patients, providers, administrators, payers) is encouraged, as it can inform future implementation research on this topic. NIMH also encourages research that includes assessment of suicidal behavior using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009).

    Applicants should address the potential for negative or other unintended effects of implementing telehealth, including potential adverse events (e.g., changes in practice leading to increases in subsequent suicidal behaviors) and the impact on the setting/system (e.g., identification of increased numbers of individuals who screen positive and require further evaluation).

    With regard to assessing financial cost implications, EDs without adequate access to on-site or telehealth mental health consultation could invoke financial cost as one of the barriers to such access. At the same time, emergency providers express concern that the lack of access to mental health consultation increases rates of ED boarding and hospitalization of individuals identified with suicide risk–which can also impose financial costs on EDs and hospitals. In this context, research under this announcement should be designed to assess possible changes in the net financial cost, from the ED or hospital perspective, from using suicide-focused telehealth methods (e.g., possible trade-off between costs of telehealth services, on the one hand, and costs associated with ED boarding and hospitalization, on the other, if telehealth services are found to reduce the latter outcomes).

    In intervention and services research application designs, 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 in-the-moment, just-in-time interventions, and clinician-facing applications to monitor status over time, to promote measurement-based care, and to facilitate the implementation of research-informed interventions.

    Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations (NOT-MH-19-033).

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

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

    Section II. Award Information

    Funding Instrument

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

    Application Types Allowed
    New

    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 a total of $7 million in FY 2020, to fund up to 2 awards.

    Award Budget
    Application budgets are not limited but need to reflect the actual needs of the proposed project.
    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 4 years.

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

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • U.S. Territory or Possession
    Other
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
       
    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 not allowed. 

    Required Registrations

    Applicant organizations

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

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

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

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

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility

     

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

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

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

    Section IV. Application and Submission Information

    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

     

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

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

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

    The letter of intent should be sent to:

    Email: nimhpeerreview@mail.nih.gov

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

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

    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

    • Describe how the proposed study will contribute to the evidence base for the use of telehealth to support the expanded use of suicide prevention practices in the ED.
    • Describe the potential impact of the proposed telehealth strategy(ies) in terms of the potential to improve identification detection and management of at-risk individuals.
    • Justify the anticipated practical benefits of the proposed telehealth approach in terms of the hypothesized effect size (e.g., in terms of the number of at-risk individuals identified, the number appropriately referred or treated), as compared to usual care or other alternatives.
    • Describe whether the approach (if safe, feasible and effective) is generalizable and scalable. For example, could a large proportion of US general medical EDs employ the telehealth enabled suicide prevention practices being tested?
    • Describe whether the approach (if safe, feasible and effective) is likely to be sustained after the study has been completed.

    Investigators

    •    Without duplicating information in the biosketches, describe the research team’s experience and capabilities to carry out a pragmatic study involving suicidal patients seen in EDs and the expertise in telehealth services.

    Innovation

    • Highlight how innovative research strategies and design/analytic elements (e.g., pragmatic trial approaches, case-control strategies, propensity analyses) are incorporated, as appropriate, in order to enhance feasibility and the 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 sustained improvement in reduced suicide risk over time.

    Approach

    • Detail strategies that will be used to track ED visits, the provision of specific telehealth services (e.g., screening, brief intervention, referral) and patient outcomes over time.
    • Describe the specific telehealth components that will be studied and provide the rationale for their inclusion (e.g., suicide risk screening, assessment/ evaluation, within-encounter brief interventions, recommendations for post-discharge or follow-up care).
    • Describe the rationale for the design selected (e.g., randomized controlled trial, quasi-experimental design with non-randomized comparison, time series designs) that consider practical constraints, safety and ethical issues, and the trade off between maximizing internal and external validity
    • Provide a plan for assessing proximal and system component changes and/or enhancements through valid and practical means (e.g., supervision observation, monitoring of health care record indicators)
    • Detail the selection of the analytic strategy and corresponding power calculations for data analyses that will be used to evaluate the proposed aims.
    • Consistent with NIMH's experimental therapeutics approach (http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml), detail plans to examine whether the intervention engages the mechanism(s) presumed to underlie the intervention effects (the proximal mechanism(s) that accounts for changes in clinical/ functional outcomes, changes in patient 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; and (3) data analyses that will be used to examine whether the intervention engages the target(s) and whether intervention-induced changes in the target(s) are associated with clinical benefit (i.e., mediation).
    • In the case of a multi-component strategy, specify the conceptual basis, ascertainment of implementation, and analytic strategy that allows for examination of the value of separate component changes/enhancements, as well as overall effects
    • Describe the potential practicality (uptake, ease of implementation, sustainability) of the telehealth service delivery approaches used.
    • As relevant, describe plans to involve collaborations and/or input from community practice partners/providers, consumers, insurers and/or 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.
    • Provide evidence of healthcare system leadership’s view of the value of the study questions posed, and study results.
    • Describe preliminary plans to examine moderators and/or the potential to contribute information regarding potential moderators to larger databases for future use.
    • Justify the assessment schedule and the proposed period of observation/follow-up, taking into account the type and extent of suicide prevention practices being examined.
    • Describe the rationale for the selection of patient measures, including those that can be found within electronic health records and would be commonly captured in other care systems.
    • As appropriate, include patient measures that are consistent with NIMH common data elements efforts (https://grants.nih.gov/grants/guide/notice-files/NOT-MH-15-009.html).
    • Describe how the assessment of suicidal behavior and related outcomes uses strategies that reflect health care system metrics (ICD codes; procedures; billing) as well as patient surveyed data 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.
    • Describe how ED-based suicide prevention practices, with and without telehealth facilitation, will be measured.
    • Detail strategies for examining patient-, provider- and setting-level factors that may impact telehealth implementation and outcomes (e.g., stakeholder beliefs, acceptability of care received; healthcare utilization; costs).
    • Address provisions for clinical management when suicidal behavior is detected. (See NIMH document that 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 to the extent possible via the NIMH Data Archive (NDA; 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.

    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.

     

    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?

    • Does the application describe how the proposed study will contribute to the evidence base for the use of telehealth to support the expanded use of suicide prevention practices in the ED?
    • Is there a compelling justification regarding the potential impact of the proposed telehealth strategy(ies) in terms of their potential to improve detection and management of at-risk individuals?
    • Does the application justify the anticipated practical benefits of the proposed telehealth approach in terms of the hypothesized effect size (e.g., in terms of the number of at-risk individuals identified, the number appropriately referred or treated), as compared to usual care or other alternatives?
    • Does the application make a compelling case that the approach (if safe, feasible and effective) is potentially generalizable, scalable, and sustainable?

    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 intervention 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?

     

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

    • Does the research team have the experience and capacity to carry out a pragmatic study involving suicidal patients seen in EDs and the required expertise in telehealth services?

    In addition, for applications involving clinical trials

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

     

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

    Does the proposed design include innovative elements (e.g., pragmatic trial approaches) and analytic approaches (e.g., propensity analyses; case control), that enhance precision, feasibility, and the potential to yield practice-relevant information?

    As relevant, does the approach 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 sustained improvement in reduced suicide risk over time?

    In addition, for applications involving clinical trials

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

     

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

    • Are strategies that will be used to track ED visits, the provision of specific telehealth services (e.g., screening, brief intervention, referral) and patient outcomes over time clearly detailed and appropriate?

    • Is there a compelling rationale for the approach that will be used to define/measure the suicide preventive practices of interest and examine how those practices impact telehealth capabilities and setting level- factors and individual patient-level suicide events?

    • Does the application describe the specific telehealth components that will be studied and provide the rationale for their inclusion (e.g., suicide risk screening, assessment/ evaluation, within-encounter brief interventions, recommendations for post-discharge or follow-up care)?

    • Is there an appropriate rationale for the design selected (e.g., randomized controlled trial, quasi-experimental design with non-randomized comparison, time series designs) that considers practical constraints, safety and ethical issues, and the tradeoff between maximizing internal and external validity?

    • Is there a plan for assessing proximal and healthcare system component changes and/or enhancements through valid and practical means (e.g., supervision observation, monitoring of health care record indicators)?

    • Consistent with NIMH's experimental therapeutics approach, how well does the application detail plans to examine whether the intervention engages the mechanism(s) presumed to underlie the intervention effects (the proximal mechanism(s) that accounts for changes in clinical/ functional outcomes, changes in patient or provider behavior, etc.)? If the approach includes multi-components, is there an analytic strategy to examine separate component changes, as well overall effects? Does the application include the following: (1) a conceptual framework that links 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 and (3) data analyses that will be used to examine whether the intervention engages the target(s) and whether intervention-induced changes in the target(s) are associated with clinical benefit (i.e., mediation)?

    • Does the application address the potential practicality (uptake, ease of implementation, sustainability) of the telehealth service delivery approaches used?

    • As relevant, does the application describe plans to involve collaborations and/or input from community practice partners/providers, consumers, insurers and/or 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?

    • Are plans to examine moderators detailed? Are data collected in a manner that can facilitate contributing information regarding potential moderators to larger databases for future use?

    • Does the application describe how the assessment of suicidal behavior and related outcomes incorporates strategies that reflect health care system metrics (ICD codes; procedures; billing) as well as patient surveyed data 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)

    • Are plans for examining patient-, provider- and setting-level factors that may impact telehealth implementation and outcomes described (e.g., stakeholder beliefs, acceptability of care received; healthcare utilization; costs)?

    • Does the application include provisions for clinical management when suicidal behavior is detected?  

    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 and safety 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?

    If applicable, 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?

    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 sites, 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

    Specific to applications involving clinical trials

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

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

     

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

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

     

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

     

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

     

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

     

    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).

     

    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. 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)

    Michael C. Freed, Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-3747
    Email: michael.freed@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

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

    Section VIII. Other Information

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


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