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
Urgent Award: COVID-19 Mental Health Research (R01 Clinical Trial Required)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • August 31, 2022 - Notice of Change to PAR-22-112, "Urgent Award: COVID-19 Mental Health Research (R01 Clinical Trial Required)”. See Notice NOT-MH-22-300
Funding Opportunity Announcement (FOA) Number
PAR-22-112
Companion Funding Opportunity
PAR-22-113 , R01 Research Project
Assistance Listing Number(s)
93.242
Funding Opportunity Purpose

NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). See "Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus" as renewed in "Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic". This Funding Opportunity Announcement (FOA) aims to address urgent, time-sensitive mental health research questions related to COVID-19, including broader secondary impacts of the pandemic as well as research on the intersection of mental health, COVID-19, and HIV. Research supported will improve public health in the near term by informing responses to the current pandemic through rapid acceleration of research to address access, reach, delivery, effectiveness, scalability and sustainability of health assessments and interventions to respond to new and worsening mental illness and HIV-related outcomes among those who experience COVID-19 as well as the broader population impacted by the pandemic. All research is anticipated to focus on particularly vulnerable populations based on existing evidence of increased mental health symptoms and illness and preexisting health disparities.

Key Dates

Posted Date
January 31, 2022
Open Date (Earliest Submission Date)
March 25, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date(s)

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
April 25, 2022 Not Applicable April 25, 2022 June 2022 Not Applicable September 2022
August 25, 2022 Not Applicable August 25, 2022 October 2022 Not Applicable December 2022
December 23, 2022 Not Applicable December 23, 2022 February 2023 Not Applicable April 2023

All applications are due by 5:00 PM local time of applicant organization. 

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.

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

Expiration Date
December 24, 2022
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

NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).

This Funding Opportunity Announcement (FOA) aims to address urgent, time-sensitive mental health research questions related to COVID-19, including broader secondary impacts of the pandemic and research on the intersection of mental health, COVID-19, and HIV. Research supported will improve public health in the near term by informing responses to the current pandemic through rapid acceleration of research to address access, reach, delivery, effectiveness, scalability and sustainability of health assessments and interventions to respond to new and worsening mental illness and HIV-related outcomes among those who experience COVID-19 as well as the broader population impacted by the pandemic. All research is anticipated to focus on particularly vulnerable populations based on existing evidence of increased mental health symptoms and illness and preexisting health disparities.

Background

The importance of expanding research on the impact of the COVID-19 pandemic on mental health is prioritized by the substantial funding proposed in the Fiscal Year 2022 budgets from both the House and Senate. Although funds have not been appropriated and NIMH operates under a Continuing Resolution that maintains funding at the previous year's level, NIMH acknowledges the contribution that research could make to understand, prevent, and treat mental illness in the context of the pandemic. Mental illness is associated with increased morbidity and mortality from COVID-19, even after adjusting for other medical comorbidities. Such elevated risks are particularly true for those with severe mental illness and in Fall 2021, the CDC added mood disorders and schizophrenia spectrum disorders to the list of medical conditions associated with higher risk for severe COVID-19. There are shared risk factors in terms of socioeconomic status, disparities, prevalence of mental health disorders in congregate settings (e.g., inpatient treatment settings, homelessness shelters and community unhoused groups, jails and prisons) but it is also likely that mental illness makes compliance with preventative behaviors more challenging or that physiologically leaves people with mental illness more susceptible to the virus. Similarly, people infected with SARS-CoV-2 have higher incident mental illness relative to uninfected persons which may be related to acute social and economic consequences of testing positive for SARS-CoV-2, physiological processes of the immune response to the virus, or other aspects of post-acute sequelae of SARS-CoV-2 and recovery from COVID-19.

Beyond the direct role of the virus related to mental illness, broader population impacts are widespread. Across the lifespan and in several areas of illness, new and worsening mental health symptoms and diagnoses are widely reported. Although depression and anxiety are most commonly studied, other illness including autism, eating disorders, and schizophrenia spectrum disorders have also been identified as adversely impacted by the pandemic. Mental health symptom complaints have risen and fallen with the rate of COVID-19 cases but remain elevated relative to similar periods prior to the pandemic. Additionally, although many of the increased symptoms are anticipated to resolve without intervention, particularly if the pandemic is well controlled, there is clearly increased need for mental health services for those whose symptoms are more chronic and impairing.

An increased proportion of emergency services were for mental health complaints in the first year of the pandemic. The proportion of youth and adult emergency encounters rose substantially relative to 2019 domestically and in several international settings where data is available. Additionally, although there was not a corresponding increase in deaths from suicide nationwide, substantial increases for specific demographics occurred (by age, sex, and racial or ethnic population). For people who utilize emergency mental health care in the pandemic, challenges remain with how they are transitioned to other care settings. Additionally, information is needed to better triage to the necessary level of care with limited capacity across multiple levels of healthcare. The existing mental health care system often does not reach all people who would benefit and requires scalable solutions. Deployment-focused interventions and alternatives to traditional services that rely on an available workforce to meet emergent psychiatric needs are urgently needed.

Beyond emergency services, additional burden of illness during and following the pandemic cannot fully be met through a shift of services to telehealth. Although use and availability of telehealth increased as a result of policy changes early in 2020, there are limits to scaling the mental health workforce, acute vacuums of service by regions without any adequate provision, a substantial digital divide where not all people have access to broadband or familiarity/comfort in the use of technology to facilitate healthcare, and some forms of existing care that are not adaptable to telehealth (e.g. brain stimulation, some autism services). Research beyond 1:1 delivery of interventions by healthcare providers to patients within traditional healthcare settings is needed. Digital health incorporates mobile health (mHealth), telemedicine/telehealth, and health information technology (mobile phones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data. Digital health interventions may yield data to demonstrate capacity to improve the accuracy and efficiency of assessment and the effectiveness and quality of intervention and service delivery. However, if studies do not address known challenges with uptake, engagement and adherence/sustained use of technology-based approaches, and consider privacy and other safety/ethical considerations associated with the use of technology for research and clinical purpose, ultimately there will be little public health benefit. To be successful in the digital health interventions space, researchers must acquire and leverage partnerships with digital health developers and existing well-established digital health delivery platforms, so that the research follows a deployment-focused model of services design and testing.

Public health needs exacerbated by the pandemic also require community interventions delivered in places of residence, community-based organizations, child welfare and human service settings, workplaces, businesses, stores and restaurants, schools, criminal justice settings, faith-based organizations, public works and facilities, recreational settings, and green spaces. One workplace-related to the pandemic that may require special attention is acute healthcare settings. Those working in hospitals and emergency departments have experienced disproportionate personal health risk, unsustainable workloads related to poor outbreak control in the community, challenges balancing personal and professional responsibilities, and elevated exposure to death which may be compounded by frustration that many deaths may have been preventable. In many areas, staffing shortages and high turnover indicate attention is warranted to bolster this essential population. Community approaches that intervene on the workplace level rather than relying exclusively on healthcare workers to individually seek services may strengthen the health of the healthcare workforce. Another critical aspect of public health are the patients who have not re-engaged in care after service disruptions. Again, rather than engaging individuals exclusively through their healthcare provider, systemic factors and a community approach focused at multiple levels can efficiently improve reach, sustainability, and delivery of care.

Preexisting mental health disparities have been worsened by the pandemic. Racial and ethnic minority populations have experienced higher rates of infection and loss of life, acute adverse employment and economic impacts, and disproportionate representation among essential workers experiencing increased risk of the virus and burden of stress to meet demands of workplaces. The disproportionate mental health burden impacting these communities is consistent and evident in surveillance reports of mental health symptoms. Other groups including sexual and gender minorities have similarly reported disproportionate impacts of the COVID-19 pandemic on mental health as have socioeconomically disadvantaged and underserved rural populations. Addressing mental health disparities, including those associated with the COVID-19 pandemic, is a priority of NIMH.

Research Scope and Objectives

This FOA will support clinical trials to rapidly establish the efficacy and/or effectiveness of interventions or implementation of evidence-based interventions to address mental health (and HIV-related prevention and care) needs related to the COVID-19 pandemic across the full lifespan, particularly among populations that experience health disparities and other vulnerable groups. NIMH requires an experimental therapeutics approach for the testing of therapeutic, preventative, and services interventions, in which studies evaluate not only the clinical effect of the intervention but also generate information about the mechanisms underlying a disorder or an intervention response. Therefore, applications are encouraged to specify intervention target/mechanism and assess whether intervention-induced changes in the target account for the hypothesized outcome. In the case of services interventions or the deployment of implementation strategies for evidence-based interventions, targets/mechanisms might involve change in service-user, family and/or provider behavior, or in organizational/system-level factors to improve access, engagement, continuity, quality, equity, and/or value of services. Studies adapting interventions for racial and ethnic minority populations (e.g., American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, and Native Hawaiians and other Pacific Islanders), sexual and gender minorities, socioeconomically disadvantaged populations, underserved rural populations or based in low and middle income countries (LMICs) are encouraged to provide an empirical rationale for the adaptation/augmentation target and a clear hypothesis and plan to address the target mechanism by which the adapted intervention will enhance outcomes. See the Support for Clinical Trials at NIMH web page for additional information.

Interventions developed in this FOA are not anticipated to be at a 1:1 level of healthcare providers and patients, given public health needs related to the pandemic exceeding existing workforce and infrastructure capacity in many settings. Instead, intervention delivery and setting should use digital health or community approaches to extend existing workforce and infrastructure in healthcare and other human service sectors. Existing evidence-based interventions or approaches delivered via digital health platforms or community organizations or other scalable deployment models are encouraged to extend access, reach, delivery, effectiveness, scalability and sustainability of interventions for new or worsened mental health related to the pandemic.

This FOA is intended to support research that reflects a timely deployment-focused model of intervention and services design and testing that considers the perspective of key stakeholders (e.g., service users, providers, administrators, payers, or community organizations addressing health needs) and the characteristics of the settings (e.g., resources, including workforce capacity; existing workflows) where optimized health interventions and services are intended to be implemented. This attention to end-user perspectives and characteristics of clinical and/or community practice settings is intended to ensure that the resultant interventions and service delivery strategies are effective and scalable. It is also deliberate to ensure that the research results will be relevant and helpful for the intended populations or communities quickly once demonstrated through research.

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

Interventions selected for evaluation are expected to have robust preliminary data and conceptual model to support late-stage intervention research, existing social and behavioral science theories to support their use, as well as known mechanisms of action for why they would be appropriate to address health needs related to the pandemic for populations experiencing health disparities or other vulnerable groups. Research supported in this initiative is expected to provide empirical evidence regarding intervention impact at scale on outcomes of interest and to explicitly inform whether the intervention engages intervention targets/identified change mechanisms previously established as relevant to reduce the burden of illness in health disparity and vulnerable populations. Depending on the nature of the intervention, the “targets” or mechanism of action might vary but should be empirically justified. Valid and reliable measures of change in the hypothesized target(s)/mechanism(s) will provide useful information about key change mechanisms that account for effects. Targets/mechanisms might involve change in service-user, family and/or provider behavior, or in organizational/system-level factors to improve access, engagement, continuity, quality, equity, and/or value of services. With appropriate justification, effectiveness testing of preventive and therapeutic interventions might be warranted in the absence of extensive efficacy data (e.g., when the intervention is primarily comprised of research informed strategies, but the specific strategies that haven't been extensively tested in combination or with a specific target population; when there is strong pilot data and the goal is to conduct further testing in a deployment-focused manner to expedite the translation into practice). Studies adapting interventions for populations with health disparities are encouraged to provide an empirical rationale for the adaptation/augmentation target and a clear hypothesis and plan to address the target mechanism by which the adapted intervention will enhance outcomes. In the case of multi-component interventions, strategies would address the target mechanisms corresponding to each intervention component, as appropriate in the effectiveness context.

Given urgent public health needs, research designs should consider communities or platforms to support intervention testing with appropriate settings, samples, and number of participants to achieve adequate statistical power such that the research follows a deployment-focused model of services design and testing. Beyond pragmatic consideration of public health needs to extend the capacity and reach of healthcare providers, both digital and community interventions provide unique opportunities to potentially improve understanding and treatment of health impacted by the pandemic. Mobile and wireless devices provide unique functionality and real-time data collection and feedback. Data from existing electronic health data in conjunction with digital health interventions can inform the clinical epidemiology, service utilization, and response to treatment, within or across large systems responsible for health service delivery to inform timing and targets for intervening. Ultimately, research supported through this FOA should be sufficient to address if the intervention should be delivered at scale to address health needs resulting from this pandemic or future large-scale events. Additionally, the research should be conducted in service settings with sufficient users for evaluation of likely uptake. Applicants should provide evidence that supports the feasibility of enrolling and retaining the proposed number of participants within the study time frame.

For many outcomes, well-established assessments and measures exist and pandemic specific measure of potentially relevant information, including mitigation behaviors exist in Common Data Elements collections and should be used.

This FOA only allows projects of a maximum of 3 years with the objective of timely results to respond to urgent public health needs. Clinical trials that require longer than 3 years to conduct should see NOT-MH-22-100, "Notice of Special Interest (NOSI): COVID-19 Pandemic Mental Health Research."

Areas of High Program Priority

Services and Intervention Research

  • Intervention effectiveness research to address vaccine hesitancy, uptake, and implementation among mental health populations.
  • Research to evaluate whether evidence-based prevention interventions in middle- and high-school settings decrease risk for mental health problems.
  • Projects to develop and test tools that would enable health and social service workers to have real-time access to resources for case management and referral to medical/psychiatric treatment, as well as social support services, to meet the complex needs of persons with mental illness.
  • Research to determine the effectiveness and utility of technology-enabled screening to identify/triage those in immediate need of in-patient behavioral health, medications, and opioid replacement therapy. Higher priority research would include evaluation of participant follow through and outcomes related to point-of-care triage and referral to services (e.g., web-based or other self-care, and/or telephone counseling that supports individual brief cognitive behavioral therapy (CBT) for distress, online group interventions, etc.).
  • Intervention research that includes testing of technology to leverage/build on the available response workforce to enable practical, scalable, and sustainable mental health screening, triage, and prevention/treatment interventions along a continuum of intensity for mental disorders across the lifespan, particularly for high-risk populations both within and outside healthcare settings (i.e., school or workplace screening is also of interest). Interventions appropriate for mass trauma response are of interest (e.g., Psychological First Aid [PFA]; enhanced PFA; self-guided and professionally assisted skills-based interventions, internet-based interventions for managing common posttraumatic symptoms and stress related symptoms and conditions; brief CBT-based approaches for distress, and Collaborative Care programs) as are those to improve de-escalation of suicidal crises, reduce suicide attempt risk, and/or improve post-acute recovery for youth at elevated risk for self-injurious thoughts and behaviors treated in acute care settings.
  • Research to improve engagement and continuity of care including approaches to facilitate (re)connection to care for persons with serious mental disorders who experience disruption in services.
  • Clinical trials that incorporate strategies to address the digital divide (e.g., augmented digital interventions with non-digital components) as it relates to vulnerable populations, including low-income communities, populations without access to broadband signals or adequate devices, as well as older adults and their caregivers, who may not easily use or access many digital interventions.
  • Strategies to identify previously understudied or unknown services and care delivery pathways that emerged as a result of the pandemic and how to capitalize on these novel digital health pathways, such as ways to segment levels of care (e.g., crisis line support that could transfer to higher levels of telehealth care for more complex cases when in person treatment is not feasible), bridge interventions and therapy or treatment sessions and promote between-session skill practice/acquisition and facilitate the transition back to face to face care, when needed.
  • Studies to refine and test adaptive interventions and just-in-time interventions that can be ‘pushed out’ via mobile technology based on information regarding the individual’s current state. For example, interventions that prompt users to complete an assessment at specific times during the day or passive ascertainment of changes in clinical status, immediately followed by provision of behavioral support, such as self-management strategies.
  • Strategies for promoting adherence to and sustained use of digitally-assisted interventions.

HIV/AIDS Research

  • Clinical trials of communication strategies to address HIV and SARS-CoV-2 testing and vaccine hesitancy, to enhance SARS-CoV-2 vaccination series initiation, completion and booster follow-up as recommended for people living with HIV or populations with a high HIV incidence.
  • Clinical trials of community approaches for effective information dissemination related to HIV/SARS-CoV-2 screening that apply strengths-based approaches to community engagement and frameworks that emphasize resilience, empowerment, positive reflections and amplify the voices of communities placed at risk that result in increased uptake of screening and linkage to care.
  • Research to promote HIV self-testing and SARS-CoV-2 self-testing including use of digital technologies, supports, or innovative strategies (e.g., secondary distribution, or communications-based) to increase frequency and timeliness of return of results, confirmatory or regular testing, contact tracing and linkage to ongoing HIV and COVID-19 prevention or treatment services.
  • Clinical trials of programs that integrate SARS-CoV-2 testing with HIV testing or other screenings, or which leverage existing HIV testing programs, strategies, and initiatives to expand access to and increase SARS-CoV-2 testing in marginalized communities.
  • Clinical trials to address CNS complications of COVID-19 in people living with HIV that aim to test evidence-based therapeutic interventions.
  • Clinical trials of interventions such as those conducted through telemedicine that promote continuity of HIV prevention and care services, including mental health services, during the COVID-19 pandemic particularly for populations experiencing health disparities.
  • Clinical trials of interventions such as those conducted through telemedicine that promote continuity of HIV prevention and care services, including mental health services, during the COVID-19 pandemic particularly for populations experiencing health disparities.
  • Studies testing implementation strategies to promote uptake of evidence-based interventions to address HIV-related prevention and care needs as they relate to the COVID-19 pandemic, such as interventions designed to strengthen infrastructure and streamline procedures for integrated HIV and SARS-CoV-2 testing programs, community-based interventions to encourage integrated HIV and SARS-CoV-2 self-testing in relevant populations, and telemedicine to address COVID-19-related barriers to HIV prevention and care continuity, such as social distance measures.

Global Mental Health Research

  • Clinical trials of digital health and systems interventions in low- and middle-income countries (LMICs) to improve de-escalation of suicidal crises, reduce suicide attempt risk, and/or improve recovery for populations at elevated risk for self-injurious thoughts and behaviors treated as a result of the COVID-19 pandemic.
  • Research focused on digital health and systems interventions in LMICs to screen and manage common mental health disorders (e.g., depression, anxiety) for populations at elevated risk (including mobile populations) of worsening morbidity as a result of the COVID-19 pandemic.
  • Research focused on integrating and increasing screening of mental health and substance use symptoms in populations accessing primary care as a result of the COVID-19 pandemic.

Additional areas of research relevant to COVID-19 and mental illness should be discussed with scientific program staff for technical assistance with NIMH priorities and potential overlap with existing research efforts.

Applications Not Responsive to this FOA

Applications that are not responsive to this FOA and will be withdrawn prior to review:

  • Applications unrelated to changes in health due to the COVID-19 pandemic.
  • Projects that are exclusively qualitative.
  • Applications where the research question focuses primarily on adapting existing face-to-face treatments to new platforms (e.g., Skype, Zoom, or other platforms requiring 1:1 engagement).

Applicants are strongly encouraged to reach out to scientific contact to discuss.

Data Harmonization

NIMH is dedicated to advancing science by improving the yield and impact of its research portfolio. One way to accomplish this is to encourage investigators to use a common set of tools and resources to facilitate collection of common data elements (CDEs) or, in the case of existing data/records apply common constructs. NIH has worked with relevant communities to develop and provide access to tools and resources that can improve consistency of data collection (e.g., mental health research collections). NIMH strongly encourages investigators collecting data to use these resources as they select COVID-related instruments for their proposed studies and devise programs to construct research data files. This is particularly important for efforts to rapidly assess the needs and impact of COVID-19 across different population groups, particularly vulnerable populations. .

The NIH Public Health Emergency and Disaster Research Response (DR2) includes COVID-19 related survey instruments and additional information such as the domains assessed, protocols, and a wide array of data collection tools and resources used in other public health emergencies and disasters (including in pediatric populations. The PhenX Toolkit hosts a collection of COVID-19 related item-module protocols drawn from the surveys listed in DR2. In addition, the PhenX Toolkit has a large collection of well-established and vetted phenotypic measurement protocols, including social determinants of health collections. These protocols are suitable for inclusion in COVID-19-related studies, enabling data harmonization across studies.

Applicants are still expected to abide by the data sharing expectations in NOT-MH-19-033 and the common data element expectations in NOT-MH-20-067.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $750,000 direct costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

  • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Email:nimhpeerreview@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

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

  • Address the potential benefit of the intervention/service delivery approach in terms of both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches.
  • Address the feasibility of enrolling and retaining the proposed number of trial participants within the study time frame.
  • Address the degree to which the proposed intervention/service delivery approach is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service structures (including MH financing), and typical service use patterns.

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

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan

Sharing Data via the NIMH Data Archive:

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

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

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

Foreign Institutions

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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 NIMH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA:

Does the application adequately address both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches?

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

Investigator(s)

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

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

Innovation

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

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

Approach

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

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

Specific for this FOA:

Evaluate the adequacy of the data sharing plan.

Are the methods proposed for enrolling and retaining the required number of trial participants feasible within the study time frame?

If the approach is successful, is it scalable and could it be disseminated into practice given typically available resources (e.g., trained, skilled providers), typical service structures (including health care financing), and typical service use patterns?

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

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)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate objective review group(s) convened by NIMH.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

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

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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)

Division of AIDS Research

Pim Brouwers, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3863
Email:ebrouwer@mail.nih.gov

Division of Neuroscience and Basic Behavioral Science

Susan Koester, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email:koesters@mail.nih.gov

Division of Services and Intervention Research

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

Division of Translational Research

Susan Borja, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1252
Email:susan.borja@nih.gov

Center for Global Mental Health Research

Leonardo Cubillos, M.D. M.Ph.
National Institute of Mental Health (NIMH)
Telephone: 301-827-9095
Email:Leonardo.cubillos@nih.gov

Office for Disparities Research and Workforce Diversity (ODWD)

Dawn Morales Ph.D.
National Institutes of Mental Health (NIMH)
Telephone: 301-827-9668
Email:dawn.morales@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)

Theresa Jarosik 
National Institute of Mental Health (NIMH) 
Telephone: 301-443-3858
Email: theresa.jarosik@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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