National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
R01 Research Project Grant
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
This initiative encourages research projects that aggregate existing data sets to examine mechanisms by which factors at multiple levels (e.g., policy, society, community, school, family, individual) contribute to, exacerbate, or reduce disparities across development in order to inform understanding of disparities in risk and etiology of mental disorders, to facilitate the development and refinement of preventive and therapeutic interventions for differentially affected individuals, and/or to inform targets and timing of services interventions to address disparities in access, engagement, quality and outcomes of mental health services.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 18, 2022 | Not Applicable | Not Applicable | March 2023 | May 2023 | July 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.
Not Applicable
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.
Background
A health disparity (HD) is a health difference that adversely affects disadvantaged populations, based on one or more of the following health outcomes: 1) higher incidence and/or prevalence and earlier onset of disease; 2) higher prevalence of risk factors, unhealthy behaviors, or clinical measures in the causal pathway of a disease outcome; 3) higher rates of condition-specific symptoms, reduced global daily functioning, or self-reported health-related quality of life using standardized measures; 4) premature and/or excessive mortality from diseases where population rates differ, and 5) greater global burden of disease using a standardized metric.
Disparities in mental health are significant and easily documented. Deaths by suicide, for example, are much more common in American Indians and Alaska Natives compared to the general population. American Indian/Alaska Native (AI/AN) communities have the highest rates of suicide of any racial/ethnic group in the United States. In addition, suicide rates among Black youth more than doubled between 1999 and 2017, and Black youth under 13 years of age are now approximately twice as likely to die by suicide as their White counterparts. The rate of deaths by suicide is also higher in rural areas.
People from racial and ethnic minority populations, as well as those from lower socioeconomic strata, and those who live in rural communities, are less likely to have access to mental health care and more likely to receive lower quality care. Although racial/ethnic minorities generally have lower prevalence of mental disorders than Whites, they tend to have more severe, persistent, and disabling mental disorders and are less likely to access mental health services, less likely to receive quality mental health care, and more likely to have poorer mental health outcomes.
Sexual and gender minority (SGM) individuals experience significant health disparities, including mental health (e.g., mental health disorders, suicide attempts, deaths by suicide) and substance use. These mental health disparities are largely accounted for by their disproportionate exposure to stigma-related stress compared to heterosexuals.
In addition, significant disparities exist regarding access to diagnosis, interventions and services for individuals with autism spectrum disorder (ASD). Research suggests that underserved and diverse individuals with autism are diagnosed at a later age than White, well-resourced counterparts and face substantial delays in accessing treatment and/or services post diagnosis. To better address these disparities, data on disparities reduction among autism diagnosis, interventions and services are needed.
These and other mental health disparities disadvantage members of minoritized groups and increase the burden of mental illness on individuals, families, and communities. The National Institute of Mental Health (NIMH) supports research aimed at understanding and reducing mental health disparities. Aggregating data sets provides the potential to examine subpopulations and low base rate behaviors.
While disparities in risk for and rates of mental health conditions and disparities in service access, engagement, service delivery, and outcomes have been documented across a variety of conditions, mechanisms by which factors at various levels (e.g., policy, society, community, school, family, individual) contribute to these disparities are less well understood. Understanding the mechanisms that underly disparities and identifying strategies to address them has proven elusive, in part because most studies do not include samples that support the identification of subgroup differences and exploration of associated mechanisms. This Funding Opportunity Announcement (FOA) encourages research using the R01 mechanism to aggregate existing data sets to examine mechanisms by which factors at multiple levels (e.g., policy, society, community, school, family, individual) contribute to, exacerbate, or reduce disparities across development in order to inform understanding of disparities in risk and etiology of mental disorders, to facilitate the development and refinement of preventive and therapeutic interventions for differentially affected individuals, and/or to inform targets and timing of services interventions to address disparities in access, engagement, quality and outcomes of mental health services. This FOA encourages the integration of existing data sets to enhance sample sizes and power in order to be able to examine subgroups and low base rate behavior.
Purpose/Research Objectives:
Given there are many existing, untapped data resources, the purpose of this (FOA) is to provide an opportunity for investigators to integrate and analyze datasets in a cost-efficient manner, to yield novel findings, identify key scientific gaps, and inform future research investments focused on a better understanding of risk and protective factors at multiple levels (e.g., policy, society, community, school, family, individual) and ways to intervene to reduce mental health disparities and increase mental health equity. A better understanding of mechanisms and trajectories at multiple levels can facilitate the development of novel preventive and therapeutic interventions, the refinement of interventions that can be used to effectively reduce disparities and increase equity, and targets and timing of services interventions to address disparities in access, engagement, quality and outcomes of mental health services.
Scale and Scope of Studies Covered Under this Announcement
This FOA is intended to support the integration and analysis of datasets in a cost-efficient manner, to yield novel findings, to identify key scientific gaps, and to inform future research investments focused on increased understanding of mental health disparities and ways to intervene to increase mental health equity. NIH defines health disparity populations as racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), and any subpopulations that can be characterized by two or more of these descriptions. The minority racial and ethnic groups defined by OMB are American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or other Pacific Islander. The ethnicity used is Latino or Hispanic. Although these five categories are minimally required, the mixed or multiple race category should be considered in analyses and reporting, when available.
Applications that address questions using combined datasets are particularly encouraged to include: 1) the identification of risk and protective factors for important mental health outcomes; 2) moderators and mediators of risk for important mental health outcomes; 3) identification of subgroups of populations (e.g., age, gender, racial/ethnic, cultural, SGM, and rural) as they pertain to low base rate behaviors; and 4) research that is poised to identify mutable mechanisms that could be used to inform targets and timing of preventive, therapeutic, and/or services interventions.
The National Library of Medicine has a website that lists NIH Data Sharing Repositories, where data dictionaries of shared studies can be reviewed for potential relevance. The NIMH Data Archive offers tools, such as Global Unique Identifiers (GUIDs) to address participant privacy and allow data to be anonymized and shared via the NIMH Data Archive Tools. Sharing of datasets for broad research use is strongly encouraged, when appropriate. Inter-university Consortium for Political and Social Research (ICPSR) maintains a data archive of more than 250,000 files of research in the social and behavioral sciences and can potentially be used as a resource for finding relevant data. The Compendium of Federal Datasets Addressing Health Disparities is a compilation of information on health equity data.
NIMH encourages the use of state-of-the-art computational approaches. For applications that propose data harmonization and analytic/computational approaches for which there is limited feasibility information, a sound rationale should support why the proposed approach is the most appropriate and likely to generate an exceptionally high impact if successful.
When multiple datasets are proposed to be aggregated, there should be a clearly documented commitment by the data owners and the informed consent documents should permit such aggregation as well as depositing the primary data in a relevant data archive. If the application includes leveraging healthcare data or social media data, there should be included appropriate permissions for using these data for research purposes, and there must be ways for other researchers to apply to use those data. There should be specific proof-of-concept test(s) that indicate how the proposed approaches will be tested and validated, along with alternative strategies should an effort fail to perform as expected.
NIMH encourages harmonization of databases where data can be publicly shared. When possible, investigators funded under this FOA are encouraged to share data via the NIMH Data Archive. The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., electronic medical record data; National Death Index acquired data).
Protection of Human Subjects: 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.
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.
NIMH Specific Areas of Research Interest:
Projects proposed under this announcement could involve, but are not limited to the integration and analyses of datasets from:
- Studies designed to specifically examine risk or protective factors for important mental health outcomes across different developmental stages among multiple disparities populations.
- Studies designed to examine mental illness trajectories within and across disparities populations.
- Studies designed to examine the role of resilience in mental health for populations with mental health disparities.
- Studies designed to answer questions about mental health, autism spectrum disorders, and associated behaviors, including substance use, within and across disparities populations.
- Prevention and treatment intervention studies to examine mental health outcomes for subpopulations and low base rate behaviors (e.g., suicide ideation and behaviors, psychosis).
Particular research topics of interest under this announcement include, but are not limited to:
Epidemiology, Etiology, Trajectories
- Integrate longitudinal studies to gain a better understanding of risk and protective factors at different levels of analysis for important mental health outcomes at different stages of development for subpopulations.
- Capitalize on larger samples to study the interaction of community, social, structural, and environmental factors with individual level risk and protective factors.
- Examine cultural sensitivity of tools used to assess risk and protective factors and/or how the identity of research personnel or assessment setting may interact with participant responses.
- Examine larger samples for distribution of diagnostic categories and the degree to which differences are driven by differences in risk factors or clinician bias.
- Identify strategies and benefits of community engagement in the research process.
- Integrate data sets to examine the role of structural racism, racial discrimination, racial identity, and racial socialization in mental health outcomes for racial/ethnic minorities.
- Integrate data sets to allow for improved decision making about workforce staffing and/or the delivery of evidence-based treatment to underserved populations.
Preventive Interventions
- Capitalize on larger samples in integrated data sets to examine moderators of response and the impact of prevention interventions on mental health outcomes in populations experiencing mental health disparities.
- Examine whether disparities populations experience improved mental health and mental health care outcomes from culturally adapted interventions.
- Aggregate prevention clinical trial datasets to better understand long-term and/or cross-over effects, unanticipated beneficial effects, of preventive interventions on reducing mental health disparities (e.g., do social-emotional learning interventions implemented early in life reduce later risk for suicide in health disparities populations?, do home visiting interventions implemented during infancy and toddlerhood reduce risk for later mental health and substance use difficulties?).
- Examine whether preventive interventions delivered early in development reduce mental health disparities in childhood, adolescence, and adulthood.
- Examine systems-level preventive interventions to assess whether they reduce disparate mental health outcomes among disparities populations.
- Integrate prevention trial data sets with data on social determinants of health to better understand why some subgroups may derive differential levels of benefits from evidence-based interventions; see PhenX Toolkit, PhenX Measures for Social Determinants of Health Collections.
Treatment Interventions
- Capitalize on larger samples in integrated data sets to examine the impact of interventions on subpopulations.
- Examine the impact of racism and discrimination as interventional targets/mechanisms of action on mental health outcomes.
- Evaluate unidentified or understudied social, behavioral, organizational, and institutional targets such as stigma, bias, discrimination, racism, etc. that may have high impact in exacerbating disparities in mental health outcomes across multiple and intersecting disparities populations.
- Integrate suicide prevention data sets to examine whether the interventions reduce risk for subpopulations (e.g., racial/ethnic minority, sexual and gender minority).
- Merge and analyze data from mental health, autism spectrum disorders and/or substance abuse treatment studies to determine whether treatment reduces risk for suicidal ideation and behaviors and for whom (e.g., racial/ethnic minority, sexual and gender minority).
Services and Dissemination & Implementation Studies
- Novel analyses (e.g., computational risk approaches, machine learning methods, intersectional analyses) of large datasets to address research questions about mental health outcomes in populations experiencing health disparities. Linking data sets may allow for tracking individuals over time to examine longer-term outcomes, and/or enabling the development of natural experiments through instrumental variables or propensity score matching.
- Research that gains a better understanding of how to improve access, continuity, engagement, equity and value of mental health services.
- Research that identifies mutable patient, provider, clinic, payer, and/or policy-level factors that impact access, continuity, utilization, quality, value, and outcomes, including disparities in outcomes, and/or adoption, scalability, or sustainability of mental health services.
- Studies employing novel methods (e.g., complex systems and simulation modeling approaches) to address the multilevel nature of disparities in mental health services and identify effective interventions to reduce these disparities.
- Studies that compare alternative financing mechanisms that promote high quality, clinically effective, and efficient mental health care across settings and populations and discourage low-value services.
- Research that rigorously evaluates public and commercial financing mechanisms that cover integrated care packages for individuals with complex needs (e.g., combination psychopharmacology, psychotherapy, rehabilitative therapy, care coordination interventions).
- Projects that study the impact of national, state, and/or healthcare system rules and regulations on participation in provider reimbursement and/or waiver programs.
Non-responsive Areas of Research
Applications proposing any of the following research topics will be identified as non-responsive and will not be reviewed:
- Applications that do not focus on primary variables of relevance to understanding mental health disparities and ways to intervene.
- Projects that primarily seek to document mental health disparities in healthcare without a clear and actionable plan to reduce those documented disparities.
- This FOA is intended to support re-analysis of existing data: collection of new data is not allowed for this FOA.
- Applications that propose analysis of data from a single study/trial or parallel analyses of separate studies/trials.
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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIMH intends to commit $2 million in total costs in FY2023 to fund 3-5 awards.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
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.
1. Eligible Applicants
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) 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.
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.
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.
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)
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: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Research supported through this FOA should focus on novel, transformative approaches that leverage and aggregate existing datasets to advance our understanding of mental health disparities.
Significance
- Describe how the proposed research substantially advances understanding above and beyond the original analyses and results of the individual studies that are included and integrated as part of the current project.
- Describe the value and appropriateness of aggregating the identified datasets and/or probing existing large healthcare records and how it will yield insight regarding the understanding of etiology, trajectories, and/or mitigation of mental health disparities.
- Justify the goals of the application in the context of the current state of the science/analysis/technology as a benchmark. Applicants must make a compelling case regarding the identified research gap and how their proposed research will advance understanding of mental health disparities.
- Describe how additional research avenues might germinate from the proposed project.
Investigators
- Without duplicating information in the biosketches, describe the Investigator team's expertise regarding 1) integrating data sets, 2) methodology and statistical/computational approaches for analyzing integrated data sets, and 3) mental health disparities.
Approach
- Describe strategies that will be used to harmonize data across studies/trials that used different measures to assess the same construct and/or to derive latent variables for key constructs of interest that were not directly assessed.
- Describe analytic methods and statistical/computational approaches that will be applied to understand mental health disparities and its mitigation.
- Provide detailed power analyses for key aims.
- Describe the characteristics of the samples with regards to the nature of the health disparities of focus and plans for examining subgroup analyses.
For applications that involve integration of prevention and/or treatment intervention data sets:
- Detail plans to examine mechanisms and mediators of risk trajectories of intervention outcomes, as appropriate.
- Address plans for examining moderators of risk and intervention response (i.e., differences across subgroups).
- Provide detailed power analyses for key aims and other analyses (e.g., to identify moderators of response and/or explore subgroup analyses)
Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes operationally-defined indicators of progress at critical junctures. The milestones should be tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project. Timelines and milestones should include the activities necessary to integrate data sets.
Letters of Support: When multiple datasets are proposed to be aggregated, a clearly documented letter by the data owners must be provided in the application with documentation that the informed consent documents permit such aggregation. Likewise, if the application includes leveraging healthcare data or social media data, appropriate permissions for using these data for research purposes must be included.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
- Where possible (e.g., permitted by appropriate consent), harmonized data sets should be submitted to the NIMH National Data Archive and serve as a resource to the research community.
Sharing Data via the NIMH Data Archive: To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-19-033). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDA.
To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA web site provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. The NDA Data Sharing Plan is available for review on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.
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.
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
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.
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.
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, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
NIMH has released expectations for collecting common data elements when an application involves human research participants. Details can be found at NOT-MH-20-067 and the NIMH webpage on Data Sharing for Applicants and Awardees.
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.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: Research supported through this FOA should focus on novel, transformative approaches that leverage and aggregate existing datasets to advance our understanding of mental health disparities.
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:
- How does the proposed research substantially extend beyond current and previous federally and privately supported activities?
- How important is the value of aggregating the identified datasets and/or probing existing large healthcare records? How will the proposed project yield insights regarding the understanding of etiology, trajectories, and/or mitigation of mental health disparities?
- How compelling of a case has been made regarding the identified research gap and how the proposed research will advance understanding in the area of mental health disparities, in the context of the current state of the science?
- How compelling of a case does the application make regarding additional research venues that might germinate from the proposed project?
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?
Specific for this FOA:
- How well does the study team do in including appropriate expertise regarding: 1) integrating/harmonizing data sets, 2) methodology and statistical/computational approaches for analyzing integrated data sets, and 3) mental health disparities?
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?
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:
- How well does the application describe and justify the strategies that will be used to harmonize data across studies/trials, including plans that will be used to integrate data from studies that used different measures to assess the same construct and/or to derive latent variables for key constructs of interest that were not directly assessed?
- How well are analytic methods and statistical/computational approaches that will be used to better understand mental health disparities and/or its mitigation appropriately described and justified?
- As appropriate, how does the application examine the adequacy of the plans to examine mechanisms and mediators of risk trajectories or of intervention outcomes?
- How well does the application provide detailed and convincing power analyses for key aims and other analyses (e.g., to identify moderators of risk/response and/or explore subgroup analyses)?
- How is the sufficiency of the detailing of the sample characteristics described with regards to the nature of the health disparities of focus and plans for examining subgroup analyses?
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?
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.
Timeline and Milestones
- Are the proposed milestones tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project? Do the timeline and milestones include the activities necessary to integrate data sets?
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
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will 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.
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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
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.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Eve E. Reider, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-1496
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]
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.
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.
and Human Services (HHS)
