Part 1. Overview Information

Key Dates

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background Alzheimer’s Disease-Related Dementias (ADRD) are neurological disorders with substantial health and financial costs. They affect approximately 55 million people world-wide and have significant disparities in diagnosis, treatment, and outcomes. In the United States, Black individuals are about two times more likely than White individuals to have ADRD; Hispanic/Latino individuals are one and one-half times more likely than White individuals to have ADRD; and Native Americans have high rates of chronic conditions, including conditions that are suspected risk factors for ADRD, such as obesity, diabetes and hypertension. Data on other groups designated by the NIH to experience health disparities (HDPs) is lacking. Optimizing health for the U.S. population requires eliminating disparities, addressing social determinants of health (SDOH), and focused efforts to address issues that impact underserved and marginalized groups.

This funding opportunity is in direct response to recommendations from the National Alzheimer's Project Act (NAPA) Advisory Council's National Plan to address AD/ADRD (Clinical Care 2C, Research 4D, Risk Reduction 3C) and the 2022 ADRD summit (Milestone 1, Milestone 8), including recommendations to:

• improve screening, assessment, and diagnosis for HDPs when commonly used instruments do not apply or lead to misdiagnosis (language, culture, disability)
• prioritize studying the impact of identity, socioeconomic status, and other factors on access to care, diagnosis & treatment, and support
• include historically underserved communities in interventions to address dementia risk factors
• facilitate community engagement in populations experiencing AD/ADRD health disparities
• prioritize research to understand drivers of inequities in cost & access to treatment and care.

In addition to the recommendations from the NAPA Council and ADRD Summit, the NINDS is dedicated to addressing neurological health inequities faced by populations that experience health disparities. A National Advisory Neurological Disorders and Stroke Council (NANDSC) expert working group commissioned by the director of the National Institute of Neurological Disorders and Stroke (NINDS) developed the NINDS Health Equity Strategic Plan.

This strategic planning effort included a public Request for Information (RFI) which demonstrated a strong public interest to develop and support health equity research that focused on Alzheimer’s disease related dementias. Recommendations also emphasize the need to develop research to address SDOH related to neurologic health across the lifespan, with the goal of developing multidisciplinary targeted interventions, co-created with patients, families, and community stakeholders. Across the board, this workgroup recommended that NINDS prioritize the implementation of community-engaged research (CEnR) as a standard research practice to aid in eliminating disparities experienced by populations designated by the NIH to experience health disparities.

Key Definitions

Alzheimer’s Disease Related Dementias (ADRD): ADRDs are the most common forms of dementia that are not Alzheimer’s disease. ADRDs share many cognitive and pathological features with and can be difficult to distinguish from AD. ADRDs include Frontotemporal degeneration (FTD), Lewy body dementias (LBD; including Dementia with Lewy Bodies and Parkinson’s Disease Dementia), Vascular contributions to cognitive impairment and dementia (VCID), Multiple-Etiology Dementias (MED), limbic-predominant age-related TDP-43 encephalopathy (LATE), and post-traumatic brain injury dementias (post-TBI AD/ADRD).

NIH Designated Populations that Experience Health Disparities (HDPs): These awards will support projects that reflect the initiative interests to advance health equity in NIH-designated populations that experience health disparities, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minorities, and people living with disabilities. Thus, a focus on HDPs is required (See Section IV for instructions). Applicants proposing work with American Indian or Alaska Native communities are encouraged to consult American Indian and Alaska Native Research in the Health Sciences: Critical Considerations for the Review of Research Applications: https://dpcpsi.nih.gov/sites/default/files/Critical_Considerations_for_Reviewing_AIAN_Research_508.pdf .

Projects that include populations that identify across more than one group are encouraged. Potential outcomes may reflect health status, disability, quality of life, mortality and morbidity, health behaviors, and access to, utilization of, or quality of health care. Within HDPs, there are subpopulations that have limited English proficiency (LEP). Please note that exclusion of non-English speaking participants without compelling scientific justification is discouraged and appropriate translation, services and resources should be provided for these participants within the research plan and the application budget.

Community Engagement and Research Inclusion (CERI): A community engagement and research inclusion plan is an essential component of this NOFO. In this plan, applicants will clearly describe their community engagement strategy. This plan should explain proposed activities to conduct community-engaged research in collaboration with people with lived experience (PWLE) [HDPs with lived experience (at risk or current/past history of ADRD), and their caregivers] as well as Community Partners (advocates, groups or organizations that represent PWLE). Applications are required to include a Community Engagement and Research Inclusion (CERI) plan submitted as Other Project Information as an attachment and details on the CERI Plan can be found in Section IV (instructions) and V (CERI Review Criteria). The CERI plan will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. Applicants are strongly encouraged to read the NOFO instructions carefully.

Social Determinants of Health (SDOH): According to Health People 2030, social determinants of health are the conditions where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risk. The five domains of SDOH, per Healthy People, are Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood & Built Environment, and Social & Community Context. Examples can include safe housing, transportation, experience of racism or discrimination, educational opportunities, access to nutritious foods or physical activity, polluted air or water, and language and literacy skills.

In addition to considering common data elements/data standards when developing a research proposal, we encourage applicants to consider using existing instruments and other resources to enhance generalizability, interoperability, and data sharing, including:

• PhenX Toolkit SDOH Collection https://www.phenxtoolkit.org/collections/view/6,
• NINDS Common Data Elements https://www.commondataelements.ninds.nih.gov/,

 When appropriate, SDOH instruments or common data elements do not exist for your research question or population, this may be an area of study (see research objectives below).

Additionally, when considering SDOH and sociocultural factors which influence health outcomes, researchers are encouraged to reference existing frameworks and multilevel models to develop their study questions (NIMHD Research Framework, NINDS Social Determinants of Health Framework for Addressing Health Inequities)

Social, Ethical, and Behavioral Implications (SEBI): SEBI research addresses how social, ethical, behavioral, structural, environmental, historical, and policy factors impact diagnosis, treatment, and outcomes in HDP. Examples of issues to consider include structural racism in the health care system, historical mistrust, low health literacy, cultural norms, limited English proficiency, discrimination toward sexual and gender minorities, and religious beliefs. The NINDS SDOH Framework may be used as a tool for determining other potential upstream targets. Frameworks or models, such as the biopsychosocial model of illness may be considered in conceptualizing the multidimensional aspects of ADRD and complex nature of the care coordinating teams. Novel ways of considering social, psychological, behavioral and ethical factors and how they impact patients, caregivers, and families dealing with the reality of their ADRD diagnosis are of particular interest.

Research Objectives

Community engaged research that explores the social, ethical, and behavioral implications (SEBI) and factors associated with disparities may shed light on issues such as distrust of medical research, privacy, consent, transparency, bias and stigma which can lead to disparities among communities who have historically been harmed by or excluded from medical research. These principles likely contribute to disparities in risk for, identification of, and treatment for ADRDs. The goal of this NOFO is to promote research, centered on at least one HDP, that identifies SEBI issues which contribute to ADRD disparities and use this information to develop interventions and/or improve quality of future clinical trial trials (such as improved recruitment, enrollment, and retention of NIH HDPs).

Research topics may include, but are not limited to:

• Historical and current structural barriers that contribute to disparities in ADRD screening, diagnosis, treatment, and outcomes.
• Social and ethical barriers in ADRD related clinical trials within NIH HDPs (e.g. such as consenting with cognitive impairment and limited English proficiency)
• Community engaged strategies and tools to build and restore trust among HDPs for ADRD research
• Differential social and cultural needs for sustainable caregiving in distinct NIH HDPs
• Societal and sociocultural norms that impact early ADRD detection and treatment in HDPs

Specific Areas of Research

The purpose of this funding opportunity is to support projects that develop community-engaged research to understand and address the drivers of ADRD health disparities in diagnosis, treatment, and outcomes among NIH defined HDPs. Specific areas of research interest may include, but are not limited to using community-engaged health equity research strategies to:

• Develop and/or validate SDoH-focused instruments to promote detection and/or assessment of ADRD within a NIH defined HDP.
  • We encourage exploration of existing SDoH-focused instruments that are not validated in certain populations experiencing health disparities
• Examine how social and community-level influences (e.g. state and local policies, cultural beliefs, community and family norms) contribute to ADRD outcomes in HDPs.
• Identify and address unique SEBI issues related to diagnosis, early detection (especially in the primary care setting), caregiving support, informed consent, and access to information related to ADRD within NIH-designated HDPs
• Development of community-driven, evidence-based interventions to reduce health disparities in ADRD in one or more populations that experience health disparities that consider:
  • Uptake and sustainability
  • Social determinants of health barriers
  • Cultural and linguistic adaptations tailored to the populations of interest

Specific Knowledge to be Developed:

Clinical Trial Readiness: Applications to this NOFO will define how their research will contribute to clinical trial readiness for future community-driven research interventions to decrease disparities in ADRD in NIH-designated populations that experience health disparities (HDPs). The expectation is that all applications will advance clinical trial readiness, not that all applicants must be prepared to initiate a clinical trial at the end of their grant. Applications should show evidence of gaps in clinical trial readiness and how their proposed study would fill these gaps to enhance success of a future clinical trial.

Examples of Clinical Trial Readiness include, but are not limited to:

• Develop HDP community-tailored outreach, recruitment, retention, and inclusion strategies to ensure rigorous and feasible clinical trials
• Establishing collaborative research teams with expertise in health disparities, community engagement, and ADRDs as well as commensurate knowledge/education in cultural humility, equity, and inclusion
• Assessing feasibility and acceptability of future community-driven, evidence-based interventions to reduce ADRD health disparities utilizing non-Clinical Trial modalities of feedback such as focus groups, surveys, etc
• Establishing research team and community partnerships in geographic locations that will facilitate future clinical trial enrollment of target HDPs to ensure future rigorous and feasible clinical trials
• Developing and assessing training materials or SOPs for clinicians, community health workers, or other study team members to facilitate future clinical trials within NIH HDPs
• Assessing the validity and acceptability of outcomes measures within NIH HDPs

As clinical trials are not allowed, any pilot studies which measure health related outcomes will not be considered responsive to this proposal. Please contact the Program Director to address questions about CT readiness proposals.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.

Non-Responsiveness Criteria:

Applications deemed to be non-responsive will be withdrawn. The following are considered non-responsive to this NOFO:

• Projects without a focus on one or more NIH-designated Populations that Experience Health Disparities (HDP)
• Projects without a focus on Alzheimer’s Disease Related Dementias (ADRD)
• Applications that include clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) will not be accepted

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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

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 Organizations) are not eligible to apply.

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• 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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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.

eRA Commons ID Requirement for all Personnel on the R&R Senior/Key Person Profile Form: Beginning January 25, 2024, an eRA Commons ID must be entered in the “Credential, e.g. agency login” field for all Senior/Key Personnel and Other Significant Contributors (OSCs) listed on the R&R Senior/Key Person Profile Form. Applicants are encouraged to check that their Commons account is active and confirm that any Senior/Key Personnel and OSCs have active Commons accounts well before applicable due dates. This is likely to impact applications with community partners who have not previously applied for NIH Funding and do not work directly for NIH-funded institutions. The NIH has an FAQ for this policy change (https://grants.nih.gov/faqs#/applying-electronically.htm?anchor=56356) as well as Special Registration Instructions for Unaffiliated/Independent Applicants (https://grants.nih.gov/grants/ElectronicReceipt/UnaffiliatedUserRegistration.pdf). 

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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 the Program Directors for this funding opportunity (Dr. Richard Benson, Dr. Rebecca Hommer, Dr. Carolina Puccini-Mendoza) via a shared inbox:
Email: SEBI-ADRD@ninds.nih.gov

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

This NOFO has an additional required attachment, the Community Engaged Reseach Inclusion (CERI) Plan which is limited to 2 pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments:

The additional instructions apply: The CERI and PEDP are required, applications without either attachment will be withdrawn.

Community Engagement and Research Inclusion (CERI) plan (Required, Maximum 2 pages)

In an Other Attachment entitled “Community Engagement and Research Inclusion (CERI) Plan”, all applicants must include a summary that describes how community engagement strategies and community-engaged research will be incorporated throughout the study; the CERI plan should specifically describefive components:

1. Communities of interest: Community(ies) of interest includes people with lived experience (PWLE; lived experience as a member of an HDP community(ies)) who have or are at risk of developing AD/ADRD as well as their caregivers. 
2. Community partners: The Community partner(s) include those who represent communities of interest. Our working definition of community partner is a person(s), group, or organization with demonstrated experience leading, advocating, representing, or partnering on behalf of the interest of or perspectives of HDP communities. Examples of community partner(s) include: community champions, key informants, community advisory board, patient advisory board, advocacy organization, community organization, community health worker, FQHC social worker, HDP community faith leader, etc. 
3. Partnership agreement: A partnership agreement should describe the roles of community partners, the organizational and decision-making structure for the partnerships and the degree of recurring discussions between research team and community partners.
4. Incorporation of input: It is expected that robust CEnR will include incorporation of input collected through CE strategies in at least two phases within the study: planning/design (i.e., participant outreach, IRB development, advisory board development, etc.), data collection (i.e., culturally appropriate materials, researcher/coordinators/practitioner HDP interviewer style/language, etc.), findings interpretation (i.e., HDP participant research attitudes, cultural context relevant to participant responses, etc.), or communication of findings (i.e., community newsletter, community seminar, health empowerment materials, etc.). 
5. Success evaluation metrics: The CERI plan should describe metrics to evaluate and assess meaningful community engagement.

The CERI plan may be no more than 2 pages in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of meaningful community engagement and community-engaged research elements to describe in the CERI plan include but are not limited to:

• Ensuring that community partners and PWLE represent interests relevant to community of interest described within the study
• Defined expectations of academic partners and community partners, including the composition and expertise of the community partners and stakeholders, the phase(s) (i.e., design, conduction, analysis, interpretation, and/or dissemination) of research the community partner will be engaged in, the program infrastructure and management of partnerships (e.g., memorandum of understanding) co-created with or approved by the community partner, if applicable
• Obtaining and incorporating community partner/PWLE input regarding utilization of appropriate linguistic and cultural competence strategies within the study design (e.g., language translation, cultural adaptation) and ensuring representation of participants who have significant social, economic and/or linguistic disadvantage anticipated to participate in study
• Describing how community partner/PWLE will be engaged at specific phases of the research study and a plan for how their input will be incorporated
• Describing plans for regular recurring reflection/topic discussions with community partner/PWLE and how these discussions will serve goals of the project
• Ensuring appropriate and equitable resources are provided to community partner/PWLE based on their time and effort spent contributing to the study, as well as mutual benefit and recognition (i.e., publication authorship, conference presentation, work group representation, etc.)
• Outlining methods and metrics to monitor community engagement efforts, including a description of how data will be collected within the framework of the grant activities
• The anticipated or planned personal benefits including dissemination of information during and following the study, knowledge and empowerment of community partner/PWLE

Plan for Enhancing Diverse Perspectives 

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

PEDP Implementation Costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Significance:

ADRD Health Burden: Under significance, applicants must provide evidence of a significant health burden that impacts ADRD diagnosis, treatment or outcomes in the population of interest or demonstrate the need for improved data to understand disparities in ADRD outcomes within a given population.

Clinical Trial Readiness: Under the significance section of the research strategy applicants must also include a further subsection with the heading Clinical Trial Readiness  This subsection must describe the need for conducting the trial readiness study at this time. Describe the need to 1) Determine the optimal plan for ensuring robust and tailored outreach, recruitment and retention of the HDP(s) of interest, (2) Assess the validity and acceptability of outcome measures within NIH HDP(s) of interest, (3) Develop and assess SOPs to facilitate future clinical trials, or other CT Readiness components. Describe the potential impact of the proposed studies in addressing significant needs in the design and increasing the likelihood of success of upcoming clinical trials.

Approach:

Under the approach section, applicants must include a description of how the PEDP, CERI and Recruitment and Retention plans will complement and inform one another for maximal success at including a focus on one or more NIH-designated populations that experience health disparities, more detail in the below paragraph. Depending on the population and study design, some of these components may be highlighted in the recruitment and retention plan, rather than the approach.

Applicants must demonstrate how their study design will lead to a majority of study participants identifying as part of one or more populations that experience health disparities, with sufficiently-powered qualitative and quantitative data for each of those groups. If the HDP(s) of focus are racial/ethnic minorities, the inclusion enrollment report must reflect majority representation by one or more HDPs. If the HDP(s) of focus are rural, demonstration of rurality through geographical data (e.g., RUCA codes) and/or recruitment from healthcare systems that serve individuals who live in rural communities must be included. If the HDP(s) of focus include sex/gender minorities (please see NOT-OD-19-139), demonstration through self-identification and/or other information related to pathways for specialty recruitment must be included. If the HDP(s) of focus include socioeconomically disadvantaged populations, demonstration of income, insurance status, or recruitment from healthcare systems (e.g., FQHCs) that deliver care to socioeconomically disadvantaged groups should be included. Within NIH-designated HDPs, there are subpopulations that have limited English proficiency (LEP). Please note that exclusion of non-English speaking participants without compelling scientific justification is discouraged and appropriate translation, services and resources should be provided for these participants in the research plan and the budget. Please note that inclusion of women (NOT-OD-18-014), and children and older adults across the lifespan (NOT-OD-18-116) are required unless there is a justification and appropriate attention to intersectionality with these groups and NIH-designated populations that experience health disparities should be considered.

NINDS urges investigators to follow the NIH guidance for rigor and transparency in grant applications (https://grants.nih.gov/policy/reproducibility/guidance.htm) and additionally recommends the research practices described at https://www.ninds.nih.gov/Funding/grant_policy. This will ensure that robust experiments are designed, potential experimenter biases are minimized, results and analyses are transparently reported, and results are interpreted carefully. These recommended research practices include, where applicable, expressing clear rationale for the chosen model(s) and primary/secondary endpoint(s), describing tools and parameters clearly, blinding, randomizing, ensuring adequate sample size, pre-specifying inclusion/exclusion criteria, appropriately handling missing data and outliers, implementing appropriate controls, preplanning analyses, and using appropriate quantitative techniques. It is also strongly recommended to indicate clearly the exploratory vs. confirmatory components of the study, consider study limitations, and plan for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications.

Investigators should indicate whether data presented or cited in the application as key support for the proposed work were collected, analyzed, and reported in a rigorous and transparent manner as indicated above. A plan to address any ambiguity, weaknesses, or limitations in the prior research should be included in the application. Proposed experiments should similarly adhere to these high standards of rigor and transparency.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Applications involving clinical (i.e. human subjects research) TBI Studies must comply with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics and data sharing policy and data management and sharing plans for TBI research should reflect this. Studies that meet at least 1 of the following criteria (taken from NOT-NS-17-029) must submit their data to the FITBIR Data Repository:

1. TBI-related clinical trials (i.e., studies funded under any of the NINDS Clinical trial FOAs),
2. all unsolicited clinical (i.e., human subjects research) TBI research grants with a budget greater than or equal to $500,000/year in direct costs,
3. NINDS ancillary studies, regardless of budget, to either TBI-related clinical trials or clinical TBI research grants (i.e., human subjects research) with budgets greater than or equal to $500,000/year in direct costs, or
4. clinical (i.e., human subjects research) TBI research grants awarded under funding opportunity announcements (FOAs) with specific requirements for FITBIR data submission.

Clinical TBI studies that do not meet at least 1 of the aforementioned criteria must submit their data to the Meta Studies Module within FITBIR, as opposed to the Data Repository. More information: https://grants.nih.gov/grants/guide/notice-files/NOT-NS-23-046.html. 

For any non-TBI studies, we recommend referencing the NINDS Data Sharing page for additional guidance on selecting repositories and developing your data management and sharing plan (https://www.ninds.nih.gov/funding/preparing-your-application/ninds-data-sharing-information-applicants-and-awardees).

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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 How to Apply - 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 How to Apply - Application Guide must be followed.

Studies submitted to this NOFO must ensure that their study population is majority represented by one or more NIH-designated populations that experience health dispariteis (HDPs). The recruitment and retention plan must include detail on how the team will achieve planned enrollment, including, but not limited to, providing information about how the study team is prepared to recruit the population(s) described, how the geographic region(s) wil facilitate recruitment, how the study team will address barriers to recruitment, and back up plan(s) to achieve desired enrollment goals.

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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 NINDS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

Applicants are required to follow the instructions for post-submission materials, as described 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.

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). As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project.

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 to this NOFO: 

• How well does the proposal demonstrate evidence of a significant health burden that impacts ADRD outcomes in the population of interest?
• How likely is the project, if successful, to increase the chances for success of a future clinical trial designed to test interventions to reduce disparities in ADRD prevention, detection, or outcomes?
• How well do the community partners and PWLE represent the HDP(s) of interest, relative to the study?
• How well does the application describe whether prior research that serves as the key support for the proposed project employed rigorous practices such as minimization of potential experimenter biases, robust experimental designs, transparent reporting of results and analyses, and careful interpretation? Does the application adequately describe ambiguity, weaknesses, or limitations in rigor of prior research, if applicable? 

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 to this NOFO: 

• How well does the team of research investigators demonstrate expertise in health disparities research AND neurological disease research in ADRDs AND Community-Engaged Research? Does the investigative team individually or collectively have a track record of publishing the results of previously completed research?

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?

Specific to this NOFO:

• To what extent do the proposed community engagement activities in the CERI Plan meaningfully contribute to innovation?

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 to this NOFO:

• How well does the CERI plan: 1) Articulate the roles of all partners/PWLE and provide resources to reflect their level of engagement? 2) Outline how specific partners/PWLE input will be incorporated? 3) Allow community partners to be full participants at various phases of the research process? 4) Describe metrics for evaluating successful community engagement? 5) Describe anticipated personal and research benefits to community partner(s) and PWLE? 6) Describe plans to disseminate information back to the community partners/PWLE and the community as a whole? 7) Describe management of the community partnership or infrastructure to resolve conflict? 8) Incorporate relevant organizations, groups, and/or stakeholders relevant to the study and HDP population(s) of interest? 
• How well does the CERI Plan include engagement of community partners and PWLE throughout the research process? 
• How well do the PEDP, CERI and Recruitment and Retention plans complement and inform one another for maximal success? 
• How likely is the study design and recruitment and retention plan to achieve the planned enrollment, including majority enrollment of one or more populations that experience health disparities?
  • Are study personnel described with the appropriate cultural sensitivity and language fluency to facilitate the recruitment, enrollment, and participation of individuals from the racial & ethnic groups indicated in the recruitment and retention plan?
  • How well does the recruitment and retention plan describe primary and back-up strategies that are likely to reduce obstacles to study participation and ensure majority enrollment of one or more populations defined by the NIH to experience health disparities (could also use HDP if previously defined)?  
  • How well does the application describe the demographics of potential study participants and is there justification that the sex/gender, race and ethnicity of the actual enrollment will match the planned enrollment based on availability of potential participants?
  • How well does the application utilize appropriate linguistic and cultural competence strategies to enable recruitment and retention of NIH-designated HDPs?
  • How well does the application address social determinants of health-related obstacles to recruitment, participation, or retention of HDPs relevant to the study design?

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?

Specific to this NOFO: 

• To what extent will the features of the environment described in the CERI plan contribute to the success of the proposed community engagement activities and the success of the project overall?

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.

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 the NINDS, 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 NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council (NANDSC). The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Representation of health disparity populations

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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.6. 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 NOFO 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:

• Federal-wide Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 

HHS recognizes that NIH 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 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. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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.

• Recipients  will provide updates at least annually on the implementation of the PEDP

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 NOFOs 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – 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.

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: https://www.era.nih.gov/need-help (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

Richard Benson M.D., Ph.D., Rebecca Hommer M.D., Carolina Mendoza-Puccini, M.D.

National Institutes of Neurological Disorders and Stroke (NINDS)
Email: SEBI-ADRD@ninds.nih.gov

Kristina Mclinden, Ph.D.
Division of Neuroscience (DN)
National Institute on Aging (NIA)
Phone: 301-827-2563
E-mail: kristina.mclinden@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.nih.gov

Philip E. Smith
National Institute on Aging (NIA)
Phone: 301-555-1212
E-mail: philip.smith2@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.

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 2 CFR Part 200.