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 Application Guide and the NOFO) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The National Institute of Neurological Disorders and Stroke (NINDS) is dedicated to addressing neurological health inequities faced by groups adversely affected by health disparities as we work to improve the neurological health for all people. The NINDS mission is in alignment with the NIH’s overall commitment to ensure that health disparities and minority health research is prioritized across clinical trials and human subject research (NIH UNITE Initiative). NIH-designated populations that experience health disparities (HDPs) include racial and ethnic minority populations (Native Americans, African Americans, Hispanic/Latino Americans, Asian Americans, Native Hawaiians and Pacific Islanders), socioeconomically disadvantaged populations, underserved rural communities, and sexual and gender minority groups.

The NINDS Community-Engaged Health Equity Research in Neuroscience Initiative (HERN) is a multi-pronged approach to 1) Advance community-engaged health equity research across all neurological disease areas within populations that experience health disparities (HDP) and 2) Support collaborations, education and capacity building to conduct such research. This initiative is in direct response to recommendations from the NINDS Health Equity Strategic Plan.

Despite research advances and improvement of health outcomes overall, health disparities within the US as a whole and within neurological disorders and stroke in particular persist. For example, while stroke incidence and mortality in the US declined in the last 20 years, Black Americans remain substantially more likely to have and die from stroke than other racial/ethnic groups. Black and Hispanic individuals have a higher incidence of severe and disabling strokes which may be driven by heterogeneity in the prevalence and severity of risk factors. The extensive body of research on disparities in stroke risk factors, incidence, mortality, prevention, and care across disadvantaged groups illustrates the many challenges that must be overcome to reduce neurological health disparities as well as the many opportunities for advancing understanding and intervention to improve neurological health equity. In addition to well-known racial disparities in stroke, health disparities exist for other neurological disorders including TBI, pain, epilepsy and Alzheimer’s Disease-related dementia and less is known about the factors contributing to differential outcomes and care within and across HDPs.

Health disparities in neurological disorders exist across the lifespan. In pediatric populations, neurological health disparities in acute care settings such as the emergency room impact the diagnosis, treatment and long-term health and longevity from childhood through adulthood. Health disparities in children and youth with epilepsy, for example, have been understudied and more information is needed on the mediating role of social determinants of health (i.e., socioeconomic status, neighborhood/place, insurance status, access to care and child and caregiver health literacy) and potential modifiable biopsychosocial factors contributing to these disparities.

Disparities in neurological diseases can not be explained by biological risk factors alone and social determinants of health (SDOH) are increasingly recognized as important drivers of inequities in neurologic disease and outcomes. I n Healthy People 2030, the U.S. Department of Health and Human Services defines SDOH as the conditions in the environments 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 risks. SDOH-related health disparities may be driven by the complex interplay between determinants or factors at the different levels of the Social Ecological Model of Health (e.g., individual, interpersonal, community, and societal levels). The National Institute on Minority Health and Health Disparities (NIMHD) Research framework offers a multi-dimensional perspective that depicts a wide array of health determinants relevant to understanding and addressing minority health and health inequities. Examples of SDOH across the lifespan can include adverse childhood experiences (ACEs), psychosocial factors, English proficiency, variation in educational experiences, poverty, food insecurity, healthcare access (access to and quality of care, health literacy), place-level determinants (safe housing, transportation, violence, access to nutritious foods and physical activity opportunities, polluted air and water), and life course exposures to racism and discrimination.

In 2020, 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) was convened to determine and address gaps in the health disparities research portfolio, suggest novel methods and collaborations to decrease or eliminate these disparities, and develop recommendations. Input from a comprehensive strategic planning effort including a Request for Information of public input (NOT-NS-20-026), a NINDS health disparities research portfolio analysis, and a three-day virtual workshop "Health Disparities and Inequities in Neurological Disorders Workshop" (HEADWAY) informed the resultant Health Equity Strategic Plan. Outputs and recommendations from this process were submitted to the journal Neurology for review and publication in an online open access format.

Emerging priorities from the strategic planning process included expanding research on disparities in neurological health and disease to other disorders beyond stroke and cardiovascular disease, where clear disparities also exist but for which little research has yet been done. These disorders include traumatic brain injury, Alzheimer’s disease and related dementias, Parkinson’s disease, pain, epilepsy, and a range of other common and rare neurological disorders. 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 (CEr) as a standard research practice to aid in eliminating disparities experienced by vulnerable populations.

Community engagement (CE) is the process of groups of people affiliated by geographic proximity, identity, special interest, or similar circumstances working collaboratively to build relationships and address issues affecting the wellbeing of those people. Many core principles (trust, inclusivity, culturally-centered, etc.) are outlined in the National Academy of Medicine’s Advancing Health Equity and Systems Transformation through Community Engagement strategy for assessing meaningful community engagement. CE should include practices that incorporate genuine bidirectional communication and education about culture, beliefs, motives, health, and clinical research. Continued respectful, equitable, and bidirectional knowledge transfer during community engagement can improve community research participation, trial retention, adherence to the study protocol, and health empowerment. While these principles of community engagement are useful and valuable for any populations of interest, they are critically needed for populations that experience health disparities who have been underrepresented in clinical studies (see: Improving Representation in Clinical Trials and Research and NOT-OD-18-014

In community-engaged research (CEr), scientists or research teams use CE strategies to develop research questions, design studies, collect data, interpret results, or disseminate findings as it relates to the specific community’s health. Incorporation of CE strategies into studies investigating health inequities can promote health and build bi-directional trust thereby reducing barriers that limit research participation, underlie medical mistrust, and drive research exclusion across NIH-designated populations that experience health disparities (HDPs). The information and input iteratively collected throughout the CE process should be visibly reflected across the research study and within the study design. Effective CEr will include plans to secure shared understanding, power and resource sharing, and mutually beneficial dissemination across research and community partners participating in the study. Engaging the community in research contributes to successful health equity study design that is inclusive of HDP participants' ideas, thoughts and beliefs across the research continuum and provides infrastructure to ensure culturally appropriate research strategies, tools, and communication are incorporated throughout the study process. Partnering with the community supports the development of sustainable interventions and the translation of study results into practice. Within the scope of our NINDS HERN Initiative, we specifically focus on CE/CEr with populations that experience health disparities.

Health equity (HE) is the principle underlying the continual process of assuring that all individuals or populations have optimal opportunities to attain the best health possible. Applying the principle of health equity requires that barriers to promoting good health are removed and resources are allocated among populations and/or communities proportional to their need(s) (See more: NIMHD Health Equity). Accordingly, health disparities research frameworks take into account SDOH and other sociocultural factors that influence health outcomes. Thus, community-engaged health equity research advances health equity by utilizing community-engaged research principles and health disparities frameworks to enable studies that have meaningful outcomes for the populations impacted.

Developing diverse and collaborative research teams representing different organizations and institutions facilitates community-engaged health equity research through bi-directional learning and capacity building. One example of a collaborative research team is a minority serving institution (MSI) partnering with an R1 institution/university which receives high levels of federal and/or private funding specifically for their academic research. MSIs are institutions of higher education that serve minority populations. Some of these colleges and universities are located in remote regions of the country, whereas others serve urban neighborhoods. Some are only a few decades old, whereas others, have been striving for more than a century to give their constituents the social and educational skills needed to overcome racial discrimination and limited economic opportunities. Thus, community engagement is an important component of Minority Serving Institutions (MSIs), see: Higher Education Collaboratives for Community Engagement and Improvement , as well as Community-based Organizations (CBOs) and Federally Qualified Health Centers (FQHCs) in that they serve specific populations, including NIH-designated populations that experience health disparities . The HERN Initiative seeks to bolster equitable partnerships between Tier 1 research institutions and one or more of CBOs, MSIs, and/or FQHCs to 1) ensure appropriate and meaningful community engagement, 2) improve recruitment, retention and inclusion of HDPs, and 3) Empower and bolster capacity for CBOs, MSIs and/or FQHCs to develop and build their research infrastructure.

Research Objectives for R01

Applications to this NOFO will propose a research plan to establish clinical trial readiness for community-driven research interventions to decrease disparities in neurological disorders in NIH-designated populations that experience health disparities (HDPs). These clinical studies will utilize community-engaged research and collaborative, multidisciplinary teams to identify, develop, and evaluate strategies to improve outcomes related to neurological disorders in HDPs and fill gaps in clinical trial readiness. Expected outcomes include 1) Identifying and understanding the drivers of health disparities and barriers to neurological health equity, 2) Identifying specific modifiable targets to prevent and/or decrease neurological morbidity/mortality and inequities among HDPs, and 3) Developing future community-driven interventions to decrease disparities and gaps in neurological health among HDPs. Neurological disorders that are known to have health disparities within HDPs, but are not well-characterized by biopsychosocial drivers, SDOH barriers and other modifiable factors will be prioritized.

The goal of this RFA is to utilize multidisciplinary expertise to develop and collect the necessary data with community buy-in to inform and develop a future community-driven clinical intervention to address neurological health disparities. It is not intended to stimulate research that is solely observational or confirmatory of the existence of health disparities. Thus, specific aims should be developed for outcomes that indicate clinical trial readiness.

Specific areas of research interest include but are not limited to conducting community-engaged health equity research to:

• Identify and validate approaches to examine the role of stigma, bias and/or discrimination as risk factors contributing to neurological health disparities at the patient, provider, community and/or systems levels
• Develop strategies to identify and measure specific modifiable social determinants of health that contribute to disparities in neurological disorders
• Elucidate the biopsychosocial mechanisms by which SDOH impact neurological disease
• Develop and validate SDOH-informed instruments to promote detection and assessment of neurological disorder HD specific to populations that experience health disparities
• Examine the role of Adverse Childhood Experiences in neurological health disparities
• Identify strategies to address structural barriers, organizational practices, policies and other social, cultural, and contextual factors that impact disparate neurological health outcomes

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

• HDP Community-tailored outreach, recruitment, retention and inclusion strategies to ensure future statistically robust and feasible trials
• Demonstration of successful community engagement with populations that experience health disparities as evidenced by: development of sustainable community/research partnerships, buy-in surveys and meaningful community engagement metrics (see: the National Academy of Medicine’s Advancing Health Equity and Systems Transformation through Community Engagement)
• Standardized and validated tools and metrics for assessing specific (multi-level and socioecological) drivers of neurological health disparities
• Established collaborative research team with expertise in health disparities, community engagement and neurological disorders and commensurate knowledge/education in cultural humility, equity and inclusion
• Development of community-driven, evidence-based interventions to reduce health disparities for a given neurological disorder in one or more populations that experience health disparities that take into account:
  • Uptake and sustainability
  • Social Determinants of Health barriers
  • Cultural and linguistic adaptations tailored to the population(s) of interest

Collaborative multi-disciplinary research teams with appropriate expertise commensurate with career stage (i.e., demonstrated research emphasis, peer-reviewed publications, prior NIH funding) in the fields of health disparities, community-engaged research and neurological diseases should be developed. Team diversity in career stage, including early career investigators should be included and will be reviewed and programmatically prioritized. In building these teams, applicants should consider:

• Demonstrating equitable partnerships and shared leadership between R1 research institutions with long-standing NIH funding and minority serving institutions (MSIs), Federally Qualified Health Centers (FQHCs) and/or Community-based Organizations
• Methods to support infrastructure development and capacity building within MSIs, FQHCs and CBOs for longevity and future independent community-engaged health equity research in neuroscience.
• Training of all research-related staff in cultural humility, implicit/explicit bias, community-based participatory research (CBPR), and health disparities frameworks

NIH-Designated Populations that Experience Health Disparities (HDPs)

HERN R01 awards will support projects that reflect the HERN Initiative interests to advance neurological 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, and sexual and gender minorities. 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 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 within the research plan and the application budget.

Community Engagement and Research Inclusion (CERI)

A community engagement and research inclusion plan to conduct community-engaged research using community engagement principles outlined above in collaboration with PWLE [HDPs with lived experience (at risk or current/past history of neurological disorders and stroke), and their caregivers] as well as Community Partners (advocates, groups or organizations that represent PWLE) is an essential component of this NOFO. Applications are required to include a Community Engagement and Research Inclusion (CERI) plan submitted as Other Project Information as an attachment (see Section IV). 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.

Plan for Enhancing Diverse Perspectives (PEDP)

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Thus, a plan for enhancing diverse perspectives (PEDP) is required (See Section IV for instructions). Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or populations that experience health disparities (HDPs) participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH’s Interest in Diversity NOT-OD-20-031 for more details. Applications are required to include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV ). The PEDP 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 and view the available PEDP guidance material .

Clinical Trials are not allowed in this NOFO

Applicants wishing to propose clinical trials (i.e., efficacy, effectiveness, feasibility, acceptability, and implementation) through separate NOFOs should consider reviewing submission guidelines listed on the NINDS clinical trials website . For clinical studies, describe the rationale for the study design, population(s) and hypotheses being tested. Describe recruitment and retention plans and back-up strategies that are likely to reduce obstacles to study participation and ensure the appropriate inclusion of participants from NIH-designated populations that experience health disparities. The proposed study design should additionally describe potential biases and/or challenges in the protocol and how they will be addressed.

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
• Applications that do not include a CERI plan
• Applications that do not include a PEDP
• Applications that include clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) will not be accepted

Use of SDOH PhenX Toolkit. Applicants are encouraged to utilize the PhenX Toolkit to maximize comparisons across datasets or studies and facilitate data integration and collaboration. PhenX includes a web-based catalog of recommended SDOH measurement protocols recommended by experts: https://www.nimhd.nih.gov/resources/phenx/

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. NINDS has identified CDEs for many clinical neurological/neuromuscular diseases and types of outcomes (e.g., patient-reported outcomes). NINDS provides resources for CDEs (https://www.commondataelements.ninds.nih.gov/#page=Default) to assist investigators in developing protocols, case report forms, and other instruments for data collection. Investigators are encouraged to consult the NINDS CDE website and describe in their applications any use they will make of these CDEs in their projects.

Multi-level Models. Applicants are strongly encouraged to consider models that hierarchically connect information at different levels of NIMHD's research framework and differentiate between individual and structural factors that contribute to health disparities in neurological diseases.

NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy). For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

Prior Consultation with Scientific/Research staff. Consultation with relevant Scientific/Research staff is strongly recommended, preferably not later than the Letter of Intent due date. If requested by the applicants, staff can advise whether the proposed project meets the goals of this NOFO and the mission of NINDS and discuss responsiveness questions. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO. During the consultation phase, if the proposed project does not meet the programmatic needs of this NOFO, applicants will be strongly encouraged to consider other Funding Opportunities.

PD/PI Meeting Attendance. The NINDS HERN Initiative will require a high level of coordination and sharing between investigators. It is expected that NINDS HERN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HERN Investigators Meeting, as well as other activities.

The National Institute of Neurological Disorders and Stroke (NINDS): The NINDS is interested in applications within the NINDS mission (NINDS Disorders Index: https://www.ninds.nih.gov/health-information/disorders). Research areas include but are not limited to stroke and other cerebrovascular diseases, Alzheimer’s disease and related dementia, vascular cognitive impairment, epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease, and other neurodegenerative disorders, brain trauma, and neurodevelopmental disorders.

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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. 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.

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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 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:

Cheryse A. Sankar, PhD
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 NOFO.

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. The additional instructions apply:

Other Attachments

Community Engagement and Research Inclusion (CERI) plan

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; specifically five components, a) communities of interest, b) community partners, c) partnership agreement, d) incorporation of input, and e) success evaluation metrics. The 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 neurological disorders as well as their caregivers. 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. 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. It is expected that robust CEr 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.). Finally, 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 (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. 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 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from historically underrepresented groups in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/vision/plan-enhancing-diverse-perspectives

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

R&R or Modular Budget

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

R&R Subaward Budget

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

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:

In Research Strategy, applications must address the following points in addition to the SF424 instructions:

Clinical Trial Readiness: The significance section of the research strategy must also include a further subsection with the heading Clinical Trial Readiness . This subsection should describe the need for conducting the trial readiness study at this time. Applicants should describe the need to 1) Develop/validate specific targets, moderators and/or mediators (e.g., SDOH, etc) for future interventions, 2) Determine which HDP populations and/or subpopulations would be most appropriate as study participants, and 3) Determine the optimal plan for ensuring robust and tailored outreach, recruitment and retention of the HDP(s) of interest. 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.

A focus on one or more 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, and sexual and gender minorities is required for this application. Applicants must describe how one or more HDPs will be majority represented enabling 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.

Under the approach section, applicants must include a description and framework of how the PEDP, CERI and Recruitment and Retention plans will complement and inform one another for maximal success.

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 SF424 (R&R) 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 SF424 (R&R) 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.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 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.

In sections 2.4 Inclusion of Women and Minorities and 2.5 Recruitment and Retention Plan applications must address the following points in addition to the SF424 instructions

2.4 Inclusion of Women and Minorities

Application attachment Inclusion of Women and Minorities additional requirements:

• Provide data if available on the demographics of individuals affected by the condition under study in the catchment area for the clinic sites proposed in the application.
• Provide annual milestones for enrollment including numbers by sex/gender, race and ethnicity.
• Identify the person/people in the research team that will carry out the proposed outreach and their qualifications or relevant abilities such as fluency in languages other than English and/or cultural sensitivity.

2.5 Recruitment and Retention Plan

Application attachment Recruitment and Retention Plan additional requirements

• Describe how the proposed recruitment and retention plan is designed to overcome obstacles to study participation. Strategies to overcome obstacles include but are not limited to the following:
  • Broaden the eligibility criteria as appropriate so as not to exclude potential participants for reasons that are unlikely to affect the outcomes of the study.
  • Minimize the burden of participating in the study by reducing the frequency and/or duration of clinic visits and overall time required.
  • Select study sites with ample numbers and diversity of potential study participants.
  • Select study sites that minimize the travel of study participants.
  • Provide support for study participant transportation, accommodations and parking as needed.
  • Provide daycare for family members during study visits.
  • Allow for clinic visits in evenings or during weekends.
  • Integrate remote data collection such as smartphone apps or wearables into the study design while also taking into consideration the need for access to broadband communication networks in rural areas.
  • Establish recruitment, enrollment and/or data collection sites in the community at locations that are convenient, familiar and trusted by potential study participants.
  • Have validated translations of consent forms and other relevant study documents available in languages that help ensure achievement of the planned enrollment.
  • Include study personnel who are bilingual and culturally sensitive to the planned enrollment population. Consider enlisting the help of community ambassadors to build trust in the communities of potential study participants.
• Describe what other research studies may be competing for recruitment of the same patient population at the same clinic sites that are proposed in the application. Describe plans for communicating to potential study participants the options available to them.

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 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 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 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 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 NINDS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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).

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:

• Is there adequate evidence of a significant health burden that impacts neurological health-related outcomes in the population of interest?
• How well does the project assess the impact of the proposed study on neurological health-related outcomes, and on improving health equity for HDPs?
• How well do the community partners and PWLE represent the HDP(s) of interest relative to the study?
• How well does the CERI plan include engagement of community partners and PWLE throughout the research process?
• How well d oes the application adequately 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 the 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 AND Community-Engaged Research? Does the investigative team individually or collectively have a track record of publishing the results of previously completed research?
• How well does the team include research investigators at diverse career stages (e.g., early stage or junior investigators)?
• If the CERI plan includes community partners as Investigators, how well do their experience and expertise fit the goals of the study and the HDP population(s) of interest?

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 to this NOFO:

• How well does the CERI plan: 1) Articulate the roles of all community partners/PWLE and provide sufficient resources to reflect their level of engagement? 2) Outline how specific community partner/PWLE input will be incorporated and applied to influence study process or outcomes? 3) Allow community partners to be full participants at various phases of the research process? 4) Describe methods and 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 do the PEDP, CERI and Recruitment and Retention plans complement and inform one another for maximal success?
• Are study personnel described with the appropriate cultural sensitivity and language fluency to facilitate the recruitment, enrollment, and participation of individuals from the racial and ethnic groups indicated in the recruitment and retention plan?
• How likely is the recruitment and retention plan to achieve the planned enrollment?
• 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 enrollment of appropriate diverse cohort(s) of participants?
• How well does the application describe the demographics of potential study participants at the recruitment sites 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 incorporated into the recruitment and retention plan to enable recruitment and retention of racial/ethnic minoritized populations?
• How well does the application address social determinants of health-related obstacles to recruitment, participation, or retention of HDPs relevant to the specific recruitment strategy proposed within the study design.
• How well does the proposed research incorporate adequate methodological rigor where applicable, including, but not limited to, clear rationale for the chosen model(s) and primary/secondary endpoint(s), clear descriptions of tools and parameters, blinding, randomization, adequate sample size, pre-specified inclusion/exclusion criteria, appropriate handling of missing data and outliers, appropriate controls, preplanned analyses, and appropriate quantitative techniques? Do the applicants clearly indicate 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?

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.

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 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.

Applications will be assigned 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 as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. 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 NOFO.

• 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 providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/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 religious nondiscrimination laws and 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. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

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 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 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

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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: [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]

Cheryse A. Sankar, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-318-2889
Email: [email protected]

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:[email protected]

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 45 CFR Part 75 and 2 CFR Part 200.