National Institutes of Health (NIH)
February 6, 2024 - Participation Added (NOT-AT-24-027) National Center for Complementary and Integrative Health (NCCIH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH) April 24, 2024 Participation Added (NOT-MH-24-245)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Sexual and Gender Minority Research Office (SGMRO)
Office of Behavioral and Social Sciences Research (OBSSR)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
The purpose of this Notice of Funding Opportunity (NOFO) is to support novel and innovative research that examines and/or intervenes on the underlying and multilevel causes, pathways, and factors adversely impacting the health and well-being of persons with disabilities at the intersections of race and ethnicity, and socioeconomic status.
Not Applicable
Dates in bold and italics reflect changes per NOT-MD-24-009
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
March 18, 2024 * | March 18, 2024 * | Not Applicable | July 2024 | October 2024 | December 2024 |
June 05, 2024 * | July 05, 2024 * | Not Applicable | November 2024 | January 2025 | April 2025 |
October 05, 2024 * | November 05, 2024 * | Not Applicable | March 2025 | May 2025 | July 2025 |
February 05, 2025 * | March 05, 2025 * | Not Applicable | July 2025 | October 2025 | December 2025 |
June 05, 2025 * | July 05, 2025 * | Not Applicable | November 2025 | January 2026 | April 2026 |
October 05, 2025 * | November 05, 2025 * | Not Applicable | March 2026 | May 2026 | July 2026 |
February 05, 2026 * | March 05, 2026 * | Not Applicable | July 2026 | October 2026 | December 2026 |
June 05, 2026 * | July 05, 2026 * | Not Applicable | November 2026 | January 2027 | April 2027 |
October 05, 2026 * | November 05, 2026 * | Not Applicable | March 2027 | May 2027 | July 2027 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the 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.
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.
Key Definitions
NIH-designated Populations Experiencing Health Disparities: Racial and ethnic minority populations, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minority groups, and people living with disabilities in the U.S.
Disability: The Americans with Disabilities Act broadly defines a disability as a "physical or mental impairment that substantially limits one or more major life activities (e.g., mobility, cognition, independent living, vision, and self-care) and the ADA Amendments Act of 2008 that added "major bodily functions", to "Major Life Activities." This funding opportunity focuses on persons across the lifespan with congenital, developmental, cognitive, and physical disabilities (e.g., Down's syndrome, cerebral palsy, or injury-related physical impairment or amputation), as well as adults with early or premature onset of a major physical disability that causes long-term impairment or limit(s) functioning indefinitely.
Intersectional Approach: Intersectionality acknowledges that individuals have multiple, interconnected social identities (e.g., gender, racial group, class, sexual orientation, and disability), and these identities intersect to shape their unique experiences and positions within society. For example, intersectionality highlights how racial and ethnic minority persons living with a disability may experience a unique set of challenges that require a more comprehensive approach to addressing discrimination and promoting health equity. Taking an intersectional approach can better predict variations in health outcomes and determine individual or population needs, and ultimately lead to more inclusive and/or multi-level research.
Background
The population of persons living with disabilities in the United States is heterogeneous, estimated at 24-26% of adults and 4.3% of children from various backgrounds, life circumstances, and health conditions. Impaired mobility (13.7%), cognition (10.8%), and independent living (6.8%) are the most common disabilities among adults, and impaired cognition (4.4%) is most common among children. Data indicate that, on average, individuals living with disabilities have poorer health-related quality of life and overall health, as well as decreased healthy life expectancy and longevity compared with people without a disability. Adults living with disabilities have a higher prevalence of preventable, chronic, and complicating comorbidities compared with the overall adult population. Examples include obesity (38.2% versus 26.2%), tobacco smoking (28.2% versus 13.4%), diabetes (16.3% versus 7.2%), and heart disease (11.5% versus 3.8%). Among persons of childbearing age, 12% live with at least one disability and are at a higher risk for maternal morbidity and mortality. Additionally, the objective signs and subjective experiences of persons living with disabilities are often dynamic, changing in nature, quality, and severity over time.
Research Objectives:
The focus of this notice of funding opportunity (NOFO) is to emphasize research at the intersection of disabilities, race and ethnicity, and socioeconomic status (SES) in persons with developmental and physical disabilities. Among racial and ethnic minority groups, the prevalence of living with at least one disability is markedly greater in American Indian and Alaska Native (30%) and Black or African American (25%) populations compared to 20% of White persons. Irrespective of racial and ethnic group, economically disadvantaged persons with disabilities are more likely to experience diminished opportunities for effective independent living driven by factors such as unemployment, adverse living conditions, housing instability, food insecurity, transportation limitations, social isolation, disaster unpreparedness, and low quality of healthcare. Additionally, residents of underserved rural communities are 9% more likely to have any disability and 24% more likely to report having three or more disabilities compared with adults in urban areas. Individuals living with disabilities, who reside in rural areas may also face barriers to healthcare access, accessible transportation, and high-quality education, and vocational or rehabilitation services. Research among sexual and gender minority persons with disabilities is scarce, although it is likely that commonly experienced barriers to accessing culturally competent physical, psychiatric, and specialty healthcare are intensified.
Furthermore, adverse social determinants of health (SDOH) amplify the challenges of health and health-related quality of life (QoL) among youth and adults living with disabilities. Examples include lack of accessible transportation or building entry/navigation, discrimination related to ableism, and clinical misperceptions within healthcare systems that may greatly complicate healthcare access and quality. Moreover, inaccessible and/or non-adaptive clinical facilities, equipment, and communication mechanisms, as well as non-inclusive clinical care guidelines and procedures impede equitable access to appropriate healthcare or lead to erroneous attribution of symptoms related to the primary disability rather than a new or co-occurring diagnosis or health crisis. Greater study is needed to inform appropriate or adaptable clinical practice guidelines for persons living with disabilities with an intersectional lens, as well as to enhance the understanding of the health and health risk behaviors (e.g., alcohol and substance use, prescription misuse, self-injurious behaviors, and interpersonal violence) over the life course. Overall, more expansive research is needed to elucidate the discrete differences, areas of overlap, relationships among factors across the lifespan, and severity of health outcomes across and within populations with health disparities. Therefore, this funding opportunity strongly encourages collaborative, mechanistic, clinical, or interventional research, implementation or translational science, and/or the use of data science research approaches in intersectional areas of study.
Research Objectives:
The overarching goals of this funding opportunity are to support innovative research that focuses on the health (e.g., conditions, outcomes, trajectories, etc.) and healthcare (e.g., modalities systemic or structural factors, access/barriers, service delivery, care quality, utilization, etc.) of persons living with disabilities and the intersections with race and ethnicity, and SES. Research focused on intersections with sexual and gender minority self-identification, and living in underserved rural locations are also of interest.
Projects may include the study of comorbid or co-occurring conditions (e.g., acute infections or chronic diseases); adaptive and maladaptive behaviors; prevention of or interventions for health risks; tailored or innovative health care processes, structures, or systems; healthcare delivery model effectiveness; and clinicians and other health care workers practices and/or biases.
Applications are expected to provide a conceptual model that describes or hypothesizes causal pathways by which clinicians and other healthcare professionals, services, or systems engage persons with disabilities to mitigate health risks, improve health outcomes, reduce health disparities, or compliment health care system.
Applications are encouraged to address more than one level of analysis (e.g., individual, interpersonal, institutional, community, and policy levels), as illustrated in the NIMHD Research Framework. They should also consider factors that will facilitate or serve as barriers to sustainability and/or adoption of healthcare models, practices, or guidelines. Resulting research initiatives will support science that advances our understanding of and efforts to mitigate the underlying causes and pathways adversely impacting the populations of focus.
Research projects for this NOFO can consist of studies that are clinical science, behavioral, epidemiological, evaluative, or observational, as well as implementation studies, pragmatic trials, and cluster randomized trials to assess health care provision, models, delivery, services, and systems in metropolitan or rural areas, regionally, and/or nationally, including the U.S. territories. Projects can involve primary data collection and/or secondary analyses of linked datasets. Projects can include research collaborations across multiple health care settings and academic institutions.
Investigators are strongly encouraged to work collaboratively with community leaders, community-based organizations, and other relevant stakeholders and/or supporting persons with disabilities to support in-depth examination of physical, social, behavioral, ethical, structural, environmental, and policy factors. Community partnerships (e.g., tribal leadership, academic, private, safety-net health systems, community organizations, public health departments, state and local governments, health care professionals, faith-based organizations, and school or childcare settings) are strongly encouraged. Applicants proposing community-engaged research should document existing collaboration with or support from community organizations. Study budgets should provide appropriate levels of funding for community partners commensurate with the roles and level of effort of the community partners in research design and implementation, if applicable.
NCCIH Areas of Interest:
NCCIH will support research that is well aligned with the NCCIH Strategic Plan. Research areas funded by the institute broadly fall into three therapeutic areas, including nutritional, psychological, and physical approaches. These may include the array of natural products derived from plants, fungi, bacteria, marine organisms, or animals, including pro/prebiotics; as well as mind and body approaches such as yoga, massage therapy, meditation, mindfulness-based stress reduction, guided imagery, clinical hypnosis, spinal/joint manipulation, acupuncture, and art- and music-based interventions. Approaches may also be combined (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR). NCCIH is interested in research that takes a transdisciplinary approach and integrates natural, social, and health sciences and transcends traditional boundaries to investigate the multifactorial process of whole person health restoration. For the purposes of this NOFO, NCCIH is interested in research on the contributions of disability status and related factors (e.g., emotional well-being, social determinants of health such as access to affordable complementary and integrative health approaches) on the mechanisms of action of interventions that include complementary and integrative therapeutics. Only Basic and Experimental Studies with Humans (BESH) clinical trials will be supported by NCCIH for such mechanistic studies. NCCIH is also interested in research that investigates the influence of disability status on the utilization and ability of complementary and integrative approaches to improve health outcomes among people from diverse racial, ethnic, socioeconomic populations. For such studies, NCCIH will only support applications in the area of complementary and integrative health that do not propose clinical trials such as analyses of large, nationally representative datasets or registries, or epidemiological/observational studies. NCCIH will not support feasibility or efficacy trials through this NOFO (please see NCCIH Clinical Trial Funding Opportunities instead for feasibility and efficacy clinical trials). Investigators are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact prior to submitting their application to identify the most appropriate NOFO for their research.
National Institute on Minority Health and Health Disparities (NIMHD)
The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities. For this funding opportunity, NIMHD priorities include research that employs an intersectional approach to the study of, or interventions targeting, the health and healthcare of persons living with disabilities. Areas of interest include, but are not limited to, the following:
Specific Areas of Research Interest for Participating Organizations:
NIDDK is interested in research toward improved prevention and management of NIDDK-related diseases and conditions in intersectional communities of people with disabilities. NIDDK mission diseases and conditions include diabetes and other endocrine and metabolic diseases; gastrointestinal, liver, and pancreatic diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases. NIDDK has many research areas within its mission, but all research related to relevant diseases may not be appropriate for NIDDK. Applicants are strongly encouraged to contact NIDDK staff as soon as possible in the development of the application, so that NIDDK staff can help the applicant understand whether the proposed project is within the goals and mission of the Institute.
Specific areas of interest related to persons living with disabilities (PWD) include, but are not limited to, the following:
NIDDK encourages applications that demonstrate consideration of the Tips for Pursuing Competent Health Equity Research (see Appendix G of Pathways to Health for All). This includes applications with interdisciplinary research teams comprised of individuals with a breadth of lived experiences and biomedical scientific expertise deemed necessary to positively inform the study design, research conduct, and applicability of research findings for the populations of interest. Applicants are also encouraged to review additional populations that experience health disparities that may be considered for research submitted to this PAR (see page 10 of Pathways to Health for All).
National Cancer Institute (NCI)
The NCI is interested in promoting research that addresses access and barriers to the delivery and receipt of cancer care that contribute to health disparities for persons with physical and/or sensory disabilities (PWD). Our focus on PWD who have a pre-existing/pre-cancer physical and/or sensory (e.g., vision loss, hearing loss) disability. NCI seeks to generate new knowledge that will help mitigate the stigma of disability and improve access to and delivery of guideline-concordant cancer preventive care and treatment, and utilization of cancer services, particularly for PWD who are members of medically underserved minority or marginalized groups (e.g., racial/ethnic minorities, sexual and gender minorities). Applicants should consider the architectural/environmental, structural, interpersonal, and procedural barriers that limit access to guideline-concordant cancer care.
Research areas of interest include, but are not limited to the following:
National Eye Institute (NEI)
The mission of NEI is to eliminate vision loss and improve quality of life through vision research. NEI invites intersectional research applications that address the health and well-being for people with visual impairment (blindness and low vision) among populations with health disparities. More information regarding NEI priorities are detailed in the institute’s strategic plan.
Areas of specific interest include but are not limited to the following:
The NEI will not support clinical trials that are greater than minimal risk on this funding opportunity. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For additional information on NEI Clinical Trial policies, see NOT-EY-23-001. Applicants are strongly advised to reach out to the NEI Scientific Contact before submitting applications for guidance about NEI’s interests and more information regarding clinical trial designations.
National Human Genome Research Institute (NHGRI)
NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.
In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:
Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.
Additionally, as described in NOT-HG-22-033, NHGRI strongly encourages that the request for an application requesting $500,000 or more in direct costs for any year be sent to the Scientific/Research Contact for PAR-23-309 at least eight weeks prior to the anticipated submission date.
National Institute on Aging (NIA)
The mission of NIA is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences.
NIA uses the definition of disability provided in the Americans with Disabilities Act and ADA Amendments Act of 2008 that added "major bodily functions", to "Major Life Activities".
NIA has the following research interests related to persons living with disabilities:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this NOFO, the NIAMS is interested in intersectional research into improving the health and health care of individuals living with disability among populations that experience health disparities and are patients suffering from a disease within NIAMS core mission. The NIAMS will not support clinical trials through this NOFO. Applications involving clinical trials should instead be submitted to a NIAMS clinical trial specific NOFO (see Clinical Research Grants). Applicants are encouraged to consult with the appropriate NIAMS program staff about potential applications.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
This mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB is interested in projects that address specific needs of populations with disabilities that are experiencing health disparities. Projects may span the development in research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols. Applications developing novel technologies should incorporate a universal design approach and those building on existing technologies should provide significantly improved accessibility and ease-of-use for all.
Research areas of special interest include, but are not limited to the following:
For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
Applicants are strongly advised to reach out to the NIBIB Scientific Contact before submitting applications for guidance about NIBIB’s interests and more information regarding clinical trial designations.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. NICHD is interested in projects at the intersection of disability and individuals other identities, including how multiple identities might interact to exacerbate health disparities. Applications seeking to establish the efficacy or effectiveness of novel interventions should address scalability and sustainability and fully consider the context in which such interventions will be implemented. Visit https://www.nichd.nih.gov/about/org/der/branches and https://www.nichd.nih.gov/about/org/ncmrr for more information about NICHD research priorities.
Research areas of interest include, but are not limited to:
National Institute on Drug Abuse (NIDA)
The mission of NIDA is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA is interested in supporting research relevant to advancing the understanding of the effects of substance use among people living with disabilities and experiencing health disparities. This includes the identification and development of innovative strategies, prevention, and intervention methods, as well as policy changes to reduce negative effects of substance use among this population, specifically among racial and ethnic minorities, sexual and gender minorities, and other underserved populations. Priority areas include but are not limited to research on the following:
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIDCD invites responsive applications addressing the needs of individuals with communication disorders, specifically those disorders that align with the Institute’s scientific programs of hearing, balance, taste, smell, voice, speech, and language. For more information, please see: https://www.nidcd.nih.gov/about/strategic-plans Any applications proposing a clinical trial must meet ALL the following criteria: not require FDA oversight, are not intended to formally establish efficacy, and have low risks to potentially cause physical or psychological harm. Application funded by NIDCD should have budgets less than $500,000 direct costs per year.
National Institute on Drug Abuse (NIDA)
The mission of NIDA is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA is interested in supporting research relevant to advancing the understanding of the effects of substance use among people living with disabilities and experiencing health disparities. This includes the identification and development of innovative strategies, prevention, and intervention methods, as well as policy changes to reduce negative effects of substance use among this population, specifically among racial and ethnic minorities, sexual and gender minorities, and other underserved populations. Priority areas include but are not limited to research on the following:
National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in applications within the NINDS mission (NINDS Disorders Index: https://www.ninds.nih.gov/health-information/disorders). NINDS aims to support multidisciplinary, community-engaged health equity research to identify develop, and evaluate strategies to improve outcomes specifically related to neurological disorders in people living with disabilities among populations experiencing health disparities. Specific areas of research interest include but are not limited to:
Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only Basic Experimental Studies with Humans (BESH) clinical trials, defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena will be supported by NINDS. Mechanistic clinical trials or clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported under this NOFO. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. Applicants are strongly advised to consult with NINDS prior to submitting an application to this NOFO to determine the appropriate funding
National Institute of Nursing Research (NINR)
The NINR supports research to solve pressing health challenges and inform practice and policy optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectional research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.
Applications NOT responsive to this NOFO
Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project. Budget requests exceeding $500,000 per in year in direct costs must be submitted to the respective institute's Scientific Contact no later than six (6) weeks prior to the application deadline.
The scope of the proposed project should determine the project period. The maximum project period is five (5) years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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:
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.
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:
The letter of intent should be sent to:
Sundania J. W. Wonnum, PhD, LCSW
Email: sundania.wonnum@.nih.gov
Page Limitations
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
R&amamp;R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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.
Investigators should include applicable Data Sharing Plan(s) in the application.
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:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the IC Referral Office by email at maryline.laude@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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).
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
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?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
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?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
NOT APPLICABLE
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
NOT APPLICABLE
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review 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 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 . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
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.
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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their 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. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 (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 Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: 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: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Beshaun Davis, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-5098
Email: beshaun.davis@nih.gov
Sekai Chideya-Chihota, MD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-552-2994
Email: sekai.chideya@nih.gov
NIDDK conducts and supports medical research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and in kidney, urologic, and hematologic diseases. Visit NIDDK's Research Programs and Contacts page to identify a scientific/research contact.
Sheba K. Dunston, EdD
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1526
Email: Sheba.Dunston@nih.gov
Sundania J. W. Wonnum, PhD, LCSW
NATIONAL INSTITUTE ON MINORITY HEALTH & HEALTH DISPARITIES (NIMHD)
Email: sundania.wonnum@nih.gov
Cheryse A. Sankar, PhD
National Institute on Neurological Disorders and Stroke (NINDS)
Phone: (301) 318-2889
E-mail: cheryse.sankar@nih.gov
Laura Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: laura.kwako@nih.gov
Cheri Wiggs
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 402-0276
E-mail: cheri.wiggs@nih.gov
Lucia Hindorff, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: hindorffl@mail.nih.gov
Toyin Ajisafe, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-9242
Email: toyin.ajisafe@nih.gov
Moria Fisher Bittmann
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: none
E-mail: moria.bittmann@nih.gov
Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov
Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084
Email: liz.perruccio@nih.gov
Yan Wang, MD, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5032
E-mail: wangy1@mail.nih.gov
Holly Lynn Storkel
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.451.6842
E-mail: holly.storkel@nih.gov
Priscilla Novak, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-496-3136
E-mail: priscilla.novak@nih.gov
Wendy Nelson
National Cancer Institute (NCI)
Phone: (240) 276-6971
E-mail: nelsonw@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov
Christina Rinaldi
National Institute on Drug Abuse (NIDA)
Phone: 301-827-0937
Email: christina.rinaldi@nih.gov
Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov
Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov
Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov
Mutema Nyankale
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (301) 827-6317
E-mail: nyankalem@mail.nih.gov
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov
Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov
Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: samantha.tempchin@nih.gov
Jeni Smits
NATIONAL INSTITUTE ON AGING (NIA)
E-mail: jeni.smits@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
E-mail: crystal.wolfrey@mail.nih.gov
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.