Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
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 Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
Office of The Director, National Institutes of Health (OD)
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.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Sexual and Gender Minority Research Office (SGMRO)
Office of Research on Women's Health (ORWH)
R01 Research Project Grant
This initiative will support (1) observational research to understand the role of structural racism and discrimination (SRD) in causing and sustaining health disparities, and (2) intervention research that addresses SRD in order to improve minority health or reduce health disparities.
July 20, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| August 24, 2021 | Not Applicable | August 24, 2021 | November 2021 | January 2022 | April 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Key Definitions for the FOA:
Discrimination: A socially structured action that is unfair or unjustified and harms individuals and groups. Discrimination can be attributed to social interactions that occur to protect more powerful and privileged groups or institutions at the detriment of other groups. Racism refers to discrimination based on race or ethnicity.
Structural discrimination refers to macro-level conditions (e.g., residential segregation) that limit opportunities, resources, and well-being of less privileged groups (Healthy People 2020, https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health/interventions-resources/discrimination).
Structural racism and discrimination (SRD): For the purposes of this FOA, SRD refers to structural discrimination on the basis of race/ethnicity and/or other statuses, including but not limited to gender, sexual orientation, gender identity, disability status, social class or socioeconomic status, religion, national origin, immigration status, limited English proficiency, or physical characteristics or health conditions.
NIH-designated Populations with Health Disparities: Racial and ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities in the U.S. (see https://www.nimhd.nih.gov/about/overview/).
Background
There is increasing recognition that racism and discrimination contribute to poorer health outcomes for racial/ethnic minorities and other populations that experience health disparities. In fact, all populations with health disparities experience increased exposure to racism and/or other forms of discrimination over the life course. There is also a growing societal recognition that racism and discrimination extend beyond the behavior of individuals to include SRD, which is embedded in historical societal, institutional, organizational and governmental structures through formal and informal processes, procedures, and practices that limit both opportunities and resources to segments of the population. SRD is supported by the power structures that exist in society and in the institutions that are most likely to influence health outcomes.
Despite this enhanced awareness, racism and discrimination are not routinely included as determinants of health in biomedical research. Health research on racism and discrimination to date has largely focused on interpersonal interactions, and to a lesser extent, one specific form of SRD, residential segregation. Typically, such research focuses on the adverse health consequences of SRD exposures. Less research has explored the resilience among populations exposed to SRD or community strategies to resist or mitigate historic or contemporary SRD exposures. Additionally, intervention research has rarely emphasized reduction of SRD as a strategy to improve health and reduce disparities. Research on mitigation of SRD is needed to inform health care and social policies at all levels.
Health research and interventions need to routinely incorporate constructs and measurement of SRD across multiple socioecological domains and levels of influence in order to improve minority health, promote health equity, and eliminate health disparities (see the NIMHD Research Framework for more information: https://www.nimhd.nih.gov/about/overview/research-framework.html). Examples of domains in which SRD may occur include, but are not limited to, the following:
Research Objectives
This initiative will support observational or intervention research to understand and address the impact of SRD on minority health and health disparities.
Projects must address SRD in one or more NIH-designated populations with health disparities in the US and should address documented disparities in health outcomes. Applications are expected to provide a justification for why the specific types of SRD included constitute SRD, such as how the racism or discrimination is structural rather than reflecting individual-level behavior and how the SRD results in differential treatment or outcomes for less advantaged individuals, groups or populations. For example, with a project examining discriminatory school disciplinary practices, documentation of different overall rates of student suspensions or expulsions by race/ethnicity would not be sufficient to label this pattern as SRD. However, different rates of student suspensions or expulsions by race/ethnicity for the same type of student behavior or violation could be evidence of SRD. Applications are also expected to provide a conceptual model identifying hypothesized pathways between the SRD and health outcomes. Potential health outcomes may reflect health status; health condition-specific or all-cause disability, quality of life, mortality and morbidity; biological measures that reflect cumulative exposures to and effects of SRD; health behaviors; or access to, utilization of, or quality of health care.
It is also expected that projects will collect data on SRD beyond individual self-reported perceptions and experiences to include data at organizational, community or societal levels. Potential data sources for SRD may include but are not limited to U.S. Census data, birth and mortality records; health surveillance data; crime statistics; traditional and social media data, school-based or educational data; labor statistics; voting records; local, state, and Federal law and policies; home ownership covenants; and organizational/institutional mission statements, policy guidance, operating procedures, or other relevant documents.
Projects are expected to involve collaborations with relevant organizations or groups or stakeholders, such as academic institutions, health service providers and systems, state and local public health agencies or other governmental agencies such as housing and transportation, criminal justice systems, school systems, patient or consumer advocacy groups, community-based organizations, and faith-based organizations. Multidisciplinary research teams, including researchers from areas outside of the health sciences, such as economics, education, history, criminology, law, and political science, are encouraged.
Observational Studies: Projects may (1) examine the impact of SRD on health, and/or (2) evaluate the impact that existing efforts to address SRD (e.g., laws, policies, programs, organizational practices and procedures) have on the health of individuals, families, and communities. Projects may involve collection of primary data/and or analysis of existing data and may involve quantitative or mixed methods approaches. Projects must be exclusively domestic, including U.S. territories. Projects using longitudinal designs or multiple sites are strongly encouraged, as are projects examining resilience in the face of exposure to SRD.
Intervention Studies: Projects may focus on health promotion, treatment, and/or prevention. Interventions may focus primarily on addressing SRD to improve health outcomes, or SRD may be included as one of several determinants of health addressed to improve health outcomes. For both types of intervention approaches, interventions must directly address the cause or source of SRD, not just help individuals or populations to cope with SRD. To this end, it is expected that investigators will collaborate with leadership from organizations, agencies, or programs where the SRD is originating from or being sustained (e.g., a project addressing SRD in the workplace should involve organizational leaders, human resource managers, or other relevant personnel involved in establishing, maintaining, or enforcing workplace policies and practices rather than only involving employees within a workplace). It is also expected that interventions will involve other relevant personnel or individuals within the setting (e.g., teachers, clinicians, co-workers, bystanders) as appropriate to enact changes to SRD, not just those who are directly experiencing SRD.
Research designs should allow for the assessment of mechanisms through which the intervention modifies SRD and how these changes result in improvement in the targeted health outcomes. Mechanisms of interest related to SRD include changes to behaviors, environments, or policies at the interpersonal, organizational, neighborhood/community, or societal level.
Cluster randomized designs for all types of intervention studies are strongly encouraged, as are research designs comparing interventions with and without SRD components. It is expected that the interventions will have potential for sustainability in the intervention setting after the project is over as well as scalability to be implemented in other settings.
Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
Applicants are strongly encouraged to assess social determinants of health using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org), as appropriate..
Applications Not Responsive to the FOA
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.
Specific Areas of Research Interest
NIMHD encourages projects that use approaches that encompass multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, health system) and multiple levels (e.g., individual, interpersonal, community, societal) to understand and address the impact of SRD on minority health and health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants of interest).
Areas of specific interest to NIMHD include but are not limited to the following:
NCCIH promotes research on the use of complementary and integrative health approaches for improving minority health and eliminating disparities in health conditions such as mental health, emotional well-being, behavioral health, or pain. Complementary approaches include those with physical and/or psychological therapeutic inputs, often called mind and body approaches (e.g., acupuncture, yoga, tai chi, qi gong, meditation, hypnosis, music therapy, art therapy, spinal or chiropractic manipulation, and massage) as well as approaches with dietary or nutritional therapeutic inputs, or considered natural products (e.g., botanicals, probiotics/microbials, naturally derived peptides, dietary supplements, and special diets). Integrative approaches include therapies that combine complementary approaches with conventional medical interventions such as pharmacologic, surgery, or device-based treatments.
Areas of interest to NCCIH include but are not limited to:
NCI is committed to eliminating cancer related disparities and promoting equity in cancer prevention, diagnosis, treatment, and survivorship. For this FOA, NCI will accept intervention projects focused on addressing structural/institutional racism/discrimination (SRD) that influence cancer-related outcomes -- from early detection through end of life. Projects submitted to NCI may focus on cancer prevention, diagnosis, treatment, and/or survivorship based and provide a conceptual model identifying hypothesized pathways or mechanisms between the SRD and cancer-related outcomes. Areas of specific interest to NCI include multilevel interventions focused on addressing SRD to improve cancer outcomes, or interventions that address several determinants of health in addition to SRD.
NCI areas of interest in intervention research include, but are not limited to:
NEI will consider applications within our mission areas of preventing, treating, or reversing vision loss and addressing the special health problems and requirements of the visually impaired, with special emphasis on structural racism influences on the delivery of eye health care in underserved populations.
NHGRI is interested in supporting both observational and interventional research that 1) will advance understanding of how SRD intersects with and impacts the field of human genomics, the practice of genomic medicine, and other uses of genomic information that impact health outcomes; or 2) will identify effective strategies for addressing SRD at various levels of influence within and across organizations, institutions, or groups that directly and indirectly contribute to health disparities in genomic medicine. NHGRI defines genomic medicine as use of genomic information in clinical care and the health outcomes associated with that clinical use at an individual, group, and population levels. Areas of specific interest include but are not limited to the following:
Applicants are encouraged to incorporate the measures from PhenX Toolkit (https://www.phenxtoolkit.org/), whenever possible.
In general, NHGRI supports studies that provide generalizable methods and knowledge that can be applied across genomics. Approaches that use a particular disease or organ system as a proof of principle, but can show that methods, outcomes and/or knowledge gained are generalizable, may be in scope for NHGRI. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function also may be in scope for NHGRI.
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. Applications relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center.
Applicants are strongly encouraged to contact the NHGRI program directors listed below to discuss the relevance of their proposed topic(s) to the research mission of NHGRI.
The NHLBI is interested in the following research topics:
NIA promotes research related to aging and life course health and well-being, including research on Alzheimer’s Disease and related dementias (AD/ADRD). A strategic priority of NIA is understanding the environmental, sociocultural, behavioral and biological drivers of health inequities and disparities related to aging and AD/ADRD. NIA also supports research to develop strategies for the improvement of health among midlife and older adults in racial minority and other populations that experience health inequities/disparities. These priorities are outlined in NIA’s strategic directions for health disparities research and the NAPA Health Disparities milestones and reflected within NIA’s Health Disparities framework.
NIA encourages investigations of the impacts of the multiple pathways of Structural Racism and Discrimination (SRD) and subsequent health consequences on individuals across the adult lifespan. NIA also encourages research that will investigate how SRD works synergistically with other mechanisms (or forms) of racism (e.g. individual or cultural racism) to influence health outcomes.
Applicants proposing to develop interventions are expected to proactively identify a theory or model that applies to the intervention proposed and the critical variables expected to result in change. Applications are required to use an appropriate experimental design to test the proposed theory, to identify the essential components of complex interventions, or to elucidate the mechanism(s) by which an intervention exerts its effects. For the development of behavioral interventions, applicants are encouraged to articulate their research aims and the stage of intervention development proposed using the NIH Stage Model framework.
NIA interests include, but are not limited to, the following:
NIAAA is interested in prevention, health services and treatment interventions that address the impact of structural racism and discrimination on the development, course and recovery from alcohol misuse and alcohol use disorders. While observational research might be part of formative work necessary to develop effective interventions, the focus of the proposed research must be on interventions to address alcohol problem. Areas of interest to NIAAA include but are not limited to:
NIAID supports basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases, with the goal of developing new therapies, vaccines, diagnostic tests, and other technologies. Research areas include microbiology and infectious diseases, HIV/AIDS and HIV/AIDS-related research, immunology, allergy, transplantation, and biodefense. NIAID is interested in intervention research within the scope of NIAID’s mission that will develop and evaluate strategies that mitigate the impact of structural racism and discrimination (SRD).
Specific areas of interest to NIAID include, but are not limited to:
HIV/AIDS Research
Allergy, Immunology and Transplantation
Infectious Diseases
NIAMS encourages research designed to understand and address the impact of SRD on minority health and health disparities, among underserved and minority populations who are also at risk for or who are patients with NIAMS diseases of interest (arthritis, musculoskeletal, skin). NIAMS has interest in research understanding and addressing macro-level factors that underlie SRD and subsequent health consequences.
Areas of specific interest to NIAMS under this RFA include but are not limited to:
Observational research with focus on:
Intervention research with focus on:
NIBIB supports the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care.
Areas of specific interest to NIBIB under this FOA include. but are not limited to the following:
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 (see NIBIB's program areas) 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.
NICHD seeks applications that will address questions relevant to the NICHD mission and should align with the NICHD Strategic Plan.
NICHD is interested in the following populations: Infants, children, adolescents, and individuals in the transition from adolescence to adulthood; pregnant and lactating women; men and women of reproductive age with regards to reproductive health; girls and women from pre-puberty through perimenopause with regards to research on gynecological and/or reproductive health; individuals of any age with intellectual delays and/or disabilities. NICHD is also interested in research on how parents and other caretakers and/or family members exposure to SRD affects health outcomes for the NICHD populations of interest. In addition, NICHD is interested in research on how prospectively measured exposures to SRD in childhood affects adult health outcomes. NICHD is interested in both observational and intervention research, and, among observational research projects using longitudinal designs, is particularly interested in use of population-representative data.
NICHD is interested in the following health and health-related outcomes: Maternal and infant mortality and morbidity, adolescent and young adult mortality and morbidity; contraceptive use and non-use; reproductive health, gynecological health, and fertility; and, for NICHD populations of interest, access to health care and diagnosis and treatment of health problems. NICHD is interested in research on all the domains in which SRD may occur that are listed in this RFA, with particular interest in educational settings; the criminal justice system, including the juvenile justice system; and gynecological/reproductive health settings. NICHD is also interested in research on SRD that affects exposure to violence among NICHD populations of interest.
The National Center for Medical Rehabilitation Research within NICHD seeks applications for intervention research on individuals with physical disabilities. Areas of interest include but are not limited to referrals for and access to health care and inpatient and outpatient rehabilitation services for both primary and secondary conditions, and outcomes related to improving functional outcomes.
NIDA is interested in supporting observational/etiologic, prevention, treatment, and health services research to address the impact of structural racism and discrimination on substance use, substance use disorders, substance use consequences, and comorbid conditions including HIV. Topics of interest include but are not limited to:
NIDCD encourages either observational or interventional projects that aim to better understand and address the impact of SRD on minority health and health disparities as they relate to the mission areas of hearing, balance, taste, smell, voice, speech, and language across the lifespan. Areas of interest include but are not limited to applications that address the influence and mitigation of SRD on:
NIDCR is interested in observational research aimed at understanding the role of structural racism and discrimination (SRD) in contributing to oral health disparities. Additionally, interventional research that addresses SRD, with the goal of improving minority oral health and reduce oral health disparities, is of interest through this FOA.
Areas of specific interest to NIDCR include, but are not limited to, the following:
NIDDK is committed to promoting health equity and reducing and eliminating health disparities relevant to diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases. For this FOA, NIDDK is interested in intervention projects focused on understanding and addressing the impact of structural racism and discrimination (SRD) on patients and populations disproportionately affected by conditions that fall within the mission of NIDDK. Meaningful stakeholder engaged approaches are encouraged to improve feasibility and maximum potential for sustainability of successful interventions beyond the funded project period. NIDDK is also interested in observational studies, such as deep characterization of SRD that will inform interventional studies and evaluation of natural experiments that employ appropriate designs and methodologies necessary to strengthen causal inferences.
NIDDK will not support studies that focus solely on training health care providers or testing communication and dissemination strategies to facilitate the use of health information.
The mission of NIEHS is to discover how the environment affects people to promote healthier lives. The NIEHS 2018-2023 Strategic Plan emphasizes our ongoing commitment to the study of environmental health disparities and need for environmental justice among communities affected by toxic levels of exposure. Importantly, structural factors contribute to disproportionate exposure burdens affecting the health of racial, ethnic, immigrant, socioeconomically disadvantaged, and rural communities. Structural factors that intersect with environmental health include, for example, reversal of environmental protections that regulate harmful pollutants, and redlining practices or residential segregation that result in the location of racial/ethnic communities near industrial and/or heavily polluted areas.
NIEHS is interested in observational research examining the role of structural racism and discrimination (SRD) as a significant determinant in environmental health disparities, or evidence-based intervention research that mitigates or prevents the negative health outcomes attributable to environmental SRD. Applicants are strongly encouraged to utilize community engaged research approaches and include letters of support from community partners. Applications that demonstrate collaborative (i.e., community-academic partnerships) approaches to understand and/or address the negative health effects of environmental SRD across multiple health disparity communities will be prioritized. Areas of specific interest to NIEHS in environmental SRD include, but are not limited to: single or combined environmental exposures (i.e., mixtures) affecting the health of communities; health impacts of climate change, extreme weather and natural or human caused disasters; the built environment and greenspace, including green gentrification; studies grounded in community identified concerns around the intersection of environmental SRD and health outcomes; the impact of environmental SRD on health outcomes across the lifespan; and the role of environmental SRD in occupational exposures.
NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS' research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS does not support research that is relevant to the diseases, organ systems, stages of life, or populations within the mission areas of other NIH Institutes and Centers. Areas of interest to NIGMS include but are not limited to studies that address:
NIMH is interested in receiving applications that address research priority areas in translational, services and interventions research focused on mental health outcomes; and applications that address NIMH priority areas in HIV/AIDS research. Areas of interest include, but are not limited to, those below.
Translational Research:
Interventions Research:
NIMH is interested in applications that focus on mental health as the primary outcome. Intervention research may include mental health promotion, prevention and/or treatment Interventions. Interventions may focus primarily on addressing structural racism and discrimination to improve mental health outcomes. Consistent with NIMH’s experimental therapeutics approach, research designs should allow for the assessment of mechanisms through which the intervention modifies structural racism and discrimination and how these changes result in improvement in the targeted mental health outcomes. See the Support for Clinical Trials at NIMH web page for additional information regarding dedicated FOAs for NIMH clinical trials research support.
Areas of interest include, but are not limited to:
Services Research:
HIV/AIDS Research:
NINDS commits to reducing the disproportionate burden of neurological diseases experienced by underserved groups of society, including racial and ethnic minoritized, rural, and socioeconomically disadvantaged populations, by funding a spectrum of research from basic science through clinical studies and training the next generation of health equity investigators (https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Health-Disparities). NINDS supports research activities focused on understanding how structural racism and discrimination (SRD) contribute to inequalities in neurologic health, healthcare, and health outcomes in disparate populations, including racial and ethnic minorities, the geographically disadvantaged, sexual and gender minoritized individuals and others who have been historically underserved, marginalized, and adversely affected by persistent inequality and socioeconomic disadvantage.
NINDS is particularly interested in:
A letter of intent and communication with NINDS program staff prior to submission of an application is strongly encouraged. Observational studies should be theory-based to enable the future development of actionable items and evidence-based interventions. Applicants proposing to develop interventions are expected to proactively identify a theory or model that applies to the intervention proposed and the critical variables expected to result in change. Applications are required to use an appropriate experimental design to test the proposed theory, identify the essential components of complex interventions, and/or elucidate the mechanism(s) by which an intervention exerts its effects. For the development of behavioral interventions, applicants are encouraged to articulate their research aims and a proposed framework.
NINR supports research that uses nursing’s holistic perspective to improve individual and population health outcomes and eliminate health inequities by bridging biomedical science and provision of healthcare services with the realities of people’s lives and living conditions (i.e., social determinants) across the clinical and community settings where nurses practice. These settings include hospitals, clinics, people’s homes, long-term care facilities, schools, workplaces, criminal justice facilities, and the community at large. NINR recognizes the importance of engaging with and responding to the experiences of individuals, households, and populations.
Areas of specific interest to NINR include but are not limited to the following topics:
NINR will not support studies that focus solely on training nurses or other healthcare providers to reduce SRD.
The OBSSR is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that behavioral and social sciences research is well integrated into the NIH research enterprise. In alignment with its strategic priorities, OBSSR is interested in providing co-funding support for project(s) funded under this RFA that do one or more of the following: incorporate novel ways of assessing SRD; focus on the mechanisms through which SRD influence health outcomes; incorporate implementation science approaches; utilize innovative methods to evaluate natural experiments of existing efforts; identify protective factors and resiliency-based approaches. Note that OBSSR does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs for inquiries regarding the suitability of the proposed project for the RFA and the IC’s research portfolio.
The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention, and disseminating the results of this research to improve public health. In partnership with the 27 NIH Institutes and Centers, ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for projects that have strong implications for disease prevention, promise for wide uptake, and that include innovative and appropriate design, measurement, and analysis methods. ODP has specific interests in projects seeking to do one or more of the following: develop analytic methods for rigorously measuring the structures and systems that sustain racial inequities; develop or adopt data sources and methods that accurately and appropriately represent minority and vulnerable communities; capitalize on community-based participatory research approaches for developing and testing interventions; assess for race/ethnic differences; incorporate implementation science approaches and strategies that will be responsive to community and health/service system needs; utilize innovative methods to evaluate natural experiments in healthcare and services delivery and health promotion interventions; and, increase uptake and long-term sustainability of evidence-based interventions and approaches. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.
Applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed above. ODP does not award grants. Please contact the relevant IC Scientific/Research Contact(s) listed below for questions regarding IC research priorities and funding.
The ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and is supported in the larger scientific community. Research in recent decades has adopted an intersectionality framework to study and explain the complex nature of inequality. Integrating the purposeful accounting of sex as a biological variable (SABV) and gender as a social variable, alongside race and social class considerations in biomedical research, will enhance understanding of the effects of discrimination and its magnitude on mental and physical health (i.e. impacts on maternal morbidity and mortality or multimorbidities among groups of women). ORWH is interested in providing support for interdisciplinary, behavioral, clinical, and/or translational studies incorporating intersectional analyses into studies of racism and discrimination exposure among populations experiencing health disparities, including groups of women who are understudied, underrepresented, and underreported in research. For additional guidance, please refer to the 2019-2023 Trans-NIH Strategic Plan for the Health of Women on the ORWH website (https://www.nih.gov/women/strategicplan).
The SGMRO resides in the NIH Office of the Director and coordinates research and activities related to the health of sexual and gender minorities (SGMs; see NOT-OD-19-139 for more information) by working directly with the agency’s Institutes, Centers, and Offices. A robust and growing body of evidence demonstrates that SGMs often face institutional discrimination and poorer health outcomes than their non-SGM peers. SGM people with intersecting identities, including those based on race, ethnicity, and/or other statuses highlighted in this FOA, may face distinct and exacerbated health issues and disparities, and structural racism and discrimination may act as key drivers, modifiers, and intensifiers of the health-related concerns and challenges of these individuals. SGMRO is interested in social, behavioral, clinical, translational, and health services research to investigate how structural racism and discrimination adversely affect the lives and well-being of the most vulnerable SGM populations and to develop sustainable long-term strategies to attend to these pressing issues.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NIMHD intends to commit $5,000,000 in FY2022 to fund 6-7 awards.
NCI intends to commit $1,000,000 in FY2022 to fund one award.
NCCIH intends to commit $850,000 in FY2022 to fund one award.
NEI intends to commit $1,000,000 in FY2022 to support one award.
NHGRI intends to commit $1,700,000 in FY2022 to fund 2 awards.
NHLBI intends to commit $1.5M to support up to 2 awards.
NIA intends to commit $4,500,000 in FY2022 to fund 6 awards, including $3,000,000 to fund 4 awards on Alzheimer’s disease and related dementias and $1,500,000 to fund 2 awards on other topics.
NIAAA intends to commit $850,000 in FY2022 to fund one award.
NIDDK intends to commit $850,000 in FY 2022 to fund one award.
NIAID intends to commit $850,000 in FY2022 to fund one award.
NIAMS intends to commit $500,000 in FY2022 to fund one award.
NIBIB intends to commit $800,000 in FY2022 to fund one award.
NICHD intends to commit $850,000 in FY2022 to fund one award.
NIDA intends to commit $2,000,000 in FY2022 to fund 2 awards.
NIDCD intends to commit $700,000 in FY2022 to fund one award.
NIDCR intends to commit $750,000 in FY2022 to fund one award.
NIEHS intends to commit $850,000 in FY2022 to fund one award.
NIGMS intends to commit $2,000,000 in FY2022 to fund 4-6 awards.
NIMH intends to commit $850,000 in FY2022 to fund one award.
NINDS intends to commit $850,000 in FY2022 to fund one award.
NINR intends to commit $2,550,000 in FY2022 to fund 3 awards.
The OD, OBSSR, ODP, ORWH, and SGMRO have committed funds in FY2022 towards co-funding.
Application budgets are limited to $500,000 direct costs annually, not including consortia F&A.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Identify the health disparity populations that will be the focus of the project and describe the documented health disparity that will be studied. Provide a justification for how the specific types of SRD to be studied constitute SRD. Provide a conceptual model that describes hypothesized causal pathways between SRD and health outcomes. Describe data sources that will be used to document SRD. Provide a data analytic plan that specifies how multi-level factors, intervention effects and interactions, or outcomes will be handled, as appropriate. Describe and specify the roles of collaborators. For intervention projects, describe how the intervention will directly address the cause or source of SRD. Specify how organizations, agencies, or programs where the SRD is originating from or being sustained will be involved in the project, including involvement of leadership from these organizations as well as other individuals or groups. Describe the potential of the intervention to be sustainable in the intervention settings after the project is over and scalable to other settings.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
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.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, 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. Any instructions provided here are in addition to the instructions in the policy.
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?
Specific to this FOA: Does this project identify clearly and provide justification for study of the targeted health disparity populations? Does the project address a documented health disparity that is clearly specified and justified? Is an appropriate justification provided for how the types of SRD to be studied constitute SRD? Is an appropriate conceptual model provided that describes hypothesized causal pathways between SRD and health outcomes? For intervention projects, is a clear and compelling rationale provided for how the intervention will directly address the cause or source of SRD? Does the intervention have potential to be sustainable in the intervention settings after the project is over and scalable to other settings?
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?
Specific to this FOA: Are the roles of collaborators clearly described and appropriate? For intervention studies, is the involvement of personnel from the organizations, agencies, or programs where the SRD is originating from or being sustained specified and appropriate?
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?
Specific to this FOA: Are the data sources used to document SRD identified and appropriate? Is an appropriate data analytic plan provided that specifies how multi-level factors, intervention effects and interactions, or outcomes will be handled, as applicable?
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)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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 awardee 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).
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. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email:[email protected]
Rochelle Long, PhD
National Institute Of General Medical Sciences (NIGMS)
Division of Pharmacology, Physiology, and Biological Chemistry (PPBC)
E-mail: [email protected]
Kenneth D Gibbs, Jr., PhD, MPH
National Institute Of General Medical Sciences (NIGMS)
Division of Training, Workforce Development, and Diversity
Division of Genetics and Molecular, Cellular, and Developmental Biology
E-mail: [email protected]
Ebony Madden
National Human Genome Research Institute (NHGRI)
Phone: 301 503-5620
E-mail: [email protected]
Rene Sterling
National Human Genome Research Institute (NHGRI)
Phone: 301.435.1275
E-mail: [email protected]
Paul Cotton, Ph.D., RDN
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 496-1051
Email: [email protected]
Judith Arroyo, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-402-0717
E-mail: [email protected]
Richard T. Benson, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 827-9071
E-mail: [email protected]
Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Telephone: 301-480-1161
Email: [email protected]
Damiya Eve Whitaker
Office Of Research On Women's Health (ORWH)
Phone: 240-276-6170
E-mail: [email protected]
Frank Bandiera, Ph.D.
Division of Behavioral & Social Research (DBSR)
National Institute on Aging (NIA)
Phone: 301-402-7629
Email: [email protected]
Damali Martin, Ph.D.
Division of Neuroscience (DN)
National Institute on Aging (NIA)
Phone: 301-402-8310
Email: [email protected]
Lyndon Joseph, Ph.D.
Division of Geriatrics & Clinical Gerontology (DGCG)
National Institute on Aging (NIA)
Phone: 301-496-6761
Email: [email protected]
Cheri Wiggs
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]
Stephanie M George
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301.594.4974
E-mail: [email protected]
Kelly Anne King
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: 301-402-3458
E-mail: [email protected]
Zeynep Erim, Ph.D
National Institute Of Biomedical Imaging And Bioengineering (NIBIB)
Phone: (301) 451-4792
E-mail: [email protected]
Della B. White, PhD
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-827-6358
Email: [email protected]
Rob Rivers, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-443-8415
Email: [email protected]
Shobha Srinivasan
National Cancer Institute (NCI)
Phone: (240) 276-6938
E-mail: [email protected]
Elise L. Rice, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-4814
E-mail: [email protected]
Diane Adger-Johnson
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2924
E-mail: [email protected]
Aria Crump
National Institute On Drug Abuse (NIDA)
Phone: 301-443-6504
E-mail: [email protected]
Dara R. Blachman-Demner, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-8522
Email: [email protected]
Alexander M. Talkovsky
National Institute of Mental Health (NIMH) Division of Translational Research
Telephone: 301-827-7614
Email: [email protected]
Janani Prabhakar, Ph.D.
National Institute of Mental Health (NIMH) Division of Translational Research
Telephone: 301-827-1321
Email: [email protected]
Eve E. Reider, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-1496
Email: [email protected]
Collene Lawhorn, Ph.D.
National Institute of Mental Health (NIMH) Divsion of AIDS Research
Telephone: 301-451-4262
Email: [email protected]
Lindsey Ann Martin
National Institute Of Environmental Health Sciences (NIEHS)
Phone: 984-287-4036
E-mail: [email protected]
Rebecca Henry, PhD, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: [email protected]
Juanita J. Chinn, PhD
Eunice Kennedy Shriver National Institute Of Child Health & Human Development (NICHD)
Phone: 301-827-4901
E-mail: [email protected]
Hiroko Iida, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7404
Email: [email protected]
Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]
Kelly Aubrecht
National Institute Of General Medical Sciences (NIGMS)
E-mail: [email protected]
Deanna L Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7858
E-mail: [email protected]
Shaheed Ziyout
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 827-8152
Email: [email protected]
Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-4704
E-mail: [email protected]
Ryan Blakeney
for Division of Behavioral & Social Research (DBSR) inquiries
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]
Robin Laney
for Division of Neuroscience (DN) inquiries
National Institute on Aging (NIA)
Telephone: 301-496-1473
Email: [email protected]
E.C. Melvin
for Division of Geriatrics & Clinical Gerontology (DGCG) inquiries
National Institute on Aging (NIA)
Telephone: 301-480-8991
Email: [email protected]
Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]
Sahar Rais-Danai
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-5032
E-mail: [email protected]
Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: (301) 435-0713
Kwesi Wright
National Institute Of Biomedical Imaging And Bioengineering (NIBIB)
Phone: (301) 451-4789
E-mail: [email protected]
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Phone: (301) 594-3788
Email: [email protected]
Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Phone: (240) 276-6277
E-mail: none
Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]
Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2988
E-mail: [email protected]
Amy M Bucheimer
National Institute On Drug Abuse (NIDA)
Phone: 301-827-6694
E-mail: [email protected]
Jenny L Greer
National Institute Of Environmental Health Sciences (NIEHS)
Phone: 984-287-3332
E-mail: [email protected]
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]
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