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Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)


Despite continued improvement in the health of the U.S. population with the introduction of medical and scientific advances, there continues to be an alarming disproportionate burden of illness among certain population groups. The mission of the NIMHD is to lead scientific research aimed at the development of innovative diagnostics, treatments, and prevention strategies to improve minority health and reduce health disparities in NIH-designated populations that experience health disparities in the United States and its territories. NIMHD focuses on all aspects of health and health care for racial and ethnic minority populations in the U.S. and the full continuum of health disparity causes as well as the interrelation of these causes. The purpose of the Funding Opportunity Announcement (FOA) is to engage and support small businesses in providing seed (i.e., early-stage investment) funding for developing technologies, services, and products that engage, empower, and motivate individuals and communities, including providers and healthcare institutions that focus on African Americans, Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, disadvantaged socioeconomic groups, underserved rural populations, and sexual and gender minorities. In using this funding recipients will hopefully lay the groundwork for sustainable health promoting activities and interventions that lead to improved health, healthcare delivery, and the elimination of health disparities. Other considerations relevant to the technology and products and the organization should include: Effectiveness in improving the current quality of care or research access for populations that experience health disparities. Affordability for the population with existing community resources or an organization’s existing infrastructure. Acceptability such as health literacy, language, and cultural competency considerations. Research Objectives While this FOA supports new and innovative technologies or products, applicants should review and refer to the NIMHD Research Framework, for additional insight on NIHMD’s strategic approach. The NIMHD Research Framework identifies diverse factors within socioecological domains and levels that influence health outcomes among populations that experience health disparities compared to the majority U.S. population. Applicants are encouraged to leverage this research framework to inform product conceptualization and design in their applications. This framework also provides insight into design thinking and outcome-driven innovation methods, including but not limited to: Physical Barriers – Factors such as proximity to healthcare facilities and transportation may limit access to healthcare. Knowledge Barriers - Health literacy and language barriers inhibiting healthcare delivery and patient information. Infrastructure Barriers - Health providers, such as rural health clinics, federally qualified health centers, and critical access hospitals, may not have the same resources and expertise of large hospitals and health networks. Economic Barriers - Lack of public and private insurance coverage or financial resources Cultural Barriers - Beliefs and practices shared among social and organizational groups. Specific Areas of Research Interest Technologies, services, and products that might achieve the objectives of this initiative include, but are not limited to: Facilitate or enhance disease self-management, patient-healthcare provider, or system communication, and/or care coordination between primary care providers, family care givers, hospital emergency department staff, specialty physicians, dental health professionals, nurse practitioners, providers of mental health and behavioral health services, patient navigators, etc., in medically underserved communities and regions. Culturally attuned behavioral or evidenced-based interventions that empower and promote opportunities for individuals, families, social networks, and communities to engage in health-seeking behaviors and health-promoting activities (diet choice, exercise/physical activity, oral hygiene, medication adherence, child immunizations, etc.) and to avoid risky behaviors (smoking, vaping, alcohol/drug misuse, unsafe sex, etc.). Detecting, measuring, and assessing a broad array of unhealthy social and environmental exposures (discrimination, stress, pollutants, allergens, noise, crime, etc.), and for characterizing cumulative exposures across multiple individuals and communities and linking this information to physiological responses and health indicators at the individual and population levels. These technologies may include efforts to improve and standardize data collection and the integration of social determinants of health (SDOH) and other data across disparate data sources, including clinical patient data, electronic medical records, public health data, census data, housing data, employment data, and crime statistics. Engage, empower, and motivate individuals, families, and communities to enhance the quality of life and to sustain health gains. Culturally appropriate survey instruments, tools, modules, and databases to promote community-based research engaging populations that experience health disparities. Culturally appropriate, evidence-based health empowering promotion and disease prevention educational media, such as software, informational videos, and printed materials. Innovative software, tools and technology for science and health education curriculum materials, interactive teaching aids, serious and applied games, models for classroom instruction for K-12 and undergraduate students, and the public. Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving communication among health care providers and between patients, families, and physicians and healthcare providers, medication adherence, diagnosis, monitoring, evaluation, medical management, screening, tracking, and treatment in underserved community settings and rural and remote locations. Promote big data science or enhance data scientist training to address health inequities and/or minority health research, for example software or tools developed to link social determinants of health easily (e.g., years of education, race/ethnicity, etc.) with massive datasets such as electronic medical record (EMR), genomic information, census data, national surveys, and other state or community-level data sources. Such technology will be instrumental in understanding fundamental causes of health disparities and developing meaningful interventions. Linking family medical histories and family ancestries. Technologies for clinical trials and biobanking, such as the rapid identification in human specimens (e.g., blood, buccal swabs, etc.) of genes and/or genomic variants of known importance to minority health. Educating prospective social entrepreneurs, and minority and health disparity communities on how to transition technologies from the bench to the bedside. Promoting precision medicine and other precision-based strategies such as utilizing All of Us Research Program research tools. Leveraging electronic health records and communication technologies to deliver and evaluate interventions that reduce health disparities by removing accessibility and health literacy barriers, facilitating population tailoring and personalization, and decreasing cost. Understanding the causes of health disparities and associated variables such as SDOH for preventing one or more health disparities. Using systems modeling, artificial intelligence, or other techniques to predict relationships between health disparities and health determinants and to assess health disparities interventions outcomes. Creating and testing tailored algorithms that identify interventions tailored, target, and optimized for implementation in specific communities for reducing or eliminating disparities in one or more specific health condition, disease, or health outcome. Leveraging robotic and autonomous systems for improving health, and preventing, reducing, and eliminating health disparities. Preventing and minimizing adverse exposures and health risks (post-traumatic stress) or promoting health, well-being, resilience, and recovery resulting from disasters or the threat of a disaster. Disasters may include public health threats such COVID-19 or a similar pandemic. Examples may include new tools, apps, education, curricula, or other technologies to detect, screen, treat, or prevent or otherwise mitigate adverse health outcomes or leverage community and or population resilience and prevention efforts IC-Specific Areas of Research Interest Topics of Interest to NHLBI: The NHLBI is interested in funding the development of diagnostic tools, monitoring and informatics devices, wearable technologies, mobile applications, and other digital health and wellness tools to improve heart, lung, blood, and sleep (HLBS) health in historically underserved, low-resource, and remote communities. The NHLBI also encourages the use of novel technological approaches and business models to improve health in these communities by addressing usability issues that are present with current technological approaches. Examples of disorders and conditions of interest to NHLBI include, but are not limited to: Hypertension, Congestive Heart Failure, Coronary Artery Disease, Stroke/Cerebrovascular Disease, Asthma, Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Pulmonary Hypertension, Lymphangioleiomyomatosis (LAM), Sarcoidosis, Obstructive Sleep Apnea, Sickle Cell Disease, anemia, thrombosis and coagulopathy, and HLBS-related complications of Acquired Immunodeficiency Syndrome (AIDS). In addition to these disorders and conditions, NHLBI also seeks applications that address issues that are more common or cause high morbidity and mortality in women throughout the life course including pregnancy and/or the post-partum period such as cardiovascular complications, deep vein thrombosis, and postpartum hemorrhage. In addition to the above conditions, the NHLBI has a strong interest in supporting innovative uses of technology to engage minoritized communities in their health, including evidence-based management of HLBS diseases and the prevention of HLBS diseases. Additionally, the NHLBI is interested in supporting the development of tools and technologies that will address barriers to uptake of the implementation and dissemination of evidence-based interventions for HLBS conditions and disorders in minority and low-income communities. These tools may include but are not limited to software programs, mobile applications, and services to improve health literacy, promote awareness of lifestyle interventions for HLBS health, increase access and promote adherence to evidence-based interventions. A complete list of NHLBI scientific focus areas is found at: Topics of interest to NIA: The NIA is interested in the FOA topics as they pertain to improving the health and wellbeing of aging adults in NIH-defined population groups who experience health disparities. Applicants should reference the NIA Health Disparities Research Framework to facilitate identifying and proposing tools, technologies, and products that are effective, accessible, and culturally acceptable by the intended health disparity population(s) and which reflect the life course perspective or theory, as well as relevant levels of analysis among the different domains described in the NIA Health Disparities Research Framework. NIA has a special interest in research and development proposals to: Study social determinants of health disparities and develop technologies and products that mitigate bias and more accurately predict health outcomes of racial and ethnic underrepresented groups of older adults. For example, creating, testing, and validating unbiased algorithms that can be broadly applied to tools and technologies to improve the health and wellbeing of aging health disparity priority population(s). For a list of health disparity priority populations, please refer to the NIA Health Disparities Research Framework. Study biological determinants of health disparities and develop technologies and products that address them. Develop accurate and equitable preventive, diagnostic, or therapeutic approaches to identify, predict, and reduce racial and ethnic disparities in clinical outcomes for aging populations. Develop technologies to ameliorate the social, structural, economic, and behavioral determinants of health disparities. Increase participation of racial and ethnic minority populations in AD/ADRD clinical trials to compliment and/or leverage existing efforts such as the NIA’s Alzheimer’s Disease Research Centers, Alzheimer’s Clinical Trials Consortium, and the National Strategy for Recruitment and Participation in Alzheimer's and Related Dementias Clinical Research. For additional information on NIA SBIR areas of interests, please refer to Applications must be responsive to this FOA and explicitly address minority health or health disparities as it pertains to the NIA mission and research interests. Topics of Interest to NIAAA: The NIAAA is interested in the above topics for this FOA as they pertain to Alcohol Use Disorder and alcohol-related problems including the development of tools and technologies to address the barriers of the implementation and dissemination of evidence-based interventions in minority or low-income communities. Applicants are strongly encouraged to contact the NIAAA SBIR Coordinator at prior to grant submission. Topics of Interest to NIBIB: The NIBIB is interested in the above topics for this FOA as they pertain to NIBIB mission. NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological functions or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest ( to determine if their research fits within the NIBIB mission. 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. Topics of Interest to NIDCR: The NIDCR is interested in supporting development of use-inspired technologies and products that promote dental, oral, and craniofacial (DOC) health equity and enhance effectiveness, acceptability, access, affordability, and sustainability of DOC health care and self-management in populations disproportionately affected by DOC diseases and conditions. NIDCR’s areas interest include, but are not limited to: Enhancing efficiency, quality, and patient-centeredness in team-based DOC health care. Detecting, measuring, assessing, and addressing structural racism and discriminations in the DOC health system. Creating and testing statistical models and algorithms to predict DOC health risks taking into account the influence of social determinants to advance personalized DOC health care delivery that improves clinical outcomes. Creating community-level opportunities to address DOC health determinants and enable DOC health promoting lifestyles in underserved communities. Aiding long-term adherence to DOC health recommendations and self-management capacity. NIDCR does not use the SBIR/STTR mechanism to support clinical trials. Topics of Interest to NIDDK: The NIDDK is interested in the above topics as they pertain to diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders associated with NIDDK diseases, and obesity; and kidney, urologic, and hematologic diseases. To be assigned to the NIDDK, applications must be directly related to the mission of the NIDDK ( Topics of Interest to NINDS: The NINDS is interested in topics as they pertain to stroke, vascular contributions to cognitive impairment and dementia (VCID), dementia, epilepsy, Parkinson's Disease, TBI, pain, migraine, and other neurological disorders.For proposals focusing on Alzheimer’s Disease and Related Dementias (AD/ADRD), note that NIA and NINDS have shared interest, with NINDS as the lead for VCID, lewy body dementia (LBD), and frontotemporal lobar degeneration (FTLD); and NIA as the lead for applications focused on Alzheimer’s Disease. The small business program at NINDS is used to achieve the mission of the Institute by supporting innovative ideas at different stages of development, including applied bench research, translational research, and early-stage clinical trials i.e., feasibility, Phase I and II, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NINDS will not support applications for a clinical trial where the primary aim is to establish or confirm definitive efficacy or applications to implement definitive efficacy trials (e.g., Phase 3 clinical trials of drugs or Pivotal device trials). NINDS is interested in funding exploratory/developmental research applications that propose to study the development, validation, feasibility, and effectiveness of innovative digital health technologies [e.g., mobile health (mhealth), telemedicine and telehealth, health information technology (IT), and remote monitoring devices]. These technologies should have application to address access, reach, delivery, effectiveness, scalability or sustainability of interventions that target health inequity experienced by marginalized populations. NINDS highly encourages inclusion of community-based participatory research in applications to this RFA. The participatory research process is such that community members, persons affected or impacted, public health and policy professionals, and other key stakeholders in the community’s health have the opportunity to be full participants in each phase of the research. This facilitates the bidirectional transfer of knowledge and skills and the creation of appropriate and effective interventions. For studies involving human subjects, appropriate linguistic and cultural competence strategies should be incorporated to enable recruitment and retention of racial/ethnic minoritized populations. Projects are encouraged to involve community partners collaborators. Applicants are expected to demonstrate their ability to leverage existing partnerships (such as with Tribal governments and organizations, academic and community medical centers or health systems, safety-net health or social service systems, Federally Qualified Health Centers, grassroots organizations, public health departments, community and faith-based organizations, and schools or child-care settings) to complete the study aims.Applicants are encouraged to provide evidence of relationship development or collaboration with community partners with whom they will work, such as through letters of support. The roles of all partners should be clearly articulated, and budgeting should reflect the level of engagement of community partners. NINDS encourages applications that can demonstrate how the composition of the core leadership team includes diverse representation (e.g. ethnic, racial, gender, career stage, institution type, geographic location, or persons with disability). For those applications that propose a clinical trial and use an FDA-regulated intervention, NINDS will give priority to those applications with (a) A protocol submitted under an open IND and the IND is not under full or partial hold. (b) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has fully approved the IDE or IDE supplement. (c) A protocol submitted under an IND and is on full or partial hold. (d) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has conditionally approved the IDE or IDE supplement. (e) A protocol is exempt from an IND. (f) A protocol is either exempt from the IDE regulations or does not require IDE approval because it is determined to be nonsignificant risk. NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. STTR applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission. Topics of Interest to NCATS: The NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients. Projects of most interest to NCATS include those that focus on drug discovery and development, biomedical, clinical and health research informatics and clinical, dissemination and implementation research. Applicants are strongly encouraged to contact the program staff at prior to submitting an application. For additional information on NCATS SBIR areas of interest, please refer to Please note that the NCATS SBIR program does not support applications that include clinical trials. Applications that do not explicitly address minority health or health disparities will be considered not responsive to the FOA and will not be peer reviewed. Potential applicants are encouraged to discuss their project with the appropriate IC Scientific Contact.
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