Consortium for Palliative Care Research Across the Lifespan (U54 Clinical Trial Optional)
Letter of Intent Due: May 31, 2024
This Notice of Funding Opportunity (NOFO) invites applications proposing the development of a specialized center. Henceforth, the center will be referred to as the “Consortium.” The aim of the Consortium will be to provide resources, expertise, and coordination to advance innovative, high-quality research on palliative care for those living with serious illnesses across the lifespan. The research infrastructure will encompass Alzheimer’s disease (AD) and AD-related dementias (ADRD), cancer, and other serious illnesses and populations relevant to NIH’s partnering Institutes, Centers, and Offices (ICOs). NIH currently funds many palliative care research projects across its ICOs, and there is a need for a research infrastructure to leverage synergies, coordinate efforts, develop the scientific workforce, and address remaining gaps in the field. An important focus will be research to understand and address disparities in access, quality, and use of palliative care services for health disparities populations (as defined by the NIA Health Disparities Framework priority populations).
Translational Neural Devices (R61/R33 - Clinical Trial Optional)
View application due dates outlined in the Notice of Funding Opportunity.
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of low risk therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study (R61 phase), as well as a subsequent small clinical study (R33 phase). The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This NOFO utilizes an Exploratory/Developmental Phased Award and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Transition from the R61 to the R33 phase is contingent upon the successful completion of proposed milestones.
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) (K12 Clinical Trial Optional)
View application due dates outlined in the Notice of Funding Opportunity.
The NIH Office of Research on Women's Health (ORWH) and participating NIH Institutes, Centers, and Offices (ICOs) invite institutional career development award applications for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs, hereafter termed "Programs". Programs will support mentored research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, data science, behavioral, clinical, and/or health services research relevant to the health of women and, where appropriate, the use of both sexes to better understand the influence of sex as a biological variable on health and disease.
This Notice of Funding Opportunity (NOFO) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)
View application due dates outlined in the Notice of Funding Opportunity.
The purpose of this notice of funding opportunity (NOFO) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD. The primary objective of this NOFO is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications.
The UG3/UH3 Cooperative Agreement involves two phases. The UG3 phase, for up to two years, is designed to support a project with specific milestones to be accomplished by the end of the period. The UH3 phase is to provide funding for up to three additional years following successful completion of the UG3. UG3 projects that meet their milestones will be administratively considered by the National Institute on Drug Abuse (NIDA) and prioritized for transition to the UH3 phase. Investigators submitting to this NOFO must address both UG3 and UH3 phases.
Strategies to Improve Health Outcomes and Advance Health Equity in Rural Populations (R01 Clinical Trial Optional)
View application due dates outlined in the Notice of Funding Opportunity.
The purpose of this initiative is to support research to improve health and promote health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes. Applications responding to this Notice of Funding Opportunity (NOFO) should develop, adapt, or implement intervention strategies addressing social determinants of health (SDOH) to improve health and promote health equity in rural populations. This funding opportunity encourages studies that use a wide range of methodological approaches that enhance access to, and acceptability and effectiveness of, interventions in rural populations, such as community-engaged research approaches that build on the strengths of rural communities.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.
Model Continuums of Care Initiative (MCCI) to Advance Health Equity and End Health Disparities Among Women and Girls in Racial/Ethnic Minority and Other Underserved Communities (U34 Clinical Trials Required)
View application due dates outlined in the Notice of Funding Opportunity.
The purpose of this NOFO is to support the planning phase of the Model Continuums of Care Initiative (MCCI) to Advance Health Equity and End Health Disparities Among Women and Girls in Racial/Ethnic Minority Communities. MCCI is a multi-ICO dissemination and implementation science initiative to advance racial equity and end health disparities in racial/ethnic minority women and girls of reproductive age. Specifically, the Model Continuums of Care Initiative will apply the latest dissemination and implementation science approaches to significantly reduce the prevalence and impact of multi-morbidity among racial/ethnic minority women and girls of reproductive age at risk and living with mental health disorders, substance use disorders, chronic stress, cardiopulmonary diseases, common metabolic disorders (e.g., diabetes), cancer, and HIV/AIDS. This concept proposes a continuum of care approach that integrates preventive health services, primary care, behavioral health, integrative care, and cardiopulmonary and endocrine specialties to fully address health care needs in each of these domains, and to have maximum impact on the overall health and well-being of racial and ethnic minority and other underserved women and girls. While MCCI is not a maternal health initiative, women and girls ages 15-44 yrs. are centered because it is during the early reproductive period, i.e., adolescence, that multimorbidity typically begins and rapidly progresses, setting the stage for multiple chronic debilitating conditions in later life. Special emphasis will be placed on using stakeholder partnerships, provider training, and infrastructure changes to improve access for subgroups of racial/ethnic minority women and girls who currently have the least access to high quality health care (e.g., racial/ethnic minority women and girls living in low resource settings). Applications that include a partnership between Research Centers in Minority Institutions and other institutions with extensive programs in women's health research are strongly encouraged.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.
Center of Excellence for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed)
View application due dates outlined in the Notice of Funding Opportunity.
The purpose of this notice of funding opportunity (NOFO) is to support the establishment of one (1) Center of Excellence (CoE) to coordinate the research community of infectious and immune-mediated disease (IID) computational modelers and advance IID modeling research across biological scales. The CoE must include three (3) Coordinating Cores and two (2) Research Projects to advance and integrate bridge models across scales in the context of IID, including HIV/AIDS. The CoE will accelerate multi-scale model development, sharing and re-use, and support collaboration to benefit the entire IID research community.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.
Botanical Dietary Supplements Translational Research Teams (RM1 Clinical Trial Required)
View application due dates outlined in the Notice of Funding Opportunity.
The purpose of this Notice of Funding Opportunity (NOFO) is to support trans-disciplinary, translational research on chemically complex botanical products or natural products traditionally used as dietary components, to inform future clinical trials of the efficacy of exceptionally promising dietary supplements for improving resilience. Clinical efficacy trials of such products are often challenged by gaps in understanding that critically affect the design and/or interpretation of a clinical trial. For example, the molecular mechanism(s) of action of a botanical dietary supplement might not be well established and thus the optimal product chemistry, for a given health outcome may not be known; in the absence of such information to guide product specifications, stability testing and assessments of bioavailability and absorption kinetics a clinical trial might not provide a good test of the effect of that botanical on the health outcome(s) assessed. Similarly, the best outcome measure for a trial of a product reputed to have many different health effects, or to have effects where many different quantitative outcomes might be relevant might benefit from deeper understanding of the biological structure(s) and/or system(s) affected by the product, and the health outcomes expected from modulating those targets. Interpretation of a clinical trial of an ingested product will benefit from the availability of methods to assess bioavailability of active constituents of the product or target engagement by those constituents. Clinical trial design will benefit from an understanding of the ways in which trial participant characteristics, whether genetics, background diet, epigenomics, gut microbiota, or health history, for example, may influence the effect of the intervention tested. The forgoing are examples of the types of knowledge gaps of interest for this NOFO.
The overarching goal of this NOFO is to address those knowledge gaps most critical to the optimal design or interpretation of a future randomized clinical trial (RCT).