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NIH Highlighted Funding Opportunities | May 2024

Understanding the Intersection of Social Inequities to Optimize Health and Reduce Health Disparities: The Axes Initiative (R01 Clinical Trial Optional)

Research shows that intersecting systems of privilege and oppression produce and sustain wide and unjust variations in health. The Axes Initiative will support research to understand health at the intersections of social statuses such as race, ethnicity, socioeconomic status, sexual orientation, and ability, by examining contributions of social and other determinants of health.

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 Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.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.

Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)

This NOFO invites applications to support a clinical trials network involving multiple institutions to collect safety and early efficacy data of psychedelic-assisted therapy (PAT) in defined groups of older adults living with specific chronic pain conditions.

This NOFO uses the UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement activity code. Applications must include a research plan describing both UG3 and UH3 phases. The first phase, the UG3 phase, may last up to two years, and should involve preliminary studies in healthy older adults across a broad age range to evaluate safety, pharmacokinetic, and pharmacodynamic properties of psychedelic agents and preliminary testing of PAT elements.

Activities in the UG3 phase will inform further development and testing in the second phase, the UH3 phase.

The UH3 phase may last up to 3 years and should include expanded safety and preliminary efficacy studies in older adults with chronic pain conditions and must include participants living with non-contraindicated co-occurring conditions representative of real-world older adults.

In both phases, participants across a broad range of ages must be included, with particular attention to strata at the upper age range (i.e., 75-80 years, and 80+ years old).

For the purposes of this NOFO, the term psychedelic includes “classic” psychedelics, typically understood to be 5-HT2 agonists such as psilocybin, N,N-Dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and mescaline, as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA). Synthetic analogs of these agents are also included. Cannabis, ketamine, and their related products are not considered psychedelic agents in this NOFO

The NCI Worta McCaskill-Stevens Career Development Award for Community Oncology and Prevention Research (K12 Clinical Trial Optional)

The purpose of the NCI Worta McCaskill-Stevens Career Development Award for Community Oncology and Prevention Research (K12) is to support the training of clinical scientists in community cancer prevention, screening, intervention, control, and treatment research. Special emphasis is placed on training clinical scientists whose career goal is to improve the care and outcomes of minority health populations and populations with health disparities that are underrepresented in clinical research by increasing their access to and representation as human subjects in cancer clinical trials using an equity lens.

This Notice of Funding Opportunity (NOFO) allows the appointment of Scholars proposing to serve as the lead investigator of an independent community-based clinical trial; proposing to increase the integration of cancer health disparities research questions into clinical trials; or proposing a separate ancillary study to an existing prevention, screening, intervention, control or treatment trial; or proposing to gain research experience in a community-based clinical trial led by another investigator; or proposing to serve as leader of innovative clinical trial approaches that expand engagement of minority health populations and populations with health disparities that are underrepresented as human subjects in cancer clinical trials, as part of their research and career development. 

Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults (R34 Clinical Trial Required)

NIMH seeks applications for pilot research to adapt, optimize, and test empirically supported behavioral interventions that address common sleep problems in adolescents and young adults with or at risk for a mental health disorder. Pilot trials should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach in real world settings, and to conduct a preliminary test of the intervention’s impact on target mechanisms and sleep and mental health outcomes, and to obtain preliminary data needed as a prerequisite a larger-scale effectiveness trial. An emphasis is placed on studies that address the needs of youth from understudied and underserved populations.

Specialized Alcohol Research Centers (P50 Clinical trial Optional)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad-based Alcohol Research Centers program to foster and conduct interdisciplinary, collaborative research on Alcohol Use Disorder (AUD), alcohol misuse and alcohol-related  problems, and other health-related consequences across the lifespan. The NIAAA Centers Program provides leadership in research, and research methodology development on a wide variety of topics relevant to the Institute’s mission. Topics include but are not limited to, the nature, etiology, genetics, diagnosis, treatment, and prevention of AUD, alcohol-related end-organ diseases, and their biomedical, psychosocial, and economic consequences across the lifespan and minority health and other NIH-designated populations that experience health disparities. Centers are also major contributors to the development of research methods, technologies, and approaches that sustain innovative goal-directed research.

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 FOA instructions carefully and view the available PEDP guidance material.

NHLBI Emerging Investigator Award (EIA) (R35 Clinical Trial Optional)

The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards (of which one must be an NHLBI-funded NIH Early Stage Investigator (ESI) award) and whose outstanding record of research demonstrate their ability to make major contributions to the heart, lung, blood and sleep (HLBS) research. The EIA is intended to support an investigator's research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards.

The EIA will support the research program of NHLBI-funded investigators for up to seven years and will provide increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer time frame. Research supported by the EIA must be within the scope of the NHLBI mission.

ML/AI Tools to Advance Genomic Translational Research (MAGen) - Development Sites (UG3/UH3 Clinical Trials Not Allowed)

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications to explore the feasibility of developing Machine Learning (ML) and Artificial Intelligence (AI) tools that can enhance the accuracy and precision of predicting how individuals with pathogenic genetic variants manifest disease. NHGRI aims to establish a research Consortium, ML/AI Tools to Advance Genomic Translational Research (MAGen), to collaboratively identify both genomic and non-genomic factors influencing disease development in individuals carrying pathogenic genetic variants. The ML/AI tools will leverage existing multimodal genomic and non-genomic data and will be cross validated in genomic translational research settings to ensure the robustness and generalizability of the tools for translational purposes. In addition, the Consortium will explore the ethical, legal, and social implications (ELSI) of integrating ML/AI tools into genomic medicine through the establishment of an ELSI Framework for their development, and through implementation of ELSI research projects.