Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)
(PAR-25-283)
National Institute of Mental Health
The purpose of this notice of funding opportunity (NOFO) is to encourage innovative research that will inform and support the delivery of high-quality, continuously improving mental health services to benefit the greatest number of individuals with, or at risk for developing, a mental illness. This announcement invites applications for non-clinical trial R01-level projects that address NIMH strategic priorities that strengthen the public health impact of NIMH-supported research as described in Goal 4 of the NIMH Strategic Plan.
Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 Clinical Trial Not Allowed)
(PAR-25-056)
National Heart, Lung, and Blood Institute
This Notice of Funding Opportunity (NOFO) encourages R21 applications that propose to conduct secondary analyses using existing human datasets in areas relevant to the National Heart, Lung, Blood Diseases and Sleep Disorders Institute (NHLBI) scientific mission. The NOFO aims to stimulate the use of existing human datasets to investigate novel scientific ideas, and/or generate new models, systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. Generation of new primary data is not allowed.
NIAID, NIDDK, NIDA, and NIAAA Research Opportunities for New and "At-Risk" Investigators (R01 Clinical Trial Optional)
(PA-25-249)
National Institute of Allergy and Infectious Diseases
National Institute on Alcohol Abuse and Alcoholism
National Institute on Drug Abuse
National Institute of Diabetes and Digestive and Kidney Diseases
The purpose of this notice of funding opportunity (NOFO) is to encourage New and ‘At-risk’ Investigators from diverse backgrounds, including but not limited to individuals from groups that have been shown to be nationally underrepresented in the biomedical, behavioral, clinical, and social sciences, to work with their institutions to submit applications for research projects within the mission of NIAID, NIDDK, NIDA, or NIAAA. This NOFO seeks to support either (a) a New Investigator (NI), who has not previously competed successfully for substantial, independent funding from NIH, or (b) an 'At-Risk' investigator, who had prior support as a PD/PI on a substantial independent research award and unless successful in securing a substantial research grant award in the current fiscal year, will have no substantial research grant funding in the following fiscal year.
Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
(PAR-24-280)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage Research Project Grant (R01) applications to pursue clinical observational (CO) studies to obtain data necessary for designing clinical studies for musculoskeletal, rheumatic, or skin diseases or conditions. Research data from observational studies supported by this NOFO can enhance clinical study design by providing essential information about disease symptoms, stages, and timing of disease progression; comorbid conditions; availability of potential research participants; and outcomes that are important to patients. They also can facilitate efforts to develop and/or validate objective biomarkers or subjective outcome measures for use in a future clinical study. A future clinical study may include a clinical trial or an observational study.
NIDCR Small Research Grants for Oral Health Data Analysis and Statistical Methodology Development (R03 Clinical Trial Not Allowed)
(PAR-25-045)
National Institute of Dental and Craniofacial Research
The goal of this Notice of Funding Opportunity (NOFO) announcement is to support meritorious research projects that involve secondary data analyses of existing oral or craniofacial database resources, or that develop needed statistical methodology for analyzing existing dental, oral or craniofacial databases.
Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Optional)
(PAR-25-156)
National Center for Advancing Translational Sciences
This is a limited competition. The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support the development and demonstration of unique hub capabilities, research platforms and/or resources to address in a timely manner critical gap areas and/or roadblocks in clinical and translational science at awarded UM1 Clinical and Translational Science Awards (CTSA) Program Hubs (PAR-24-272). Successful programs supported through this funding opportunity are expected to lay a strong foundation for future adoption and/or dissemination of capabilities to additional CTSA Program Hubs.
Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)
(PAR-25-159)
National Institute on Alcohol Abuse and Alcoholism
Office of Disease Prevention
This Notice of Funding Opportunity (NOFO) for R34 planning grant applications focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and incidence of FASD and (2) interventions for FASD.
It is expected that research conducted via this mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale FASD prevention or intervention studies.
Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)
(PAR-25-177)
National Institute of Mental Health
NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials.
This NOFO seeks to support well-powered clinical trials consistent with NIMH's priorities for: 1) optimizing preventive and therapeutic interventions with previously demonstrated efficacy for use with broader target populations or for delivery routine care, school, community, or online settings, and 2) research on implementation strategies that support the delivery and sustainability of optimized interventions in accessible settings. Applications responsive to this NOFO are hybrid effectiveness implementation trials that examine the effectiveness and clinical impact of interventions to prevent or treat mental illness, implementation challenges and strategies within the intervention setting, and at least one mechanism of action associated with an intervention and/or implementation strategy. The research covered under this announcement addresses practice-relevant questions and must be conducted within accessible intervention settings where the typical consumer can be identified as in need of care and be readily connected to an intervention.
Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)
(PAR-25-178)
National Institute of Mental Health
NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of interventions, confirmatory efficacy trials, through to effectiveness trials.
This NOFO seeks pilot hybrid effectiveness implementation research consistent with NIMH's priorities for: 1) refining and optimizing preventive and therapeutic interventions with previously demonstrated efficacy for use with broader target populations or for delivery routine care, school, community, or online settings, and 2) research on implementation strategies that support the delivery and sustainability of evidence supported interventions in accessible settings. This NOFO supports pilot research designed to generate the preliminary data needed as a prerequisite to a well powered clinical trial. This includes research designed to assess the feasibility, acceptability, safety, and fit of approach, and explore the impact of the approach on both the outcomes of interest and at least one hypothesized mechanism of action.
Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
(PAR-25-179)
National Institute of Mental Health
NIMH solicits clinical trial applications through a series of notices of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials.
The purpose of this NOFO is to support confirmatory efficacy testing of non-pharmacological preventive and therapeutic interventions, and under certain conditions, selected pharmacological interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support "go/no-go" decisions about further development, effectiveness testing, or dissemination of the intervention. Interventions to be studied include, but are not limited to, behavioral, cognitive, interpersonal, and device-based (both invasive/surgically implanted as well as noninvasive/transcranial) approaches, or a combination thereof. Pharmacological interventions to be studied under this grant mechanism are expected to primarily focus on drugs approved for marketing by the FDA (for any indication). These will include medications off-patent which are undergoing development for a new mental health indication.
Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)
(PAR-25-060)
This Notice of Funding Opportunity (NOFO) encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal of this NOFO is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Models proposed for this NOFO would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention. This NOFO is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.
Development of Resources and Technologies for Enhancing Rigor, Reproducibility, and Translatability of Animal Models in Biomedical Research (R01 Clinical Trial Not Allowed)
(PAR-25-076)
The Office of Research Infrastructure Programs (ORIP) encourages research project grant applications aimed at developing and implementing broadly applicable technologies, tools, and resources for validating animal models and enhancing rigor, reproducibility, and translatability of animal research. Research projects submitted under this Notice of Funding Opportunity (NOFO) should be hypothesis driven with strong preliminary data. Proposed studies, models, resources, or technologies under this NOFO must either address research interests of multiple NIH Institutes and Centers (ICs), explore multiple organ systems, or be applicable to diseases and processes that impact multiple organ systems in order to align with ORIP’s NIH-wide mission and programs. Applications should aim to enhance the rigor, reproducibility, and translatability of animal research through the development and implementation of technologies, tools, and resources that have significant impact across a broad range of research areas using animal models. Applications must demonstrate how the proposed resources and technologies impact rigor and reproducibility of animal studies.
CCRP Initiative: NIH Countermeasures Against Chemical Threats (CounterACT) Translational Exploratory/Developmental Research Projects (R21 Clinical Trial Not Allowed)
(PAR-25-114)
This Notice of Funding Opportunity (NOFO) supports translational exploratory/developmental research that directly advances the discovery of novel treatment strategies, i.e., medical countermeasures (MCMs), that address serious morbidity and mortality after acute exposure to highly toxic chemical threats. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pesticides, and ultra-potent synthetic (UPS) opioids.
