NIH HEAL Initiative: Coordinated Approaches to Pain Care in Health Care Systems
This Notice of Funding Opportunity (NOFO) solicits research applications that propose implementation science methodology to embed existing evidence-based coordinated pain care models into a variety of public and private health care systems (HCS) where this type of care does not exist.
This NOFO is intended to embed the coordinated care model under study into the health care delivery system of applicant institutions. Coordinated pain care approaches proposed for study are expected to include interventions from multiple disciplines as described below and should aim to improve pain management based on the biopsychosocial model of pain. Emphasis should be on reaching populations of patients with greatest need.
Models of coordinated care proposed by the study team should be aligned with health care resources of the participating HCS and should be informed through engagement of stakeholders including patients, providers, healthcare system executives, policymakers, and payors. The study teams are expected to include health care providers from multiple disciplines and implementation scientists.
Trials will be supported by the Coordinating Center (CC) of the HEAL Pragmatic and Implementation Studies to Improve the Management of Pain and Reduce Opioid Prescribing (PRISM) Program ( https://rethinkingclinicaltrials.org/.) The Coordinating Center will provide technical expertise in all aspects of research and coordination across studies awarded through this NOFO. Recipients will work with the CC to facilitate planning and refinement of proposed studies in partnership with health care delivery systems.
Interventions to Address Disparities in Liver Diseases and Liver Cancer
This initiative will support multi-level and/or multi-domain intervention research to reduce disparities in liver diseases and liver cancer among populations who experience health disparities in the United States (U.S.).
Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to establish a Center that educates and mentors researchers in formal product development for new substance use disorder (SUD) pharmacotherapeutics and to advance the best concepts through initial experiments via technical and financial support.
NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
This Notice of Funding Opportunity Announcement (NOFO) solicits cooperative agreement (UG3/UH3) applications for implementation of investigator-initiated, single or multi-site, interventional clinical trials (all phases). Investigators who have completed all necessary preparation (e.g., the trial design, protocol synopsis, data analysis plan, etc.) through other means may apply for a NIAMS UG3/UH3. The UG3 phase is designed to allow the investigators to prepare the final aspects needed to start the trial, (e.g., establishing the single IRB (sIRB), contracts and reliance agreements with sites, hiring of staff, etc.). Transition to the UH3 phase to begin the trial is dependent upon completion of the UG3 milestones proposed by the investigator and approved by NIAMS. UG3 projects that meet their milestones will be administratively considered by NIAMS and prioritized for transition to the UH3 phase. NIAMS expects trials to be hypothesis-driven and have the potential for high clinical impact within the research mission of NIAMS.
BRAIN Initiative: Brain-Behavior Quantification and Synchronization – Transformative and Integrative Models of Behavior at the Organismal Level (U01 Clinical Trials Not Allowed)
This Brain-Behavior Quantification and Synchronization notice of funding opportunity (NOFO) seeks applications using non-human animal models that bring together transdisciplinary teams and aim to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the organismal level, with synchronous capture of data from the dynamic environment of the organism; 2) develop advanced analytic approaches to integrate multidimensional behavioral, neural and environmental data; and 3) develop and test new theoretical and computational models aiming to advance understanding of behavior as a complex dynamic system. Proposed projects are expected to be designed with the capacity to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. This NOFO is intended for applications using non-human animal models. Applicants proposing research involving humans or use of human subjects data as a significant component should submit under the companion NOFO RFA-DA-24-040.
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.
Functional Target Validation for Alzheimer's Disease-Related Dementias (R61/R33 Clinical Trial Not Allowed)
This NOFO invites applications that propose the comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer's Disease-Related Dementias (ADRD). This NOFO seeks to promote critical target validation approaches to help de-risk subsequent translational research and accelerate the advancement of novel therapies for ADRD. Target(s) or molecular pathway(s) to be considered for validation must have been already identified using tissue expression or genetic data generated in human samples. In its initial phase, this NOFO provides support for up to two years (R61 stage) for the development of customized technologies, models, and protocols to modulate the expression or activity of target candidate(s) in cells and/or tissues and monitor their functional biological consequences in vitro or in vivo disease models. Upon demonstration of technical feasibilities, a second phase (R33 stage) will carefully and reproducibly measure and cross-validate the impact of the target modulation in different modalities across collaborating laboratories using the NIH rigor and reproducibility guidelines. This NOFO will support applications that address objectives for both the R61 and R33 phases and are expected to have a substantial collaborative effort between independent laboratories.
This NOFO is not specific for anyone or group within the ADRD spectrum of disorders. Disorders covered in these applications are frontotemporal degeneration (FTD), Lewy body dementias (LBD) (including dementia with Lewy bodies (DLB)), Parkinson disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), and mixed dementias including the multiple etiology dementias (MED).
Mechanistic Investigations into ADRD Associated Protein Structures in Biological Settings (R01 - Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) supports studies proposing to utilize methodologies for in-cell structural biology to address the mechanistic insights and causal cellular and molecular relationships between molecular pathology and Alzheimer’s disease-related dementias (ADRD) clinical phenotypic outcomes. The applications are expected to focus on determining structures of ADRD-linked macromolecular in native (healthy and pathological) settings. The proposed methodology is expected to provide high-resolution information on the identity, dynamics and relative abundance of macromolecular species associated with ADRD and how pathological environments influence dynamics and structural conformations. Studies in response to this NOFO can also include the development of in situ research tools and resources to further characterize and validate the structural findings. The long-term goal of this funding opportunity is for these structural studies in the native cellular environment to inform efficient tools development and designs that better identify and monitor the accumulation of dysfunctional proteins in patients, as well as for other diagnostic, treatment response, therapeutic development and other related applications.
HEAL Initiative: JCOIN Phase II Clinical Research Hubs (UM1 Clinical Trial Required)
The intersection of the criminal-legal system and the community-based healthcare system is a critical target for addressing the overdose crisis. Given the recent evolution of both the epidemiology of the overdose crisis and public policies intended to support overdose prevention efforts, new research is needed to take effective interventions to scale in law enforcement, jails, courts, and community corrections. There is also a pressing need to rigorously test new and emerging models for effectively addressing the complex needs of individuals with substance use disorder (SUD) and/or high overdose risk in these settings. Of particular importance is the coordination of services between public health and public safety agencies, to ensure continuity of care for individuals as they transition between these systems.
To support research on effective interventions and implementation strategies for addressing SUD, overdose risk, and common co-occurring conditions in these populations and systems, the National Institute on Drug Abuse (NIDA) intends to continue the Justice Community Overdose Innovation Network (JCOIN) – Phase II. The purpose of the network is to bring together a national consortium of investigators and practitioner partners to conduct an array of research and capacity building activities to improve the delivery of effective interventions for adults and youth, spanning the key points of the sequential intercept model (i.e., crisis intervention, emergency response, law enforcement diversion/deflection, pre-trial services, courts, jail, prison, re-entry services, probation, parole).
The structure of the network will include multiple research centers, working in collaboration with four complementary resource and support centers. This notice of funding opportunity (NOFO) seeks applications for JCOIN Phase II Clinical Research Hubs.
This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).