Funding Opportunity Announcements

This Funding Opportunity Announcement (FOA) solicits applications for team-centric development and validation of innovative non-invasive imaging technologies that could have a transformative impact on the study of brain function/connectivity. Applications are expected to turn a novel concept into a functional prototype using this phased grant mechanism. The feasibility should be established by the end of its first phase and serve as a foundation for the transition to its second phase. Fully developing the technology into a functional prototype and validating it by in-vivo animal or human function/connectivity imaging are anticipated in the second phase. The research plan should provide a realistic timeline and tangible milestones to support the proposed development effort. Awards will be integrated into the BRAIN Non-Invasive Imaging Consortium, as a coordinated network on brain function/connectivity imaging.

The goal of this effort is to support the development and validation of next generation platforms and analytic approaches to precisely quantify behaviors in humans and link them with simultaneously recorded brain activity. Tools used for analyzing behavior should be multi-modal and should be able to be linked to brain activity and thus have the accuracy, specificity, temporal resolution, and flexibility commensurate with tools used to measure and modulate the brain circuits that give rise to those behaviors. This phased award will support novel tool development (i.e., hardware/software) in the R61 phase and synchronization of novel tools for measuring behavior and human brain activity in the R33 phase.

The goal of this effort is to support the development and validation of next generation platforms and analytic approaches to precisely quantify behaviors in humans and link them with simultaneously recorded brain activity. Tools used for analyzing behavior should be multi-modal and should be able to be linked to brain activity and thus have the accuracy, specificity, temporal resolution, and flexibility commensurate with tools used to measure and modulate the brain circuits that give rise to those behaviors. This phased award will support novel tool development (i.e., hardware/software) in the R61 phase and synchronization of novel tools for measuring behavior and human brain activity in the R33 phase.

This FOA will support integrated, interdisciplinary research teams from prior BRAIN technology and/or integrated approaches teams, and/or new projects from the research community that focus on examining circuit functions related to behavior, using advanced and innovative technologies. The goal will be to support programs with a team science approach that can realize meaningful outcomes within 5-plus years. Awards will be made for 5 years, with a possibility of one competing renewal. Applications should address overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. Applications should incorporate theory-/model-driven experimental design and should offer predictive models as deliverables. Applications should seek to understand circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions. Applications are expected to employ approaches guided by specified theoretical constructs, and are encouraged to employ quantitative, mechanistic models where appropriate. Applications will be required to manage their data and analysis methods in a prototype framework that will be developed and used in the proposed U19 project and exchanged with other U19 awardees for further refinement and development. Model systems, including the possibility of multiple species ranging from invertebrates to humans, can be employed and should be appropriately justified. Budgets should be commensurate with multi-component teams of research expertise including neurobiologists, statisticians, physicists, mathematicians, engineers, computer scientists, and data scientists, as appropriate - that seek to cross boundaries of interdisciplinary collaboration.

Invasive surgical procedures offer the opportunity for unique intracranial interventions such as the ability to record and stimulate intracranially within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and need to be aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to the brain from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and by quantitative, mechanistic models where appropriate. 

Awardees will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community. 

Reissue of RFA-MH-19-135 The purpose of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis and manipulation of complex circuits and provide insights into cellular interactions that underlie brain function. Critical advances in the treatment of brain disorders in human populations are hindered by our lack of ability to monitor and manipulate circuitry in safe, minimally-invasive ways. Clinical intervention with novel cell and circuit specific tools will require extensive focused research designed to remove barriers to delivery of gene therapies. In addition to identification and removal of barriers, the need to specifically target dysfunctional circuitry poses additional challenges. Neuroscience has experienced an impressive influx of exciting new research tools in the past decade, especially since the launch of the BRAIN Initiative. However, the majority of these cutting edge tools have been developed for use in model organisms, primarily rodents, fish and flies. These cutting edge tools, such as viral delivery of genetic constructs, are increasingly adaptable to large brains and more importantly are emerging as potential human therapeutic strategies for brain disorders. A pressing need to develop tools for use in large brains, more directly relevant to the human brain is the focus of this initiative. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs in research areas relevant to the BRAIN Initiative. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development and Research Experiences. The purpose of this FOA is to encourage applications for the continuation and/or expansion of ongoing and new research education programs that will significantly advance the educational goals of the BRAIN Initiative as described in BRAIN 2025: A Scientific Vision including neuroethics and opportunities to increase the workforce diversity in BRAIN Initiative research areas. Proposed programs are expected to offer hands-on research experiences, an in-depth conceptual understanding of the techniques and tools employed, and the knowledge to apply appropriate analytic approaches to the resulting data. Participants are limited to undergraduate, graduate/medical students, medical residents, postdoctoral scholars, and/or early-career faculty with an emphasis on diversity as defined by NIH (NOT-OD-20-031). Proposed programs will facilitate the development of a sophisticated cadre of future investigators with the knowledge and skills to apply BRAIN Initiative techniques and approaches and data resources (BRAIN cell census data https://bicon.org/data) to research questions about brain function and behavior. Programs appropriate for this FOA must include participants from a regionally/nationally recruited cohort.

This funding opportunity announcement (FOA) supports efforts to disseminate resources and to integrate them into neuroscience research practice. Projects should be highly relevant to specific goals of the BRAIN Initiative, goals that are described in the planning document "BRAIN 2025: A Scientific Vision." They should engage in one or more of the following activities: distribution of tools and reagents; user training on the usage of new technologies or techniques; providing access to existing technology platforms and specialized facilities; minor improvements to increase the scale/efficiency of resource production and delivery; minor adaptations to meet the needs of a user community. Applications strictly focused on technology or software development, rather than dissemination of an existing resource, are not responsive to this FOA. Refinements to microscopes or tools necessary to customize them to the experimental needs of the end users is allowed. Projects should address compelling needs of neuroscience researchers working toward the goals of the BRAIN 2025 report that are otherwise unavailable or impractical in their current form.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of 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 an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. 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 FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information 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. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

Reissue of RFA-NS-19-011: The purpose of the NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award is to support a defined pathway across career stages for outstanding graduate students who are from backgrounds that are nationally underrepresented in neuroscience research. This two-phase award will facilitate completion of the doctoral dissertation and transition of talented graduate students to strong neuroscience research postdoctoral positions, and will provide career development opportunities relevant to their long-term career goal of becoming independent neuroscience researchers.

This is a reissue of RFA-MH-19-147. This FOA supports the development of software to visualize and analyze the data as part of programs of building the informatics infrastructure for the BRAIN Initiative. Other informatics programs include developing data standards that are needed to describe the new experiments that are being created by or used in the BRAIN Initiative ( RFA-MH-19-146 ), and creating the data infrastructures that will house the data from multiple experimental groups ( RFA-MH-19-145 ). Each of the programs is aimed at building an infrastructure that is used by a particular sub-domain of experimentalists rather than building a single all-encompassing informatics infrastructure now. Building the infrastructure one experimental area at a time will ensure that the infrastructure is immediately useful to components of the research community. As our understanding of the brain improves, it may be possible to create linkages between these various sub-domain specific informatics programs. Investigators of the informatics programs should keep that goal in mind and build for the future even though the current efforts are more limited in scope.

This Funding Opportunity Announcement (FOA) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives teams will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this FOA. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this FOA. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research.