National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
This FOA is being funded by the NIH BRAIN Initiative.
U01 Research Project Cooperative Agreements
See Notices of Special Interest associated with this funding opportunity
April 25, 2023 - This RFA has been reissued as RFA-NS-23-025
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
This funding opportunity announcement (FOA) is designed to support teams of three or more (up to six) PDs/PIs that seek to cross boundaries of interdisciplinary collaboration to elucidate the contributions of dynamic circuit activity to a specific behavioral or neural system. Applications are encouraged to propose adventurous and challenging goals that can only be tackled by a synergistic team-based approach and have the potential to be transformative and/or to enable significant advances. These studies at the exploratory stage are intended for the development of experimental capabilities and/or theoretical frameworks in preparation for a future competition for larger-scale or extended efforts, including the BRAIN TargetedBCP (R01) or the multi-component, Team-Research BRAIN Circuit Programs (U19).
The overall goal of this FOA is to enable a large-scale analysis of neural systems and circuits within the context and during the simultaneous measurement of an ethologically relevant behavior. Toward this end, teams are expected to assemble and leverage multi-disciplinary expertise, and to integrate experimental with computational and theoretical approaches. Teams are expected to bridge fields by incorporating rich information on cell-types, on circuit functionality and connectivity, in conjunction with sophisticated analyses of an ethologically relevant behavior of an organism or a well-defined neural system. Teams are also expected to aim for a mechanistic understanding of the circuits of the central nervous system (CNS) by applying cutting-edge methods such as those for large-scale recording, manipulation, and analysis of neural circuits across multiple regions of the CNS.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 14, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
| June 15, 2023 | Not Applicable | Not Applicable | November 2023 | January 2024 | April 2024 |
| June 14, 2024 | Not Applicable | Not Applicable | November 2024 | January 2025 | April 2025 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
The BRAIN Initiative
Since 2014, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.
As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Funding Opportunity Announcements (FOAs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group.
The NIH BRAIN Initiative recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.
To support the best science, the NIH BRAIN Initiative encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:
- Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
- Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
- Individual applications and partnerships that enhance geographic and regional heterogeneity.
- Investigators and teams composed of researchers at different career stages.
- Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
- Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.
The NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs.
The BRAIN Initiative requires a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities such as the annual PI meeting. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.
This FOA is related to the Recommendations in Section III. 2, 3, 4, 5 and 7 of the Final Report (http://www.nih.gov/science/brain/2025/index.htm) of the BRAIN working group. Specifically, this FOA solicits applications that will address the recommendations on Maps at Multiple Scales , "The Brain in Action", "Demonstrating Causality", "Identifying Fundamental Principles" and From BRAIN Initiative to the Brain (Section III Implementation: Goals, Deliverables, Timelines and Costs, Parts 2 3, 4, 5 and 7) of the Final Report.
Integrated Approaches Funding Opportunities
The broad goal of the BRAIN Initiative is to understand the circuits and patterns of neural activity that give rise to mental experience and behavior, which will provide a foundation for understanding and treating diverse neurological, psychiatric, and behavioral disorders. It is the dynamic activity of massively interconnected ensembles of neurons in specially organized networks that give rise to the internal states we experience as sensations, perceptions, emotions, thoughts, memories, and movements. The activity of these networks is the substrate of cognitive processes such as attention, intention, emotions, and rational processes such as reasoning and decision making. Ultimately, these covert, internal activities are translated into patterns of neural activation that lead to overt behaviors, from simple reflexes to highly coordinated movements such as reaching and walking, to more complex behaviors such as navigating the environment and foraging, or speech and language. Dysfunction of these large systems of neurons due to disease, injury or developmental anomaly is the basis of neural and mental disorders.
We can seek to understand circuits of the CNS by systematically controlling stimuli and measuring the resulting behaviors, while actively recording and manipulating the dynamic patterns of neural activity. We now have transformational technologies that allow us to record large, interrelated ensembles of neurons on an unprecedented scale during active behaviors. For example, it is now possible to study the collective neural activities of entire sensory-motor circuits. By clever manipulation of environments and contingencies, we can devise behavioral tasks that engage memories, decision making, and selective attention, while documenting and manipulating the functional relationships within the neural circuits that subtend the behaviors.
Increasingly, sophisticated approaches are required for data acquisition, analysis, interpretation, and dissemination. These demanding requirements often involve expertise not typically associated with traditional neurobiological experiments and training, such as expertise in physics, computer and information science, hardware and software engineering, statistics, machine learning, and computational methods. As new, large-scale, systems approaches become routine, it will be essential to develop testable theories of how information originating from millions of neurons in diverse and widespread CNS regions can be integrated to produce a wide range of internal, motor, sensory, and cognitive behaviors, and how this information evolves dynamically to adapt, refine, and learn.
Towards the goal of understanding the circuit basis of behavior, we offer a family of Integrated Approaches NIH BRAIN FOAs that share an overall goal of understanding the circuit basis of behavior. These FOAs range from small or exploratory (Targeted BCPP R34) vs targeted brain circuits projects with specific research deliverables (Targeted BCP R01) to large, team-research projects with exploratory aims (eTeamBCP U01, this FOA) or with extensive and elaborated goals and a 5-10 year horizon of discovery (Team BCP U19). This set of funding opportunities is designed to allow for the tackling of scientific questions at different scales and of various complexities, and to balance support for individual-lab science and team-science approaches. In each case, the FOAs are guided by BRAIN 2025 A Scientific Vision: The Application of Integrated Technologies to Study Fundamental Questions in Neuroscience: Numerous long-standing problems in CNS science will benefit dramatically from the integrated experimental approach made possible by the BRAIN Initiative. Potential applicants are encouraged to visit the NIH BRAIN Initiative website for information and guidance https://www.braininitiative.nih.gov/funding/initiatives.htm.
Program Objectives and Scope
Per the BRAIN 2025 report, "No single researcher or discovery will solve the brain’s mysteries. The most exciting approaches will bridge fields, linking experiment to theory, biology to engineering, tool development to experimental application, human neuroscience to non-human models, and more, in innovative ways. Hence, the purpose of this exploratory FOA is to provide resources for the integration of experimental, computational, and theoretical capabilities for the large-scale analysis of neural systems and circuits within the context and during the simultaneous measurement of behavior.
This exploratory FOA will support the building of teams of experts that seek to cross boundaries of interdisciplinary collaboration by bridging fields and by linking theory, modeling, and/or data analysis to experimental design. Teams must have three or more (up to six) PD/PIs who will each bring a distinct scientific viewpoint or expertise necessary to pursue the interdisciplinary approach. Teams are expected to develop or adopt a conceptual or quantitative modeling framework, which incorporates theories about causal mechanisms of circuit functions, to drive experiments and build testable hypotheses. Innovative and mechanistic approaches to cross-cutting questions in neuroscience are expected; this FOA emphasizes the use of cutting-edge methods of activation, recording, and/or analysis to understand the behavior of circuits at cellular and sub-second levels of spatial and temporal resolution, that is, at the level of the functional units of circuits. Diverse species or experimental systems and a cross-species/comparative approach are welcome and should be chosen based on their power to address the specific question at hand and to reveal generalizable and fundamental principles.
Proposed exploratory studies should lead to subsequent, competing applications for support of team-research projects (e.g. Targeted BCP R01, TeamBCP U19) consistent with the BRAIN Initiative's goal to understand the circuits of the CNS, to measure the fluctuating patterns of electrical and chemical activity flowing within those circuits, and to understand how their interplay creates our advanced cognitive and behavioral capabilities. See Section IV for the full list of FOA requirements.
Applications are required to include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material.
If proposing a clinical trial, this FOA will only accept basic experimental studies involving humans (BESH), in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena. Human studies with invasive (intra-cortical) recording and/or stimulating must include neuroethical considerations, such as consent of patients recruited into studies with possibility for risk beyond therapeutic standards of care without expectation of personal therapeutic benefit. Additional risks should be identified and justified as minor and manageable. The consent methodology needs to address how the possibility of coercion or undue influence, and therapeutic misconception, will be minimized.
The list below includes representative, but not exhaustive, examples of topics that could be considered responsive to this FOA. We welcome basic research projects that employ mechanistic, cutting-edge, integrated, and innovative approaches to:
- Understand network coding of sensory information and/or multi-sensory integration, at multiple stages of processing, in response to diverse naturalistic inputs and perceptual contexts.
- Assess motor coding during complex behaviors or in freely-moving subjects.
- Understand neural circuitry associated with diverse social behaviors.
- Reveal large-scale, dynamic changes in functional circuit connectivity that underlie the brain's ability to store information and to learn new behaviors.
- Reveal distributed circuits that contribute to the coordination of motivational states and reward behavior.
- Capture and assess information processing across brain regions during memory consolidation, memory retrieval, spatial/relational processing, attention, or planning.
- Assess distributed representations and the information processing underlying advanced mental processes such as decision making, numerical cognition, reasoning, and metacognition.
- Understand how behavioral states are emergent properties of the interaction of neurons, circuits, and networks.
- Advance principles of circuit function and neural systems in the central nervous system that regulate homeostasis, including biorhythms, and the balance of temperature, respiratory, energy and metabolic functions.
- Understand circuit function across stages of development.
- Understand the role of interactions between neuronal and non-neuronal cells in shaping neurocircuit function.
Non-Responsiveness Criteria:
Applications deemed to be non-responsive will be withdrawn. The following are considered non-responsive to this FOA:
- Applications for the study of specific disease mechanisms, or specific disease therapeutics and treatments will be considered nonresponsive to this BRAIN Initiative FOA. While fundamental basic research often generates insights relevant to disorders of the nervous system, this FOA is not intended to stimulate research that is explicitly disease-related. Studies for the investigation of specific diseases and disorders should be directed to the appropriate NIH Institutes.
- Applications with clinical trials that are not considered basic experimental studies involving humans (BESH).
- Applications that lack the required one-page PEDP attachment.
Prior Consultation with Scientific/Research staff
Consultation with relevant Scientific/Research staff is strongly recommended, preferably not later than the Letter of Intent due date. If requested by the applicants, staff can advise whether the proposed project meets the goals of this FOA and the mission of the BRAIN initiative, and discuss responsiveness questions. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed project does not meet the programmatic needs of this FOA, applicants will be strongly encouraged to consider other Funding Opportunities.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
NIH BRAIN Initiative intends to commit up to $12M per fiscal year to fund around 5 awards.
The project period must be three years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Eligible Agencies of the Federal Government - Including the NIH Intramural Program
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The application is required to be submitted as a multiple PD/PI application, with a minimum of 3 and a maximum of 6 PDs/PIs. Visit the multiple PD/PI Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide, and the Grant Policy Statement on Multiple Principal Investigators. Minimum allowed efforts by the PDs/PIs are described in the R&R Budget instructions in Part 2. Section IV.2.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Dr. Karen K David
6001 Executive Blvd
North Bethesda, MD
Telephone: 301-496-9964
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The PEDP may be no more than 1-page in length.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Attachments:
Plan for Enhancing Diverse Perspectives (PEDP)
In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:
- Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
- Description of any planned partnerships that may enhance geographic and regional diversity.
- Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
- Proposed monitoring activities to identify and measure PEDP progress benchmarks.
- Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
- Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
- Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
- Publication plan that enumerates planned manuscripts and proposed lead authorship.
- Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PEDP implementation costs:
- Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).
Data sharing costs:
- Applicants may include costs associated with preparing and submitting data to a data archive (as outlined in this data sharing policy: https://grants.nih.gov/grants/guide/notice-files/NOT-MH-19-010.html
Research Budget: To be successful, programs of this level of complexity are expected to require significant effort from all PDs/PIs involved. All PDs/PIs must commit at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.67% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award.
Certain supporting functions such as equipment, animal research costs, and clinical research costs may be requested if well justified and unique to the institution(s) involved. Within the research budget, equipment, including data sharing and management systems, can be included if well justified. Equipment that duplicates existing institutional or regional shared facilities that are available to investigators must be identified and the proposed duplication should be well justified. Do not request inflationary increases in the overall budget or any of the budget categories. Changes in budget should reflect changes in activities required by the science.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: This FOA supports exploratory collaborative studies to develop experimental capabilities and theoretical frameworks to prepare for a future team-science effort, focused on understanding a specific behavioral or neural system in terms of circuit dynamics.
All applications should include the following points, which should be incorporated within the page limits of the Research Strategy:
- Statement of the neurobiological questions to be addressed. Applications should propose to elucidate the contributions of dynamic circuit activity to a specific behavioral or neural system. Applications should identify fundamental principles about circuit dynamics and functional connectivity for understanding the biological basis of neural processes through application of cutting-edge methods and computational tools. This FOA welcomes basic research using human or non-human animal subjects.
- Justification of the team of experts to address the multiple components of approach. Applications should propose teams of investigators that seek to cross boundaries of interdisciplinary collaboration by bridging fields and by linking theory, modeling, and/or data analysis to experimental design. Projects should engage research teams that integrate across diverse approaches for observation, experimental perturbation, and theoretical modeling of circuits and neural dynamics. Teams should leverage appropriate multi-disciplinary expertise to develop new principles and methods for data acquisition, analysis, and interpretation. The application is required to be submitted as a multiple PD/PI application, with a minimum of 3 and a maximum of 6 PDs/PIs.
- Detailed description of the theories and models that frame explicit empirical questions, and discussion of the computational tools for interpretation of results. The purpose of this FOA is to promote the integration of experimental, computational, and/or theoretical capabilities for large-scale analysis of neural systems and circuits.
- Studies are required to develop or use a conceptual or quantitative theoretical framework for building testable hypotheses (i.e., model-driven empirical design). Mechanistic tests of cause-and-effect are expected, such as testing whether modifying electrophysiological patterns during behavior can alter the observed behavior.
- The development or use of innovative algorithmic approaches for dynamic tracking of function in continuous data and real-time signal processing is encouraged, as are methods for interactive data exploration and dimensionality reduction in high-dimensional data sets.
- Computational methods and experimental approaches to link neural processes across multiple scales of structure and time (spanning the requirement of cellular recording resolution) are encouraged (e.g., channels, to cell compartments/structures, to spike rates/timing, to LFPs/oscillations, to circuits/networks/ensembles, to brain states).
- Description of large-scale recording/manipulation methods that will be employed or developed to approach the questions as a functional system. Projects should describe how they will employ and/or develop new and emerging capabilities for large scale recording and manipulation of neural activity of specific circuits or systems, ideally across multiple brain regions.
- Scale of recording should be sufficient to account for the dynamic activity of the circuit or distributed ensemble of neurons under study, or to validate a specific, model-predicted outcome. This will be evaluated using species-appropriate considerations.
- A cellular resolution of recording circuit activity, with sub-second temporal resolution, is expected in order to address mechanistic understanding of circuit functions. The resolution of mechanistic manipulation of circuits is relaxed from that of single cells to that of cell type/location specificity (e.g., compatible with focal TMS, micro-stimulation, micro-injection, and optogenetic/DREADD/etc. manipulation, including by non-germ cell induction such as viral vectors in non-transgenic species).
- Explanation of the experimental strategies to investigate mechanisms within the circuits studied. Applicants should demonstrate how new and unprecedented experimental capabilities can be used to transform general understanding of neural information processing within the context of specific systems or circuits. Diverse species or experimental systems and a cross-species/comparative approach are welcome and should be chosen based on their power to address the specific question at hand and to reveal generalizable and fundamental principles.
- Description of tractable goals, contingency plans, or milestones for the project, which will serve as a basis for a subsequent application in a competition for large-scale, multicomponent projects.
- This chart/table is required and must be included within the page limit for the Research Strategy: Applicants should include a project timeline in the form of a Gantt chart (or similar) that includes all major tasks to be performed during the project as well as critical benchmarks for success. The chart should also include estimated start and completion dates for those tasks, and should identify the contributions expected from each PD/PI and/or key personnel toward accomplishing each task. For a truly integrated collaborative project, it is expected that most or all of the scientific aims will require substantial contributions from more than one PD/PI. This chart will aid reviewers in assessing the feasibility and likelihood that the work plan is adequate for achieving project objectives within the funding period. It will also aid in assessing the degree of integration and collaboration, and the availability of appropriate intellectual and technical expertise for each aim.
- Overall, the project should offer potentially transformative and paradigm-shifting advances in understanding brain circuitry underlying behavioral or neural systems
Other specific requirements and considerations:
- With studies involving humans, only basic science experimental studies are allowed (BESH). Human studies with invasive (intra-cortical) recording and/or stimulating devices must include neuroethical considerations, such as consent of patients recruited into studies with possibility for risk beyond therapeutic standards of care without expectation of personal therapeutic benefit. The consent methodology needs to address how the possibility of coercion or undue influence, and therapeutic misconception, will be minimized. Applicants must also consider FDA-defined conditions of non-significant risk/significant risk beyond established standards of clinical care, ethical and practical considerations of invasive device maintenance and ultimate removal, and other ethical issues specific to invasive human neuroscience research.
- The multiple approaches and collaborations described should offer a team-research synergy that would not be possible as separately funded R01s or other individual research project award mechanisms.
- Applications should describe how they incorporate rich information on cell types and circuit connectivity to inform assessments of neural activity patterns.
- Studies of dynamic neural activity should be performed in conjunction with sophisticated analysis of ethologically relevant behaviors or behavior of a well-defined neural system. When simple circuits are employed, it should be made clear how they are ideal for revealing general principles about the circuit basis of the specific behavior of interest. Studies of complex behaviors, including behavioral assays of freely-moving animals up to objective measures of cognitive/perceptual processes, are encouraged.
- Projects should have a plan for innovative approaches to large-scale data analysis, visualization, storage and dissemination, to maximally leverage the value of newly acquired data for broad communities of researchers.
- Because projects are expected to be early-stage and potentially high-risk, preliminary data are not required.
Applications should strive to promote diversity of research teams, must apply NIH standards of experimental and publication rigor (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html), and must comply with NIH policy on reporting disaggregated sex-based data and other consideration of sex as a biological variable as elaborated in NOT-OD-15-102, NOT-OD-15-103 and NOT-OD-16-031.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
- All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan as part of the Resource Sharing Plan. The BRAIN Initiative has published a guide notice in reference to data sharing (NOT-MH-19-010). Data sharing plans should reflect the guidance in this notice. The Resource Sharing Plan should outline how all the data and tool deliverables from this FOA (e.g. algorithms, theories, models, methods, software, technology, constructs, transgenic lines, etc.) will be shared and disseminated. Project-specific details will be established at the time of award. Budgets should include sufficient resources to prepare and disseminate data.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.
Applications Involving the NIH Intramural Research Program
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
This FOA supports exploratory collaborative studies to develop experimental capabilities and/or theoretical frameworks to prepare for a future larger-scale or extended research effort, focused on understanding a specific behavioral or neural system in terms of circuit dynamics.
Because projects are expected to be early-stage and potentially high-risk, preliminary data are not required. However, a sound rationale should be provided as to why the approach is tractable, the research team are the most appropriate, and the project likely to generate an exceptionally high impact if successful. Although reviewers will be asked to consider feasibility, they will be instructed to not penalize unavoidable risks that are intrinsic to new and innovative approaches .
In addition, for applications involving clinical trials:
A proposed clinical trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or leads to new avenues of scientific investigation.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this announcement:
?Does the project seek to identify fundamental principles or produce conceptual foundations about circuit dynamics and functional connectivity ?? Does the project justify how its development of experimental capabilities and/or theoretical frameworks will prepare for a future competition for larger-scale or extended team-research awards? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this announcement:
Reviewers should assess whether the multiple approaches and collaborations offer a team-research synergy that would not be possible as separately funded individual research project award mechanisms. Reviewers should assess whether the team seek to cross boundaries of interdisciplinary collaboration by bridging fields and linking theory and data analysis to experimental design.
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this announcement:
?Does the project offer potentially transformative and paradigm-shifting advances in understanding brain circuitry underlying behavioral or neural systems? Are the approaches and questions innovative?
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this announcement:
Reviewers should assess the methods, justification, or integration plans, as follows:
Does the project use cutting-edge methods of activation and recording to understand behavior or a neural system in terms of a mechanistic understanding of specific circuits at cellular and sub-second levels of spatial and temporal resolution? Is the scale of recording sufficient to account for the dynamic activity of the circuit or distributed ensemble of neurons under study, or to validate a specific, model-predicted outcome? This should be evaluated using species-appropriate considerations.
Does the project justify how the selected species offer the best conditions for revealing general principles about the circuit basis of the specific behavior or neural system of interest?
Does this project seek to bridge fields, integrating experimental, computational, and/or theoretical capabilities? Is there a theoretical framework (conceptual or quantitative) for building testable hypotheses?
How well does the Data Sharing Plan provide a summary of the shared data, a description of the data standards, a plan for the data archiving, and a timeline for data submission to the archive and sharing data with the research community?
Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this announcement:
To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms and (2) Genomic Data Sharing Plan (GDS).
Does the Resource Sharing Plan outline how all the resources and tool deliverables from this FOA (e.g. algorithms, theories, models, methods, software, technology, constructs, transgenic lines, etc.) will be shared and disseminated?
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities including the PEDP.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
- PDs/PIs will determine and coordinate the research approaches and procedures, conduct experiments, and analyze and interpret research data generated under this award.
- PDs/PIs will endeavor to meet or exceed the timeline stated in their application.
- PDs/PIs will agree to participate as a voting member in a Research Consortia composed of other BRAIN Initiative awardees and NIH staff.
- PDs/PIs will share resources and data, final results, and technology with the broader research community as appropriate and consistent with achieving the goals of the program.
- PDs/PIs will ensure that results are published in a timely manner.
- PDs/PIs will submit data for quality assessment and/or validation in any manner specified by the NIH Program Officer.
- PDs/PIs will submit periodic progress reports.
- PDs/PIs will accept and implement any other common guidelines and procedures approved by the Program Officer.
- PDs/PIs will attend BRAIN Initiative-related meetings. It is likely that there will be one in-person meeting per year and that other meetings will be by telephone or using internet-assisted meeting software.
- PDs/PIs will provide updates at least annually on implementation of the PEDP.
- Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance and be named on the Notice of Award.
- A group of NIH program staff from the ICs contributing to the NIH BRAIN Initiative will form a Project Team for this award.
- The Project Team, led by the Program Officer(s) for these BRAIN Initiative awards, will review annual progress reports and other documents from the awardees and will advise the Program Officer about their view of the progress being made by the awardee as well as about progress being made by others in the field.
- One extramural NIH program staff member will be assigned as the Project Coordinator for this award. The same person may serve as the Project Coordinator for multiple BRAIN Initiative awards.
- The Project Coordinator will provide technical assistance, advice, coordination, and other program actions supporting the Program Officer and recipients of these cooperative agreements during the conduct of an activity, which may be above and beyond the levels required normally for program stewardship of grants.
- The additional duties of the Project Coordinator may include attending and participating in meetings of Principal Investigators and NIH Staff, assisting in the development of the meeting agendas, assisting in evaluating achievement of proposed outcomes, and as needed, assisting with the establishment of a consortium for the purpose of sharing information and coordination of research activities among the recipients of these cooperative agreements.
- In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.
Areas of Joint Responsibility include:
None; all responsibilities are divided between awardees and NIH staff as described above.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D, and DHHS regulation 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Karen K David, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
and Human Services (HHS)
