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U24 Resource-Related Research Projects – Cooperative Agreements
NOT-MH-21-262 - Notice of Intent to Publish a Funding Opportunity Announcement for BRAIN Initiative Cell Atlas Network (BICAN): Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE) (U24 Clinical Trial Not Allowed)
This Funding Opportunity Announcement (FOA) intends to support a Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE) that will be composed of four elements to establish respectively (1) a common sequencing data processing pipeline, (2) a common imaging data processing pipeline, (3) a comprehensive brain cell knowledge base, and (4) an engagement and outreach element to coordinate the research within and beyond BICAN. The overall goals of CUBIE are to (i) enable the exploration of large-scale brain cell atlas data and knowledge, and inspire research in brain function and disorders; and (ii) ensure research rigor and data reproducibility by making the data Findable, Accessible, Interoperable, and Reusable (FAIR), and the process transparent. An application is expected to propose only one of the above four respective elements.
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 |
| November 09, 2021 | Not Applicable | Not Applicable | March 2022 | May 2022 | July 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
No late applications will be accepted for this Funding Opportunity Announcement.
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.
Background
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:
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 by the Advisory Committees to the NIH Director as described in “Priority Area 1: Discovering Diversity” and “Priority Area 2: Maps at Multiple Scales” in “BRAIN 2025 Report,” and the transformative project, “The Human Brain Cell Atlas,” in “The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures.”
BRAIN Initiative cell census and atlas efforts are expected to produce a new foundational framework for analyzing brain structure and function in health and disease, with the possibility of extending the quantitative analysis to many other species to elucidate the conservation and divergence of molecular and cellular mechanisms underlying the brain function and disorders.
The BRAIN Initiative Cell Atlas Network (BICAN) and Goals
The BRAIN 2025 Report envisioned a systematic census of neuronal and glial cell types in multiple mammalian species. The NIH BRAIN Initiative has implemented this vision by successfully completing a 3-year pilot phase (2014-2017), followed by launching a 5-year phase 2 (2017-2022) BRAIN Initiative Cell Census Network (BICCN) with an emphasis on the mouse brain. The BICCN has applied a set of advanced single-cell approaches to characterizing molecular signatures, anatomical phenotypes, and functional properties of brain cell types, and rapidly disseminated the cell census data to the public. The BICCN is on track to complete a comprehensive cell census spanning the entire adult mouse brain, as well as to set the stage for large-scale cell atlas research in human and non-human primate (NHP) brains. Advances in single-cell transcriptomic and epigenomic profiling, anatomical mapping at cellular resolution, and other approaches have proven to be powerful and scalable. At this time, the BRAIN Initiative Cell Census Program is looking to establish the BICAN to broaden and deepen the systematic cell census and atlas efforts with a new emphasis on human brain. This FOA and the companion announcements intend to establish a network of projects that will work cooperatively to:
The expected outcomes of the BICAN include:
The BICAN will be made up of interactive projects with complementary roles from the following funding oppourtunities:
The BICAN will operate as a collaborative network to promote collaboration and coordination within and beyond the network. All projects in the BICAN will work together to achieve the common goals. In addition, the BICAN will coordinate and collaborate with external research consortia, programs, and entities (e.g., Human Cell Atlas, Human BioMolecular Atlas Program, Human Tumor Atlas Network, LungMAP, GUDMAP, KPMP, RBK), which have joined interests in sharing technology know-how and developing common data and knowledge frameworks for the characterization of cell diversity in health and disease.
Research Objectives
This FOA seeks to fund a group of cooperative agreement awards to form a Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE). The aggregated capabilities of the awardees from this FOA are expected to result in an ensemble of data analysis tools required to interpret the diverse cell atlas data types. CUBIE will serve as a central unit of the BICAN to coordinate and collaborate with all BICAN projects. In particular, CUBIE will work closely together with the BRAIN Initiative Data Archives funded under RFA-MH-20-600 and the related FOAs, which are expected to establish cloud-based data archiving infrastructure for storing BICAN data and provide a high performance computing environment and software development tools. The data analysis tools developed for the common data processing pipelines are expected to be optimized and implementable in the computing environment of the BRAIN Initiative Data Archives. Thus, models, analytical tools, and analyzed data generated under this FOA are expected to be deposited to an appropriate BRAIN Initiative Data Archive where the investigators can optimize software toolchain and create data sandboxes for testing and comparing their codes and analysis results. Further, CUBIE is expected to collaborate with the broader research community to analyze and interpret all existing brain cell census/atlas data to enhance statistical power, ensure research rigor and data reproducibility, and foster the formation of a brain cell atlas ecosystem.
I. Specific elements and goals of CUBIE
CUBIE will be composed of the following four distinct elements. Applicants to this FOA are expected to have both computational and biological expertise in one of the following four areas. An application to this FOA is expected to propose only one of the following four elements. However, applicants may describe and propose how cross-element coordination and analysis have been and can be established when appropriate and feasible.
1. Common sequencing data processing pipeline. The goal is to establish a common cloud-based platform for analysis, visualization, integration, and query of sequencing data-based molecular signatures of brain cells in human, NHP, and mouse. Expected sequencing data include single-cell, single-nucleus, and bulk transcriptomics (e.g.,10X Genomics, SMART-seq, sci-RNA-seq); single-cell, single-nucleus, and bulk epigenomics (e.g., ATAC-seq, mC-seq, HiC); multi-omics; spatial transcriptomics (e.g., Slide-seq); and whole genome sequence (see BICCN data examples, https://biccn.org/data). Expected activities include but are not limited to:
2. Common imaging data processing pipeline. The goal is to establish a common cloud-based platform for image registration to Common Coordinate Frameworks, analysis, visualization, and query of imaging-based molecular and anatomical phenotypes and features. Expected imaging data include those acquired from multiscale whole brain imaging in human, NHPs, and mouse at cellular resolution, 3D and 2D, immunohistochemistry, cytoarchitecture histology (e.g., Nissl, H&E, myelin, nuclei, mitochondria), spatial transcriptomics (e.g., MERFISH), single neuron morphology (fMOST, MouseLight), neural circuit tracing, etc. Imaging modalities include fluorescence, bright-field, MRI, etc. (see BICCN data examples, https://biccn.org/data). Expected activities include but are not limited to:
3. Comprehensive brain cell knowledge base. The goal is to build a comprehensive brain cell knowledge base that includes data-driven brain cell taxonomies and ontology, and literature reference to link vast data, information, and resources across data modalities, lifespan stages, and species. Expected activities include but are not limited to:
4. Engagement and outreach element. The goal is to coordinate and harmonize data and metadata across the BICAN; facilitate data and metadata submission and public release; track data flow and provenance and data use statistics; collect data users’ experience within and outside BICAN; establish a BICAN web portal for easy access and query of brain cell atlas data, resource, and knowledge; and organize meetings, working groups, and outreach activities. Expected activities include but are not limited to:
II. Common goals of CUBIE
All CUBIE awards will be coordinated and integrated closely with BICAN, BRAIN Initiative data archives, standards, secondary analysis projects in the respective working groups to be established during the BICAN project years. As a whole, CUBIE will work together to:
The brain cell census and atlas data will be an important and unique resource for use by the broad research community, and thus applicants are expected to address the following issues related to the large-scale brain cell atlas data production and analysis and the BICAN operation as a whole.
Common Coordinate Systems.
The BRAIN Initiative embraces the existing efforts of the research community to collaboratively build atlases with broadly accessible common coordinate systems to integrate and disseminate the brain cell atlas and census data in order to enable cross-modality, cross-scale, and cross-species data integration, as well as to facilitate the analysis of individual variability and the transfer of information and knowledge between basic and clinical or structural and functional studies. Applicants may describe how imaging–based cell census/atlas data will be registered to common coordinate systems, which include in situ hybridization, immunohistochemistry, cell morphology, neuronal connectivity mapping, and functional cell imaging. In case non-imaging based approaches are used, applicants may propose how to spatially assign the data to the brain regions as accurately as possible.
Data Quality and Reproducibility. Two of the cornerstones of science advancement are rigor in designing and performing scientific research and the ability to reproduce biomedical research findings. Data reproducibility is especially important in view of the inherent biological variation and expected technical noise. The BICAN will strive to quantify and benchmark variabilities throughout the data generation and analysis pipelines, and establish and disseminate data and metadata standards. Applicants are expected to develop and establish stringent data quality control and quality assurance processes to their best capabilities for the sample and data processing, assay and statistical approaches, to ensure that the data generated will be broadly referenced and used by the research community.
Data Open Access and Rapid Sharing. The broad use of reference brain cell census and atlas data will be facilitated by data open access and rapid sharing of data and preprints. Rapid sharing of verified raw data and data analysis has played a critical role for the BICCN in enhancing research rigor and data reproducibility, cross validating assay technologies, and facilitating joint analysis and joint publications. BICAN projects are expected to abide by the agreed data and resource sharing policy and public release timeline to ensure unhindered data and resource exchange and sharing.
Milestones
The success of the project will be facilitated by the adoption of clear, quantitative milestones with realistic and efficient timelines. Applications to this FOA must include annual milestones with metrics that will document progress towards the achievement of the specific aims. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn before review. At the beginning of the project, joint overall data production and analysis milestones will be coordinated and established across BICAN projects. During the project period, the awardees will be expected to refer to these milestones in progress reports. The funding institute will use the milestones and other measures of productivity and success to evaluate the progress, impact, and value of the program, and modify the milestones accordingly.
Plan for Enhancing Diverse Perspectives (PEDP)
This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material. Applications must 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.
Applications Not Responsive to this FOA
Proposed research that is not responsive to this FOA and will not be reviewed include the following:
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
Issuing IC and partner components intend to commit an estimated total of $5M per year to fund 4-8 awards.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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. This means that the NIH will not accept:
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.
Letter of Intent
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:
The letter of intent should be sent to:
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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:
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 Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
BICAN Semi-annual In-person Meeting Costs:
Awardees will be required to attend the semi-annual in-person BICAN meeting. Applications may include allowable costs for participating..
PEDP implementation costs:
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:
An application to this FOA is expected to propose only one of the following four elements of the Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE): (1) Common sequencing data processing pipeline, (2) Common imaging data processing pipeline, (3) Comprehensive brain cell knowledge base, or (4) Engagement and outreach element. However, applicants may describe and propose how cross-element collaboration and analysis have been and can be established when appropriate and feasible. As CUBIE will work closely together with the BRAIN Initiative Data Archives to be funded under RFA-MH-20-600 and the related FOAs, applicants are expected to propose to their best knowledge the data processing tools and models to be optimizable and implementable in the cloud computing environment.
Specific Aims:
Describe in priority order the aims of the project related to one of the above four elements.
Research Strategy:
I. Use standard sections (Significance, Innovation, and Approach) to address the following common goals:
and the specific goal under one relevant element:
1. Common sequencing data processing pipeline. The goal is to establish a common cloud-based platform for analysis, visualization, integration, and query of sequencing data-based molecular signatures of brain cells in human, NHP, and mouse;
2. Common imaging data processing pipeline. The goal is to establish a common cloud-based platform for image registration to Common Coordinate Systems, analysis, visualization, and query of imaging-based molecular and anatomical phenotypes and features;
3. Comprehensive brain cell knowledge base. The goal is to build a comprehensive brain cell knowledge base that includes data-driven brain cell taxonomies and ontology, and literature reference to link vast data, information, and resources across data modalities, developmental stages, and species;
4. Engagement and outreach elements. The goal is to coordinate and harmonize data and metadata across the BICAN; facilitate data and metadata submission and public release; track data flow and provenance and data use statistics; collect data users’ experience within and outside BICAN; establish a BICAN web portal for easy access and query of brain cell atlas data, resource, and knowledge; and organize meetings, working groups, and outreach activities.
Applicants are expected to propose according to their best knowledge and capabilities the research strategy to achieve the above common and subunit-specific goals, which include but are not limited to:
II. Milestones. For each approach, clear, quantitative outcomes should be set and described. Annual milestones should reflect the current ability from the beginning of the project, and include plans for critically evaluating and revising these milestones on a regular basis. Year 1 milestones will include planning and defining joint CUBIE strategies including data harmonization and processing across BICAN, which should be communicated in these milestones. The milestones should be regarded as criteria for evaluating the progress and direction of the project and should not be just a restatement of the specific aims.
Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants.
The applications are expected to include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including subcontractors) to the effect that the institution supports and agrees to abide by the resource sharing plans put forth in the application if applicable. Such letters would be clear expressions of commitment. A separate letter should be sent by each participating organization including each subcontractor. Please note that institutional sign-off on the grant application signifies that all relevant components of the institution, including the relevant office handling intellectual property matters have reviewed and approved the document.
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.
The following modifications also apply:
A central goal of this FOA is to build up a comprehensive brain cell atlas data resource that will be widely used throughout the research community for further advancing research. It will take the combined resources of researchers in the public and private sectors many years to catalog and characterize the biology of brain cells, neuronal connectivity of interest, to understand brain function, and then to use that information to further the study of neurobiology and to improve public health. The open sharing of the brain census data, research tools, and resources will not only lead more rapidly to their broad use by the research community, but also encourage scientific rigor in data production and analysis, with resulting benefits to public health. In order to reap the maximum value from this program, all molecular, anatomical, and physiological data, experimental protocols, tools generated are expected to be made publicly available. Applications must include a detailed plan for sharing data and resources and include the following key elements:
Data and Data Analysis Sharing. Applicants must provide a specific proposal for data sharing in the application, and address the issues related to the public release of data and data analyses (see the rationale for Findability, Accessibility, Interoperability, and Reusability (FAIR) Data Principles). NIH BRAIN Initiative Cell Census Program is also committed to the timely release of open source software and data analyses including models, tools, analytic workflows, and user manuals. Applicants are expected to propose open dissemination of computational methods, software, and tools for unrestricted redistribution and modification. After the initial peer review, the BRAIN Initiative program staff will be responsible for any additional administrative review of the sharing plan and may negotiate modifications of the sharing plan with the prospective awardee prior to award. The final negotiated version of the sharing plan will become a term and condition of the award of the cooperative agreement. After all of the awards have been made, the BICAN Steering Committee, of which all awardees will be members, will develop a final, common data and resource release plan as appropriate for the project that will address the interests of the data producers and analysts, as well as the users of the BICAN brain cell census/atlas data sets. Applicants should indicate their willingness to participate in the development of such a final plan and to accept it. The NIH expects that verified raw data will be submitted ”in real time” or other agreed-upon timeframe depending on the data types and verification requirements to BRAIN Initiative data archives or other long-term publicly accessible archives such as GEO or others as appropriate. Agreement to abide by the data and data analysis sharing policy is a requirement for anyone to join the BICAN.
Resource Sharing. Resources generated by the BICAN projects should be made rapidly available to the research community, which include assay protocols, technology platforms, tools, reagents, user manuals, and preprints. Rapid dissemination of these resources would accelerate scientific exploration and avoid duplicative resource development effort. The applicant should provide specific plans for resource sharing and distribution via repositories such as protocols.io, Addgene, GitHub, bioRxiv, or other open repositories in the application. After the initial peer review, the BRAIN Initiative program staff will be responsible for any additional administrative review of the plan for sharing resources and may negotiate modifications of the resource sharing plan with the prospective awardee prior to award. The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.
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.
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.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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.
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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. 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 before review.
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.
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.
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).
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.
Does the proposed Coordinating Unit address the needs of the research projects that it will serve? Is the scope of activities proposed for the Coordinating Unit appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research project?
How well do the proposed aims and scientific questions align with the common and element-specific goals of the CUBIE? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Unit? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing cooperative research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Unit? Does the applicant have experience overseeing selection and management of subawards, if needed?
Are the PD/PI and other key personnel devoting sufficient time/effort to achieve the goals? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?
Does the application propose novel organizational concepts, management strategies, or methods in coordinating the research projects the Coordinating Unit will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or methods proposed?
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the Coordinating Unit will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the projects are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the projects? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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?
How well will the approach enable the exploration and use of large-scale brain cell atlas data or knowledge?
To what extent will the approach ensure the data to be Findable, Accessible, Interoperable, and Reusable?
Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
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?
How well does the Resource Sharing Plan provide a summary of the shared resources, a plan for the resource dissemination via open repositories, and a timeline for sharing the resources with the research community?
Will the institutional environment in which the Coordinating Unit will operate contribute to the probability of success in facilitating the research projects it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Unit proposed? Will the Coordinating Unit benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
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?
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.
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.
Milestones
Are the milestones and timelines sufficiently clear, quantitative, and actionable? Do the milestones provide proper criteria for evaluating the progress and direction of the proposed research? How thorough and appropriate are the plans for critically evaluating and revising milestones on a regular basis? How feasible are the timelines proposed for achieving the milestones?
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, 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 on the basis of established PHS referral guidelines 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:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
Awardees 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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. More information is provided at Award Conditions and Information for NIH Grants.
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. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.
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 “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 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 and 2 CFR 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH 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 resides with the awardees 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 responsibilities as described below:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
BRAIN Cell Atlas Network (BICAN) Steering Committee:
The Steering Committee will be composed of the PD(s)/PI(s) of the BICAN awards (UM1 Center(s), U01 Collaborator(ies), U24 CUBIE, R24 archive(s), and R01 scalable tools projects) listed in Section I, along with assigned NIH Project Scientist(s). The Steering Committee will be established to help monitor progress, encourage improvements, and coordinate the production of brain cell census datasets and resources through the BICAN. It is anticipated that additional coordination mechanisms will be set up with other U.S. and international groups that may join this effort. The BICAN Steering Committee members will meet periodically to plan and design activities, review and discuss progress, and establish priorities and policies. A chair will be designated on a rotating basis as needed. Each PD(s)/PI(s) will have one vote each and the NIH will have one vote through the participation of the Project Scientist(s). The frequency of meetings will be determined jointly with the NIH program staff. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
The BICAN Steering Committee will:
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.
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Yong Yao, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6102
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email:[email protected]
Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
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 42 CFR Part 52, 45 CFR Part 75, and 2 CFR 200.