Background

The BRAIN Initiative: The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This and other FOAs issued as part of the BRAIN initiative are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

NIH encourages BRAIN Initiative applications from investigators that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.

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 (http://braininitiative.nih.gov/funding/index.htm).

In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Review staff if they have any questions about the best FOA for their research.

The BRAIN Initiative will require 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.

This Funding Opportunity Announcement (FOA) is related to the recommendations in Section III.5 of the BRAIN 2025 Report. Specifically, this FOA solicits applications that will address the recommendations on Identifying Fundamental Principles .

Research Objectives

The purpose of this FOA is to provide support for the creation and management of more than one data archive to hold data related to the BRAIN Initiative. This is part of the programs of building the informatics infrastructure for the BRAIN Initiative. The other informatics programs include developing data standards that are needed to describe the new experiments that are being created by or used in the BRAIN Initiative (RFA-MH-17-256 and RFA-MH-19-146) , and developing software to visualize and analyze the data (RFA-MH-17-257 and RFA-MH-19-147) . Each of the programs is aimed at building an infrastructure that is used by a particular sub-domain of BRAIN Initiative related experiments rather than building a single all-encompassing informatics infrastructure now. Building the infrastructure one experimental area at a time will ensure that the infrastructure is immediately useful to the research community. As our understanding of the brain improves, we plan to create linkages between these various sub-domain specific informatics programs. Investigators of the informatics programs should keep that goal in mind and build for the future even though the current efforts are more limited in scope.

The data archives supported under this FOA are expected to use relevant standards that describe BRAIN Initiative experiments, and to be integrated with relevant software tools for visualization and analysis of archived data. Such standards and tools may be developed under BRAIN Initiative informatics awards or may already exist. Awardees under all the informatics programs are expected to work together. The awardees should budget for hackathons and other collaborative efforts that will be necessary to integrate the products produced by all awardees. Collaborations with neuro-informatics efforts outside of the BRAIN Initiative are both welcome and encouraged.

This FOA supports the development of data infrastructures that will house the data from multiple experimental groups. The data that will be deposited in a particular archive need not be restricted to data sets funded by BRAIN Initiative awards. Applicants are strongly encouraged to extend existing data archives if possible. NIH expects to provide ongoing support to successful archives once the initial award period is complete.

A data archive will develop a data submission pipeline ensuring appropriate quality control standards for laboratories who are trying to upload data. For example, if an experimental standard defines an allowable range of values for a particular data element, the submission pipeline should make sure that uploaded data respect the current data standard. Ideally, the data archive will create both a submission pipeline and a related validation tool to allow researchers to check the quality of their data even if they are not trying to upload data. Such validation tools should help the research community improve the rigor and reproducibility of their data. Data submission pipelines that originate with the data collection instrument in the depositor’s laboratory and require minimal manual intervention would be ideal but are not required.

A data archive will work closely with BRAIN Initiative awardees and others to collect and archive relevant datasets. Each data archive should plan for a help desk to work with those who are trying to upload data. Each data archive must develop plans to make the data readily available to the broad research community and to citizen scientists, as appropriate. Depending on the type of data, data submission agreements and data access agreements may be necessary.

The preceding two paragraphs focused on uploading raw data from a data collection instrument. In many cases, processed data may be as useful to the research community as the raw data produced in the laboratory. Each data archive should consider storing and curating the appropriate data (either raw or processed) and make it available to the community.

A data archive may propose evaluating deposited data and scoring them to allow the research community to have some guidance about data quality. Each data archive should plan to assign persistent identifiers to deposited data and to processed data to allow the research community an easy way to cite the data sets that are being used.

A data archive should allow researchers to have a space where they can share data privately to facilitate collaboration prior to publication. Such private enclaves must only last for a defined period of time before that data set is shared with the rest of the research community.

A data archive may help users deposit data into other sustainable databases, such as those supported by the National Center for Biotechnology Information, but this is not a requirement. There may be cases where data are stored in more than one data archive. In those cases, a data archive funded under this FOA will ensure that the user community can find all relevant data using appropriate linkages or database federation strategies no matter where the data are actually stored.

Furthermore, each data archive will provide an interface that is accessible to anyone with a web browser. A data archive will make appropriate query tools and summary data easily available to allow the research community to check whether data of interest are held in the archive. The user interface should make the maximum amount of information available to the research community while considering user friendliness and ease of interpretation. The website is expected to have a broad user base that includes both na ve and experienced users. An interface that will accommodate both types of users is expected.

In many cases, users will want to analyze and/or use visualization tools to interact with the data without downloading any data. Those interactions should be anticipated by the data archive. Expensive computations could result from some analysis activities, and the data archive should explain plans to deal with such eventualities. A data archive may, but is not required to, use cloud storage and computing capabilities to enable the research community to analyze data without downloading it. A data archive should, but it is not required to, allow users to bring their own analysis tools to the data.

Each data archive will be expected to have staff who are knowledgeable about informatics and the experimental data being collected. The informaticists will be responsible for coordination with other relevant informatics efforts. In particular, a data archive will be expected to identify and federate the archive with other data repositories and knowledge bases, as appropriate. This data archive integration should create ways for users to query all relevant data repositories for relevant information. Funded data archives will be members of a larger BRAIN Initiative Data Network that will work across BRAIN Initiative activities to promote integration of a variety of data types. In addition, the data archive will interact, as appropriate, with informatics activities outside of the BRAIN Initiative such as the work of the International Neuroinformatics Coordination Facility.

When possible, a data archive is expected to use existing infrastructures and standards. These could include persistent identifiers such as Digital Object Identifiers. The awardee will have the responsibility for operating an infrastructure that is useful to the community. While there will be some parts of the application that propose to do research for optimal solutions, the focus should be on delivering the infrastructure not on research.

Sub-domains that might be ready for the development of standards that describe the experiments being conducted include:

• Integrated approaches to understanding circuit function in the nervous system. This would include awards made in response to RFA-NS-14-009, RFA-NS-15-005, RFA-NS-18-008, as well as awards that are anticipated in a second phase of the program.
• Invasive devices for recording and modulation in the human central nervous system. This would include awards made in response to RFA-NS-15-006, RFA-NS-15-008, RFA-NS-16-010, RFA-NS-17-006, RFA-NS-16-008, RFA-NS-17-019, and RFA-NS-16-009.
• Non-invasive neuromodulation. This would include awards made in response to RFA-MH-16-810, RFA-MH-17-240, RFA-MH-16-815, and RFA-MH-17-245.
• Next generation imaging. This may include awards made in response to RFA-MH-14-217, RFA-MH-15-200, as well as awards that are anticipated in a second phase of the program. It might be possible to include awards made in response to RFA-MH-16-750 and RFA-MH-17-235 in this sub-domain as well.

This list is focused on awards made under existing BRAIN Initiative focus areas. The list is not exhaustive and other sub-domains of similar size and complexity related to the BRAIN Initiative are welcome.

The BRAIN Initiative only intends to fund one data archive in a particular sub-domain. The list of currently funded data archives is available at https://projectreporter.nih.gov/reporter.cfm (enter RFA-MH-17-255 and RFA-MH-19-145). Applications in the same sub-domain as a funded data archive are not responsive. Potential applicants should talk to the Science/Technical staff contact if they have any questions concerning the overlap between a potential application and an existing award.

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)

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)

• Eligible Agencies of the Federal Government - Including the NIH Intramural Program

• 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

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

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.

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:

• 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 NOT-OD-11-101)

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. 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. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When involving NIH-defined human subjects research, clinical research, and/or 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.

All instructions in the SF424 (R&R) Application Guide must be followed. 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. 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.