RFA-NS-28-010-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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)

Funding Opportunity Title

BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R01 Clinical Trial Not Allowed)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of

RFA-NS-22-041

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-NS-28-010

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.372, 93.853, 93.213, 93.173, 93.867, 93.242, 93.279, 93.866, 93.273, 93.286, 93.865

Funding Opportunity Purpose

This funding opportunity supports transformative, mechanistic research aimed at understanding how the human brain functions. Applications should seek to reveal how the dynamic activity of individual neurons and ensembles of neurons within spatially organized brain networks gives rise to internal experiences, such as sensations, perceptions, emotions, thoughts, and memories, as well as to observable motor and social behaviors.

To achieve fundamental mechanistic insights into human brain function, proposed studies are expected to leverage opportunities made possible by invasive surgical procedures in humans, such as intracranial recording or stimulation. These investigations may be enhanced by incorporating complementary experimental models or systems that provide access to knowledge, techniques, or resources not otherwise available in human neuroscience research. Such integration is encouraged to strengthen the mechanistic understanding of human brain function and to connect discoveries across species and biological scales. This program builds on cutting-edge advances enabled by the BRAIN Initiative and the broader neuroscience community.

Projects supported through this opportunity are expected to produce transformative outcomes by the end of the funding period. Approaches should be rigorous, mechanistic, and innovative by (1) maximizing opportunities to conduct innovative in vivo human neuroscience research made available by direct access to the human brain from invasive surgical procedures, (2) employing approaches guided by specified theoretical constructs and/or quantitative, mechanistic models.

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

Funding Opportunity Goal(s)

To provide extramural research support for the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative's aim of revolutionizing our understanding of the brain and its function in unprecedented detail. The NIH BRAIN Initiative's focus is foundational development of new technologies and tools to map, monitor, and modulate brain circuits in model systems and humans – toward the ultimate goal of treating and curing human brain disorders.

Key Dates

Posted Date

September 30, 2026

Open Date (Earliest Submission Date)

January 08, 2027

February 08, 2027

February 08, 2027

Not Applicable

December 2027

February 08, 2028

February 08, 2028

Not Applicable

December 2028

February 08, 2029

February 08, 2029

Not Applicable

December 2029

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

February 09, 2029

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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 Notices of Funding Opportunities (NOFOs) 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 and Neuroethics Working Group.

The BRAIN Initiative requires a high level of coordination and sharing between investigators. BRAIN Initiative recipients are encouraged to 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 BRAIN Initiative Conference. The data sharing expectations for BRAIN Initiative awards can be found at BRAIN Data Knowledge Resources.

The BRAIN Initiative Research Opportunities in Human Neurosciences This Notice of Funding Opportunity (NOFO) will support transformative, mechanistic investigations that leverage invasive surgical procedures in humans, such as recording and stimulating neuronal activity intracranially within precisely localized brain structures, to understand how the human brain functions. Applications should be high-impact investigations of how single cells and neuronal ensembles in spatially organized networks give rise to internal states, such as sensations, perceptions, emotions, thoughts, and memories, and to observable motor and social behaviors.

Projects will to produce transformative outcomes by the end of the funding period (e.g. rigorously challenge established neuroscience paradigms, overcome barriers to knowledge or practice, and generate innovative principles or models about human brain function). Approaches are should be rigorous, mechanistic, and innovative by (1) maximizing opportunities to conduct innovative in vivo human neuroscience research made available by direct access to the human brain from invasive surgical procedures, and (2) employing approaches guided by specified theoretical constructs and/or the development and testing of quantitative, mechanistic models. Bridging fundamental discoveries and approaches across species and biological scales is encouraged to strengthen the mechanistic understanding of human brain function. While fundamental basic research often provides insights relevant to disorders of the nervous system, this program is not intended to support research targeting disease mechanisms or therapeutics.

Interdisciplinary teams, comprising clinicians, scientists, device engineers, computational/data scientists, and regulatory and neuroethics experts, are essential. Mentorship that fosters expertise in human intracranial studies is encouraged. While teams may be based at a single institution, collaboration across sites, including new partnerships with centers not yet part of the Research Opportunities in Humans Consortium, is strongly recommended due to limited patient availability at any one center. Recipients are expected to actively participate in a consortium working group, coordinated by the NIH, to identify consensus standards of practice.

We anticipate that implantable devices for most of these applications will rely on existing technology sufficiently advanced for an IRB non-significant risk designation and/or FDA IDE without needing significant additional pre-clinical testing on the device, though newly IDE-approved devices may become available over the course of these awards. Investigators proposing to use non-FDA approved devices are strongly encouraged to complete any needed FDA risk assessment and/or the IDE process prior to submission. NIH BRAIN supports new device development and regulatory approval through other initiatives, including template Memoranda of Agreements (MOUs), Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs) with device providers that may facilitate adoption of novel technologies.

Topics and Activities Supported Representative, but not exhaustive, examples of topics and activities that could be considered responsive to this NOFO:

Direct brain access and multimodal integration:

Systems and circuit-level investigations:

Integrative approaches:

Prior Consultation with Scientific/Research Staff Consultation with relevant Scientific/Research staff is strongly recommended. to discuss responsiveness and fit with the goals of this NOFO and the mission of the BRAIN Initiative. Staff will not evaluate the technical and scientific merit of the proposed project.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Renewal

Resubmission

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated total of up to $8M to fund 5 awards per receipt date.

Award Budget

Application budgets need to reflect the actual needs of the proposed project. It is anticipated that most awards will not exceed $1M direct costs.

Award Project Period

The scope of the proposed project should determine the project period. 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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

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

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 NOFO. However, Intramural Scientists cannot participate as MPI's on Extramural awards. 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.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. The same UEI must be used for all registrations, as well as on the grant application.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

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 their organization to develop an application for 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 How to Apply-Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

Other Attachments:

Team management plan An "Other Attachment" of up to 1-page entitled "Team management plan" must be included as a separate attachment in pdf format. NIH strongly encourages applicants to form interdisciplinary teams that consist of clinicians, scientists, device engineers, mathematicians, statisticians, data scientists, regulatory experts and neuroethics specialists, as appropriate. This interdisciplinary team should be able to address the details of the plans and experiments, and to execute the research strategy. An organizational structure that clearly defines the team structure and relationships among the various components should be described in the team management plan and illustrated in an organizational chart. This plan should also describe the governance and organizational structure of the leadership team, including communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. For publications, policies to address the ordering and recognition of authors, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable), should be presented. The team management plan should establish a Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions. Those individuals identified in the team management plan, who together would have the intellectual and leadership responsibilities, would likely be members of the Scientific Steering Group. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included. Although all team members are expected to actively participate in the Research Opportunities in Humans (ROH) consortium working group, the team should designate a team member who can undertake a larger leadership role towards consortium activities, including data coordination (e.g., standardization, harmonization, analyses, and data sharing pipelines, best practices for multimodal data acquisition and device integration) and neuroethics.

SF424(R&R) Senior/Key Person Profile

Applications to this NOFO should assemble integrated, multi-disciplinary teams of clinicians, scientists, device engineers, mathematicians, statisticians, data scientists, regulatory specialists and/or ethics specialists, as appropriate, to propose innovative research plans within the context of the unique research opportunities offered by these clinical procedures. These teams may be assembled within a single university or medical center, or may comprise integrated teams across multiple institutions to aggregate these limited opportunities to address high-impact neuroscience questions.

R&R or Modular Budget

The budget should include funds necessary for travel for up to two key personnel to participate in the BRAIN Initiative Biennial Conference.

Data sharing costs: Applicants may include costs associated with preparing and submitting data to a data archive (as outlined in the BRAIN data sharing policy: BRAIN Data Knowledge Resources.).

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.

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy:

The goal of this Funding Opportunity (NOFO) is to support transformative and mechanistic human neuroscience investigations. Applications to this NOFO must propose to investigate fundamental questions in human neuroscience. Harmonization of research participant recruitment and methods (including collection, curation, and analysis) across multiple sites should be well planned and described as appropriate and consistent with achieving the goals of the program. While fundamental basic research often generates insights relevant to disorders of the nervous system, this NOFO is not intended to generate research that is explicitly disease-related. The project must appropriately engage interdisciplinary teams consisting of clinicians, scientists, device engineers, data/computational scientists, regulatory experts, and ethics specialists.

All applications are required to include the following points, which must be incorporated within the page limits of the Research Strategy:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

PHS Human Subjects and Clinical Trials Information 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 How to Apply- 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

Section 3- Protection and Monitoring Plans

3.1 Protection of Human subjects

Neuroethical considerations Applicants must describe and discuss the following in detail:

Please note that the Federal mandate for cooperative research at 45 CFR 46.114 requires a single IRB and the National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board of Record for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46 (NOT-OD-16-094).

Long-Term Plan for Patients: Applicants must describe a plan for the care of patients at the end of the study and after the study period, if appropriate. These plans may vary from project to project, but examples might include 1) explant of indwelling devices once the approved study period is complete, 2) surgical removal of batteries and capping the exposed metals from leads/IS-1 connectors, 3) manufacturer-supported device maintenance for participants, as appropriate, 4) manufacturer support for filing of compassionate use exemptions for device maintenance, etc.

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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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

4. Submission Dates and Times Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

6. Funding Restrictions 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply – 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 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply – 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.

Use of Common Data Elements in NIH-funded Research Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human participants research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Investigators are encouraged to consult the NIH CDE Repository and describe in their applications any use they will make of NIH-supported CDEs in their projects, when applicable. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological diseases), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Repository Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

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.

The BRAIN Initiative invites applications with high levels of innovation, which assumes some degree of risk. Reviewers should evaluate whether a sound rationale has been provided as to why the proposed approach is the most appropriate and likely to have an exceptionally high impact, if successful.

In addition to the standard review criteria below, reviewers will assess the technical, procedural, and ethical aspects specific to invasive studies involving human patients, and the strategic plans for addressing functional studies of a specified neural system in the context of patients with neural dysfunctions and invasive device interventions.

In the interest of adopting improved technologies during the award, when applicants propose either newly developed devices with IDE approval, or devices pending FDA approval, reviewers should assess feasibility, risk and opportunity, along with strategic contingencies.

Overall Impact

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

Factor 1. Importance of the Research (Significance and Innovation)

Innovation

Specific to this NOFO:

Significance

Innovation Evaluate the extent to which the project maximizes opportunities for innovative in vivo neuroscience research enabled by direct access to the brain during invasive surgical procedures.

Factor 2. Rigor and Feasibility (Approach)

Rigor:

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility: