BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01) | RFA NS 16 008

FAQs: NIH BRAIN Initiative - Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01)

What is this funding opportunity?

This is an NIH BRAIN Initiative funding opportunity titled "Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01)" (Funding Opportunity Number RFA-NS-16-008). It supports research that uses rare clinical neurosurgical situations to enable direct, precisely localized recording from and stimulation of human brain tissue.

What is the main goal of the FOA?

The main goal is to advance human neuroscience by using invasive neural recording and/or stimulation approaches in people to answer high-impact questions that are hard or impossible to address with noninvasive tools, particularly when studying specific neural circuits or linking circuit activity to symptoms in neurological and psychiatric disorders.

Why does NIH emphasize invasive approaches in humans for this program?

The FOA is based on the idea that invasive human studies can provide insights that noninvasive methods cannot, especially when the research requires precise localization in particular brain structures or when the aim is to directly connect neural circuit activity to clinical symptoms.

What problem is the FOA trying to solve in this research area?

The FOA aims to address practical limitations that often weaken invasive human studies, including small numbers of eligible patients, limited clinical time, and the difficulty of running complex research protocols in hospital settings. It also highlights that single sites often cannot enroll enough participants for strong statistical power and that datasets are not consistently combined across centers.

How does the FOA suggest overcoming small sample sizes and limited statistical power?

The FOA encourages applicants to form integrated, multidisciplinary teams that can coordinate across investigators and, when appropriate, across sites. The expectation is that teams will build clinical-research infrastructure, harmonize protocols, and aggregate data so that conclusions are more robust and broadly useful.

What kinds of projects does the FOA support?

The FOA is designed to support either: (1) experimental projects that generate meaningful empirical findings using invasive neural recording and/or stimulation methods in humans, or (2) exploratory research and planning activities that help assemble teams, establish pipelines, and produce preliminary data.

Does the FOA support planning and early-stage work, or only full experiments?

It supports both. In addition to experimental projects that produce empirical findings, the FOA also supports exploratory and planning activities intended to build teams, establish workflows and pipelines, and generate preliminary data.

What does NIH mean by describing this award as "enabling"?

The FOA frames the work as enabling in the sense that the award is intended to position groups to compete for continued funding later, either through future BRAIN Initiative funding opportunities or other NIH Institute funding streams.

What grant mechanism is used for this opportunity?

The mechanism is a U01 cooperative agreement.

What does a U01 cooperative agreement imply for how the project will be run?

A U01 cooperative agreement generally means NIH expects substantial scientific and programmatic involvement during the project period compared with a standard research grant. In practice, the FOA indicates this can involve closer coordination with NIH program staff, milestone-driven management, and a strong emphasis on collaboration, sharing, and building resources that can scale beyond a single laboratory.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

What types of organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as other Native American tribal organizations.

Are specific institution types explicitly listed as eligible?

Yes. The FOA explicitly calls out additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Are non-U.S. or foreign organizations eligible to apply?

No. The FOA restricts non-U.S. participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.

Can a U.S. organization include non-U.S. components in the project?

No. The FOA states that non-domestic components of U.S. organizations are not eligible.

Are foreign components allowed under NIH policy for this opportunity?

No. The FOA states that foreign components (as defined by NIH policy) are not allowed.

What research setting is this FOA focused on?

The FOA focuses on rare clinical situations in which neurosurgical procedures make it possible to record from and/or stimulate human brain tissue directly and with precise localization, typically in hospital or clinical settings where time and logistics can be constrained.

Is multi-site collaboration required?

The FOA encourages coordination across investigators and, where appropriate, across sites, particularly to address enrollment constraints and to support protocol harmonization and data aggregation. The provided text does not state that multi-site collaboration is strictly required in every case.

What kinds of team structures does NIH expect?

The FOA encourages integrated, multidisciplinary teams. The expectation is that teams will coordinate across investigators (and sometimes across sites) and will build infrastructure, harmonize protocols, and aggregate data to strengthen statistical power and generalizability.

What kinds of outputs or outcomes is NIH trying to promote?

Based on the description, NIH is trying to promote studies and infrastructure that lead to more coordinated, better-powered, and more informative invasive human electrophysiology and stimulation research, along with reusable resources and approaches that can scale beyond a single lab and support future funding competitiveness.

How many awards were expected?

The expected number of awards was 10.

What is the application deadline listed in the source?

The original closing date was January 13, 2016.

When was this opportunity first posted/created?

The posting creation date was October 5, 2015.

Is there an award ceiling (maximum award amount) stated?

No. The award ceiling is not specified in the provided text.

What CFDA numbers are associated with this opportunity?

The opportunity was listed under multiple CFDA numbers: 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867.

What is the larger program context for this FOA?

This opportunity sits within the broader NIH BRAIN Initiative and is aimed at accelerating progress in human neuroscience by improving coordination, rigor, and scalability of invasive human recording and stimulation studies, while laying groundwork for longer-term efforts aligned with BRAIN Initiative and NIH priorities.