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

BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R01 Clinical Trial Not Allowed) is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Encourages research using invasive neural technologies to understand brain function.

NOT-NS-21-064: Notice of Intent to Publish a Funding Opportunity Announcement for BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required) Notice of Intent to Publish a Funding Opportunity Announcement for BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required) Estimated Publication Date of Funding Opportunity Announcement: First Estimated Application Due Date: Earliest Estimated Award Date: Earliest Estimated Start Date: RFA-NS-19-001 - BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required) NOT-MH-19-010 - Notice of Data Sharing Policy for the BRAIN Initiative National Institute of Neurological Disorders and National Eye Institute ( NEI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Center for Complementary and Integrative Health ( NCCIH ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Office of Behavioral and Social Sciences Research ( OBSSR ) This Notice informs the research community that the NIH BRAIN Initiative intends to reissue Funding Opportunity Announcement (FOA) BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Clinical Trial Required).

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in Fall 2021 with an expected application due date in Fall 2022. This FOA will utilize the U01 activity code.

Details of the planned FOA are provided below. Research Initiative Details Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans.

Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power.

Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience.

Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and quantitative, mechanistic models where appropriate.

Recipients will join a consortium work 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. This RFA will require that applications include a Plan for Enhancing Diverse Perspectives (PEDP) in the proposed research.

When a PEDP is required, applications submitted without such a plan will be considered incomplete and will be withdrawn prior to peer review. Evaluation of the applicant’s PEDP will be made during the peer review stages as part of the scorable criteria and during programmatic reviews, and will be used to inform funding decisions. For more information on the PEDP, please visit https://braininitiative.

nih. gov/about/plan-enhancing-diverse-perspectives-pedp. This RFA will also require that the Resource Sharing Plan complies with the policy outlined in NOT-MH-19-010 .

Expected Number of Awards Application budgets are not limited but need to reflect the actual needs of the proposed project. Awards are for five years of support.

Primary Assistance Listing Number(s) Anticipated Eligible Organizations Public/State Controlled Institution of Higher Education U.S. Territory or Possession Private Institution of Higher Education Non-domestic (non-U.S.) Entity (Foreign Organization) Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education) For-Profit Organization (Other than Small Business) Eligible Agencies of the Federal Government Indian/Native American Tribal Government (Federally Recognized) Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments) Indian/Native American Tribal Government (Other than Federally Recognized) Applications are not being solicited at this time.

Please direct all inquiries to: National Institute of Neurological Disorders and Stroke (NINDS) Weekly TOC for this Announcement NIH... Turning Discovery Into Health ®