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Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional)

PA
Monday, May 10, 2021
Wednesday, May 8, 2024
R21
PA-21-219

Funding Opportunity Purpose

The Joint NINDS/NIMH Exploratory Neuroscience Research Grant program supports exploratory and innovative research projects, which fall within the missions of the NINDS and NIMH. Awards will provide support for the early and conceptual stages of projects. These studies often assess the feasibility of a novel avenue of investigation and involve considerable risk, but have the potential to bring about breakthroughs in the understanding of important areas of neuroscience, or to the development of novel techniques, agents, methodologies, or models, of high value to the neuroscience community. While this funding opportunity also accepts clinical trials, only applications proposing mechanistic clinical trials or studies or basic experimental studies with humans (BESH) will be considered for funding. For information on the types of clinical trial that are within scope of this funding opportunity announcement, refer to Funding Opportunity Description, below.

Summer Research Education Experience Program (R25 Clinical Trial Not Allowed)

PAR
Monday, May 10, 2021
Wednesday, May 8, 2024
R25
PAR-21-168
Lauren Ullrich

Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. The proposed program needs to fit within the mission of the participating IC that the application is being submitted to and should not have a general STEM focus (see below and Table of IC-Specific Information and Points of Contact).

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)

RFA
Friday, May 7, 2021
Wednesday, February 21, 2024
UG3/UH3
RFA-NS-21-023

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)

RFA
Friday, May 7, 2021
Wednesday, February 21, 2024
UH3
RFA-NS-21-024

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

NINDS Exploratory Clinical Trials (U01 - Clinical Trial Required)

PAR
Friday, May 7, 2021
Sunday, May 8, 2022
U01
PAR-21-236

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may evaluate drugs, biologics, and devices, as well as surgical, behavioral and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (http://www.ninds.nih.gov/)

Research Program Award (R35 Clinical Trial Optional)

RFA
Thursday, May 6, 2021
Clinical Trials Research
Wednesday, July 14, 2021
R35
RFA-NS-21-020

Funding Opportunity Purpose

The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased freedom and flexibility to Program Directors (PDs)/Principal Investigators (PIs) to allow them to redirect their time away from the administrative burden of writing and managing multiple grant applications and towards engaging in the lab. This RPA affords investigators at most career stages the opportunity to advance their long-term research goals, rigorously explore exciting research opportunities, and mentor trainees, which support and align with the mission of NINDS. RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PIs recent NINDS support (Part 2, Section II). This greater funding stability will provide eligible investigators increased security, allowing them to undertake research projects that require a longer timeframe or to embark upon research that breaks new ground. Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center, will not be considered through this program.

NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Wednesday, March 6, 2024
U01
PAR-21-223
Codrin Lungu

Funding Opportunity Purpose

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

Notice of Special Interest (NOSI): NIH Research Project Grant (R01) Applications from Individuals from Diverse Backgrounds, Including Under-Represented Minorities

Notice of Special Interest
Monday, May 3, 2021
Monday, May 8, 2023
R01
NOT-NS-21-049

Funding Opportunity Purpose

The National Institute of Neurological Disorders and Stroke seeks to promote diversity in all of research programs and to increase the participation of underrepresented groups. As the US population becomes increasingly diverse, reflection of that diversity among the biomedical research workforce is vital to our science enterprise and the NIH research mission (See NOT-OD-20-031). NIH is committed to implementing approaches to address the funding gap for researchers from diverse backgrounds and committed to instituting new ways to support diversity, equity, and inclusion, and identifying and dismantling any policies and practices that may harm our workforce and our science.

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