Key Dates

Related Announcements

• March 8, 2024 -  Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional). See RFA-MD-24-006
• March 8, 2024 - Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional). See RFA-MD-24-007

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

This Notice announces the participation of the National Institute of Neurological Disorders and Stroke (NINDS) in RFA-MD-24-006 "Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)," and RFA-MD-24-007 "Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional)" effective immediately.

The following text has been added to reflect NINDS’s participation in this RFA:

Part 1. Overview Information

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853

Section I. Funding Opportunity Description

B. NIH Institute and Center Interests and Guidance

National Institute of Neurological Disorders and Stroke (NINDS)

The NINDS is interested in topics as they pertain to stroke, vascular contributions to cognitive impairment and dementia (VCID), dementia, epilepsy, Parkinson's Disease, TBI, pain, migraine, and other neurological disorders. For proposals focusing on Alzheimer’s Disease and Related Dementias (AD/ADRD), note that NIA and NINDS have shared interest, with NINDS as the lead for VCID, lewy body dementia (LBD), and frontotemporal lobar degeneration (FTLD); and NIA as the lead for applications focused on Alzheimer’s Disease.

The small business program at NINDS is used to achieve the mission of the Institute by supporting innovative ideas at different stages of development, including applied bench research, translational research, and early-stage clinical trials i.e., feasibility, Phase I and II, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NINDS will not support applications for a clinical trial where the primary aim is to establish or confirm definitive efficacy or applications to implement definitive efficacy trials (e.g., Phase 3 clinical trials of drugs or Pivotal device trials). NINDS is interested in funding exploratory/developmental research applications that propose to study the development, validation, feasibility, and effectiveness of innovative digital health technologies [e.g., mobile health (mhealth), telemedicine and telehealth, health information technology (IT), and remote monitoring devices]. These technologies should have application to address access, reach, delivery, effectiveness, scalability or sustainability of interventions that target neurologic health disparities and inequities experienced by marginalized populations.

NINDS is dedicated to addressing neurological health inequities faced by groups adversely affected by health disparities as we work to improve the neurological health for all people. NINDS highly encourages inclusion of community engaged research strategies, such as community-based participatory research, in applications to this RFA. The participatory research process is such that community members, persons affected or impacted (i.e., people with lived experience), public health and policy professionals, and other key stakeholders in the community’s health have the opportunity to be full participants in each phase of the research.  The NINDS Health Equity Strategic Plan includes recommendations on Community-Engaged Research Approaches and utilization of a NINDS Social Determinants of Health Framework to address determinants of inequities in Neurologic disease.

This facilitates the bidirectional transfer of knowledge and skills and the creation of appropriate and effective interventions. For studies involving human subjects, appropriate linguistic and cultural competence strategies should be incorporated to enable recruitment and retention of racial/ethnic minoritized populations. Projects are encouraged to involve community partners collaborators. Applicants are expected to demonstrate their ability to leverage existing partnerships (such as with Tribal governments and organizations, academic and community medical centers or health systems, safety-net health or social service systems, Federally Qualified Health Centers, grassroots organizations, public health departments, community and faith-based organizations, and schools or child-care settings) to complete the study aims. Applicants are encouraged to provide evidence of relationship development or collaboration with community partners with whom they will work, such as through letters of support. The roles of all partners should be clearly articulated, and budgeting should reflect the level of engagement of community partners.

NINDS encourages applications that can demonstrate how the composition of the core leadership team includes diverse representation (e.g., ethnic, racial, gender, career stage, institution type, geographic location, or persons with disability).

For those applications that propose a clinical trial and use an FDA-regulated intervention, NINDS will give priority to those applications with (a) A protocol submitted under an open IND and the IND is not under full or partial hold. (b) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has fully approved the IDE or IDE supplement. (c) A protocol submitted under an IND and is on full or partial hold. (d) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has conditionally approved the IDE or IDE supplement. (e) A protocol is exempt from an IND. (f) A protocol is either exempt from the IDE regulations or does not require IDE approval because it is determined to be nonsignificant risk.

NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. STTR applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission.

All other aspects of this Notice remain the same.

Part 2. Section VII. Agency Contacts

Scientific/Research Contact(s)

Jessica Forbes, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-1778
Email: [email protected]

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

Inquiries

Please direct all inquiries to:

Jessica Forbes, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-1778
Email: [email protected]