November 20, 2023
- May 10, 2022 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional). See NOFO PAR-22-105.
- May 10, 2022 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional). See NOFO PAR-22-109.
The purpose of this notice is to inform applicants of NINDS' IC-specific information for PAR-22-105 Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) and PAR-22-109 Dissemination and Implementation Research in Health (R21 Clinical Trial Optional). Language has been added to show NINDS' IC-specific information for each of these notices of funding opportunity (NOFOs). The following language has been added to PAR-22-105 and PAR-22-109:
National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in mission relevant applications. The NINDS supports dissemination and implementation research focused on identifying, monitoring, scaling-up, and/or testing strategies for overcoming environmental, social, community, structural, and healthcare system factors that lead to or are associated with disparities (or inequities) in neurological diseases and care across the lifespan. Some priority disease areas include stroke and other cerebrovascular diseases, Alzheimer s disease-related dementias (including frontotemporal neurodegeneration, Lewy body dementias, vascular contributions to cognitive impairment and dementia and mixed etiology dementia), epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease, and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, and the neurological consequences of HIV/AIDS. Applicants are encouraged to incorporate community engagement strategies into their study designs. Applicants are also encouraged to incorporate a plan to enhance diverse perspectives (https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp) and community engagement strategies into their study designs when appropriate.
Applicants considering submitting a clinical trial should review the NINDS Clinical Trial policy (https://www.ninds.nih.gov/current-research/research-funded-ninds/clinical-research).
Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following types of clinical trials will be supported:
- Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).
- Basic Experimental Studies with Humans (BESH), defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.
Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, dissemination and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported by NINDS under this NOFO. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. The NINDS encourages the use of common data elements (see NINDS CDE Project: https://www.commondataelements.ninds.nih.gov/). A letter of intent and communication with NINDS program staff prior to submission of an application is strongly encouraged.
Changes to the NOFOs are shown below.
Currently Reads:
Part 2. Full Text of Announcement
Section I.Funding Opportunity Description:
Information relevant to Specific Institutes/Centers
Office of Research on Women s Health (ORWH)
The Office of Research on Women s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. In general, ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. ORWH encourages interdisciplinary approaches and would be interested in partnering to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women, especially research on the consequences of pregnancy for the health of a woman across her life course. The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 - 2023 is available on the ORWH website (https://www.nih.gov/women/strategic plan) for additional guidance.
See Section VIII. Other Information for award authorities and regulations.
Modified to Read:
Part 2. Full Text of Announcement
Section I. funding Opportunity Description
Information relevant to Specific Institutes/Centers
Office of Research on Women s Health (ORWH)
The Office of Research on Women s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. In general, ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. ORWH encourages interdisciplinary approaches and would be interested in partnering to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women, especially research on the consequences of pregnancy for the health of a woman across her life course. The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 - 2023 is available on the ORWH website (https://www.nih.gov/women/strategic plan) for additional guidance.
National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in mission relevant applications. The NINDS supports dissemination and implementation research focused on identifying, monitoring, scaling-up, and/or testing strategies for overcoming environmental, social, community, structural, and healthcare system factors that lead to or are associated with disparities (or inequities) in neurological diseases and care across the lifespan. Some priority disease areas include stroke and other cerebrovascular diseases, Alzheimer s disease-related dementias (including frontotemporal neurodegeneration, Lewy body dementias, vascular contributions to cognitive impairment and dementia and mixed etiology dementia), epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease, and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, and the neurological consequences of HIV/AIDS. Applicants are encouraged to incorporate community engagement strategies into their study designs. Applicants are also encouraged to incorporate a plan to enhance diverse perspectives (https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp) and community engagement strategies into their study designs when appropriate.
Applicants considering submitting a clinical trial should review the NINDS Clinical Trial policy (https://www.ninds.nih.gov/current-research/research-funded-ninds/clinical-research).
Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following types of clinical trials will be supported:
- Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).
- Basic Experimental Studies with Humans (BESH), defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.
Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, dissemination and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported by NINDS under this NOFO. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. The NINDS encourages the use of common data elements (see NINDS CDE Project: https://www.commondataelements.ninds.nih.gov/). A letter of intent and communication with NINDS program staff prior to submission of an application is strongly encouraged.
See Section VIII. Other Information for award authorities and regulations.
All other aspects of these NOFOs remain unchanged.
Richard T. Benson, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: Richard.benson@nih.gov
and Human Services (HHS)
