Notice Number: NOT-NS-18-011
Key Dates
Release Date: December 18, 2017
Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
Purpose
The purpose of this Notice is to announce NINDS’s participation on the NIH Research Project Grant (Parent R01 Clinical Trial Required) Funding Opportunity Announcement (FOA) and subsequent reissuances of these FOAs. For applications submitted on or after January 25, 2018, NINDS will only accept applications to this FOA that propose human mechanistic trials/studies that meet NIH's definition of a clinical trial and that fall within the NINDS research priorities.
NIH defines a clinical trial as A research study 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. (NOT-OD-15-015)
NIH defines a mechanistic clinical trial as follows: "A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
NINDS supports hypothesis-driven mechanistic clinical trial studies in basic and/or translational discovery research in healthy human subjects and in the pathobiology, pathophysiology, and neuropathology of neurological disorders. The goal is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding neurological disorders. Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention. NINDS supports biomarker studies that may provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses. The submitted studies are defined as clinical trials (as noted above) but do not seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions. preventive, therapeutic, and services interventions. Such designs should be submitted to an NINDS clinical trial-specific funding announcement (listed on the NINDS website at https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinical-Research). Applicants are strongly advised to consult with NINDS program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.
Examples of types of applications intended to be supported by NINDS under the NIH Parent Clinical Trial R01 FOA include, but are not limited to:
The following types of clinical trials are not intended to be supported by NINDS under the NIH Parent Clinical Trials R01 FOA:
Resource
Part 1. Overview Information
Components of Participating Organizations
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Drug Abuse (NIDA)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Nursing Research (NINR)
National Institute of Neurological Disorders and Stroke (NINDS)
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.853
Inquiries
Please direct all inquiries to:
Marlene Peters-Lawrence, B.S.N., R.N., R.R.T.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-9135
E-mail: [email protected]