Notice Number: NOT-NS-16-034

Key Dates
Release Date: July 20, 2016 (Rescinded - April 03, 2018)

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to define the types of clinical studies which may be submitted to NINDS in response to the NIH parent R01 and R21 Funding Opportunity Announcements (FOAs) PA 16-160 and PA-16-161, and subsequent reissuances of these FOAs. NINDS will not accept investigator-initiated R01 and R21 applications which include clinical trials under PA 16-160 or PA-16-161. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about the safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions.

This policy does not apply to (1) other NINDS-specific announcements that specifically solicit clinical trials, (2) exploratory IND studies as defined by the FDA (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf) or (3) early feasibility studies of devices as defined by the FDA (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103).

Applicants submitting investigator-initiated applications to NINDS which contain a clinical trial must submit to one of the following NINDS FOAs specifically designed for clinical trials:

• NINDS Exploratory Clinical Trials (R01) PAR 13-281
• NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials (U01) PAR 13-278

Or the subsequent reissuance of these FOAs.

Inquiries

Please direct all inquiries to:

Peter Gilbert, Sc.M.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-0870
Email: GilbertP@ninds.nih.gov