Update: The following update relating to this announcement has been issued:
Release Date: February 6, 2013
This Notice replaces NOT-NS-12-007
National Institute of Neurological Disorders and Stroke (NINDS)
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 Funding Opportunity Announcement (FOA) PA-11-260 and subsequent revisions to this FOA. NINDS will not accept investigator initiated R01 applications which include clinical trials under PA-11-260. 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 applies only to clinical trials submitted to PA-11-260 for investigator initiated R01 applications and subsequent revisions. 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.pdf).
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:
Please direct all inquiries to:
Crina Frincu, PhD
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2210
6001 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-9135
Fax: (301) 410-1080