NINDS Policy for Submission of Applications Containing Clinical Trials

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.