Notice Number: NOT-NS-12-007

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Release Date: March 13, 2012

Related notices NOT-NS-11-018 issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to inform NINDS grant applicants that, beginning with applications submitted for the June 5, 2012 submission date, NINDS will not accept unsolicited R01 applications which include clinical trials of potential therapies under the NIH parent R01 Funding Opportunity Announcement (FOA) PA-11-260 and

subsequent revisions to this FOA. A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about pharmacologic, behavioral, biologic, surgical, or device interventions.

Applicants submitting unsolicited applications to NINDS which contain a clinical trial of such inter-

ventions must submit to one of the following NINDS FOAs specifically

designed for clinical trials:

•     NINDS Exploratory Clinical Trials (R01) PAR-10-199

•     NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials (U01) PAR-11-173

Clinical trial applications also may be submitted to NINDS in response to other NINDS-specific an-

nouncements that specifically solicit clinical trials.

This policy applies only to the NIH parent FOA PA-11-260 for unsolicited R01

applications and subsequent revisions. An application submitted in response to the NIH parent R01

may not include a clinical trial within the aims; such applications will not be accepted by NINDS.

If you have any questions regarding this notice, please contact Holly Sommers at hsomme2@emory.edu