NINDS Policy for Submission of Applications Containing Clinical Trials

Notice Number: NOT-NS-12-007

Update: The following update relating to this announcement has been issued:

• February 6, 2013 - This Notice has been replaced with, NOT-NS-13-006; NINDS Policy for Submission of Applications Containing Clinical Trials.

Release Date: March 13, 2012

NOT-NS-11-018

National Institute of Neurological Disorders and Stroke (NINDS)

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 interventions 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 announcements 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.

Please direct all inquiries concerning this policy 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
Email: [email protected]

For inquiries about review issues contact:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Blvd.
Bethesda, MD 20892-9529
Telephone: (301) 496-9223
Fax: (301) 402-0182
Email: [email protected]