New NHLBI Policy: Investigator-Initiated Multi-Site Clinical Trials

Notice Number: NOT-HL-16-321

Key Dates
Release Date:  June 14, 2016

Related Announcements
NOT-HL-16-449
NOT-HL-16-448
NOT-HL-16-336
PAR-16-300
PAR-16-301
PA-16-160     

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

This Notice informs potential applicants of changes in NHLBI policies and procedures for the acceptance, review, and funding of investigator-initiated multi-site clinical trials. The purpose of this Notice is to announce that any application requesting funding for a Phase II or above clinical trial (using the NIH definition of a clinical trial), and proposes to include more than one site for the purposes of recruitment, must be submitted to two specific Funding Opportunity Announcements (FOAs) or their reissuances:

PAR-16-300 Clinical Coordinating Center for Multi-site Clinical Trials (Collaborative UG3/UH3)
PAR-16-301 Data Coordinating Center for Multi-site Clinical Trials (Collaborative U24)

On September 8, 2016, NHLBI will no longer accept applications for multi-site clinical trials if submitted through the Research Project Grant (Parent R01) FOA (PA-16-160 or subsequent reissuances).

Inquiries

Please direct all inquiries to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov