New NHLBI Policy: Investigator-Initiated Single-Site Clinical Trials (Phase II and beyond)

Notice Number: NOT-HL-16-336

Key Dates
Release Date:  August 25, 2016

Related Announcements
NOT-HL-16-450
PAR-16-405
PAR-16-300
PAR-16-301
PA-16-160
NOT-HL-16-321

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 single-site clinical trials. The purpose of this Notice is to announce that any application requesting funding for a Phase II and beyond clinical trial (see the NIH definition of a clinical trial) using a single site must be submitted to PAR-16-405 Single-Site Investigator-Initiated Clinical Trials (R61/R33) or its reissue. For the purposes of this FOA, the definition of a single site clinical trial is one in which the protocol is implemented by one investigational site that conducts and coordinates the protocol. While a single site clinical trial may enroll participants from multiple locations/clinics within a geographic area, those participants will receive an intervention or undergo outcome assessments under the direction and oversight of one research team at one investigational site. 

For due dates on or after January 8, 2017, NHLBI will no longer accept applications for single-site clinical trials if submitted through the Research Project Grant (Parent R01) FOA PA-16-160 or its reissue.

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