Revision: NHLBI Policy for Submission of Investigator-Initiated Single-Site Clinical Trials (Phase II and beyond)

Notice Number: NOT-HL-17-518

Key Dates
Release Date: May 31, 2017

Related Announcements
NOT-HL-17-519
NOT-HL-16-450
PAR-16-405
PAR-16-300
PAR-16-301
NOT-HL-16-321
NOT-HL-16-336

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

Purpose

This revised Notice replaces NOT-HL-16-336 to clarify the types of applications that are appropriate for PAR-16-405 and its reissue.

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 that has a Phase II and beyond clinical trial as its central purpose (see the NIH definition of a clinical trial) and is using a single site must be submitted to PAR-16-405 Single-Site Investigator-Initiated Clinical Trials (R61/R33) or its reissue. PAR-16-405 is meant for applications with the primary intent of conducting clinical trial(s) for testing the efficacy, safety, clinical management, or implementation of intervention(s). This FOA is not meant, for example, for applications with a primary intent of conducting clinical trials to address hypotheses related to biologic and pathobiologic mechanisms of health and/or disease. 

Potential applicants are strongly encouraged to contact NHLBI scientific staff for further guidance.  Frequently Asked Questions (FAQs) are available at this site: https://www.nhlbi.nih.gov/research/funding/new-foa-investigator-initiated-phase-ii-and-beyond-single-site-clinical-trials-par-16-405-frequently. NHLBI anticipates updating the FAQ page as needed and recommends that applicants check back for updates to the FAQ regularly.

Inquiries

Please direct all inquiries to:

Email:  NHLBIClinicalTrials@mail.nih.gov