Notice Number: NOT-HL-17-518
Release Date: May 31, 2017
National Heart, Lung, and Blood Institute (NHLBI)
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.
Please direct all inquiries to: