Notice Number: NOT-HL-18-663

Key Dates
Release Date: December 12, 2018

PA-18-345
NOT-HL-18-662

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

Purpose

The purpose of this Notice is to inform potential applicants that NHLBI accepts investigator-initiated basic experimental studies involving humans (BESH) that meet NIH’s definition of a clinical trial only in response to PA-18-345 NIH Research Project Grant (Parent R01 Clinical Trial Required) and its reissues. NHLBI considers BESH studies as fundamentally important to its mission, and directs investigators interested in such research to PA-18-345 or its reissue.

I f the proposed research project includes a clinical trial other than a mechanistic or basic experimental study with humans, applicants are strongly advised to contact NHLBI staff to determine the appropriate alternative NHLBI-specific clinical trial FOA. Applicants are also encouraged to refer to the NHLBI Policy Regarding Submission of Clinical Trial Applications (see NOT-HL-18-611).

Inquiries

Please direct all inquiries to:

W. Keith Hoots, MD, Director
Division of Blood Diseases and Resources
Telephone: 301-435-0080
Email: hootswk@nhlbi.nih.gov

Katie Kavounis, MPH, Clinical Trials Specialist
Division of Cardiovascular Sciences
Office of Clinical Research
Telephone: 301-594-1369
Email: katherine.kavounis@nih.gov

James P. Kiley, Ph.D., Director
Division of Lung Diseases
Telephone: 301-435-0202
Email: kileyj@nhlbi.nih.gov

George A. Mensah, MD, FACC, Director
Center for Translation Research and Implementation Science (CTRIS)
Telephone: 301-435-0422
Email: george.mensah@nih.gov