Notice Number: NOT-HL-19-690

Key Dates
Release Date: April 16, 2019

PA-20-183

NOT-HL-18-662 Rescinded

NOT-HL-18-663 Rescinded

NOT-HL-19-695

NOT-HL-20-737

NOT-HL-21-025

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

Purpose

The purpose of this Notice is to define the types of investigator-initiated clinical trial applications that may be submitted to NHLBI in response to the NIH Research Project Grant (Parent R01 Clinical Trial Required) FOA.

NHLBI will accept applications in response to the NIH Parent (R01 Clinical Trial Required) FOA that propose:

• mechanistic studies that meet NIH’s definition of a clinical trial and that have the primary goal of understanding how an intervention works. Mechanistic studies are designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (the goal must not be to evaluate safety, pharmacokinetics or pharmacodynamics, efficacy, or clinical trial feasibility)
• fundamental or basic experimental studies involving humans (BESH) that do not have specific processes or products in mind
• hybrid applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic or BESH clinical trial(s)
• Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect (these must not be efficacy studies, see next section) of the proposed mechanistic and fundamental or basic experimental study

The following types of clinical trials are not allowed and will not be accepted by NHLBI under the NIH Research Project Grant (Parent R01 Clinical Trial Required) FOA:

• Early Phase Clinical Trials for Therapeutics and/or Diagnostics
• Studies to develop or conduct tests of the clinical efficacy/effectiveness of treatments.
• Studies that have safety, clinical efficacy, clinical management, and/or implementation goals.

Applicants are strongly encouraged to consult the NHLBI Scientific/Research Contact listed on the NIH Research Project Grant (Parent R01 Clinical Trial Required) FOA prior to submission to confirm the NHLBI-specific clinical trial FOA to which the application should be submitted.

Applicants are also encouraged to refer to the NHLBI Clinical Trial Funding Opportunities webpage.

Inquiries

Please direct all inquiries to:

Julie A. Panepinto, MD, MSPH
Director, Division of Blood Diseases and Resources
Telephone: 301-827-7210
Email: julie.panepinto@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