NHLBI Accepts Only Investigator-Initiated Clinical Trial Applications Proposing Mechanistic Studies and Basic Experimental Studies Involving Humans (BESH) in Response to the NIH Parent R01 Clinical Trial Required Announcement

Notice Number: NOT-HL-18-662

Key Dates
Release Date: December 12, 2018

Related Announcements
PA-18-345
NOT-HL-18-610 Rescinded
NOT-HL-18-611

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

Purpose

The purpose of this Notice is to inform potential applicants that NHLBI will only accept investigator-initiated mechanistic studies and fundamental or basic experimental studies involving humans (BESH) that meet NIH’s definition of a clinical trial in response to PA-18-345 NIH Research Project Grant (Parent R01 Clinical Trial Required) and its reissues.

NIH defines a mechanistic study as a study "designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention."  NIH defines basic research consistent with the definition of basic research in federal code, "the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena or of observable facts without specific applications towards processes or products in mind." (32CR 272.3)

NHLBI recognizes a difference between 1) "clinical trials" that are designed to answer specific questions about the clinical effect of interventions, and 2) both mechanistic studies that have the primary goal of understanding how an intervention works and basic experimental studies involving humans that do not have specific applications towards processes or products in mind. NHLBI recognizes that some of the aims of applications that propose a mechanistic clinical trial may also include exploration of fundamental mechanisms that are a major precursor to, or an iterative element of, a clinical study where the latter design or conduct is predicated at least in part on the results of these basic and early translational research aims. As such, NHLBI recognizes that applications can be "hybrid" meaning that they may include as their aims not only a mechanistic clinical trial but also fundamental basic science experimental research aims. NHLBI will accept such hybrid applications as well as applications solely proposing mechanistic trials or basic experimental studies with humans in response to PA-18-345 and its reissues.

If 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