NIAMS Policy for Submission of Applications Containing Clinical Trials

Notice Number: NOT-AR-14-021

Key Dates
Release Date: August 29, 2014

Related Announcements
PA-16-160
PA-13-302
PAR-14-199
PAR-14-200
PAR-14-060
PAR-14-192

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

The purpose of this Notice is to define the types of clinical studies that may be submitted to NIAMS in response to the NIH parent R01 Funding Opportunity Announcement (FOA) PA-13-302 and subsequent reissuances to this FOA.  Effectively immediately, NIAMS will not accept investigator-initiated R01 applications that include clinical trials under PA-13-302.  A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about the safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions. 

This policy applies only to clinical trials submitted to PA-13-302 for investigator-initiated R01 applications and subsequent reissuances.  This policy does not apply to other NIAMS-specific announcements that specifically solicit clinical trials.

Applicants submitting investigator-initiated applications to NIAMS that contain a clinical trial must submit to one of the following NIAMS FOAs specifically designed for clinical trials:

PAR-14-192 Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21)
PAR-14-060 Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21)
PAR-14-200 NIAMS Clinical Trial Implementation Cooperative Agreement (U01)
PAR-14-199 NIAMS Clinical Trial Planning Cooperative Agreement (U34) 

More about NIAMS clinical trials policies can be found at: Policies and Guidelines for Investigator-Initiated Clinical Trials.

Inquiries

Please direct all inquiries to:

Laura K. Moen, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-6515
Email: moenl@mail.nih.gov