Notice of Clarification of NIGMS Policy on Acceptance of Applications for Clinical Trials


Notice Number:

NOT-GM-14-130

Key Dates

Release Date:   September 25, 2014

Related Announcements

 PAR-14-348, NOT-GM-13-126, NOT-GM-15-104

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

The purpose of this Notice is to clarify NIGMS's policy regarding clinical trials that may be submitted to NIGMS. NIGMS supports a limited number of clinical trials in areas of high significance to its mission, which encompasses the clinical fields of trauma and burn, peri-operative injury, sepsis, wound healing, anesthesiology, and peri-operative pain.  A clinical trial should address a mechanistic question of relevance to these NIGMS-supported clinical research programs and should not solely be a comparison of outcome measures.  The trial should test a proposed scientific hypothesis and have the potential to make a significant impact upon a clinical field that is supported by NIGMS.  Any clinical trial must fall within an area of explicit programmatic interest to NIGMS; the institute does not intend to fund applications in areas that are most appropriate for the mission of other Institutes and Centers at the NIH.

Applicants interested in submitting investigator-initiated applications to NIGMS that contain a clinical trial should note that Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply for the R34 FOA (PAR-14-348) or to apply to NIGMS for multi-site or large-scale clinical trials.

NIGMS continues to accept applications in response to the parent R01 announcement (PA-13-302) for clinical studies that are not trials. Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks prior to the application due date to determine if NIGMS is willing to accept assignment of the application for funding consideration. We strongly encourage advance discussion of all clinical trial applications with appropriate NIGMS staff.

Inquiries

Please direct all inquiries to:

Trauma, Burn, Peri-operative Injury, and Wound Healing
Scott D. Somers, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: somerss@nigms.nih.gov

Sepsis
Sarah E. Dunsmore, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: dunsmores@mail.nih.gov

Anesthesiology and Peri-operative Pain
Alison E. Cole, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: colea@nigms.nih.gov