Notice Number: NOT-GM-13-126
Key Dates
Release Date: August 23, 2013
Issued by
National Institute of General Medical Sciences (NIGMS)
Purpose
Note: This Notice has been superseded by NOT-GM-14-130
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 accept 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:
NIGMS continues to accept applications in response to the parent R01 (PA-13-302) for clinical studies that are not trials. All applications above $500,000 direct costs in one year are subject to NIH pre-submission requirements (see NOT-OD-02-004).. 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.
Telephone: 301-594-3827
Email: somerss@nigms.nih.gov
Sepsis
Sarah E. Dunsmore, Ph.D.
Telephone: 301-594-3827
Email: dunsmores@mail.nih.gov
Anesthesiology and Peri-operative Pain
Alison E. Cole, Ph.D.
Telephone: 301-594-3827
Email: colea@nigms.nih.gov
Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov
Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: Lm236j@nih.gov