NOT-GM-13-126: Notice of Clarification of NIGMS Policy on Acceptance of Applications for Clinical Trials

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

Notice Number: NOT-GM-13-126

Key Dates
Release Date: August 23, 2013

Related Announcements
PAR-11-287

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Note: This Notice has been superseded by NOT-GM-14-130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:

Any multi-site or large-scale clinical trial (budget in excess of $500,000 direct costs in any one year) must either 1) successfully complete an R34 Planning Grant (see http://www.nigms.nih.gov/Research/ClinicalTrials/planninggrants.htm) or 2) request a waiver of the planning grant process from NIGMS staff. If granted, the waiver letter from NIGMS must be submitted electronically as part of and at the same time as the R01 application. The letter will demonstrate that NIGMS staff agrees that advance planning for management and coordination of a multi-site or large-scale trial is satisfactory (e.g., preparation of a manual of operations, creation of a DSMB charter, etc.).
Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply for the R34 FOA or to apply to NIGMS for multi-site or large-scale clinical trials.

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:

Scientific/Research Contact(s)

Trauma, Burn, Peri-operative Injury, and Wound Healing
Scott D. Somers, Ph.D.
Telephone: 301-594-3827
Email: [email protected]

Sepsis
Sarah E. Dunsmore, Ph.D.
Telephone: 301-594-3827
Email: [email protected]

Anesthesiology and Peri-operative Pain
Alison E. Cole, Ph.D.
Telephone: 301-594-3827
Email: [email protected]

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Financial/Grants Management Contact(s)

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: [email protected]