The Institute accepts investigator-initiated applications for full clinical trials using the R01 mechanism. Features of an R01 clinical trial application include:
- Peer review of scientific rationale, within the context of current needs of the field
- Supports costs according to the trial needs, as NIGMS’ budget allows
- Assurance that all necessary planning and study documents are complete
- For a multi-site trial application, successful completion of an R34 planning grant is a pre-requisite*
*Applicants may request a waiver may where justified. If granted, submit the permission letter from NIGMS electronically as part of and at the same time as the R01 application. The letter will demonstrate that NIGMS staff agree that advance planning for management and coordination of a multi-site trial is satisfactory (e.g., preparation of a manual of operations, creation of a DSMB charter, etc.).
NIGMS continues to accept R01 applications for clinical studies that are not trials. We strongly encourage advance discussion with NIGMS staff. All applications above $500,000 direct costs in one year are subject to NIH pre-submission requirements. See NIH Guide notice GM-13-126 for more information on the NIGMS policy for the acceptance of clinical trial applications.