NIGMS accepts investigator-initiated applications for
clinical trials using the
R01 mechanism with the following considerations and limitations (see NOT-GM-22-027 for further details).
Clinical studies that do not meet the
Revised NIH Definition of “Clinical Trial” should be submitted via the
NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) funding opportunity announcement. NIGMS encourages discovery research in the NIGMS
clinical research areas – for example, an observational study intended to provide biospecimens for molecular analyses that provide mechanistic understanding that will inform future clinical research/trials. We strongly encourage advance discussion with NIGMS staff of all applications that involve clinical studies or clinical trials. All clinical study and clinical trial applications above $500,000 direct costs in any one year are subject to
NIH pre-submission requirements.
This page last updated on
2/8/2022 12:30 PM
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