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
PA 20-185NIH 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.
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