National Institute of
General Medical Sciences

The Institute accepts investigator-initiated ap​plications for clinical trials using the R01 mechanism. Currently, two options are available:

PA-18-345 NIH Research Project Grant (Parent R01 Clinical Trial Required)
PAR-17-056 Investigator Initiated Extended Clinical Trial (R01)

Both R01 clinical trial application funding opportunity announcements feature:

• Clinical trial-specific review criteria
• Pre-submission requirements for budget requests of $500,000 or more in direct costs in any year
• The New Human Subjects and Clinical Trial Information Form

Successful completion of tasks outlined in a R34 planning grant is recommended for all multi-site clinical trial applications to either funding opportunity announcement.

We strongly encourage advance discussion with NIGMS staff of all applications that involve clinical studies or clinical trials.  Clinical studies that do not meet the Revised NIH Definition of “Clinical Trial” should be submitted via the PAR-16-160 NIH Research Project Grant (Parent R01) funding opportunity announcement.  All clinical study and clinical trial applications above $500,000 direct costs in any one year are subject to NIH pre-submission requirements.