For clinical trials, NIAID defines “high-risk” as a clinical trial that involves any of the following:
- A nonroutine intervention, i.e., an intervention that would not otherwise be provided for the condition under study in the facility where the study is being conducted.
- An unlicensed product.
- A licensed product for an unapproved indication.
For advice on what level of risk your research entails, discuss your plans with the scientific contact listed in one of the following NOFOs.
- NIH Research Project Grant (Parent R01, Clinical Trial Required)—best for standard, 5-year clinical trials.
- NIH Exploratory/Developmental Research Project Grant (Parent R21, Clinical Trial Required)—best for mechanistic or investigative studies that are not high-risk.
- NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)—the only choice for small businesses.
Note, after you apply, NIAID may determine that your investigator-initiated clinical trial application proposes high-risk research or substantial staff involvement is necessary for other reasons. In these cases, NIAID will ask you to apply for a cooperative agreement or convert your R01 award to a cooperative agreement after award. Your program officer will discuss these options with you when applicable.
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