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.
NIAID funds high-risk investigator-initiated clinical trials (IICTs) through two notices of funding opportunities (NOFOs):
- NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required)—for all applicants.
- NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)—for small businesses only.
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 clinical trials that are not high-risk.
- Investigator-Initiated Extended Clinical Trial (R01, Clinical Trial Required)—best for clinical trials that require an extended project period.
- NIH Exploratory/Developmental Research Project Grant (Parent R21, Clinical Trial Required)—best for mechanistic or investigative studies that are not high-risk.
- NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required)—best for clinical trials that are high-risk.
- NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)—the only choice for small businesses.
Note, NIAID may determine that your IICT 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 U01 or convert your award to a U01 after award.
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