On January 25, 2018, NIH implemented policy changes for applications proposing clinical trials that
- Refine what research projects NIH classifies as clinical trials
- Limit applications proposing clinical trials to only funding opportunity announcements (FOAs) that specifically allow clinical trials
- Update the forms and information required from applicants proposing clinical trials
Learn more about the NIH policy changes at Clinical Trial Requirements for Grants and Contracts. Pay close attention to Does your human subjects research study meet the NIH Definition of a clinical trial? for guidance on whether your research project qualifies as a clinical trial.
These policies complement NIAID’s policies for investigator-initiated clinical trials (IICTs).
NIAID uses the following suite of FOAs to receive applications proposing IICT research:
- NIAID Clinical Trial Planning Grant (R34)—for investigators who seek a planning period funded by NIAID
- NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required)—for investigators who are ready to begin a clinical trial that is not high-risk* and can be completed within the two-year project period
- NIH Research Project Grant (Parent R01, Clinical Trial Required)—for investigators who are ready to begin a clinical trial that is not high-risk* and not lasting more than five years
- Investigator-Initiated Extended Clinical Trial (R01, Clinical Trial Required)—for investigators who are ready to begin a clinical trial that can be high-risk* and may need more time to complete (up to six or seven years)
- NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required)—for investigators who are ready to begin a high-risk* clinical trial
- NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)—for small businesses who are ready to begin a clinical trial
*For the NIAID definition of high risk, see How do I determine level of risk and choose an award type for my application?
Additional Steps for IICT Applications
NIAID has a prior consultation process for IICTs; before you apply, staff can confirm NIAID’s interest in your research, make sure you are aware of all rules and requirements for clinical trials, verify your budget is commensurate with your proposed research, and share resources with you that can improve and strengthen your application. We explain the process further at Investigator-Initiated Clinical Trial Resources.
In short, you should contact the NIAID program officer listed in the IICT FOA as a scientific/research contact at least 10 weeks before the receipt date; 12 weeks for the extended R01.
He or she will discuss with you in detail the items listed at Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.