As you should know by now, NIH is overhauling the submission process for applications due on or after January 25, 2018, that include a clinical trial. For such applications, you must:
- Confirm that your research meets the NIH definition of a clinical trial using the Decision Tree for NIH Clinical Trial Definition.
- Choose a funding opportunity announcement (FOA) specifically designated as allowing clinical trials. See our article “Updated FOAs: Titles Tell You Yes, No, or Maybe About Clinical Trials” for more information.
- Complete section G.500 - PHS Human Subjects and Clinical Trials Information of SF 424 (R&R) - Forms Version E when you apply.
NIAID plans to discontinue its R01 FOA—NIAID Clinical Trial Implementation Grant (R01)—and in its place use two new NIH clinical trial FOAs for investigator-initiated research:
- NIH Research Project Grant (Parent R01, Clinical Trial Required)
- NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required)
NIAID recommends that you use these FOAs only for low-risk clinical trials, and we encourage you to instead use the NIAID Clinical Trial Implementation Cooperative Agreement (U01) for high-risk trials. Refer to the U01 FOA for a definition of high-risk clinical trials.
To optimize your chances of success and leverage NIAID’s Investigator-Initiated Clinical Trial Resources, we recommend that you contact an NIAID program officer at least 10 weeks before applying. See Contacts and Special Interests to find an appropriate program division contact.
Keep in mind: clinical trials are complicated, as are components of the application—study design, risk to participants, feasibility, and budget. Missing or inadequate information could result in your application being withdrawn before review or not funded even after receiving a meritorious score.
Be absolutely certain that your budget is sufficient to support the proposed research. Applicants who request a single year budget of $500,000 or more must receive prior approval following the process explained in our Big Grants SOP.
Even if your application’s budget request is under the $500,000 threshold, prior consultation with an NIAID program officer is still the best way to ensure you aren’t wasting time developing an application that is either incomplete or not a priority to NIAID.