Investigator—Initiated Clinical Trial (IICT) Awards-General Questions and Answers

The U01 requires you include NIAID staff in your research, usually in an oversight or advisory capacity. NIAID uses the U01 whenever your clinical research is considered “high risk”—see How do I determine level of risk and choose an award type for my application?

The R01 is a standard research project grant. If we fund your R01 application, you do not need to include NIAID staff in your research.

If you’re unsure which to choose, apply for the R01 and if NIAID determines your research is high-risk, we will convert your application to a U01. Better yet, raise the question during your prior consultation.

Possibly. To figure out whether your sample collection is considered a clinical trial, answer the questions on NIH’s decision wizard, Does your human subjects research study meet the NIH Definition of a clinical trial?

Possibly. To figure out whether your nontherapeutic intervention is considered a clinical trial, answer the questions on NIH’s decision wizard, Does your human subjects research study meet the NIH Definition of a clinical trial?

Go to Investigator—Initiated Clinical Trial Resources and contact staff listed in the Guide notices.

NIAID has an extensive infrastructure of networks and programs to support clinical trials, and we will not fund investigator-initiated research that overlaps with work funded through our infrastructure.

We created the IICT process so that we can support a limited number of IICTs outside our existing clinical trial networks. Consulting with NIAID in advance ensures that investigators do not waste their time preparing applications that we cannot consider for funding.

The process also helps investigators by enabling them to delineate the detailed plans, processes, and documentation needed to conduct a clinical trial.

Principal investigators (PIs) who are ready to conduct a clinical trial can apply directly for one of the following:

Yes. For all clinical trial funding opportunities, program staff may be able to help you access Institute-funded resources, for example, those in existing networks, facilities, and laboratories.

For the U01 and U44, PIs also benefit from the ongoing involvement of NIAID staff.

No. However, we do strongly encourage you to request a prior consultation with NIAID staff. Learn more in the Investigator—Initiated Clinical Trial Planning and Implementation Awards SOP.

No. The R34 is not a prerequisite.

Yes, in one of these situations:

  1. Your research might fit better into our existing clinical trial infrastructure.
  2. Your research is more appropriate for a different notice of funding opportunity (NOFO): a request for applications (RFA), a program announcement, or a solicitation.
  3. Your research might not qualify as a clinical trial as defined by NIH on Clinical Trial Requirements for Grants and Contracts. Use NIH’s Decision Tool to determine whether your research includes a clinical trial.

In all cases, we highly recommend that you speak to the NIAID point of contact listed on the NOFO to confirm.

We discuss whether your proposed research meets NIAID's scientific priorities and should be supported with existing funds, but we do not discuss technical or scientific merit.

In contrast, as an IICT, initial peer review assesses an application's scientific and technical merit using the initial peer review criteria stated in the Guide notice and assigns an overall impact score. For more information, see How NIH Review Criteria Affect Your Score on our Scoring and Summary Statements page.

NIAID considers your application “high risk” whenever you plan to provide a non-routine intervention—i.e., an intervention that would not otherwise be provided for the study condition in the facility where the trial is being conducted—or you plan to administer an unlicensed product or use a licensed product for an unapproved indication.

If you discuss your plans with the scientific contact listed in one of the NOFOs, he or she can advise you on award type. Choose which award type to apply for based on level of risk.

The NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) supports high-risk clinical trials as described in the NOFO.

For studies that are not high risk, applicants apply for the following:

The Investigator-Initiated Extended Clinical Trial (R01, Clinical Trial Required) supports clinical trials that require an extended project period of six or seven years.

The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) award encourages high-risk clinical studies, though applicants may also propose studies that are not considered high risk.

Additionally, NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01 or convert your award to a U01 after award.

For the clinical trial part of your research, small businesses must use the IICT NOFOs:

With the exception of the U44, you cannot apply for support for an NIAID IICT through a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) application at this time.

For the other parts of your research, you can apply for an SBIR or STTR grant. To learn more about small business awards, visit our Small Business Programs page.

Yes. NIAID supports investigator-initiated independent clinical trials under the NIAID Physician Scientist Pathway to Independence Award K99/R00.  This allows applicants to apply for independent support of a clinical trial using the clinical trial required NOFO (PAR-20-070); otherwise applicants must use the nonclinical trial NOFO (PAR-20-071). Failure to use the correct NOFO under this program will result in a withdrawn application.

All other K awards (K01, K08, K22, K23, K24, K25, and Parent K99/R00) that NIAID supports do not allow applicants to conduct an investigator-initiated independent clinical trial. This does not mean that these K applicants cannot conduct clinical trial research (gaining clinical trial research experience is a good), but cannot propose an independent clinical trial as the lead PI on these K programs and must do any proposed clinical trial research under the mentor's guidance; where the mentor leads the clinical trial.

This is the clinical trial process for K awards at NIAID, there may be different rules at other NIH ICs. Read the NOFOs to be sure.

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at
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