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

Investigators proposing an IICT must go through a defined process for any of these award types:

If you need a planning phase, you may apply for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed). For high-risk trials, you must apply for the U01. Check NIAID’s Criteria for High-Risk Clinical Trials.

We strongly encourage you to request a prior consultation with NIAID staff at least 10 weeks before you apply (12 weeks for the extended R01 or applications that request more than $1 million a year in direct costs). Include NIAID’s summary of the consultation with your application. Learn more in Requesting Prior Consultation — Clinical Trial Applications and Planning Grants.

Use NIH’s Decision Tool, Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?.

NIAID staff can’t assist with your application.

For R01s, R21s, and R34s, NIAID staff do not participate in your research.

U01s and U44s require substantial involvement from NIH program or scientific staff, who provide coordination or facilitation. U01s are for research NIAID considers high-risk. U44s are for small businesses.

If you’re unsure which to choose, raise the question during your prior consultation and follow this rule of thumb:

  • Small business: Apply for the U44.
  • Everybody else: Apply for a U01 if your research is high-risk. Apply for an R01 for everything else.

Extended R01s fund clinical trials that require 6 or 7 years of support. Only new or resubmission types of applications are accepted. Also, prior consultation happens at least 12 weeks before application submission.

Parent R01s fund new, renewal, revision, and resubmission applications. Prior consultation happens at least 10 weeks before application submission (12 weeks for applications requesting more than $1 million in direct costs).

Possibly. To determine whether your sample collection is considered a clinical trial, answer the questions on NIH’s Decision Tool, Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?.

Possibly. To determine whether your nontherapeutic intervention is considered a clinical trial, answer the questions on NIH’s Decision Tool, Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?.

Go to Investigator-Initiated Clinical Trial Resources.

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 of those networks. Consulting with NIAID in advance ensures that you do not prepare an application that we cannot fund.

The process also helps you 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:

If you need a planning phase, you may apply for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed).

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.

Only if your budget request exceeds $500,000 in direct costs in any given year. However, we strongly encourage you to request a prior consultation with NIAID staff regardless of your requested budget. Learn more in Requesting Prior Consultation — Clinical Trial Applications and Planning Grants.

With prior consultation, 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, peer review assesses an application's scientific and technical merit using the initial peer review criteria stated in the notice of funding opportunity (NOFO) and assigns an overall impact score. For more information, check How NIH Review Criteria Affect Your Score on our Scoring & Summary Statements page.

A program officer will send you a letter summarizing the prior consultation and signed by an NIAID division director. Include this letter as an Other Attachment in your application.

No. The R34 is not a prerequisite.

Yes, if you follow procedures for a multiple PI application. Read more at Multiple Principal Investigators.

Possibly.

While still in the planning stage of your application, you should speak to the NIAID scientific contact listed in the relevant notice of funding opportunity:

Yes, in any of these situations:

  1. Your research might fit better into our existing clinical trial infrastructure.
  2. Your research is more appropriate for a different NOFO: a request for applications, program announcement, or 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 scientific contact listed on the NOFO to confirm.

Check the criteria on NIAID’s Criteria for High-Risk Clinical Trials.

Discuss your plans with the appropriate Scientific/Research Contact listed in your chosen NOFO under “Section VII. Agency Contacts.” They can advise you on award type.

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

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

For other types of studies, apply for one of the following:

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.

Typically, no. However, if the trial requires an IDE or IND, NIAID can hold it.

Other arrangements are possible; discuss them with the appropriate NIAID program staff listed in the notice of funding opportunity under “Section VII. Agency Contacts.” NIAID will make the final decision on whether to hold the IDE/IND.

A study of unapproved diagnostic tests in which the results of the test are reported back to either the treating physician, the subject, and/or public health authority, will need to come back under the investigator-initiated clinical trial process.

Possibly. To figure out whether your sample collection is considered a clinical trial, answer the questions on NIH’s Decision Tool, Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?.

For further advice, discuss your project with the NIAID point of contact listed in the relevant notice of funding opportunity.

Yes, as long as providing samples for your studies represents minimal additional risk to the clinical trial subjects.

You should explicitly state that you are not requesting support for the clinical trial. You will need to provide documentation that the clinical trial sponsor is aware of your proposal and will provide necessary access to the samples.

No. Find your application’s review criteria in Section V of the relevant notice of funding opportunity.

Yes. If this is not possible, you may write a brief statement in your application to explain why you can’t do so. For more information, check the following resources:

Possibly. To learn more, read the NIAID Policy for Extension of Investigator-Initiated Clinical Trials Guide notice.

Also check our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Extension of Investigator-Initiated Clinical Trials Questions and Answers.

You cannot apply for support for an NIAID IICT through standard Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications at this time.

For that reason, NIAID created the special NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) notice of funding opportunity, also known as the U44.

To apply for funding outside of the U44, small businesses must use the IICT NOFOs below for the clinical trial part of the research:

Small businesses can apply for an SBIR or STTR grant for other parts of the research. 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. In that case, applicants must apply for independent support of a clinical trial using any NOFO that carries the label "Clinical Trial Required" in the funding opportunity title. For any other type of application, they must use a NOFO that carries the label "Clinical Trial Not Required" in the funding opportunity title.

Failure to use the correct NOFO under this program will result in a withdrawn application.

For other K awards that NIAID supports (K01, K08, K22, K23, K24, K25, and Parent K99/R00), K applicants can conduct clinical trial research.

However, these applicants cannot propose an independent clinical trial as the lead PI. They must do all proposed clinical trial research under the mentor’s guidance. In other words, the mentor must lead the clinical trial.

Other NIH institutes and centers may have different rules. Read the relevant NOFO to be sure. For additional questions, contact the appropriate NIAID program staff listed in the NOFO under “Section VII. Agency Contacts.”

If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

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