Investigator—Initiated Clinical Trial Resources

If you haven’t done so already, check NIAID’s Clinical Trial Research page and confirm whether your planned research meets NIH’s definition of a clinical trial. Then read this page for NIAID’s unique requirements for investigator-initiated clinical trials (IICTs).

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Follow the NIAID IICT Process

To apply for your own clinical trial outside of NIAID’s Networks, you must follow NIAID’s rules and process for IICTs as described below. Otherwise, we will not accept your application.

Start with NIAID’s Investigator—Initiated Clinical Trial Planning and Implementation Awards SOP, then read the following:

Decide which notice of funding opportunity (NOFO) best suits your research:

*For the NIAID definition of high risk, check How do I determine level of risk and choose an award type for my application? on IICT Awards – General Questions and Answers.

If you need support to get ready for the launch of an IICT, such as planning, designing, and preparing the documentation necessary for implementing an IICT, consider applying first for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed). An R34 is not a prerequisite for any other clinical trial award.

Then, at least 10 weeks before your application’s due date, speak to the scientific/research contact listed in the NOFO to request a prior consultation.

The purpose of this consultation is four-fold:

  1. Assure you that your proposed clinical trial meets NIAID’s goals, fits within our mission, and addresses a high-priority research area
  2. Determine the risk level of your proposed trial
  3. Review the information and documents you’ll need to include in your application
  4. Identify other mechanisms to support your clinical trial, e.g., through a different notice of funding opportunity or one of our clinical trial networks

Prepare for that discussion using our guide, Requesting Prior Consultation—Clinical Trial Applications and Planning Grants.

Last, write your application and gather all documentation you’ll need when you apply. Learn more and get advice from NIAID:

What To Do If You Need an Extension After Award

If you can't complete a clinical trial by the end of the award, you may be able to apply for an extension. For NIAID policy on extending an IICT, read the following pages:

IICT Resources for Staff and Applicants

In addition to the websites noted above, we have the following resources to help you with your application:

For more information, see NIAID Research Using Human Subjects, which includes SOPs. Also learn more about how to Apply for a Grant and First-Level Peer Review.

We also advise you to review NIAID’s clinical research policies Rules and Policies for Clinical Research. These policies may differ somewhat depending on your research and topic area.

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