Investigator-Initiated Clinical Trial Resources

Note: The information on NIAID’s investigator-initiated clinical trial (IICT) pages is being updated. Refer to the scientific/research contacts listed in our IICT funding opportunity announcements if you have any questions.

Table of Contents

Is Your Research Covered by NIAID Policy?

See the NIAID IICT Policy Guide notice. If you plan an IICT, you must go through the NIAID process for the following awards:

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 a Clinical Trial Planning Grant (R34). An R34 is not a prerequisite for an implementation award.

*For the NIAID definition of high risk, see How do I determine level of risk and choose an award type for my application?

Learn More About the Process

Request Prior Consultation

You are strongly encouraged to request prior consultation from program staff before you apply.

Prepare Your Application

In addition to the resources noted above, we have the following help for writing your application:

For more information, see Research Using Human Subjects, including related SOPs. Also learn more about Peer Review.

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 investigator-initiated clinical trial, read the January 30, 2007 Guide notice and see the following pages:

NIAID Division Clinical Websites

Resources for NIAID Staff

For more information, see Research Using Human Subjects.

Content last reviewed on May 23, 2016