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).

Table of Contents

• Follow the NIAID IICT Process
• What To Do If You Need an Extension After Award
• IICT Resources for Staff and Applicants

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:

• Investigator-Initiated Clinical Trials Questions and Answers
• Four Tips for Investigator-Initiated Clinical Trial Applications

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

• NIH Research Project Grant (Parent R01, Clinical Trial Required)—best for clinical trials that are not high-risk*
• NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required)—best for mechanistic or investigative studies that are not high-risk*
• NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required)—best for clinical trials that are high-risk*
• NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)—the only choice for small businesses

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

At least 10 weeks before your application’s due date (12 weeks for applications that request more than $1 million a year in direct costs), 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’s Special About Clinical Trial Applications?
• Four Tips for Investigator-Initiated Clinical Trial Applications

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:

• Investigator-Initiated Clinical Trial Administrative Extension SOP
• Extension of Investigator-Initiated Clinical Trials Questions and Answers

IICT Resources for Staff and Applicants

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

• Requesting Prior Consultation—Clinical Trial Applications and Planning Grants
• Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP
• Investigator-Initiated Clinical Trials Questions and Answers
• Types of Funding Opportunities
  • Research Using Human Subjects. Includes IRB and assurance information
  • Checklists for Planning and Writing a Human Subjects Grant Application
  • Apply for a Grant. Advice on how to plan and write an application and manage a grant
• NIAID Clinical Terms of Award
  • NIAID Clinical Terms of Award—Guidance for Compliance on using the Terms
• Rules and Policies for Clinical Research
• ClinRegs—an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research
• Human Subjects Warning
• Sample Letter to Document Training in the Protection of Human Subjects
• Research Methods Resources

For more information, check 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.