Seek NIAID’s Help for an Investigator-Initiated Clinical Trial Application

Funding News Edition: February 01, 2023
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Far too often, we’ve seen applicants underestimate the time, cost, or regulatory requirements of an investigator-initiated clinical trial (IICT). This can lead to award delays while you revise your plans.

There’s a Process

To ensure applicants approach each IICT research proposal fully aware of the associated requirements, NIAID strongly encourages consultations to apprise principal investigators of the obligations that come with seeking and receiving an IICT award. That process is described at Investigator-Initiated Clinical Trial Resources and in our IICT Planning and Implementation Awards SOP.

In short, NIAID staff will evaluate your research plan and clinical protocol materials, then discuss with you whether your research interest is within NIAID’s scientific mission, the risk level of your project, what required documentation you’ll need to complete, and useful resources that could help facilitate your project’s success. Critically, NIAID staff will steer you to the appropriate funding opportunity announcement (FOA) for your project based on its likely scope and risk level, as explained in a corresponding Notice of Information.

Be sure to allow at least 10 weeks of lead time before the application due date when Requesting Prior Consultation: Clinical Trial Applications and Planning Grants.

As You Begin the Process

To address common pain points for IICT applicants, we fashioned Four Tips for Investigator-Initiated Clinical Trial Applications. Here are quick summaries of the page sections:

  • Craft an Appropriate Budget. This section provides a rule of thumb for personnel costs and links to the Budgeting for Your Planned Clinical Trial section of NIAID's Clinical Trial Research page. While we always advise you to propose a realistic budget regardless of size, remember that NIAID IICTs using the U44 small business innovation research grant mechanism are subject to a budget cap.
  • Plan for Regulatory Approvals. Pay special attention to requirements for off-label use of FDA-approved products. We encourage you to determine the investigational new drug/investigational device exemption sponsor well before you apply, as that choice will affect your other administrative and budget decisions. You should plan for appropriate clinical research monitoring as well as safety monitoring and consider how these plans will impact your budget.
  • Build Contingencies Into Your Plans. The list of questions in the Build Contingencies Into Your Plans section will help you anticipate and account for potential issues.
  • Consider an Alternative to an IICT. For some types of studies, you may be able to revise your plans to avoid the extra requirements of an IICT. For example, you could collaborate with another researcher who is conducting a clinical trial and leverage his or her study. That way, you can obtain samples that fit your research needs without having to propose your own IICT—saving time and money.

Final Notes

If you aren’t sure whether your plans will meet NIH's definitions for human subjects or clinical trial research, review NIAID's Are You Conducting Human Subjects Research? and Clinical Trial: NIH's Definition for decision tools and more.

Lastly, we advise you to review the clinical research policies of NIAID’s program divisions as they may further inform your research approach given your scientific topic area:

Contact Us

Email us at for help navigating NIAID’s grant and contract policies and procedures.

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