Table of Contents
- How NIAID Funds Clinical Trials
- Clinical Trial: NIH’s Definition and Why It Matters for Your Application
- Do You Have an Investigator-Initiated Clinical Trial?
- How to Apply For Funding
- What To Do If You Need an Extension After Award
- IICT Resources for Staff and Applicants
NIAID funds most of our clinical trials through Networks and collaborations where NIAID determines the research topic and project scope.
However, you can apply for funding for your own clinical trials–called investigator-initiated clinical trials (IICT)–outside of these networks.
Make sure you follow our special rules, which we describe below. If you don’t follow these rules, NIAID will not accept your application.
NIH has a specific definition of what’s considered a clinical trial:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
This may sound straightforward, but what if your research involves nontherapeutic interventions for data or sample collection? Mechanistic studies that support larger, non-clinical research projects? Small-scale, routine interventions that entail no risk to human subjects?
In some cases, NIH will consider your research a clinical trial, even if you and your institution don’t think it is.
NIH’s Definition of a Clinical Trial webpage provides additional context. Why does this matter for your application?
First, you cannot include any research considered a clinical trial – no matter the scope – in any application you submit to any funding opportunity announcement (FOA) that says “Clinical Trial Not Allowed.” This means if you don’t check whether your research fits, NIH may reject your application, even if you don’t think your proposed research includes a clinical trial.
Second, even if you correctly submit a clinical trial to a funding opportunity announcement that allows clinical trials, you have to make sure you provide all the necessary documents. If you don’t, NIH will reject your application.
Fortunately, as long as you follow the instructions below, you’ll know your application is responsive and appropriate for one of NIAID’s IICT FOAs.
Your first step: use NIH’s decision-making tool, Does your human subjects research study meet the NIH definition of a clinical trial? to determine whether your research qualifies as an IICT.
The tool links to case studies and examples to help you it figure out. You can also ask your program officer for his or her thoughts.
Read NIAID’s Investigator-Initiated Clinical Trial Awards—General Questions and Answers and other IICT Questions and Answers.
First, once you’ve confirmed that your research meets that criteria, decide which FOA 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
- 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, see How do I determine level of risk and choose an award type for my application?
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 NIAID Clinical Trial Planning Grant (R34). 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 on the FOA to request a prior consultation.
The purpose of this consultation is four-fold:
- Assure you that your proposed clinical trial meets NIAID’s goals, fits within our mission, and addresses a high priority research area
- Determine the risk level of your proposed trial
- Review the information and documents you’ll need to include in your application
- Identify other mechanisms to support your clinical trial, e.g., through a different funding opportunity announcement or one of our clinical trial networks
Prepare for that discussion using our guide, Requesting Prior Consultation to Discuss Submission of a NIAID Clinical Trial Application.
Last, write your application and gather all documentation you’ll need when you apply.
Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP and visit Apply for a Grant.
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 Extensions SOP
- Investigator-Initiated Clinical Trial Administrative Extensions Questions and Answers
In addition to the websites noted above, we have the following resources to help you with your application:
- Requesting Prior Consultation to Discuss Submission of a NIAID Clinical Trial Application
- 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
- Guidance for Compliance on using the Terms
- Trans NIAID Clinical Research Toolkit
- ClinRegs—for country-specific clinical research regulatory information, including comparison information, presented in plain language
- Human Subjects Warning for Applications
- Sample Letter to Document Training in the Protection of Human Subjects
- Research Methods Resources
We also advise you to review NIAID’s clinical research policies. These policies may differ somewhat depending on your research and topic area.