Some links will work for NIAID staff only.
Table of Contents
- Is Your Research Covered by NIAID Policy?
- Learn More About the Process
- Request Prior Consultation
- Prepare Your Application
- If You Need an Extension After Award
- NIAID Division Clinical Web Sites
- Resources for NIAID Staff
Is Your Research Covered by NIAID Policy?
If you plan an investigator-initiated clinical trial, you must go through the NIAID process for the following awards:
- Milestone-driven Clinical Trial Implementation Grant (R01)—for investigators who are ready to begin a clinical trial that is not high-risk*
- Clinical Trial Implementation Cooperative Agreement (U01)—for investigators who are ready to begin a high-risk* clinical trial
- SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)—for small business investigators who are ready to begin a clinical trial
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
- Get instructions at Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP
- Find answers at Investigator-Initiated Clinical Trials Questions and Answers
- See the funding opportunity announcements linked above
Request Prior Consultation
You are strongly encouraged to request prior consultation from program staff before you apply.
- Use Requesting Prior Consultation to Discuss Submission of a Clinical Trial Planning (R34) or Implementation (R01, U01, or U44) Application to prepare for your consultation
- See the Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications
- Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP
- Include documentation of prior consultation with NIAID in your application
Prepare Your Application
In addition to the resources noted above, we have the following help for writing your application:
- 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 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
For more information, see NIAID Human Subjects Resources, including SOPs and questions and answers. Also learn more about Application and 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:
- Investigator-Initiated Clinical Trial Administrative Extensions SOP
- Investigator-Initiated Clinical Trial Administrative Extensions Questions and Answers
NIAID Division Clinical Websites
- Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedure Documents
- Division of Microbiology and Infectious Diseases (DMID) Office of Clinical Research Affairs
- Division of Allergy, Immunology, and Transplantation (DAIT) Clinical Research Policies and Standards
Resources for NIAID Staff
For more information, see NIAID Human Subjects Resources.