This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
Purpose
To support investigator-initiated clinical trials (IICTs) at the planning stage.
Procedure
R34 awards provide up to $150,000 in direct costs for up to 1 year to support the planning activities of an IICT. For examples of activities supported by the R34, refer to the related notice of funding opportunity (NOFO), NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed).
Applicants may apply for any number of R34 awards. However, each R34 application will support planning for one clinical trial.
At the end of each R34 award, principal investigators can apply for an IICT award based on elements developed under the R34 planning period. Funding for the future IICT application is not guaranteed.
R34s do not allow investigators to prospectively gather preliminary data to support the rationale for a clinical trial. NIAID Clinical Terms of Award do not apply.
To apply for an R34 award to support clinical trial planning activities, applicants are strongly encouraged to request prior consultation with NIAID programmatic staff listed in Section VII. Agency Contacts of the R34 NOFO.
Applicants and Principal Investigators
Before Applying
- Assess whether the IICT process is appropriate for your application.
- Your research might fit better into our existing clinical trial infrastructures.
- Your research is more appropriate for a different funding opportunity: a request for applications, program announcement, or solicitation.
- Consult with a program officer at least 10 weeks before applying. For instructions, read Requesting Prior Consultation—Clinical Trial Applications and Planning Grants.
Applying
- Follow instructions in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) NOFO.
- Include your prior consultation letter as an Other Attachment. You will receive this letter by email after your consultation. The letter will summarize the discussion.
Program Staff and Management
- When contacted by applicants for a prior consultation, discuss the items listed at Requesting Prior Consultation—Clinical Trial Applications and Planning Grants.
- Follow your division’s internal process to create a letter summarizing the prior consultation discussion and send this letter to the applicant. You may use the Request Form for Prior Consultation for an Investigator-Initiated Clinical Trial Application if applicable.
Contacts
- DEA—DEAPolicyShop@niaid.nih.gov
- DAIDS—Martin Gutierrez
- DAIT—Ellen Goldmuntz
- DMID—NIAID_DMID_IICT@niaid.nih.gov
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.
Links
- Human Subjects Research Requirements in Grants SOP and other Human Subjects Resources SOPs listed at Research Rules & Policies
- Investigator-Initiated Clinical Trial Resources—list of other IICT award types, their suitability to your research, and their application requirements.
- Investigator-Initiated Clinical Trials Questions and Answers
- Rules and Policies for Clinical Research
- Request Form for Prior Consultation for an Investigator-Initiated Clinical Trial Application (staff routing form)
- NIAID IICT Policy Guide notice