R01 and R21 Investigator-Initiated Clinical Trial Award SOP

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) for 5 or fewer years. For projects that may require 6 or 7 years of support, follow instructions in the Extended R01 Investigator-Initiated Clinical Trial Award SOP.

Procedure

NIAID supports R01 and R21 grants through the following notices of funding opportunities (NOFOs):

• NIH Research Project Grant (Parent R01, Clinical Trial Required)
• NIH Exploratory/Developmental Research Grant Project Grant (Parent R21, Clinical Trial Required)

R01 and R21 clinical trial grants do not support planning activities for a clinical trial, such as development of study design, clinical protocol, milestone plans, research teams, informed consent or assent documents. For those activities, principal investigators (PIs) may consider applying for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed).

If NIAID determines that a study is high-risk, it may ask applicants to submit an NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required). For example, during prior consultation, a program officer may believe the PI should submit a U01 or, after receiving an R01, NIAID may determine substantial staff involvement is needed. Refer to NIAID’s Criteria for High-Risk Clinical Trials.

If the trial requires an investigational new drug (IND), NIAID will decide who will hold the IND. PIs can discuss options with the appropriate NIAID program staff.

Prospective IICT applicants will benefit from prior consultation with program staff as described below.

After award, NIAID will consider the successful attainment of milestones as part of its annual assessment of progress. NIAID may periodically review the progress of the clinical trial.

Applicants and Principal Investigators

Before Applying

• Consult with a program officer at least 10 weeks before applying. For instructions, read Requesting Prior Consultation—Clinical Trial Applications and Planning Grants.
  • If you plan to request a budget of $1 million or larger in direct costs in any year, request your consultation at least 12 weeks before applying.
  • If you have questions about an IND, ask your program officer during the consultation.
  • After the consultation, provide the information listed in the “Follow Up After Prior Consultation” section of Requesting Prior Consultation—Clinical Trial Applications and Planning Grants.
• If NIAID determines that substantial staff involvement is necessary, we may ask you to apply for a clinical trial implementation cooperative agreement. Refer to the U01 Investigator–Initiated Clinical Trial Award SOP.

Applying

• Follow the instructions in the relevant NOFO linked above.
• 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.
• Describe all milestones in your Study Timeline. These milestones will be incorporated into your terms of award.
• Describe each stage of the clinical trial, provide criteria for completing it, and give contingency plans if you cannot meet the timeline.
• Include a sufficient and appropriate budget to support these activities.

After Award

• Follow the NIAID Clinical Terms of Award.
• If you’re unable to complete a trial within the performance period of your award, contact the appropriate Program Division Contact listed in the Investigator-Initiated Clinical Trial Administrative Extension SOP to see if NIAID will consider extending your award.

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.
• For applications with total direct costs of $500,000 or more in any year, follow the process described in the Big Grants SOP in addition to the IICT process.

Contacts

• DEA—DEAPolicyShop@niaid.nih.gov
• DAIDS—Martin Gutierrez
• DAIT—Ellen Goldmuntz (R01s)
• DAIT—Patricia Fulkerson (R21s)
• 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
• IICT Notice of Information