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 Small Business Innovation Research (SBIR) grant applications from small business concerns that propose to implement investigator-initiated clinical trials (IICTs) related to the research mission of NIAID.
Procedure
U44 SBIR Phase II implementation awards are reserved for projects that require substantial staff involvement.
For this funding opportunity, NIAID encourages high-risk clinical studies as defined on NIAID’s Criteria for High-Risk Clinical Trials webpage.
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.
- Provide the following information when you request NIAID prior consultation (you will provide more information later):
- Complete clinical protocol.
- Informed consent and, if applicable, assent forms.
- Statistical analysis plan.
- Plan for acquiring and administering study agents.
- Investigator’s Brochure or equivalent for study products.
- Documentation of adequate co-funding, if applicable and necessary for completing the trial.
- Plan for submitting regulatory documents to appropriate regulatory authorities, for example, investigational new drug (IND) and Institutional Review Board submissions.
- Listing that includes identification and qualifications of clinical trial sites, pharmacies, and laboratories.
- Table of Contents for the Manual of Operations.
- Comprehensive laboratory plan.
- Data management plan.
- Site quality management plan.
- Learn more in the Questions and Answers for NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required).
Applying
- Follow instructions in the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) notice of funding opportunity.
- Include your prior consultation letter as an Other Attachment.
- Describe all milestones in your Study Timeline. These milestones will be incorporated into your terms of award.
- Describe in sufficient detail all the support services that would be required for successfully implementing the proposed clinical trial. This includes but is not limited to regulatory submission, clinical site monitoring, safety monitoring, and quality management. Conversely, support services do not extend to IND/investigational device exemption-enabling studies for clinical trial interventions with drugs or medical devices that the FDA has not already approved.
- Include a sufficient and appropriate budget to support these activities. Funding depends on several factors, including technical merit, relative program priority, sufficiency of proposed budget, and available funds.
After Award
- NIAID will consider the successful attainment of milestones as part of its ongoing assessment of progress. NIAID retains the option of a periodic external peer review of progress.
- 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. Also read the Extension of Investigator-Initiated Clinical Trials Questions and Answers.
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
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