See the Glossary for more terms.
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Investigators proposing an investigator-initiated clinical trial must go through a defined process for any of these award types:
If you need a planning phase, you may apply for a Clinical Trial Planning Grant (R34). If you're ready to begin a clinical trial, see How do I determine level of risk and choose an award type for my application?
We strongly encourage you to request a prior consultation with NIAID staff at least 10 weeks before you apply and include NIAID's summary of the consultation with your application. Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.
Go to Investigator-Initiated Clinical Trial Resources and contact staff listed in the Guide notices.
NIAID has an extensive infrastructure of networks and programs to support clinical trials, and we will not fund investigator-initiated research that overlaps with work funded through our infrastructure.
We support a limited number of investigator-initiated clinical trials. Consulting with NIAID in advance ensures that investigators do not waste their time preparing applications that we cannot consider for funding.
The process also helps investigators by enabling them to delineate the detailed plans, processes, and documentation needed to conduct a clinical trial.
Investigators who are ready to conduct a clinical trial can apply directly for one of the following:
Yes. For the U01 and U44, PIs benefit from the ongoing involvement of NIAID staff.
For all the funding opportunities, program staff may be able to help you access Institute-funded resources, for example, those in existing networks, facilities, and laboratories.
No. However, we do strongly encourage you to request a prior consultation with NIAID staff. Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.
No. The R34 is not a prerequisite.
Possibly. While still in the planning stage of your application, you should speak to the NIAID point of contact listed in the announcement:
Yes, in one of these situations:
In all cases, we highly recommend that you speak to the NIAID point of contact listed on the Guide notice to confirm.
We discuss whether your proposed research meets NIAID's scientific priorities and should be supported with existing funds, but we do not discuss technical or scientific merit.
In contrast, as an investigator-initiated clinical trial, initial peer review assesses an application's scientific and technical merit using the initial peer review criteria stated in the Guide notice and assigns an overall impact score. For more information, see How NIH Review Criteria Affect Your Score in the Strategy for NIH Funding.
If you discuss your plans with the scientific contact listed in one of the funding opportunity announcements, he or she can advise you on award type. Choose which award type to apply for based on level of risk.
The Clinical Trial Implementation Cooperative Agreement (U01) supports high-risk clinical trials as described in the funding opportunity announcement.
For studies that are not high risk, applicants apply for the Clinical Trial Implementation Grant (R01).
The SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) award encourages high-risk clinical studies, though applicants may also propose studies that are not considered high risk.
(NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01.)
No. It is only for investigator-initiated applications.
Most institutions are eligible, whether academic, for-profit, non-profit, domestic or foreign. Read more in the relevant Guide announcement.
For the clinical trial part of your research, small businesses must use the NIAID investigator-initiated clinical trial funding opportunities:
With the exception of the U44, you cannot apply for support for an NIAID investigator-initiated clinical trial through a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) application at this time.
For the other parts of your research, you can apply for an SBIR or STTR grant. To learn more about small business awards, visit our Small Business Awards questions and answers.
Yes. NIAID does not support independent clinical trials under career development awards. You may use career development award funds for training and career development only.
If you want to conduct a clinical trial under a career development award, it must be supported with other resources.
If your study does not meet the NIH definition of a clinical trial, this process does not apply. Speak to the NIAID point of contact listed on the Guide notice to confirm.
NIAID special emphasis panels will peer review all award types.
If the trial requires an IND, NIAID can hold it. Other arrangements are possible; discuss them with the appropriate NIAID program staff.
For both AIDS and non-AIDS applications, you may submit in September, January, and May. For specific dates, see the relevant Guide notice:
NIAID will not peer review or fund any investigator-initiated clinical trial application that is nonresponsive. We encourage you to contact other NIH institutes to see if they might accept your application.
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Last Updated January 25, 2016
Last Reviewed September 25, 2015