See the Glossary for more terms.
Table of Contents
Investigators proposing an investigator-initiated clinical trial must go through a defined process for any of the award types listed below.
We strongly encourage you to request a prior consultation with NIAID staff at least 10 weeks before you apply for any of these awards 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 either an R01 implementation grant or a U01 implementation cooperative agreement.
Yes. For the U01, PIs benefit from the ongoing involvement of NIAID staff.
For both the R01 and U01, program staff may be able to help you access Institute-funded resources, for example, those in existing networks, facilities, and laboratories.
There are two main differences between the old policy and the new one:
See How do I determine whether to apply for an R01 implementation grant or U01 implementation cooperative agreement? for a definition of risk.
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 R01 or U01 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.
The R01 clinical trial implementation grants are for projects that are not high risk, which we define as follows:
For studies that do not meet this definition—are high risk—applicants apply for a clinical trial implementation U01.
For more information, read the funding opportunity announcements:
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, you must go through the NIAID investigator-initiated clinical trial process and apply for an R34, R01, or U01; small businesses are eligible for all three awards. With the exception of the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (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 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 three 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 listed at Investigator-Initiated Clinical Trial Resources.
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 February 18, 2015
Last Reviewed September 16, 2014