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Investigator-Initiated Clinical Trial Awards—General Questions and Answers

Table of Contents

In a nutshell, how is NIAID supporting investigator-initiated clinical trials?

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.

Where can I find more information about clinical trial planning and implementation awards?

Go to Investigator-Initiated Clinical Trial Resources and contact staff listed in the Guide notices.

Why does NIAID have an investigator-initiated clinical trial process?

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.

Does the investigator-initiated clinical trial process have other benefits to PIs?

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.

What are the main differences between NIAID's former and new policies for investigator-initiated clinical trials?

There are two main differences between the old policy and the new one:

  • For investigators who are ready to begin a clinical trial, the clinical trial planning grant (R34) is optional rather than required.
  • For the implementation phase, NIAID is now supporting these award types: a milestone-driven R01, an extended milestone-driven R01, or a cooperative agreement (U01) depending on the level of risk to trial participants.

See How do I determine whether to apply for an R01 implementation grant or U01 implementation cooperative agreement? for a definition of risk.

Must I have permission to apply for an R34, R01, or U01?

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.

Do I need the R34 before I apply for the R01 or U01?

No. The R34 is not a prerequisite.

Can I propose an investigator-initiated clinical trial as only a part of my grant?

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:

Are there circumstances where an investigator-initiated clinical trial is not required or appropriate?

Yes, in one of these situations:

  1. Your research might fit better into our existing clinical trial infrastructure.
  2. Your research is more appropriate for a different funding opportunity: a request for applications, a program announcement, or a solicitation.
  3. Your research might not qualify as a clinical trial as defined by NIH. The process would usually not be required for clinical studies that:
    • Evaluate a diagnostic test unless the results of the studies will be used to:
    • Evaluate subjects undergoing a procedure or receiving a vaccine, drug, or biologic as part of clinical care and involve collecting additional samples that do not pose more than minimal additional risk to the subject.

In all cases, we highly recommend that you speak to the NIAID point of contact listed on the Guide notice to confirm.

How does the NIAID prior consultation process differ from peer review?

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.

How do I determine whether to apply for an R01 implementation grant or U01 implementation cooperative agreement?

The R01 clinical trial implementation grants are for projects that are not high risk, which we define as follows:

  • The investigators plan to provide a routine intervention, i.e., an intervention that would normally be provided for the study condition in the facility where the trial is being conducted.
  • The investigators plan to administer a licensed product for an approved indication.

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:

Does the investigator-initiated clinical trial process apply to requests for applications or other solicitations?

No. It is only for investigator-initiated applications.

What types of institutions are eligible to apply for an investigator-initiated clinical trial?

Most institutions are eligible, whether academic, for-profit, non-profit, domestic or foreign. Read more in the relevant Guide announcement.

How does the investigator-initiated clinical trial process apply to small business applicants?

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.

Does the investigator-initiated clinical trial process affect career development awards?

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.

What should I do if my research does not meet the NIH definition of a clinical trial?

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.

Who will peer review the R34, R01, and U01 applications?

NIAID special emphasis panels will peer review all three award types.

Who will hold the IND for my clinical trial?

If the trial requires an IND, NIAID can hold it. Other arrangements are possible; discuss them with the appropriate NIAID program staff.

When can I submit my application?

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.

If NIAID determines that my application is nonresponsive, can I send it to NIH as an investigator-initiated application?

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.

What if my question wasn't answered here, or I'd like to suggest a question?

Email with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.

Last Updated February 18, 2015

Last Reviewed September 16, 2014