Investigator-Initiated Clinical Trial (IICT) Awards: General Questions and Answers

Table of Contents

In a nutshell, how does NIAID support IICTs?

Investigators proposing an IICT 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.

How do I know if my research is a clinical trial under NIH’s definition?

Use NIH’s decision wizard, Does your human subjects research study meet the NIH Definition of a clinical trial?.

What is the difference between an IICT R01 and U01?

The U01 requires you include NIAID staff in your research, usually in an oversight or advisory capacity. NIAID uses the U01 whenever your clinical research is considered “high risk”—see How do I determine level of risk and choose an award type for my application?

The R01 is a standard research project grant. If we fund your R01 application, you do not need to include NIAID staff in your research.

If you’re unsure which to choose, apply for the R01 and if NIAID determines your research is high-risk, we will convert your application to a U01. Better yet, raise the question during your prior consultation.

Can a simple sample collection be considered an IICT?

Possibly. To figure out whether your sample collection is considered a clinical trial, answer the questions on NIH’s decision wizard, Does your human subjects research study meet the NIH Definition of a clinical trial?

Do I need to apply for an IICT to conduct a nontherapeutic intervention?

Possibly. To figure out whether your nontherapeutic intervention is considered a clinical trial, answer the questions on NIH’s decision wizard, Does your human subjects research study meet the NIH Definition of a clinical trial?

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 IICT 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 created the IICT process so that we can support a limited number of IICTs outside our existing clinical trial networks. 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.

Principal investigators (PIs) who are ready to conduct a clinical trial can apply directly for one of the following:

Does the IICT process have other benefits to PIs?

Yes. For all clinical trial funding opportunities, program staff may be able to help you access Institute-funded resources, for example, those in existing networks, facilities, and laboratories.

For the U01 and U44, PIs also benefit from the ongoing involvement of NIAID staff.

Must I have permission to apply for IICT planning and implementation awards?

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 an IICT implementation award?

No. The R34 is not a prerequisite.

Can I propose an IICT as only a part of my grant?

Possibly. You may include mechanistic studies in your application.

While still in the planning stage of your application, you should speak to the NIAID point of contact listed in the announcement:

Are there circumstances where an IICT 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 announcement (FOA): a request for applications (RFA), a program announcement, or a solicitation.
  3. Your research might not qualify as a clinical trial as defined by NIH on Clinical Trial Requirements for Grants and Contracts. Use NIH’s Decision Wizard to determine whether your research includes a clinical trial.

In all cases, we highly recommend that you speak to the NIAID point of contact listed on the FOA 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 IICT, 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 on our Scoring and Summary Statements page.

How do I determine level of risk and choose an award type for my application?

NIAID considers your application “high risk” whenever you plan to provide a non-routine intervention—i.e., an intervention that would not otherwise be provided for the study condition in the facility where the trial is being conducted—or you plan to administer an unlicensed product or use a licensed product for an unapproved indication.

If you discuss your plans with the scientific contact listed in one of the FOAs, he or she can advise you on award type. Choose which award type to apply for based on level of risk.

The NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) supports high-risk clinical trials as described in the FOA.

For studies that are not high risk, applicants apply for the NIH Research Project Grant (Parent R01, Clinical Trial Required) or NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required).

The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) award encourages high-risk clinical studies, though applicants may also propose studies that are not considered high risk.

Additionally, NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01 or convert your award to a U01 after award.

Does the IICT process apply to RFAs or other solicitations?

No. It is only for investigator-initiated applications.

What types of institutions are eligible to apply for an IICT?

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

How does the IICT process apply to small business applicants?

For the clinical trial part of your research, small businesses must use the IICT FOAs:

With the exception of the U44, you cannot apply for support for an NIAID IICT 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 independent clinical trial process affect career development (K) awards at NIAID?

Yes. NIAID supports investigator-initiated independent clinical trials under the NIAID Physician Scientist Pathway to Independence Award K99/R00.  This allows applicants to apply for independent support of a clinical trial using the clinical trial required FOA (PAR-18-679); otherwise applicants must use the nonclinical trial FOA (PAR-17-329). Failure to use the correct FOA under this program will result in a withdrawn application.

All other K awards (K01, K08, K22, K23, K24, K25, and Parent K99/R00) that NIAID supports do not allow applicants to conduct an investigator-initiated independent clinical trial. This does not mean that these K applicants cannot conduct clinical trial research (gaining clinical trial research experience is a good), but cannot propose an independent clinical trial as the lead PI on these K programs and must do any proposed clinical trial research under the mentor's guidance; where the mentor leads the clinical trial.

This is the clinical trial process for K awards at NIAID, there may be different rules at other NIH ICs. Read the FOAs to be sure.

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

First, check NIH’s Decision Wizard to determine whether your research includes a clinical trial according to NIH’s definition.

Then, speak to the NIAID point of contact listed on the FOA to confirm.

If your study does not meet the NIH definition of a clinical trial, this IICT process does not apply.

Who will peer review the IICT planning and implementation award applications?

NIAID special emphasis panels will peer review R34, U01, and U44 applications. CSR will review R01 and R21 applications.

Who will hold the investigational new drug (IND) application 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. The final decision whether NIAID will hold the IND is with NIAID.

When can I submit my application?

Refer to the Key Dates section of the relevant FOA:

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

Email deaweb@niaid.nih.gov 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.

Content last reviewed on March 22, 2018