Investigator-Initiated Clinical Trial R34 Planning Grants Questions and Answers

Table of Contents

R34 General Information

Planning the Application

Writing the Application

Applying and After

R34 General Information

What is an R34 planning grant?

An NIAID Clinical Trial Planning Grant (R34) provides PIs with funds to prepare 1) materials NIAID needs to determine a project's feasibility and 2) documentation required for applying for an NIAID clinical trial implementation grant (R01), cooperative agreement (U01), or SBIR Phase II award (U44).

Examples of activities supported by the R34 are:

  • Establishing a research team.
  • Identifying collaborators and enrollment sites.
  • Designing the study.
  • Developing milestones.
  • Developing the complete clinical protocol.
  • Developing plans for data and safety monitoring, statistical analysis, data management, and data sharing.
  • Creating the informed consent and assent form, if applicable.
  • Developing the investigator's brochure and manual of operations.
  • Writing a description of recruitment strategies.
  • Developing a plan to acquire and administer study agents.
  • Obtaining Office of Human Research Protections assurances.
  • Preparing agreements and arrangements.
  • Determining whether the trial will be conducted under an IND or IDE and who will hold it.
  • Preparing the package to submit to regulatory authorities.
  • Developing a detailed budget for the clinical trial including preparation of a final study report.
  • Developing training materials and training plans for study staff.

Is there anything an R34 planning grant cannot support?

It cannot be used to prospectively gather preliminary data to support the rationale for a clinical trial.

Does getting an R34 planning grant guarantee that I will be funded under an R01, U01, or U44 application?

No.

Is an R34 required before I may request prior consultation to discuss submission of an R01, UO1, or U44 application?

No. However, you must have ready all the documentation you would have prepared during an R34 clinical trial planning grant.

Can I benefit from NIAID resources?

Yes. NIAID program staff may be able to provide or direct you to information that can help you prepare your clinical trial documentation.

How do I know if I'm eligible for an R34 planning grant?

Most institutions are eligible, whether academic, for-profit, nonprofit, domestic or foreign. Read more in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement.

Will NIAID's clinical terms of award apply to my R34 planning grant?

No. However, you may find the NIAID Clinical Terms of Award helpful for developing the documentation needed for a later R01 or U01 clinical trial application.

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

Yes, in one of these three 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 under NIH’s Definition of a Clinical Trial.

In any case, you should speak to the NIAID point of contact listed in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement to confirm.

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

Go to Investigator-Initiated Clinical Trials and Agency Contacts listed in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement.

Planning the Application

Must I have permission to submit an R34 application?

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.

How do I start the process for an R34 planning grant application?

We recommend that you follow these steps:

  1. Prepare for a discussion.
  2. Call or email. At least 10 weeks before the application due date, call or email the program officer listed in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement to discuss your research idea and get advice.
    • Allow enough time. We strongly recommend that you request prior consultation as soon as possible—it may take six weeks for us to respond.
  3. Prepare request. Within two weeks of your prior consultation (a minimum of eight weeks before the receipt date) do the following:
    • Send all information your program officer requested from you.
    • Allow six weeks for Institute response.

See Requesting Prior Consultation to Discuss Submission of a Clinical Trial Planning (R34) or Implementation (R01 or U01) Application and the questions below for details.

Is there a page limit for the prior consultation package?

Yes, the limit is five pages.

How do I get documentation of my prior consultation for an R34 planning grant?

A program officer will send you a letter signed by the NIAID division director that summarizes the prior consultation, which you will include with your R34 application.

Do I need to include a letter of intent?

No. The letter of intent is optional. See your funding opportunity announcement for deadlines and instructions.

How much time and money can I request for an R34 planning grant?

You may request up to $150,000 in direct costs for up to one year of support.

Is there a limit to the number of R34 planning grant applications I can submit?

No, you may submit more than one application provided each is scientifically distinct.

Can I propose more than one clinical trial in my application?

No, each R34 application will support planning for one clinical trial.

Writing the Application

Where can I find resources for writing my application?

Go to these NIAID resources:

Contact the appropriate NIAID point of contact in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement for division-specific procedures.

How do I prepare my R34 planning grant application?

Prepare your application using the SF 424 grant application. Read the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement for details.

How do I include the prior consultation summary letter in my R34 application?

Attach a copy in the SF424 (R&R) Cover form of the Grant Application.

What is the page limit for my Research Plan?

Your Research Plan is limited to one page for the Specific Aims, 12 pages for the Research Strategy.

What should I address in the Research Strategy?

The following three sections comprise the Research Strategy: Significance, Innovation, and Approach. Your Research Strategy may not exceed 12 pages and must include:

  • A discussion of the significance of the problem being studied, the need for the trial, and the potential impact of the results of the trial, as well as how the trial will test the hypotheses proposed;
  • A concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the trial;
  • Sufficient details of the clinical trial (e.g. study design, primary objective, inclusion and exclusion criteria, proposed study population, proposed study agent(s), preliminary sample size, clinical end points, duration of recruitment and follow-up, etc.) to allow  assessment of the likelihood that a feasible clinical trial will be developed;
  • A description of the potential problems, alternative strategies, and benchmarks for success of the planning period and future trial;
  • A description of how the planning period will be used and descriptions of the activities to be carried out during the planning period, including participants in the planning process and their roles;
  • Information about how the clinical trial documents will be developed; and
  • A description of how the trial will be organized and managed, including the plans to identify and select additional collaborators, if applicable.

How do I comply with requirements for human subjects?

Although your planning grant will not involve human subjects, your application must describe the availability and attributes of the study population and plans for recruitment, outreach, and follow-up. 

Also describe plans to address ethical and safety issues and any challenges you anticipate to adherence to the protocol.

Do I need resource sharing plans?

No.

Can the application have more than one principal investigator?

Yes, if you follow procedures for a multiple PI application. Read more at Multiple Principal Investigators.

Should I prepare a detailed or modular budget?

Prepare a modular budget if you are applying from a single domestic institution.

Prepare a detailed budget if you are applying from a foreign institution or your application involves multiple institutions—see How do I prepare an application that involves multiple institutions?

What should I include in the Appendix?

Follow the instructions in the SF 424 Application Guide and the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement. Don't put anything in the Appendix that belongs in the Research Strategy to circumvent the page limits; if you do, the review of your application may be delayed.

How do I prepare an application that involves multiple institutions?

If you propose research at multiple institutions, designate one institution as the prime institution and the other as a subcontract (subaward) to be administered by the prime institution.

If you are preparing a modular budget, submit the budget component for the prime institution only; do not include separate budgets for subawards.  Provide information on the subaward's budget in the budget justification.

If you are preparing a detailed budget, the prime institution submits the Research & Related Budget component. Attach the individual budgets for the subawards separately to the Research & Related Subaward Budget Attachment Form. 

Follow the Grant Application Guide for further instructions.

Applying and After

How do I submit my R34 planning grant application?

Apply electronically using the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement. Find general information about electronic application in our Applying for a Grant.

When can I submit my R34 application?

For both AIDS and non-AIDS applications, you may submit in September, January, and May. For specific dates, see the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement.

Should I check the box that human subjects are involved?

No. Check the "No" button in the human subjects section of the PHS 398 Cover Page Supplement.

Who will peer review my R34 application?

NIAID's special emphasis panels will peer review it.

Does the R34 planning grant have specific review criteria?

Yes, but only for the Significance, Investigator(s), and Approach review criteria. In addition to the standard review criteria, reviewers will assess the following factors:

Significance. If mechanistic studies are proposed, are they appropriate and will they provide important scientific information? Are the study objectives and hypotheses adequately defined?

Investigator(s). Is there adequate expertise and ability of the investigator and the clinical trial team to develop, organize, manage, and execute the proposed trial?

Approach. Are there sufficient preliminary data and justified rationale to support the clinical trial? Are the activities proposed for the planning phase appropriate and adequately described for timely and successful trial implementation? Do the proposed planning activities address all major barriers to the future clinical trial? Are there adequate plans for the development of an effective organizational structure for carrying out the proposed trial?

Can I resubmit my R34 application?

Yes, one time. Before resubmitting a revised application, we strongly suggest that you repeat the prior consultation process with NIAID.

Use the results from the previous review to strengthen your project.

Will I be able to renew my grant?

No.

If I can't complete a clinical trial within the performance period of my R34, can I apply for an extension?

You may be able to apply for an extension. You can also take a no-cost extension—read more in the No-Cost Extension SOP.

Also see our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Investigator-Initiated Clinical Trial Administrative Extensions Questions and Answers.

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

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.

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