See the Glossary for more terms.
Table of Contents
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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) or cooperative agreement (U01).
Examples of activities supported by the R34 are:
It cannot be used to prospectively gather preliminary data to support the rationale for a clinical trial.
No. However, you must have ready all the documentation you would have prepared during an R34 clinical trial planning grant.
Yes. NIAID program staff may be able to provide or direct you to information that can help you prepare your clinical trial documentation.
Most institutions are eligible, whether academic, for-profit, nonprofit, domestic or foreign. Read more in the NIAID Clinical Trial Planning Grant (R34) Guide announcement.
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.
Yes, in one of these three situations:
In any case, you should speak to the NIAID point of contact listed in the NIAID Clinical Trial Planning Grant (R34) Guide announcement to confirm.
Go to Investigator-Initiated Clinical Trials and Agency Contacts listed in the NIAID Clinical Trial Planning Grant (R34) Guide announcement.
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.
We recommend that you follow these steps:
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.
Yes, the limit is five pages.
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.
NIAID will provide a prior consultation summary letter within six weeks after the consultation.
No. The letter of intent is optional. See your funding opportunity announcement for deadlines and instructions.
You may request up to $150,000 in direct costs for up to one year of support.
No, you may submit more than one application provided each is scientifically distinct.
No, each R34 application will support planning for one clinical trial.
Go to these NIAID resources:
Contact the appropriate NIAID point of contact in the NIAID Clinical Trial Planning Grant (R34) Guide announcement for division-specific procedures.
Prepare your application using the SF 424 Grant Application Package. Read the NIAID Clinical Trial Planning Grant (R34) Guide announcement for details.
Attach a copy in the PHS 398 Cover Letter File of the grant application package.
Your Research Plan is limited to one page for the Specific Aims, 12 pages for 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:
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.
Yes, if you follow procedures for a multiple PI application.
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?
Follow the instructions in the SF 424 Application Guide and the NIAID Clinical Trial Planning Grant (R34) 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.
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 PHS 398 Modular 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.
Apply electronically using the NIAID Clinical Trial Planning Grant (R34) Guide announcement. Find general information about electronic application in our Applying for a Grant Questions and Answers.
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) Guide announcement.
No. Check the "No" button in the human subjects section of the PHS 398 Cover Page Supplement.
NIAID's special emphasis panels will peer review it.
Yes, below are the factors added to the standard review criteria.
Significance. Is the need to perform a future trial adequately justified? 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?
Innovation. Nothing added.
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?
Environment. Nothing added.
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. To resubmit, follow the suggested format in the electronic grant application package.
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.
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.
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Last Updated May 23, 2016
Last Reviewed July 01, 2015