Atom | NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed)

Funder: National Institutes of Health

Due Dates: May 13, 2025 (New, Renewal, Resubmission, Revision, AIDS) | September 15, 2025 (New, Renewal, Resubmission, Revision, AIDS)

Funding Amounts: Up to $150,000 direct costs for a maximum project period of 1 year per award.

Summary: Supports planning, design, and documentation activities necessary to prepare for high-priority, investigator-initiated clinical trials aligned with NIAID’s mission; clinical trial implementation is not allowed.

Key Information: Consultation with NIAID staff at least 10 weeks before the deadline is strongly encouraged; applications proposing actual clinical trials are not allowed.

Description

This opportunity from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, provides support for the planning, design, and preparation of documentation required to implement investigator-initiated clinical trials. The grant is intended for hypothesis-driven, milestone-defined trials that are considered high-priority by NIAID and align with its research mission, which includes infectious, immunologic, and allergic diseases.

The grant does not support the conduct of clinical trials themselves, but rather the preparatory work needed to ensure a future trial is feasible, well-designed, and ready for implementation. This includes activities such as protocol development, statistical analysis planning, regulatory documentation, and site selection.

Due Dates

May 13, 2025: New, Renewal, Resubmission, Revision, and AIDS applications
September 15, 2025: New, Renewal, Resubmission, Revision, and AIDS applications
Letters of Intent: 30 days prior to each application due date (April 13, 2025 and August 15, 2025, respectively)

All applications are due by 5:00 PM local time of the applicant organization.

Funding Amount

Direct Costs: Up to $150,000 per award
Project Period: Maximum of 1 year
Number of Awards: Contingent on NIH appropriations and the number of meritorious applications

Eligibility

Eligible organizations include:

Public/State and Private Institutions of Higher Education
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Native American tribal governments (federally recognized and other)
Faith-based and community-based organizations
Regional organizations
U.S. territories and possessions
Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations

Eligible Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s).

Application Process

Letter of Intent: Strongly encouraged, due 30 days before the application deadline. Should include project title, PI(s), key personnel, institutions, and the funding opportunity number/title. Email to the designated NIAID contact.
Consultation: Strongly encouraged to consult with NIAID staff at least 10 weeks before the application deadline to ensure alignment with NIAID priorities and clarify documentation requirements.
Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required Registrations: Applicant organizations must be registered with SAM, eRA Commons, and Grants.gov. All PDs/PIs must have an eRA Commons account.
Application Instructions: Follow the SF424 (R&R) Application Guide and the specific instructions in the funding announcement.

Additional Information

Scope: Supports planning activities for a single, future clinical trial only. Activities may include protocol development, statistical and data management plans, regulatory strategy, site selection, budget planning, and training materials.
Not Supported: Actual conduct of a clinical trial, collection of new clinical or pre-clinical data, or investigational product development.
Data Management and Sharing: All applications must include a Data Management and Sharing Plan.
Review Criteria: Applications are evaluated for significance, investigator(s), innovation, approach, and environment, as well as alignment with NIAID priorities.
Resubmissions: Allowed, but duplicate or highly overlapping applications will not be accepted.

External Links

Contact Information

Area	Contact	Email	Phone
General Grants Info	NIH Grants Information	GrantsInfo@nih.gov	301-480-7075
Scientific/Research (DMID)	DMID IICT Central Contact Mailbox	NIAID_DMID_IICT@niaid.nih.gov
Scientific/Research (DAIT)	Ellen Goldmuntz, M.D.	egoldmuntz@niaid.nih.gov	240-627-3502
Scientific/Research (DAIDS)	Martin Gutierrez	mgutierrez@niaid.nih.gov	240-292-4844
Peer Review	Louis Rosenthal, Ph.D.	louis.rosenthal@nih.gov	240-669-5070
Grants Management	Regina Kitsoulis	regina.kitsoulis@nih.gov	240-669-2946
eRA Service Desk			301-402-7469 or 866-504-9552
Grants.gov Support		support@grants.gov	800-518-4726

For additional contacts and details, see Section VII. Agency Contacts in the full announcement.