The "NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed)" is a funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) under the National Institutes of Health (NIH). This program supports the planning and design of clinical trials that align with NIAID's research mission. However, it does not fund the actual implementation of trials. The grant is designed to assist investigators in preparing necessary documents and plans for future clinical trials, focusing on trials that are hypothesis-driven and meet high-priority research areas within the NIAID's scope. A key objective of this grant is to ensure the preparedness of trial proposals by developing detailed protocols, regulatory documentation, and other essential planning components.

The grant supports activities related to forming a research team, identifying collaborators and sites for enrollment, finalizing study design, and developing the clinical protocol and other required documents. Specific activities funded include drafting statistical and data management plans, preparing consent forms, and ensuring compliance with regulatory requirements such as Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, if needed. Importantly, this grant also covers the development of a detailed budget and data management plans, ensuring that the proposed clinical trial can be effectively organized and managed upon future implementation.

The maximum project period for this grant is one year, with a budget cap of $150,000 in direct costs. The number of awards will depend on the NIH's budget and the number of meritorious applications submitted. The planning grant does not guarantee funding for the clinical trial itself, but it is intended to prepare applicants for subsequent applications for implementation grants such as R01, U01, or U44 mechanisms.

Eligible applicants for this funding include higher education institutions, nonprofits, for-profit organizations (including small businesses), government entities, and foreign institutions. The opportunity is open to institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, and Tribally Controlled Colleges and Universities (TCCUs), among others. Researchers from diverse backgrounds, including women and individuals from underrepresented groups, are encouraged to apply. All potential applicants must complete necessary registrations, including with the System for Award Management (SAM), eRA Commons, and Grants.gov, well in advance of the submission deadlines.

The application process involves submitting a letter of intent 30 days prior to the application deadline, although this step is not mandatory. Application submissions are accepted through several platforms, including NIH's ASSIST system, institutional system-to-system solutions, or Grants.gov Workspace. It is crucial that applicants adhere strictly to the SF424 (R&R) Application Guide and any specific instructions outlined in the Notice of Funding Opportunity (NOFO) to avoid delays or rejection during the review process.

Review criteria for applications include the significance of the proposed trial, the qualifications of the research team, the innovation of the approach, and the feasibility of planning and executing the trial within the proposed timeframe. Additional considerations include the protection of human subjects, inclusion of diverse populations, and adherence to data sharing policies.

Key dates for submission and review include a rolling set of deadlines, with the earliest submission date being August 13, 2023, and the opportunity expiring on May 14, 2026. Applicants should pay attention to the specific deadlines for AIDS-related applications, as these differ slightly from general submission timelines.