NOT-OD-26-058: Inviting Input on a Proposed Clinical Trial Specific Application Form for the NIH

Key Dates

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

The National Institutes of Health (NIH) seeks public input on a Proposed Clinical Trial Specific Application Form designed to streamline investigator-initiated clinical trial applications. Specifically, NIH proposes to combine components of the current Research Plan in clinical trial applications and the PHS Human Subjects and Clinical Trials Information Form into a single, consolidated form. By requiring a semi-structured application specifically designed for clinical trials, NIH aims to (1) simplify the application process for investigators and (2) improve the availability of critical information needed for the review of clinical trials.

Background

In 2025, NIH convened an internal working group composed of leaders with expertise in human subjects research and clinical trials to address persistent challenges in how clinical trials information is presented and reviewed in NIH grant applications. The working group examined longstanding concerns about inefficiencies stemming from redundancies, variability, and dispersion of required clinical trial information across multiple application components. Collectively, these challenges can obscure critical elements of trial design and conduct, increase administrative burden for applicants, and complicate the peer review process.

To better understand these issues, the working group conducted a comprehensive review of existing NIH clinical trial grant applications and widely accepted clinical trial reporting standards (e.g., CONSORT, SPIRIT), as well as relevant intramural research protocols. Based on this assessment, the working group concluded that a single, standardized clinical trial specific application form—employing a semi-structured yet flexible format—could substantially improve the clarity, consistency, and efficiency of clinical trial applications. Accordingly, the working group developed a prototype Proposed Clinical Trial Specific Application Form that integrates essential clinical trial elements currently distributed across the Research Plan in clinical trial applications and the PHS Human Subjects and Clinical Trials Information Form.

The proposed form is designed to clarify expectations for investigators, reduce redundancy, and streamline application preparation by consolidating required clinical trial information into a cohesive, organized format. Its semi-structured design is intended to accommodate a wide range of clinical trial designs, intervention types, and scientific approaches, while preserving investigators’ ability to provide study-specific details critical to understanding the proposed research. By ensuring that core clinical trial elements are presented in a clear and consistent manner, this approach has the potential to enhance the efficiency, rigor, and transparency of peer review.

Information Requested

NIH invites input on the Proposed Clinical Trial Specific Application Form (Table 1 below) from clinical trials investigators, peer reviewers, and others involved in the design, conduct, oversight, or review of NIH-supported clinical trials. Respondents are encouraged to comment on any or all of the following topics:

• Anticipated level of effort associated with the proposed form, including the estimated number of hours added to or reduced from the application process.
• Completeness of the proposed form, including any missing essential elements or additional items that would be informative.
• Conciseness of the proposed form, including elements that could be eliminated or combined.
• Proposed form structure, including page limits and the distribution of content across sections.
• Applicability of the proposed form for the entire range of clinical trial designs and interventions.
• Implications for investigators and/or research teams, including potential benefits, challenges, and/or barriers to using the proposed form.
• Implications for peer review, including potential benefits or challenges, and impacts on efficiency, quality, and consistency of review.
• Implications for institutional grants offices and research administration workflows.
• Suggested details to include in the proposed form instructional text (not included here; to be developed) that will define required application elements.
• Any additional suggestions or considerations.

Proposed Form

The Proposed Clinical Trial–Specific Application Form (Table 1) consolidates required clinical trials information –- excluding the full protocol –- into a single, semi-structured format with defined sections. Required information that is currently distributed across the Research Plan and the PHS Human Subjects and Clinical Trials Information Form would be reorganized into sections aligned with peer review criteria and key aspects of clinical trial design, conduct, and oversight.

Each section of the form will be accompanied by instructions (not included here; to be developed) that define required elements and specify the recommended level of detail. These instructions will aim to promote consistent formatting, minimize duplication across sections, and facilitate efficient review by clearly identifying core clinical trials components.

The proposed form has an overall limit of 23 pages with section-specific limits designed to balance completeness and conciseness. Table 3 outlines the proposed structure, required elements, and page limits.

See Notice for further information.

Submitting a Response:  To ensure consideration, comments must be submitted electronically to https://rfi.grants.nih.gov/?s=6998c6f85af314d3d80c0b72  by April 17, 2026.