46 - Check It Out: Building a Consent Form Language Library

Background: : Informed consent is essential for the ethical conduct of clinical research. Informed consent forms (ICFs) must be accurate and understandable to ensure regulatory compliance and participant protection. Institutions should utilize resource documents for those drafting or revising ICFs to maintain consistency in style and participant-friendly language across ICFs.

Program

Description: : The Protocol Activation & Review and Human Research Protection Program at a cancer treatment and research institution is a centralized unit focused on activation and participant protection. The Protocol Activation Core (PAC) within the unit manages the activation of protocols and associated ICFs.

-PAC has 15 Study Start-up Managers (SSUMs) who draft ICFs and an Editorial team of 3 who review the initial draft and all revisions (investigator, sponsor, and IRB revisions).

-The institution has longstanding resource documents for drafting/revising ICFs, including ICF templates and an ICF instructions document that includes language for populating sections.

-In 2018, PAC created a Consent Library (CL) to collect participant-friendly language used in ICFs approved by the institutions IRB. Early versions included sections for risk, drug mechanism of action, and procedure descriptions. Over time, PAC has expanded existing sections and created new ones (e.g., language for radiology studies). The CL has become an essential resource supporting consistency and readability across ICFs.

Program

Assessment: : The risks section of the CL is the most robust section, currently providing over 1000 definitions/explanations of risks. To evaluate the effectiveness of this section, members of the unit analyzed a sample of 60 institutional IRB/Privacy Board (PB) initial review determination letters, focusing on comments related to risk language in the ICF.

-Thirty letters were from a period when PAC relied on early, less extensive versions of the CL for drafting/revising ICFs (2019-2020), and 30 were from a period when PAC relied on more current versions (2024-2025). All ICFs were associated with therapeutic studies for which the institution was the IRB of Record.

-We identified IRB/PB comments that could have been avoided by using risk definitions/explanations available in the most current version of the CL, such as comments requesting the ICF include the signs or symptoms of a lab test result.

We found a significant reduction in comments in the period when PAC relied on more current versions of the CL. Our analysis showed a two-fold decrease in the percentage of ICFs with comments.

[TABLE/TIMELINE GRAPHIC]

Limitations:: -The CL was created as an internal resource within PAC. Study teams managing ICFs after studies are open to accrual currently do not have access for amendment-related ICF revisions.

-ICFs sent to an external IRB of Record require only certain standard institutional language (e.g., injury and privacy sections). PAC generally does not add CL language to these forms. Some language (including risk language) is not consistent with language in ICFs reviewed by the institutions IRB.

Discussion: : Fully informed participants are vital for successful research studies that advance science. Understandable and accurate ICFs enhance the informed consent process and aid in participant retention.

ICF resources such as the CL are crucial for ensuring regulatory compliance, efficient ICF drafting, and consistency in style and understandable language across ICFs.

PAC will continue to improve the CL, performing regularly scheduled reviews of existing language and adding more entries and specialized language (e.g., language for psychiatry and behavioral health studies).

The CL may become available to intuition teams outside of PAC.