P221: Demystifying Legal Language: Co-Creating Clear Data Privacy and Withdrawal Language for Informed Consent
Poster Presenter
Kristi Malone
Lay Language & New Media Medical Writer
Boehringer Ingelheim United States
Objectives
To incorporate patient perspectives to simplify legal language (specifically data privacy and withdrawal information) in informed consent form (ICF) content to improve participant understanding and trust
Method
We gathered pre-meeting feedback and conducted workshops with international advisory boards that included patients, experts, and health care professionals. Participants gave input on existing ICF legal text, a data privacy graphic, and plain language alternatives for ~20 legal terms.
Results
Participants described legal language in ICFs as overwhelming, confusing, and anxiety-inducing, with word cloud associations of “complex,” “obscure,” “jargon,” “risk,” and “intimidating.” Baseline confidence in understanding withdrawal and data privacy concepts was moderate (3.6/5, 1 = poor understanding, 5 = strong understanding). Before the workshop, participants showed inconsistent or incomplete understanding of data coding, data-retention timelines (e.g., what happens after 30 years), and the difference between full withdrawal and stopping study treatment.
During the workshop, participants evaluated a data privacy figure and reviewed ICF text on data flow, coding, identity protection, and withdrawal options. They selected preferred plain language alternatives for ~20 legal terms (e.g., “coded data,” “processing,” “retention,” “identifiable information”) and suggested options when needed. They emphasized simple, culturally adaptable wording; concrete examples; intuitive visuals, and clear explanations of why collected data may be used after withdrawal.
Expert and patient feedback highlighted that GDPR-driven wording is increasingly complex and poorly translated into patient-centered language, with regional terminology differences adding challenges. Recommendations included reducing abstract terms and clarifying coding differences and data retention and destruction in clear, direct language.
Using this feedback, we redesigned the data privacy figure to read left-to-right, added arrows to illustrate data flow, clarified terminology (e.g., replacing names with study numbers), and added recognizable symbols (such as padlocks). Participants found the revised graphic significantly easier to understand.
Following a teach-back exercise, understanding scores improved (4.2/5). Participants more accurately identified the meaning of coded data, the fate of data after 30 years, and the implications of full withdrawal. They reported feeling more “connected,” “inspired,
Conclusion
Participant feedback revealed substantial gaps between regulatory-mandated legal language and participant comprehension in informed consent materials. By integrating advisory board insights, expert review, and teach-back methodology, we created clearer, more intuitive explanations of data privacy and withdrawal, topics known to be complex due to evolving global privacy laws such as GDPR.
The revised text and graphics improved participants’ understanding, reduced perceived complexity, and increased confidence in their ability to make informed decisions. The legal terms preference exercise further illustrates how collaborative plain language development can simplify terminology while preserving regulatory accuracy.
This work demonstrates a scalable, evidence-based approach for modernizing informed consent materials. Embedding patient co-creation for legal language design enhances transparency, strengthens trust, and supports ethical, participant-centered clinical research.
