Advancing Patient-Centered Informed Consent in Clinical Research

Published in Summer 2025 issue of International Clinical Trials –
Page 48: View Publication

Authors
Behtash Bahador, MS, Boston, MA
Matt Chapman, Portland, OR

Abstract
Despite longstanding requirements and general consensus that clinical trial informed consent forms (ICFs) are typically complex and difficult for potential participants to understand, broad adoption of existing practices to remedy the situation remains to be seen. This article explores the renewed regulatory focus on participant comprehension and outlines best practices for improving ICFs through plain language, thoughtful design, and patient and public involvement. It also examines operational strategies for research sponsors, including pilot projects, template development, and the use of supplemental tools like ICF information guides and infographics. By aligning regulatory expectations with communication science and patient engagement, sponsors can enhance prospective and active study participant understanding, build trust, and improve trial outcomes.

International Clinical Trials. 2025:48–52. www.calameo.com/read/006113385fbe5e2addc8c?page=48

Key Takeaways:

1.

Comprehension Is the New Compliance Standard

Regulatory bodies like the ICH, FDA, EU, and NHS are shifting focus from merely meeting informed consent requirements to ensuring true participant comprehension. Updated guidelines emphasize the use of plain language, non-technical terms, and visual aids to make consent forms understandable to a lay audience. This reflects a broader movement toward patient-centered research where informed consent is seen as a dynamic, communicative process—not just a legal formality.
2.

Health Literacy and Patient Involvement Are Critical

The article highlights that limited health literacy is widespread, affecting nearly half of Europeans and over a third of Americans. To address this, ICFs should be written at appropriate reading levels and apply good design practices. Involving the patient community and the public in the co-development and review of consent materials helps ensure relevance, clarity, and trust—especially when their contributions are recognized.
3.

Sponsors Can Operationalize Improvements Through Pilots, Templates, or ICF Supplements

Research sponsors can enhance ICF accessibility by adopting pilot projects, developing patient-friendly templates, and using supplemental tools like infographics and information guides. These strategies help balance regulatory compliance with practical implementation, making it easier to embed patient-centered practices into clinical workflows without overburdening teams.

From Compliance to Comprehension: Advancing Patient-Centered Informed Consent in Clinical Research

Comprehension Is the New Compliance Standard

Health Literacy and Patient Involvement Are Critical

Sponsors Can Operationalize Improvements Through Pilots, Templates, or ICF Supplements

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