Key stakeholders in the clinical trials enterprise acknowledge that informed consent documents are too lengthy and difficult for research participants to understand, and the informed consent process is not meeting the needs of the participants; however, there is currently little consensus around what a more effective informed consent model should look like. Actionable recommendations are needed, and CTTI is working to address this unmet need.

In March CTTI convened a multi-stakeholder group of experts and thought leaders from across the clinical trials enterprise to explore more effective informed consent processes. Specifically, the meeting attendees set out to:

• Discuss previous and current efforts to improve informed consent documents and the informed consent process, including alternatives to the traditional paper informed consent document
• Identify potential remedies for concisely communicating the required elements of informed consent, including how consenter training affects the informed consent process
• Propose a more effective process, including informed consent documentation, for ensuring research participants’ understanding of critical informed consent elements
• Suggest potential strategies and opportunities for pilot testing the informed consent process improvement recommendations

We are pleased to share the summary, as well the presentation materials from this expert meeting. These materials describe the current challenges involved with the consent process and provide an evidence-based foundation for moving forward.

Click here to view all meeting materials.