CLINICAL TRIALS & RESEARCH
Our Work
Home|Our Work|Reimagining Informed Consent

Reimagining Informed Consent

Reimagining Informed Consent

The complexity of current informed consent models limit, rather than support, patient comprehension. Informed consent forms (ICFs) often reach dozens of pages long, exceed the general reading levels of clinical trial participants, and are focused on regulatory compliance and liability concerns rather than participant understanding of their rights and options as clinical trial participants.

The MRCT Center seeks to reimagine informed consent processes, moving beyond compliance-focused documentation toward innovative, participant-centered approaches. This initiative is exploring disruptive solutions within the informed consent development timeline, from structural changes to pre-IRB approval innovations to post-IRB approval, personalized consent pathways that adapt a “fit-for-purpose” consent model.

Our goal is to fully re-envision the informed consent process with global partnerships, while respecting participant autonomy throughout the research process. This work will develop in parallel project workstreams dedicated to structural changes to the ICF, as well as to changes in content and process. To learn more or get involved, please email Blythe Chen.

OBJECTIVES

  • Scope current field of informed consent and identify strategies for improvement
  • Develop and validate models of new informed consent processes, incorporating new technologies
  • Develop multi-stakeholder consensus on improved informed consent processes in multi-national academic and industry clinical trials, aligned with regulatory and ethical expectations.
  • Create tools and resources to enable adoption of innovative informed consent approaches.

KeY MILESTONES

  • March 2026: Project launch
  • September 2025-March 2026: Convened the subject matter experts to scope the opportunities for reinventing informed consent processes in clinical trials.
  • October 2025: Organized an interactive brainstorming session during the MRCT Center’s Annual Symposium on the Reimagining the informed Consent Process, beginning the project workstream.

project Leadership & sTAFF

  • Barbara Bierer, MD, Faculty Director, MRCT Center
  • Sarah White, MPH, Executive Director, MRCT Center
  • Blythe Chen, MPH, Research Assistant II, MRCT Center

Project Resources