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Health Literacy in Clinical Research

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

In April 2018, the MRCT Center brought together a workgroup of diverse representatives, including people from industry, foundations, academia, patient advocates and advocacy groups, non-profits and government representatives. Taking a systems-based approach, the workgroup developed clinical research-focused health literacy resources to help clinical research stakeholders implement health literacy strategies at all points across the clinical trial life cycle. In October 2019, the MRCT Center launched the Health Literacy in Clinical Research website.

Since then, the MRCT Center’s programmatic focus on health literacy throughout the clinical research process has continued to grow. In addition to considering how health literacy best practices can enhance other MRCT Center project deliverables, especially when designed for an audience of patients and participants, we continue to develop additional health literacy-related products:

  1. The Plain Language Clinical Research Glossary Pilot

In 2020, the MRCT Center assembled a small pilot workgroup of dedicated stakeholders from across the clinical development spectrum, and including patients and patient advocates, to pilot the development of a plain language clinical research glossary.  The pilot Clinical Research Glossary website was launched in June 2021 and has been widely championed and used. We are now exploring expansion opportunities and convening a consortium of stakeholders from across the research ecosystem to continue this important work.  If you are interested in joining the Clinical Research Glossary effort or want to learn more, please contact us.

2. Health Literacy Training and Checklist for Institutional Review Boards

In 2021, a variety of resources, including training materials and an IRB-focused health literacy review checklist were developed by a small MRCT Center-led workstream and piloted within two IRB systems. These materials are currently available here. They are also being adapted to our EthosCE Learning Management System where users will be able to register and receive a Certificate of Completion.  The updated EthosCE training will be available in early 2022. Please contact us to be notified of its release.

3. COVID-19 Research Fliers

Since the onset of the coronavirus global pandemic, the MRCT Center co-developed (with Harvard Catalyst) and released a suite of COVID-19 research fliers that were designed using health literacy best practices.  Additional educational materials to explain general research principles and specific COVID-19 research concepts continue to be developed and are released as they become available.

Status: Development, Dissemination and Communication

Impact: Use of the website and the related health literacy resources are being assessed on an ongoing basis.  Website analytics, user surveys, and other evaluation methods are being employed to assess the impact of the health literacy initiative.


  • To establish and support initiatives that increase the adoption of health literacy best practices when developing clinical research-related communications for patients, participants and their caregivers.
  • To develop and share resources with sponsors and funders, investigators and their study teams, and institutional review boards that maximize their efforts to integrate health literacy throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.

Key Milestones:

  • February 2018: Initial meeting of leadership team
  • April 2018: Workgroup launch
  • December 2018: Presentation at MRCT Center Annual Meeting
  • October 2019: Launched interactive Health Literacy in Clinical Research website
  • December 2019: Panel Discussion at MRCT Center Annual Meeting
  • March 2020: Launched a small team effort to develop a training resource on Health Literacy Considerations for Institutional Review Boards
  • May 2020:  Released COVID-19 research fliers that were developed and designed using health literacy best practices.
  • June 2020: Launched Plain Language Clinical Research Glossary Pilot workgroup
  • December 2020: Clinical Research Glossary Pilot activities completed
  • June 2021: Launch of Clinical Research Glossary
  • August 2021: Release of health literacy resources for IRBs

The original health literacy project was co-chaired by:

  • Barbara E. Bierer, MD. Faculty Director, MRCT Center
  • Laurie Myers, MBA. Global Health Literacy Director, Merck (MSD)
  • Christopher Trudeau, JD. Associate Professor, University of Arkansas for Medical Sciences, Center for Health Literacy, and Faculty of Law at the University of Arkansas Little Rock, Bowen School of Law
  • Sarah White, MPH. Executive Director, MRCT Center

Program Manager:

Sylvia Baedorf Kassis, MPH. Program Manager, MRCT Center