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Health Literacy in Clinical Research

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

Clear research communications that are understandable to patient and participant communities are critical to inclusive, representative research studies.

After completing work on return of research results that included a focus on health literacy, in 2018 the MRCT Center convened a workgroup of diverse representatives from across the research ecosystem to address the issue of limited health literacy in the clinical research context. Guided by the fundamental belief that communicators are responsible for sharing information in ways that are designed to promote understanding and empowerment, one of the workgroup’s goals was to develop clinical research-focused health literacy resources that support the integration of health literacy strategies across the clinical trial life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.

Since then, we strive to develop MRCT Center deliverables with an eye towards promoting understanding, especially when the audience includes patients, participants and caregivers. Our most recent health literacy resource is the plain language, patient-centric Clinical Research Glossary which was piloted in 2020 and is currently undergoing expansion via a collaborative consensus-building workgroup.  We also continue to develop health literacy-focused products including a Health Literacy Training and Checklist for IRBs, and COVID-19 Research Flyers.

Impact: Use of the health literacy websites and resources is assessed on an ongoing basis.  Website analytics, user surveys, and other evaluation methods are employed to assess the impact of the health literacy initiative. The application of health literacy best practices and use of the health literacy resources the MRCT Center develops contributes meaningfully to clinical research ecosystem improvement exercises.

Objectives: 

  • Establish and support initiatives that increase the use of health literacy best practices when developing clinical research-related communications for patients, participants and their caregivers.
  • 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 principles throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.
  • Promote the use of plain language in clinical research via a harmonized, patient co-developed Clinical Research Glossary that can be used across the research industry, and used by research professionals and potential participants to foster clear, bi-directional information exchange.

Key Milestones:

  • June 2022: Launched online Health Literacy Training for IRBs
  • March 2022: Launched Clinical Research Glossary Expansion activities
  • August 2021: Released health literacy resources for IRBs
  • June 2021: Launched Clinical Research Glossary
  • June 2020: Launched Plain Language Clinical Research Glossary Pilot workgroup
  • May 2020:  Released COVID-19 research fliers that were developed and designed using health literacy best practices.
  • March 2020: Launched a small Taskforce to develop a training resource on Health Literacy Considerations for Institutional Review Boards
  • October 2019: Launched interactive Health Literacy in Clinical Research website
  • April 2018: Health Literacy in Clinical Research Workgroup launch

Project Leadership and Workgroup Members:

For Health Literacy in Clinical Research project, please see

For Clinical Research Glossary, please see