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Health Literacy in Clinical Research

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

Health Literacy in Clinical Research

The public should be provided with clear, meaningful, and culturally-relevant information about clinical research and what it means to be a research participant. At the root of ethical research conduct is informed consent, delivered in a language and format that is understandable to the potential research participant. While definitions of health literacy often emphasize the skills and abilities of the person receiving information (i.e., the potential participant), they say little about the skills and abilities of the communicator (i.e., investigator and research staff.) Taking a systems-based approach, we have been developing clinical research-oriented tools and resources for all clinical research stakeholders such as the primary authors, reviewers, and communicators of study information, including sponsors and funders, institutional review boards (IRBs), and principal investigators and their study teams.

In April 2018, the MRCT Center convened a workgroup of diverse stakeholders, including people from industry, foundations, academia, patient advocates and advocacy groups, non-profits and government representatives. To date, our work has been accomplished via monthly workgroup calls, between-meeting assignments, and separate work streams focused on developing tools and resources that support adopting and implementing health literacy principles at all points of the clinical research life cycle.

Status: Workgroup Active

Impact: The full impact of the workgroup will be achieved via the launch of a full suite of targeted tools and resources to support all clinical research stakeholders who play a role in creating and reviewing clinical research materials and communicating that information to participants


  • To understand and assess the current health literacy landscape as it pertains to the clinical research environment.
  • To address barriers to the adoption of existing resources and health literacy in the context of clinical research-related communications.
  • To create a comprehensive roadmap of how sponsors, investigators and their study teams, and institutional review boards should use resources throughout the clinical research life cycle from recruitment and informed consent through close-out and return of results.
  • To launch a web-based collection of resources that are relevant to multiple stakeholder communities, including research participants.
  • To develop a summary guidance document of key findings and deliverables, including principles and best practices of health literate communications in clinical research.


  • Fall 2019: Launch of interactive Health Literacy in Clinical Research website

Key Milestones:

  • February 2018: Initial meeting of leadership team
  • April 2018: Workgroup launch
  • December 2018: Presentation at MRCT Center Annual Meeting

Project Leadership:

  • 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