See All Projects

Health Literacy in Clinical Research

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

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 center of ethical research conduct is informed consent, delivered in a language and format that is understandable to the potential research participant. Clear communication goes beyond informed consent, however, to include all points at which a potential or enrolled research participant is provided with clinical research information, from the time of initial awareness, recruitment and consent, through all study visits and procedures to the end-of-study.

Definitions of health literacy often emphasize the skills and abilities of the person receiving information (i.e., the potential participant), but say little about the skills and abilities of the communicator (i.e., investigator and research staff.).  It is critically important that members of the clinical research stakeholder community (including sponsors and funders, institutional review boards (IRBs), and principal investigators and their study teams) each play an active role in advancing a clinical research practices that promote active participant engagement and the design of studies and study materials that are responsive, meaningful and understandable.

To this end, 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. Taking a systems-based approach, the workgroup developed clinical research focused health literacy resource for all clinical research stakeholders such as the primary authors, reviewers, and communicators of study information to implement at all points throughout the clinical trial life cycles.  The resulting deliverable, the MRCT Center’s Health Literacy in Clinical Research website launched in October 2019 and can be accessed here.

Status: Dissemination and Communication

Impact:  The launch and dissemination of the website is under evaluation.  Website analytics, user surveys, and other evaluation methods are being employed to assess the impact of this initiative.


  • To address barriers to the adoption of existing resources in health literacy in the context of clinical research-related communications.
  • To identify the opportunities for sponsors and funders, investigators and their study teams, and institutional review boards 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


  • Evaluation of website

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, MPH. Program Manager, MRCT Center