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Health Literacy in Clinical Research

Focus Area: Ethics, Conduct, and Oversight

Health Literacy in Clinical Research

Prospective research participants should be provided with comprehensible, individually meaningful, and culturally-relevant information about clinical research and the implications of research participation. Foundational to the ethical conduct of research involving human participants is informed consent, delivered in a language and format that is understandable to the person. That, unfortunately, occurs all too rarely. While definitions of health literacy emphasize the skills and abilities of the recipient of information (i.e., the prospective participant), they say little about the skills and abilities of the communicator (i.e., investigator and research staff.) Taking a systems-based approach, we propose to develop clinical research-oriented tools and resources for the primary authors, reviewers, and communicators of study information, including principal investigators and their study teams, institutional stakeholders (e.g., legal and risk management personnel), sponsors, and IRBs.

In April 2018, the MRCT Center convened a workgroup of diverse stakeholders, including industry, foundations, academia, patient advocates and advocacy groups, non-profits and government representatives to challenge and overcome the barriers to adopting and implementing health literacy principles in clinical research.

Our work will be accomplished via monthly workgroup calls, between-meeting assignments, and separate work streams, as needed, to focus on the creation of specific, tailored tools and resources that increase the application of health literacy principles to the clinical research space.

Status: Workgroup Active

Impact: While supporting comprehension and engagement of the research participant, develop targeted resources to capacitate the health literacy skills and abilities of all stakeholders responsible for creating, reviewing, and communicating clinical research materials for the participant.


  • 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.

Key Milestones:

  • February 2018: Initial meeting of leadership team
  • April 2018: Workgroup launch

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