11
Oct2019

Clinical research is based on foundational principles that include respect for persons—a concept that implies individuals will be able to understand and make an informed choice about whether to participate in a research study. US federal regulations[1] require that informed consent information be “in language understandable to the subject or the legally authorized representative” (45 CFR 46.116 (a)(3)).

Too often, however, clinical research materials are so technical that they fall short of their intended purpose, failing to be as informative as they could (and should) be. Research comprehension is challenged by the fact that one third of the US population has limited levels of health literacy,[2] a number that is likely even higher in the research context given the complexity of information and the circumstances under which research conversations often occur. Add to this that a new and serious medical diagnosis will disrupt the processing ability of even the most educated and credentialed individual, and that a non-native English speaker may need additional support when considering whether they or a loved one should participate in a research study, even if they appear proficient in English. To help support participant understanding through clear communications across the entire clinical research life cycle, The Multi-Regional Clinical Trials (MRCT) Center is thrilled to announce the availability of a comprehensive, publicly-available resource.

The MRCT Center is a research and policy center that, in 2018, convened a workgroup of diverse stakeholders to address the health literacy need in clinical research. Taking a systems-based approach and recognizing the limitations of a health literacy definition that focuses exclusively on the individual’s ability to understand (see Ratzan and Parker, 2000)[3], the workgroup focused on the responsibility of communicators to share information in ways that are designed to be understood and empower the recipient.  The workgroup identified opportunities across the clinical trial life cycle for clinical research stakeholders (including sponsors/funders, investigators and study teams, and institutional review boards/ethics boards (IRB/ECs)) to develop clear communications for participants.

IRB/ECs are charged with providing ethical and regulatory oversight of the entire clinical research study, including ensuring that participant-facing materials are understandable. These committees are in a unique position to support the integration of health literacy best practices into clinical research by:

  • Requesting information from investigators about the intended communities of participants and how clinical research materials have been developed specifically for those populations;
  • Reviewing all participant-facing written materials to ensure the content is clear and understandable to the intended audience;
  • Educating the research community about health literacy best practices in the context of clinical research;
  • Providing clinical research-focused health literacy resources and tools to the investigator community they serve;
  • Using health literacy best practices in the creation of their own institutional templates intended for participants and patients.

The MRCT Center has developed an ever-growing Health Literacy in Clinical Research website of resources, tools, and guidance to optimize research communications that launches on October 21, 2019. Register here to join us for a webinar featuring some of the website’s highlights.

Sylvia Baedorf Kassis, MPH is affiliated with The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Cambridge, Massachusetts


[1] https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668931/

[3] Ratzan SC, Parker RM. 2000. Introduction. In: National Library of Medicine Current Bibliographies in Medicine: Health Literacy. Selden CR, editor; Zorn M, editor; Ratzan SC, editor; , Parker RM, editor. , Editors. NLM Pub. No. CBM 2000-1. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services. https://www.ncbi.nlm.nih.gov/books/NBK216033/

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