Integrate Health Literacy Training into Your IRB’s Onboarding and Professional Development Activities

On January 13, 2022, PRIM&R hosted a webinar, Health Literacy and Human Research Protections: How the IRB Can Make Research More Understandable, with Sylvia Baedorf Kassis, MPH, Program Manager at the Multi-Regional Clinical Trials (MRCT) Center. This webinar provided an overview of health literacy as well as provided practical examples of how health literacy can be championed by IRBs. Below is her summary and some additional resources for IRBs. 

In the years when I worked as an IRB reviewer and later supported investigators with their IRB submissions, I would often identify far too complex participant-facing materials, but I wouldn’t know where to start to simplify or clarify the content. Since that time, I’ve had the opportunity to focus on health literacy and how health literacy best practices can fundamentally change the way science and research are communicated to patients, participants, and their caregivers. And now, I’m thrilled to be able to share a new freely available, online health literacy training course, especially designed for IRBs.

The Evolving Definition of Health Literacy:

The definition of health literacy, which used to focus exclusively on the skill of the individual recipient to understand information provided to them, has in recent years shifted to include the responsibility of the communicator to share information in ways that are understandable. To this end, there has notably been a move to emphasize how organizations can support clear communications through the application of health literacy principles and best practices. Healthy People 2030 includes such a focus on organizational health literacy, defining it as “the degree to which organizations equitably enable individuals to find, understand, and use information and services to inform health-related decisions and actions for themselves and others.” IRBs are arguably a critical part of the organizational landscape of research, and attention to health literacy can help fulfill the IRB’s mission of protecting human research participants.

Health Literacy and the IRB:

Health literacy best practices are in line with the Belmont Principles, help support OHRP regulatory requirements like the consent regulations described at §46.116(a)(4) and §46.116(a)(5), and fulfill key AAHRPP accreditation standards. FDA endorses the importance of health literacy. Lastly, ICH Good Clinical Practice E6(R2) also alludes to health literacy (Section 4.8.6).

Ensuring that the participant-facing materials IRBs review are clear and tailored to meet the needs of the intended study population is one way the IRB can put health literacy into action. Further, such a focus dovetails with any equity and inclusion efforts an organization may also be engaged in, as clear research communications demonstrate a commitment to a culture of inclusivity.

Health Literacy Training for IRBs:

The MRCT Center has created a Health Literacy Training for IRBs to raise awareness and introduce health literacy concepts and best practices that can be integrated into day-to-day IRB activities. Anyone from any institution can register to take the course.

This free, online training includes:

  • An introductory, informative video,
  • Teach-back questions to amplify lessons from the video,
  • Before-and-After examples to demonstrate how health literacy techniques can be used to simplify research materials,
  • A Before-and-After activity for trainees to apply those techniques to sample exercises,
  • A quiz to reiterate key takeaways,
  • An evaluation to share trainee feedback about the training with the MRCT Center, and
  • A Certificate of Completion.

The Health Literacy Training for IRBs also includes a Facilitation Guide so that once individual team members have each completed the online training module, a group discussion can take place to review areas of organizational strength and possible next steps to advance health literacy best practices within the IRB’s activities. This training can be added into every new IRB member’s onboarding process and included as part of the continuing education curriculum for staff professional development. 

Finally, to support the integration of health literacy best practices into IRB review activities, the MRCT Center has created the Health Literacy in Clinical Research: IRB Checklist. This tool can serve as an adjunct to any other existing research review tool or checklist, and allows for health literacy best practices to be applied to participant-facing materials, including assent and consent documents.

Health Literacy Training: Quality Improvement User Testing Experience:

Before the release of the Health Literacy Training for IRBs, the MRCT Center conducted a Quality Improvement (QI) user testing process at two separate USA-based IRBs to determine the acceptability of the training materials.

The user testing sites included:

  • a large center (200+ members): participants included one full board panel, the expedited review team, and administrative staff
  • a small center (<15 members): participants included one full board panel, expedited reviewers and administrative staff

The user testing sites:

  • were provided with a link to the resources,
  • followed the training instructions as described on the website and in the Facilitation Guide,
  • engaged in the training activities/process, and
  • tested the IRB checklist.

As part of the QI exercise, twenty-one users (facilitators and trainees; IRB chairs, members and staff) completed a voluntary, anonymous feedback survey. All 21 found the training to be clear and easy to follow and reported having enough information at the end of the training to apply health literacy concepts to participant-facing materials. Most trainees reported they would recommend the training to others in the human research protections field.

Other Useful Health Literacy Resources:

After taking the training and starting to use the Health Literacy in Clinical Research IRB checklist, IRBs can continue to integrate additional health literacy resources to support the creation of understandable research participant-facing materials, such as the Consent Guide for applying health literacy to informed consents for research and the MRCT Center Clinical Research Glossary  (a plain language resource of participant-centric, consensus-developed, harmonized definitions to be used across the research ecosystem). More information about the process of developing the Clinical Research Glossary can be found in the Journal of Clinical and Translational Science.

How to Get Started:

Participant-facing materials can be more understandable, and the IRB can play a critical role in that process.  Given the MRCT Center’s experience creating and testing these training materials, we recommend the following steps to inform the process of engaging with health literacy concepts in a more deliberate way:

  • Take the training yourself,
  • Invite your team to take the training,
  • Engage in a health literacy-focused team discussion using the Facilitation Guide,
  • Use the checklist and other health literacy resources mentioned above to support the creation of more clear and understandable materials (for example, update consent templates or add health literacy-related questions to protocol templates and application submissions)
  • Share useful health literacy tools and resources, such as those on the MRCT Center’s health literacy page, with your research community

I wish that I’d had a resource like this when I was starting out in the IRB world. Not only does attention to health literacy contribute to the creation of more understandable materials, it allows IRB reviewers to more intentionally consider what the study population might need to understand the proposed research.

The IRB can help support the communication of clear, understandable research information. Taking the online Health Literacy Training for IRBs is a straightforward way to integrate clear communication best practices into the critically important IRB review process.

Sylvia Baedorf Kassis, MPH, CYT, is a Program Manager at the Multi-Regional Clinical Trials Center. With 20 years of clinical research-related experience, her expertise includes ethical/regulatory review of research, clinical trial workforce training and capacity building, and study coordination, management and oversight. In her current role, Sylvia is focused predominantly on efforts to make clinical research more understandable and accessible to patients and participants through her work on Health Literacy in Clinical Research.

Questions and feedback can be directed to Sylvia at