Are you sure that the participant-facing materials you review and approve are clear to participants?
The MRCT Center has developed two health literacy resources specifically for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs).
IRBs can play an important role in supporting research study participants by applying health literacy best practices to their reviews of participant-facing materials.
NOTE: These materials are currently being piloted. If you have feedback please email mrct@bwh.harvard.edu, and check back soon for updated versions!
IRB Health Literacy Training
This training can be self-guided or facilitated by someone at your organization.
The purpose of the training is to introduce health literacy and how it applies to the review and approval of clinical research.
IRB Health Literacy Checklist
This checklist, created for IRBs reviewing research materials, covers:
- Considerations for participant-facing materials
- General assent/consent-specific considerations
- Targeted assent/consent process considerations
The MRCT Center would like to acknowledge the following people for their contributions to the development of these IRB-focused resources:
- Amy Ben-Arieh, JD, MPH (Fenway Institute)
- Diana Lynnette Fisher, MS, MPH, CPH (Lilly)
- Margaret Rankovic, MEd, CIP (CITI Program)
- Christopher Trudeau, JD (University of Arkansas, Bowman School of Law)