Health Literacy and Informed Consent Materials: Designed for Documentation, Not Comprehension of Health Research.

Minority populations with health disparities are underrepresented in research designed to address those disparities. One way to improve minority representation is to use community-based participatory methods to overcome barriers to research participation, beginning with the informed consent process. Relevant barriers to participation include lack of individual or community awareness or acceptance of research processes and purposes. These barriers are associated with limited health literacy. To inform recommendations for an improved consent process, we examined 97 consent documents and 10 associated Institutional Review Board websites to determine their health literacy demands and degree of adherence to principles of community-based research. We assessed the reading level of consent documents and obtained global measures of their health literacy demand by using the Suitability and Comprehensibility Assessment of Materials instrument. Although these documents were deemed suitable as medical forms, their readability levels were inappropriate, and they were unsuitable for educating potential participants about research purposes. We also assessed consent forms and Institutional Review Board policies for endorsement of community-based participatory principles, finding that very few acknowledged or adhered to such principles. To improve comprehension of consent documents, we recommend restructuring them as educational materials that adhere to current health literacy guidelines.