IRB Policies and Health Literacy: Ethical Challenges to Informed Consent

Ethical research requires informed consent. However, complex language and lack of detail in consent materials can leave participants, especially those with low health literacy, with limited understanding of research. Racial/ethnic minorities are severely underrepresented in clinical trials, an important avenue of access to new health treatments. This situation may stem from a poor fit between consent materials and the average health literacy skills of many minorities.

We evaluated consent forms used in projects of the 10 Centers for Population Health and Health Disparities. We determined reading grade level and health literacy attributes, including content, literacy demand, numeracy, quality of graphic materials, layout, and typography. Next, we evaluated institutional IRB policies for each site that approved the forms and compared the extent to which the forms matched their policies. Finally, we compared IRB policies across Centers.

We found that IRB policies at all 10 Centers acknowledged the need for minimum grade-level readability but devoted varying degrees of attention to health literacy. Readability across consent forms often exceeded the eleventh grade level. Nevertheless, consent forms typically met other health literacy criteria, such as limiting numeracy demands and providing definitions and simple tables.

While consent forms are not intentionally deceptive, they often contain confusing medical and legal jargon that may impede participants’ ability to understand research purposes, processes, risks, and benefits. We provide simple recommendations to better align the consent process with participants’ literacy needs and preferences. These recommendations may increase participation in therapeutic clinical trials, a key concern for vulnerable populations.