Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document.

The US government recently updated the Common Rule, a set of federal regulations to ensure the ethical conduct of human subjects research. The new regulations require that consent documents provide information that is clear and concise enough to enable truly informed consent. This study explores potential American Indian research participants' understanding and perceptions of an example consent document, focusing on possible improvements to better serve the requirements of the revised Common Rule. Participants completed a survey that collected demographic data and measured health literacy, numeracy, and comprehension of the example document. Next, they participated in focus groups to answer open-ended questions regarding their views on the example document. We calculated mean scores and frequencies of response to analyze quantitative survey data and performed a qualitative thematic analysis of focus group transcripts. Results demonstrated that American Indian participants with relatively strong health literacy skills clearly understood key elements of the consent document, including the purpose of signing it, confidentiality, compensation, and whom to contact for questions. However, they were overwhelmed by details on research procedures and were concerned about the document's layout. To make consent documents more readily comprehensible, participants recommended the addition of headings, bullets, graphics, and relevant pictures. They also recommended a two-step consent process, comprising a short introduction to the research project followed by a longer explanation of procedures. These results illustrate the potential advantages of community engagement in drafting consent materials. Health researchers would likely benefit from community recommendations like the ones we elicited as they design consent documents adherent to the revised Common Rule.