Evaluation of donor informed consents and associated predonation educational materials in the United States and Canada: variability in elements of consent and measures of readability and reading burden.

Donor consent documents and associated materials vary widely, are written at challenging grade levels, present considerable reading burden, contain substantial jargon, and are missing key elements of consent. The authors recommend an organized effort, including blood donors, legal experts, and blood collection experts, to reach consensus on the minimal requirements for standardized clear and concise consent documents in an optimized format.