Informed consent and patient's rights documents: a right, a rite, or a rewrite?

Both research participants and patients are presumably offered protection from harm through the processes of informed consent and patient's rights. However, both documents are often written at unacceptably high "college" reading levels, making them incomprehensible to the "average" reader who may be reading at a junior-high reading level. Readability researchers are often unfamiliar with important details of readability software, leading to consistent underestimates of document readability. Most informed consent and patient's rights documents are writtin in a one-size-fits-all style and fail to take into account important differences based on cognitive development. Several strategies are described to improve the quality and effectiveness of these materials.