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Risk of Death Greater With Low Literacy Levels

hrough this consent process."

Only 28 percent of subjects got all questions right on the first pass.

Fifty-two percent needed a second pass and 20 percent needed three or more passes before they fully understood the consent form. Two percent of subjects did not understand the form completely after six passes.

"The good news is that only two passes were required for 80 percent of people," Sudore notes. "The bad news is that most subjects had poor comprehension on the first pass - in spite of the form being written at a sixth-grade reading level and read aloud, and also in spite of participants being asked frequently if they had any questions."

After taking into account age, race, education, gender, language, and literacy, the researchers found that only low literacy and minority status were associated with requiring two or more passes through the consent form.

According to Sudore, "Among blacks as opposed to whites, the odds of requiring more passes were 2.5."

Sudore speculates the reasons might have to do with an already-existing high level of distrust of medical studies among African Americans.

She cites the Tuskegee Study, in which the United States Public Health Service withheld syphilis treatment from a group of 399 African-American men for 40 years, from 1932 to 1972. "A history like that is not going to engender an atmosphere of trust and openness," she says, noting that the study could not assess the affects of potential mistrust of black versus non-black research staff because none of the research assistants were African American.

Sudore also notes that language was very important. Among subjects who stated they were fluent in English or Spanish but were native in another language, "every single one required more than one pass, regardless of literacy level," she says.

Sudore concludes that modifying the medical consent process "has now become
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