-- Robert Preidt
FRIDAY, Aug. 13 (HealthDay News) -- The length and complexity of
consent forms for people enrolling in clinical trials don't affect
the ability of the participants to understand the key points of the
study, researchers say.
Some previous studies have suggested that volunteers often fail
to comprehend consent forms, which are an ethical cornerstone of
research involving people. To address that concern, recent efforts
have been made to simplify consent forms.
In this new study, U.S. researchers had volunteers read either a
standard or a concise consent form for a low-risk phase 1 study of
a marketed drug. The participants' comprehension levels were
similar with both forms, and the shorter form didn't appear to harm
the quality of informed consent, the study authors found.
The researchers also noted that paid participants had slightly
higher comprehension than unpaid participants. This challenges a
common assumption that people who are paid to enroll in research
may be "blinded by money" and thus ignore important details about
the study when reading the consent form.
Another finding was that overall comprehension was not affected
by socioeconomic status. This appears to counter claims that people
who are socially or financially disadvantaged require special
protections when enrolling in clinical trials, according to study
authors Ezekiel Emanuel, Christine Grady and colleagues.
The study is published in the July/August issue of the journal
IRB: Ethics & Human Research, published by the Hastings Center, a nonprofit bioethics research institute in Garrison, N.Y. Emanuel and Grady are Hastings Center Fellows and bioethics leaders in the federal government.
The U.S. Food and Drug Administration has more about
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