Readability Standards for Informed-Consent Forms as Compared with Actual Readability
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Open Access
- 20 February 2003
- journal article
- research article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 348 (8) , 721-726
- https://doi.org/10.1056/nejmsa021212
Abstract
Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight.Keywords
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