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February 19, 2003New England Journal of Medicine769 citationsOpen Access

Readability Standards for Informed-Consent Forms as Compared with Actual Readability

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MPMichael K. Paasche‐OrlowHTHolly A. TaylorFBFrederick L. Brancati

Key Points

  • This research aims to compare the readability of informed-consent forms provided by IRBs with established readability standards.
  • Assessment of informed-consent forms from multiple IRBs against readability metrics.
  • Analysis of federal oversight impact on readability levels.
  • Informed-consent forms frequently did not meet readability standards set by IRBs.
  • Better readability is associated with federal oversight in consent forms.

Abstract

IRBs commonly provide text for informed-consent forms that falls short of their own readability standards. Federal oversight is associated with better readability.

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Cite This Study

Paasche‐Orlow et al. (2003) studied this question.

synapsesocial.com/papers/69dbcb5c3d9adb00e76851e2https://doi.org/10.1056/nejmsa021212
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