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The final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.
Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.
The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.
Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
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