Journal
JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE
Volume 1, Issue 6, Pages 361-365Publisher
CAMBRIDGE UNIV PRESS
DOI: 10.1017/cts.2017.312
Keywords
Informed consent; readability; plain language; human subjects; health literacy
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Funding
- Translational Research Institute (TRI) through the NIH National Center for Research Resources [UL1TR000039]
- Translational Research Institute (TRI) through the NIH National Center for Advancing Translational Sciences [UL1TR000039]
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IntroductionThe 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.MethodsReadability 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.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
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