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Hadden KB, Prince LY, Moore TD, et al. Improving readability of informed consents for research at an academic medical institution. J Clin Transl Sci. 2017;1(6):361-365doi: 10.1017/cts.2017.312.
Hadden, K. B., Prince, L. Y., Moore, T. D., James, L. P., Holland, J. R., & Trudeau, C. R. (2017). Improving readability of informed consents for research at an academic medical institution. Journal of clinical and translational science, 1(6), 361-365. https://doi.org/10.1017/cts.2017.312
Hadden, Kristie B, et al. "Improving readability of informed consents for research at an academic medical institution." Journal of clinical and translational science vol. 1,6 (2017): 361-365. doi: https://doi.org/10.1017/cts.2017.312
Hadden KB, Prince LY, Moore TD, James LP, Holland JR, Trudeau CR. Improving readability of informed consents for research at an academic medical institution. J Clin Transl Sci. 2017 Dec;1(6):361-365. doi: 10.1017/cts.2017.312. PMID: 29707258; PMCID: PMC5915809.
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J Clin Transl Sci. 2017 Dec;1(6):361-365. doi: 10.1017/cts.2017.312.

Improving readability of informed consents for research at an academic medical institution.

Journal of clinical and translational science

Kristie B Hadden, Latrina Y Prince, Tina D Moore, Laura P James, Jennifer R Holland, Christopher R Trudeau

Affiliations

  1. Center for Health Literacy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

PMID: 29707258 PMCID: PMC5915809 DOI: 10.1017/cts.2017.312

Abstract

INTRODUCTION: 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.

METHODS: 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.

RESULTS: The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.

CONCLUSIONS: Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Keywords: Informed consent; health literacy; human subjects; plain language; readability

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