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

  • Kristie B. Hadden (a1), Latrina Y. Prince (a1), Tina D. Moore (a1), Laura P. James (a1), Jennifer R. Holland (a1) and Christopher R. Trudeau (a1)...
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.

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Copyright
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-ncnd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Corresponding author
*Address for correspondence: K. B. Hadden, Ph.D., University of Arkansas for Medical Sciences, Center for Health Literacy, 4301 W. Markham Street, Slot 599 A, Little Rock, AR 72205-7199, USA. (Email: khadden@uams.edu)
References
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1. Office of Human Research Protections. Basic HHS Policy for Protection of Human Research Subjects (45 CFR 46). Rockville, MD: Office of Human Research Protections, 2010.
2. Tamariz, L, et al. Improving the informed consent process for research subjects with low literacy: a systematic review. Journal of General Internal Medicine 2013; 28: 121126.
3. Larson, E, Foe, G, Lally, R. Reading level and length of written research consent forms. Clinical and Translational Science 2015; 8: 355356.
4. Office of Human Research Protections. Informed consent [Internet]. Washington, DC: US Department of Health and Human Services, 2016 [cited June 1, 2017]. (http://www.hhs.gov/ohrp/policy/consent/index.html)
5. Manta, CJ, et al. From the patient perspective, consent forms fall short of providing information to guide decision making. Journal of Patient Safety 2016. doi: 10.1097/PTS.0000000000000310.
6. Ownby, RL, et al. Health literacy predicts participant understanding of orally-presented informed consent information. Clinical Research and Trials 2015; 1: 1519.
7. Sherlock, A, Brownie, S. Patients’ recollection and understanding of informed consent: a literature review. ANZ Journal of Surgery 2014; 84: 207210.
8. Agency for Healthcare Research and Quality. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research [Internet]. Agency for Healthcare Research and Quality, 2015 [cited May 31, 2017]. (http://www.ahrq.gov/funding/policies/informedconsent/index.html)
9. Montalvo, W, Larson, E. Participant comprehension of research for which they volunteer: a systematic review. Journal of Nursing Scholarship 2014; 46: 423431.
10. Fortun, P, et al. Recall of informed consent information by healthy volunteers in clinical trials. QJM 2008; 101: 625629.
11. Lee, R, et al. Subjects agree to participate in environmental health studies without fully comprehending the associated risk. International Journal of Environmental Research and Public Health 2011; 8: 830841.
12. Sugarman, J, Paasche-Orlow, M. Confirming comprehension of informed consent as a protection of human subjects. Journal of General Internal Medicine 2006; 21: 898899.
13. Hochhauser, M. Consent forms: not easy to read. Applied Clinical Trials 2007; 16: 74.
14. Denzen, EM, et al. Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biology of Blood and Marrow Transplantation 2012; 18: 183189.
15. Donovan-Kicken, E, et al. Health literacy, self-efficacy, and patients’ assessment of medical disclosure and consent documentation. Health Communication 2012; 27: 581590.
16. Paasche-Orlow, MK, et al. Readability of consent form templates: a second look. IRB 2013; 35: 1219.
17. Kutner, M, et al. National Center for Educational Statistics (ED), American Institutes for Research (CRESS). The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. NCES 2006-483. Washington, DC: National Center for Education Statistics, 2006.
18. Nishimura, A, et al. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics 2013; 14: 28.
19. National Institutes of Health. Plain language at NIH [Internet]. Bethesda, MD: U S Department of Health and Human Services, 2016 [cited May 31, 2017]. (http://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/plain-language)
20. Department of Homeland Security et al . Federal Policy for the Protection of Human Subjects. Report No.: 2017-01058. Rockville, MD: Federal Register, National Archives and Records Administration, 2017.
21. Kim, EJ, Kim, SH. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level. Clinical Trials 2015; 12: 232236.
22. Perrenoud, B, et al. The effectiveness of health literacy interventions to improve the informed consent process in healthcare users: a systematic review of quantitative evidence. JBI Database of Systematic Reviews and Implementation Reports 2015; 13: 8294.
23. Stunkel, L, et al. Comprehension and informed consent: assessing the effect of a short consent form. IRB 2010; 32: 19.
24. Kass, NE, et al. A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results. Clinical Trials 2015; 12: 5466.
25. Fry, E. Fry’s readabilty graph: clarifications, validity, and extension to level 17. Journal of Reading 1977; 21: 242252.
26. Flesch, R. A new readability yardstick. Journal of Applied Psychology 1948; 32: 221233.
27. McLaughlin, GH. SMOG grading: a new readability formula. Journal of Reading 1969; 12: 639646.
28. Centers for Disease Control and Prevention. Plain language resources [Internet]. Atlanta, GA: U S Department of Health and Human Services, 2015 [cited Jan 8, 2016]. (http://www.cdc.gov/healthliteracy/developmaterials/plainlanguage.html)
29. National Institutes of Health. Plain language: getting started or brushing up [Internet]. Bethesda, MD: National Institutes of Health, 2013 [cited May 31, 2017]. (http://www.nih.gov/clearcommunication/plainlanguage/gettingstarted/index.htm)
30. Centers for Medicare and Medicaid Services. Toolkit for making written material clear and effective [Internet]. Bethesda, MD: U S Department of Health and Human Services, 2016 [cited Jan 11, 2016]. (https://www.cms.gov/Outreach-and-Education/Outreach/WrittenMaterialsToolkit/index.html?redirect=/writtenmaterialstoolkit/)
31. Hadden, K. The stoplight method: a qualitative approach for health literacy research. HLRP: Health Literacy Research and Practice 2017; 1: e18e22.
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