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

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 IRB 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 IRB approved informed consents from 2013–2015. A plain language informed consent template was developed and implemented and readability was assessed again after one year. Results The mean readability of the baseline sample was 10th grade. The mean readability of the post intervention sample (n= 82) was 7th grade. Conclusions Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Readability of consent forms in veterinary clinical research

“…Some previously published suggestions for clinicians and administrators crafting consent forms include using “plain language” as much as possible, keeping sentences to a maximum of 8‐10 words, limiting the use of words with 3 or more syllables, eliminating jargon and defining technical terms when use is required, using headings and subheadings to divide text into smaller sections, using questions as subheadings, leaving ample white space to avoid cramped text, and using active voice . Additionally, provision of informed consent templates by institutions can help investigators navigate the process of drafting readable consent forms, and provision of forms for study participants to read and digest in advance of their hospital visit could assist with understanding. Lastly, assessing readability of draft forms using mechanisms already available in Microsoft Word, such as the F‐K Grade Level and FRES, should help authors gauge appropriateness of their content.…”

“…One common way of documenting this process is by having the owner sign a consent form that delineates, in writing, the information deemed necessary by investigators and institutional approval bodies for informed consent. Although written consent forms are a cornerstone of the consenting process across species, research in the human medical setting indicates that many forms have poor “readability” suggesting that they are not optimized for patient comprehension . “Readability” is an objective measure of whether a written text is understandable for an individual with a particular level of reading skills .…”

“…A wealth of recent publications describing consent in human clinical trials has focused on readability and comprehension of medical consent forms . A survey conducted by the National Assessment of Adult Literacy concluded that approximately half of Americans have only basic literacy skills and that 14% have literacy skills that are less than basic .…”

Feasibility and Acceptability of a Culturally Tailored Website to Increase Fruit and Vegetable Intake and Physical Activity Levels in African American Mother-Child Dyads: Observational Study

“…Moreover, 13% of African Americans do not use the internet [40]. Health literacy [41], internet self-efficacy [42], and parental consent form literacy [43] may have been enrollment barriers. Technological limitations hampered recommending the videos to others.…”

Enhancing consent forms to support participant decision making in multimodal learning data research

“…Kass et al (2015) argue that informed consent "rests on an assumption that individuals considering research participation have adequately understood the information provided to them" (p. 2). The requirement of understanding is echoed by many (Buccini, Iverson, Caputi, Jones, & Gho, 2009;Hadden et al, 2017;Hallinan, Forrest, Uhlenbrauck, Young, & McKinney, 2016;Joffe, Cook, Cleary, Clark, & Weeks, 2001;Muravyeva, Janssen, Dirkx, & Specht, 2018;Tait, Voepel-Lewis, Robinson, & Malviya, 2002;Young, Hooker, & Freeberg, 1990). Buccini et al (2009) write that "to treat potential research participants as autonomous agents, it is imperative to ensure understanding of the consent information has actually occurred, thereby, enabling them to make autonomous decisions about participation" (p. 7).…”