Reading Level and Comprehension of Research Consent Forms

Abstract

Consent forms continue to be at a higher reading level than the recommended sixth to eighth grade, making it difficult for participants to comprehend information before enrolling in research. To assess and address the extent of the problem regarding the level of literacy of consent forms and update previously published reports, we conducted an integrative literature review of English language research published between January 1, 2000, and December 31, 2013; 35 descriptive and eight intervention studies met inclusion criteria. Results confirmed that developing forms at eighth-grade level was attainable though not practiced. It was found that risks of participation was the section most poorly understood. There was also a lack of consensus regarding the most effective method to increase comprehension. Further research using standardized tools is needed to determine the best approach for improving consent forms and processes.

Improved pregnant women’s understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research

“…This finding is consistent with a recent integrative review on ICFs which showed that the section describing the risks of research participation is generally least understood 23. Inadequate understanding of risks is commonly evidenced as a major ethical challenge in conducting neonatal or paediatric research requiring parental consent 4 34 35.…”

A comparison of genomic laboratory reports and observations that may enhance their clinical utility for providers and patients

“…The average reading level in the United States is estimated to be around 8th grade (Houts, Doak, Doak, & Loscalzo, ). Foe and Larson () recommend a reading level of health information materials to be between the 6th and 8th grade levels. This means the average report from any laboratory is substantially beyond most patient's or family's reading comprehension.…”

“…Although there is no definition of “effective communication” in a laboratory report, several factors are likely to influence communication of technical writing. These may include writing text at an appropriate level for nongenetics providers, as communication and comprehension of a text depend in part on readability, regardless of the literacy level of the intended audience (Foe & Larson, ; Friedman & Hoffman‐Goetz, ; Kušec et al, ). Other aspects of “effective communication” likely include clearly formatting important information, incorporating quality information including preferred reporting details (i.e., “non‐ACMG elements”), and providing follow‐up recommendations (Haga et al, ; Scheuner et al, ; Williams et al, ).…”

Effective Practices to Improve Recruitment, Retention, and Partnerships in School-Based Studies

“…Consent forms are generally recommended to be written at a 6 th grade reading level (Foe & Larson, 2016). However, consent forms continue to routinely be written at a higher level than recommended (Foe & Larson, 2016; Larson, Foe, & Lally, 2015).…”

“…However, consent forms continue to routinely be written at a higher level than recommended (Foe & Larson, 2016; Larson, Foe, & Lally, 2015). In communities characterized by low literacy, English as second language, or low parent education levels, consent form language is often confusing and may be intimidating to parents and guardians.…”