Institutional review boards and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that (...) length and comprehension are inversely related, length of consent forms increased linearly. The findings demonstrate the dilemma in attempting to provide information on consent forms that is simultaneously accurate and concise. (shrink)

The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under study (...) where examined to identify whether they had any formal policies/guidelines on the readability of informed consent documents. The two HRECs were contacted via e-mail to also determine whether they utilised any informal readability standards or “rules of thumb” that may not have been mentioned in the published documents. The HIV/AIDS and type 2 diabetes informed consent documents were, on average, written at a grade 13 reading level. Formal readability standards had not been established by the two local HRECs, however, they did verify the use of informal rules for assessing readability of informed consent documents. Based on Australian literacy data, the majority of informed consent documents were written well beyond the reading ability of many Australians. Unreadable informed consent documents may result in patients rejecting trial participation altogether or conversely may result in their participating in a trial with inadequate consent. Therefore, a step toward reducing the complexity of informed consent documents may be to implement objective readability assessments into the human research ethics application and review process. (shrink)