Readability of Participant Informed Consent Forms and Informational Documents

Abstract

Objective To assess the readability of the informed consent forms from the phase III COVID-19 vaccine trials conducted in the United States. Patients English consent forms utilized for patients in phase III COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Methods Using Microsoft Word tools, we analyzed the readability (i.e., the ease of reading) of written consent forms and informational documents from phase III COVID-19 vaccine clinical trials in the United States from the following manufacturers: AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax. Results Due to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase III COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7 th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine-trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.

"How about me giving blood for the COVID vaccine and not being able to get vaccinated?" A cognitive interview study on understanding of and agreement with broad consent for future use of data and samples in Colombia and Nicaragua

“…A 2015 systematic review of qualitative and quantitative studies published prior to 2013 found a number of issues related to understanding of IC for participation in clinical trials [ 36 ]. More recent studies that evaluated understanding of IC for clinical trials applied a quantitative score to assess IC readability [ 37 , 38 ], post-IC quizzes with research participants [ 39 ], surveys [ 40 ], or semi-structured interviews [ 41 ] and similarly found that IC language was not well understood. Only one study we identified evaluated potential understanding of the language used to convey broad consent.…”

Ethical issues in the use of leftover samples and associated personal data obtained from diagnostic laboratories

“…In this sense, studies have found that readability of consent documents to be unacceptably low [28] , [29] . For instance, recent reports showed that consent for COVID-19 vaccine trials were long and difficult [28] , [30] . In addition, this situation will likely worsen, since legal requirements demand more disclaimer phrases to be incorporated into consents [28] .…”

The Complexity of Medical Device Regulations Has Increased, as Assessed through Data-Driven Techniques

“…Historically, it was widely accepted in the field of financial research that the Gunning Fog Index was most suitable to measure the readability of documents and it was therefore almost universally used. First published in 1952 [37], the Gunning Fog Index is a metric that generates a grade level from 0 to 20 to indicate the level of education required to read the text, much like the other readability methods described earlier [38]. The formula combines the total number of words, number of sentences and also the number of complex words.…”