Study: COVID-19 Vaccine Trial Consent Forms Were Too Long, Complex
Informed consent forms used for COVID-19 vaccine clinical trials were unnecessarily long, difficult to read and required recipients to have at least a ninth-grade reading level — compared to a norm of sixth-grade — to fully comprehend, according to a new study.
Researchers from the Perelman School of Medicine’s Department of Medical Ethics and Policy at the University of Pennsylvania analyzed informed consent documents that AstraZeneca, Johnson & Johnson, Moderna and Pfizer issued during their phase 3 COVID-19 vaccine trials.
The researchers found the informed consent forms averaged nearly 22 pages in length with 8,333 words. It would take an average reader, at a reading rate of 240 words per minute (wpm), nearly 35 minutes to finish reading a form, not accounting for any rereading. Adults with a slower reading ability (175 wpm) would require more than 47 minutes to read a form without stopping.
All of the forms studied exceeded a ninth-grade reading level, which is higher than the recommended sixth-grade reading level for such forms.
Read the published study here: https://bit.ly/3h8IYin.