title: Interactive informed consent: randomized comparison with paper consents.
abstract: Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p = .07) in the direction of iPad subjects testing better on the online test (mean correct  =  77%) compared with paper subjects (mean correct = 57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.
authors.affiliation: California Pacific Medical Center Research Institute, San Francisco, California, USA. rowbotm@cpmcri.org
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
authors.forename: John
authors.initials: J
authors.lastname: Astin
authors.forename: Kaitlin
authors.initials: K
authors.lastname: Greene
authors.forename: Steven R
authors.initials: SR
authors.lastname: Cummings
mesh_terms: D001296:Audiovisual Aids / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods*; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000523:psychology* / Q000592:standards; D009862:Online Systems; D011446:Prospective Studies; D011897:Random Allocation; D035842:Research Subjects / Q000523:psychology*