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.
Highlights
Informed consent is the cornerstone of human research subject protectionResearch studies are growing in complexity and duration
Overview The prospective randomized study, approved by the Institutional Review Board (IRB) of California Pacific Medical Center, was conducted in two parts: In Part 1, clinical research professionals at California Pacific Medical Center Research Institute who agreed to participate were randomized by computer to learn about a chemotherapy neuropathy clinical research study by reviewing either the IRB-approved standard paper consent form or the same consent form via an iPad based interactive system
In Part 2, patients drawn from a variety of clinical practices at CPMC who agreed to participate were randomized by computer to learn about the same clinical research study by reviewing either the IRB-approved paper consent form or via the same iPad based interactive system used for Part 1
Summary
Informed consent is the cornerstone of human research subject protectionResearch studies are growing in complexity and duration. Informed consent is the cornerstone of human research subject protection. The consent form is a detailed – and generally long – description of the protocol, possible benefits and harms, study procedures, and patient rights. The first step is giving a paper consent form to the potential subject to review. Staff and the study investigator may assist the potential subject in reviewing the consent form and answering questions, but this may be insufficient and is generally not standardized. Many subjects sign – and thereby provide consent – without understanding the study purpose, procedures, risks, benefits, and their rights. The standard process of informed consent is risky because the subject may have complications that he or she did not realize were inherent in the research or procedure.
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