Applied Clinical Trials
In July, at a meeting called by the U.S. Department of Health and Human Services on Human Research Protections, I reviewed the fascinating results of a randomized study that recently compared paper-based informed consent to electronic informed consent.
In July, at a meeting called by the U.S. Department of Health and Human Services on Human Research Protections, I reviewed the fascinating results of a randomized study that recently compared paper-based informed consent to electronic informed consent. Researchers wanted to know how the delivery of informed consent information affected understanding. What they learned contributes valuable data to our thinking on the future of informed consent, and suggests clinical and human benefits that flow from the wise use of technology.
Concerns persist around the adequacy of the consent process and whether subjects are fully informed and truly understand what they are given to read prior to a clinical trial. Consent forms are long and detailed – a “babble of words” as one patient in the study put it -- describing the protocol, possible benefit and harms, study procedures and patient rights. Even when provided with direct, professional support to explain the trial information, many people sign consent documents without really understanding what they’ve read or been told. Nevertheless, informed consent remains the cornerstone of human research subject protection.
In early 2012, the Institutional Review Board (IRB) of California Pacific Medical Center set out to compare an interactive, tablet-based presentation of a clinical research consent form with a paper version of the same consent. The interactive system was tested in a simulated situation where research professionals were asked to pretend they were conducting a chemotherapy neuropathy trial and patients were asked to pretend they had cancer and were considering entering a research study. Although the specific content for each group varied, all participants were asked to complete an online survey the day after they had read the material to test delayed recall.
Among both professionals and patients, next-day comprehension was significantly better in subjects randomized to the interactive, iPad consent form.
Of the 90 participants in the study, 69 completed the online test and day-after survey questions. Among research professionals about 77% of those on the iPad had correct recall compared to 57% correct among paper consent subjects. The difference was even greater among the patient group. Patients using the iPad for informed consent versus patients using standard paper consent showed a difference of 75% iPad versus 58% paper. 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 – an introductory video, consent form and seven-question interactive quiz. Common sense and years of research in learning behaviors confirm that the longer a person spends reading and studying information the more likely they are to do better on tests. The extra minutes on the iPad certainly contributed to better recall of the material.
Although more research needs to be done, this early randomized study indicates that electronic consent leads to better informed patients and so potentially better trial subject -- a major advance in both the protection of human subjects and in clinical trial research.