Multimedia for Delivering Participant Informed Consent in Cardiovascular Trials

Multimedia for Delivering Participant Informed Consent in Cardiovascular Trials
Niamh Chapman, Rebekah Mcwhirter, Matthew Armstrong, Ricardo Fonseca, Julie Campbell, Mark Nelson, Martin Schultz, James Sharman
Journal of Hypertension, April 2021; 39 pp e217-e218
Open Access
Abstract
Objective
Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy, legalistic in character, and may fail to achieve desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of stand-alone multimedia delivery of participant consent relating to a cardiovascular trial.
Design and method
A total of 298 participants (63 ± 8 years; 51% female) were randomised to delivery of cardiovascular research study information and signed consent via multimedia (intervention; n = 146) compared with standard paper-based approach (control; n = 152) in a clinical research setting. Intervention was free of research staff and included short audio-visual explanations, with computer-based finger-signed consent. Efficacy, usability and acceptability were assessed by questionnaire.
Results
All participants successfully completed allocated interventions. Efficacy parameters were significantly higher among intervention participants, including better understanding of study requirements compared with controls (P < 0.05 all). Intervention participants were also significantly more likely to engage with the study information and spend more time on the consent process and study questionnaire (P = 0.038 and P = 0.007, respectively). Both groups reported similar levels of acceptability of the consent process, although more control participants reported that the study information was too long (24% versus 14%; P = 0.020).
Conclusions
A standalone multimedia consent process is effective for achieving participant understanding and obtaining consent on cardiovascular research in a clinical research setting free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs, and achieve informed consent in clinical cardiovascular research.