the long-term goal of this research is to develop multimedia technology and interactive instructional strategies to improve the effectiveness and efficiency of obtaining informed consent for human DNA and tissue biorepositories. Studies suggest that individuals do not sufficiently understand the information presented during biorepository consent processes, and that traditional consent processes pose resource challenges for large-scale biorepositories. Based on experiments testing multimedia presentations for patient education purposes, multimedia has the potential to improve the effectiveness and efficiency of obtaining biorepository informed consent by increasing participant understanding and recollection of information presented. Yet, this potential has not been systematically investigated in the unique context of biorepository consent. In particular, there is a need to understand the separate effects of interactivity (i.e., question asking, feedbac provided to subjects) and multimedia (i.e., multiple information delivery formats) on participant knowledge, understanding, and decision to participate. This study will compare a standard paper-based consent process (control) to multimedia and interactive consent processes, using an experimental design with random assignment, integrated into actual recruitment at the University of Iowa Hospitals and Clinics'(UIHC) comprehensive DNA and tissue biorepository. To assess the separate effects of interactivity and multimedia, low and high interactivity conditions will be tested for both the paper and the multimedia conditions. In the high interactivity conditions, participants will be asked questions about the information presented and provided feedback on their responses. Interactivity and multimedia are expected to significantly improve subject knowledge and understanding when compared to the paper-based control. High interactive multimedia is expected to decrease staff time devoted to obtaining informed consent. Two hundred (200) patients will participate in the study from the Dermatology and Immunology/Rheumatology Clinics at the UIHC. Participants will be enrolled into the UIHC biorepository via one of the four study conditions. Results of the study will be used to develop a multisite comparative study designed to demonstrate the effectiveness and efficiency of interactivity and multimedia consent under different environments, forms of media, and informed consent protocols. This research has the potential to improve on current paper-based informed consent processes and to establish the feasibility of alternative, and more effective, multimedia consent processes for human DNA and tissue biorepositories and other research-driven efforts in genetics and genomics.
Biorepositories may ask thousands of people a year to donate biological samples, allow access to their health information, and participate in research. Yet, there is little research on the best ways to deliver informed consent information to individuals so that they can make an informed decision about participating in biorepositories. This study will test an interactive, multimedia tool for delivering informed consent information about biorepositories to individuals in an understandable and effective way.
|Simon, Christian M; Klein, David W; Schartz, Helen A (2016) Interactive multimedia consent for biobanking: a randomized trial. Genet Med 18:57-64|