User Centric Makes All the Difference at NWABR and Quorum Review IRB Conference

by Marie-Térèse Little, PhD

The 2015 Revolutionizing Informed Consent Conference session topic Emerging Trends in Research given by Mr. John Wilbanks was especially riveting. Mr. Wilbanks is Chief Commons Officer at Sage Bionetworks and he has focused his career on advancing open content, open data and open innovation systems. With a bridge grant from the Robert Wood Johnson Foundation, Sage Bionetworks developed and maintains the Participant-Centered Consent (PCC) toolkit . The toolkit was built for architects of clinical studies who are interested in leveraging technology and employing electronic consents in a mobile context with the goal to make their informed consent user-centered, rather than document-centered. Wilbanks demonstrated that the publicly available PCC toolkit contains the building blocks of a visual, interactive approach to informed consent that creates visual summaries of consent forms mapped to key underlying text, for use in software or print. Visual summaries can assist with clarifying key research concepts so the participant is engaged, well-versed and cognizant of the risks, benefits and alternatives of a clinical study. A mixture of icons and text labels are designed to convey the essential concepts of a study in a more intuitive manner facilitating a meaningful and fulsome conversation about informed choices. The toolkit is used to develop mobile-centric informed consent processes for the collaborative clinical studies involving Sage Bionetworks. The tools are used to assist the learning in the consent process and include: tiered information accessed by the participant, pictorial dominant first tier information (with icons, text slugs and labels), a text dominant second information tier and a short learning assessment. The PCC toolkit was developed with the Electronic Data Methods (EDM) Forum, a project funded by the US Agency for Healthcare Research and Quality as a part of the Collaborative Methods Project. With this framework, one can only imagine our participants eagerly participating with fascination and engrossed in this engaging e-consent informed consent process.


Marie-Térèse Little, PhD is a volunteer member of Island Health clinical research ethics board on Vancouver Island, B.C. She worked at the Fred Hutch developing novel strategies for reduced intensity bone marrow transplants and she now lives in Victoria, BC with her family. Marie-Térèse is the founder and chief consultant at 4th Dimension Biomedical Research Communications ( where complex bio-medical and scientific information is distilled into clear, meaningful and comprehensible communications. Stay tuned for additional featured speaker sessions.