Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)

Volume 19, Issue 5, May 2019, Page 22-24.

Electronic informed consent represents an opportunity to redesign the way that participants understand and elect to enroll in clinical research studies. However, electronic consent faces certain barriers common to all informed consent processes and other barriers specific to the technical environment. At Sage Bionetworks, we designed an electronic consent process as a software product and released it as an open source tool. We believe that using contemporary design processes to intentionally create cognitive friction, where potential study participants are confronted with (...) interfaces that require them to slow down and contemplate study concepts, offers a significant opportunity for ethical design as research increasingly uses smartphones and digital methodologies. (shrink)

Volume 19, Issue 5, May 2019, Page 27-28.

Volume 19, Issue 5, May 2019, Page 34-36.

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

Volume 19, Issue 5, May 2019, Page 29-31.