Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer’s Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

COVID-19 has forced medical research institutions to conduct clinical research remotely. Here, we describe how a university’s mHealth Research Core helped facilitate the shift to remote research during the COVID-19 pandemic. In 2019 (pre-pandemic), we conducted stakeholder interviews and leadership group sessions to identify, create, and implement resources and core functions to support investigator-initiated mHealth research. Between April 2019 and February 2020, we identified four investigator needs: 1) a seminar series on trends in mHealth research, 2) mHealth case consultation services, 3) liaison services with institutional regulatory compliance groups, and 4) online navigation tools for implementation of mHealth methods (e.g., eConsent) and for building partnerships with technology vendors. To date, the mHealth Research Core has held seven seminars, completed 71 case consultations, assisted four COVID-related clinical studies, advised the IRB on shifting to remote research, and widely disseminated eConsent navigation tools. Although pre-pandemic stakeholder and investigator needs led to the creation of the mHealth Research Core, this institutional resource played a critical role in continuing clinical research during the pandemic by assisting investigators in rapidly shifting to remote study methodology.