All of Us

The All of Us Research Program, a keystone of the Precision Medicine Initiative, aims to assemble a cohort of one million or more people to accelerate research and improve health. Central to the program’s aims is ensuring that the cohort is representative of the diversity of those living in the United States (US). Enrollment targets are based off the US 2040 census projections and the catchment demographics of participating institutions. One of the first challenges of the program was to develop a scalable, self-administered consent process accessible to the broadest group of US residents possible. We will review the development path and current iteration of the All of Us Research Program’s self-navigable, electronic informed consent process.

A former botanist and middle school teacher, Megan Doerr joined the genetic counseling community in 2006. Meg led the clinical development and implementation of Cleveland Clinic’s family history and risk assessment tool before joining the Governance team at Sage Bionetworks in 2015. At Sage, Meg’s efforts have been concentrated on supporting innovative, participant-centric approaches in open science. Her work has a strong focus on app-based research, including the ELSI issues associated with informed consent, research participation, and data sharing for secondary use in entirely remote, mobile platform-based research studies including for the All of Us Research Program.