THIS IS A THURSDAY MEETING
TOPIC: eConsent and Mobile Health Research
TOPIC DESCRIPTION: Mobile technologies have the potential to revolutionize both the way in which individuals monitor their health as well as the way researchers are able to collect frequent, yet sparse data on participants in clinical studies. In order for data from these devices to have maximal impact in a research setting however, the development of systems to collect, manage, and broadly share these data is essential. Possibly more important are the social constructs on which these systems need to be built to allow maximal utility to come from these data while minimizing adverse impact on individual participants. More specifically, the union of these systems and constructs must be an ecosystem build upon trust. We will present one such ecosystem focused on putting the participant at the center of the data collection: specifically by acknowledging possible risks to both individual participants as well as sub-populations of participants, providing opt-in settings for broad data sharing, and the development of an open research ecosystem built upon a social contract between researchers and research participants. A case study of one such mHealth study, leveraging Apple’s ResearchKit framework, will be presented and discussed.
SPEAKERS: Megan Doerr and Brian Bot
SPEAKERS BIOGRAPHIES:
Megan Doerr: A former botanist and middle school teacher, Meg 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.
Brian Bot: Brian Bot is a Principal Scientist and leads Outreach and Strategic Development at Sage Bionetworks in Seattle, WA. Previously, he worked for seven years as a statistician at the Mayo Clinic. His current work aims to make the biomedical research system more effective by challenging the traditional roles of researchers, institutions, funders, and research participants. At its heart, this work is rooted in building trust between these parties as well as with the public at large.
WHO: Clinical, regulatory, quality, manufacturing and legal
This meeting includes:
- Coffee and tea
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification