Copyright 2016 The Regents of the University of California. All rights reserved. thecore.ucsd.edu @UCSDtheCORE Technology for Early Awareness of Addiction and Mental Illness (TEAAM-I) New York City October 14, 2016 Ethics in the Digital Age Camille Nebeker, Ed.D., M.S. Assistant Professor of Behavioral Medicine Family Medicine & Public Health | School of Medicine Center for Wireless & Population Health Systems | Qualcomm Institute UC San Diego
Transcript
Copyright 2016 The Regents of the University of California. All rights reserved.
thecore.ucsd.edu @UCSDtheCORE
Technology for Early Awareness of Addiction and Mental Illness (TEAAM-I) New York CityOctober 14, 2016
Ethics in the Digital Age
Camille Nebeker, Ed.D., M.S. Assistant Professor of Behavioral Medicine Family Medicine & Public Health | School of MedicineCenter for Wireless & Population Health Systems | Qualcomm Institute UC San Diego
Major Influences on HealthWe can capture how humans live, eat, sleep, consume media, move,
behave at home and make inferences about them.
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 6
Image courtesy of Dr. Kevin Patrick, Principal Investigator of the Health Data Exploration Project and Director of the Center for Wireless and Population Health Systems
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Bridging the Gap in Research Ethics
• Consent• Device
Experience • Privacy• By-catch• Censor Practice
• Barriers to use of wearable tech • Somali/Refugee• Latino • Native Hawaiian/
Pacific Islander
• Risk/Benefit Assessment
• Risk Management
• Consistency
Apple Watch Exit Survey
Participant Perspectives?
Digital Divide
Cultural Differences?
IRB Review
Consistent?
Nebeker, C., Linares-Orozco, R., & Crist, K., (2015). A multi-case study of research using mobile imaging, sensing and tracking technologies to objectively measure behavior : Ethical issues and insights to guide responsible research practice. Journal of Research Administration 46(1):118-137.Nebeker, C. et al. (2016 in press) Engaging participants to inform the ethical conduct of mobile imaging, pervasive sensing and location tracking research, Translational Behavioral Medicine: Practice, Policy and Research
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Challenges and Recommendations for Reform...
• Disproportionate focus on consent forms • Lack of alignment with social science
researchers • Economically inefficient• Multi-site issues• Lacking performance and effectiveness data • Deficient monitoring of approved studies • Underfunded and understaffed • Inefficient systems to report adverse events• Varied expertise among IRB members• Ethics training required for researchers is
• Crowdsource guidance and expertise• Reduce inconsistent IRB risk assessment• Innovate the informed consent process• Engage participants in the process• Create standards for sharing and securing
personal health information
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Mobile Imaging, pervasive Sensing, Social-media and location Tracking (MISST) data collection methods are challenging researchers and Institutional Review Boards (IRBs) due to new ethical, legal and social implications (ELSI) introduced. The Connected and Open Research Ethics (CORE) project is working with stakeholders, including IRBs and
researchers, to address these challenges.
Qualitative research methods are being used to guide the CORE content and functionality. Stakeholders are active participants in this process.
• Stakeholders (i.e., IRB affiliates, researchers) are contributing to the CORE design.
• Six focus groups were conducted with IRB stakeholders in fall 2015.
The CORE platform will host a discussion forum to facilitate stakeholder dialogue. Likewise, a library of resources (i.e., protocols, consent language) will be accessible to stakeholders designing or reviewing MISST-related research studies.
• Audio recordings were transcribed and analyzed using qualitative methods.
• A growing demand for greater guidance and expertise to inform protocols and best practices for research involving MISST technologies.
• Challenges included unfamiliarity with MISST technologies and related difficulties determining the potential risks to research subjects.
IRB Researchers
+
Stakeholder-engaged participatory
approach
Deliverables
IRBs and Researchers using MISST methods
Q&A Forum
Resource Library
IRBs & Researchers share questions/expertise
House best practices (i.e., protocols and consent language)
National resource
Credible resource for diverse research organizations
Facilitate ethical design and review of MISST research
Potential application to other emerging fields (i.e., ‘omics’)
Academic
Community
Benefits
Use results to inform scaling and sustaining
Co-design and build the CORE prototype platform that will house MISST resources.
