Technology for Early Ethics in the Digital Age Awareness ...€¦ · in shaping the ethical conduct of ... Digital Age • Informed consent ... The Connected and Open Research Ethics
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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
Objectives
• Describe the changing landscape of 21st century research
• Identify key ethical challenges introduced by the use of new methods and tools.
• Describe stakeholders and their respective role in shaping the ethical conduct of 21st century research.
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
MISSTMobile
Imaging
PervasiveSensing
Location TrackingSocial MediaCopyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
MISST data collection methods introduce new ethical aspects
that are challenging researchers and Institutional Review Boards
(IRBs)
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Characteristics of 21st Century Research
• Research participation can be 24/7 on the fly and in real time.
• Research isn’t exclusively an academic venture - industry and non-profits are actively involved.
• We can now know ‘everything’ at a granular level using pervasive sensing technologies.
• Promising data anonymity is not realistic.
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Major Influences on HealthWe can capture how humans live, eat, sleep, consume media, move,
behave at home and make inferences about them.
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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
Ethical Challenges in the Digital Age
• Informed consent: Do people have sufficient technological literacy to comprehend the type and quantity of data?
• Risks and Benefits: How are IRBs evaluating the probability and magnitude of harm or benefits?
• By-Catch: What about the rights of bystanders (i.e, audio/image recording) - should the IRB have oversight?
• Data Management: What standards for data storage, security and sharing should we use when not covered by HIPAA?
Copyright 2016 The Regents of the University of California. All rights reserved.
Design Thinking Approach
Ideate
DefineEmpathize
Repeat Prototype
Test
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How Might We…
• Redesign the consent form and process?
• Empower researchers to protect participants?
• Learn from our efforts to protect participants?
• Make the IRB system more efficient?
• Help IRBs review new forms of research enabled by technological advances?
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Imagine a Different System …Time for a Paradigm Shift?
• Do we keep the existing system?
• Do we transition to a new model?
• Do we create a hybrid?
• Can we design a system that is responsive to both academic and corporate researchers?
• Who should be involved in deciding?
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 10
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
Imagine a Human Research Protection System Responsive to 21st Century Science
• Can we design a system that is responsive to stakeholders?
• Do we keep the existing system?
• Do we transition to a new model?
• Do we create a hybrid?
• How to initiate a societal conversation?
A paradigm shift is a change in how we think about something that is advanced by stakeholders
(T. Kuhn, 1962)
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
inadequate
RWJF Commissioned
Stakeholders Shaping 21st Century Research Ethics
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1 2 3 4Tool Makers Human Subjects Researchers IRBs
make innovative technologies used in health
research.
participate in research studies and contribute data to advance
knowledge
conduct health studies using 21st century
tools/methods.
reviews research risks and benefits
to make sure participants are protected from
harm.
Stakeholder-engaged Participatory Research Approach
IRB Researchers
+
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Formative Research Engaging Researchers and IRBs
• What are the risks?• How to stay current?• Dynamic solutions?
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
What Stakeholders Say…
• 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
A solution:
The CORE Platform where stakeholders can access the Q&A Forum,
contribute to dynamic “best practices” within our Resource Library and
Network with experts to facilitate the ethical design
and review of MISST research.
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
What can CORE do?IRBs and Researchers using
MISST tools/methods
Q&A ForumResource Library
Network members post questions & share expertise
Collect and curate best practices including IRB
approved research protocols and informed consent
language
NetworkConnect stakeholders including researchers,
privacy experts, technologists, ethicists,
regulators & participants
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
CORE Benefits
• Assist researchers to design ethical research• Assist IRBs in the timely and relevant review • Potential application to other emerging fields (i.e.,
‘omics’)• Credible resource for diverse research organizations
• Academic
• Industry
• CommunityCopyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Join the CORE Network:
thecore.ucsd.edu/network
thecore.ucsd.eduthecore-platform.ucsd.edu@UCSDtheCOREthecore@eng.ucsd.edu
View CORE Tutorial:
bit.ly/COREtutorial
Copyright 2016 The Regents of the University of California. All rights reserved.
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.
Evaluate the CORE functionality and utility.
Background
Methods
Analysis & Results
Conclusion
Formative Research:
• Risk identification, strategies, platform requirements
Design & Build
Test and Improve
Objective
The CORE Platform is where stakeholders can access a Q&A Forum, contribute to dynamic “best practices” within a Resource
Library and Network with experts to facilitate the ethical design and review
of MISST research.
Copyright 2016 The Regents of the University of California. All rights reserved.
Driven by Participatory
Action Research
thecore.ucsd.edu @UCSDtheCORE
Support provided by
PI: Camille Nebeker Co-Investigators: Cinnamon Bloss, Nadir WeibelProject Manager: Araceli López-ArenasStudents/Trainees: Rasheed Al Kotob, Vincent Chan, Sarah Dunseath, Rebeca Giacinto, Lynn Hao, John Harlow, Michelle Takemoto.
Network
Interdisciplinary expertise (i.e.,research, privacy, technology,
regs.)
Industry
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
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