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Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Shaping Research Ethics in the Digital Age
Connected and Open Research Ethics
Copyright 2016 The Regents of the University of California. All rights reserved.
thecore.ucsd.edu @UCSDtheCORE
OHRP/HHCFoundations of Trust: Connecting our Community to ResearchOctober 25, 2016
Assistant Professor of Behavioral Medicine Family Medicine & Public Health | School of MedicineCenter for Wireless & Population Health Systems | Qualcomm Institute UC San Diego
Camille Nebeker, Ed.D., M.S.
CAPRI :Collaborative for Advancing Professional and Research Integrity Disclosure
The Connected and Open Research Ethics (CORE) initiative is building a national resource to support the ethical design and responsible review of research studies that utilize emerging technologies. The CORE is supported by a grant from the Robert Wood Johnson Foundation and the UC San Diego Chancellor’s Interdisciplinary Collaboratory Fellowship Award.
@UCSDtheCORE | thecore.ucsd.edu
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
The Building Research Integrity & Capacity (BRIC) programs promote research integrity by educating “research” Community Health Workers (CHWs)/Promotores about the scientific method and human research ethics. The BRIC programs have received support from the NIH, ORI and UC San Diego’s CTRI.
@UCSD_BRIC | bric.ucsd.edu
Objectives
• Describe the changing landscape of 21st century research
• Identify key challenges introduced by emerging technologies
• Know stakeholders and their respective roles in shaping ethical research
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Major Influences on Health
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 5
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
MISSTMobile
Imaging
PervasiveSensing
Location TrackingSocial MediaCopyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Characteristics of 21st Century Research
• We live in an increasingly smart and connected environment and research methods and tools are changing.
• Research participation is no longer discrete or circumscribed.
• Now participants can be monitored and/or intervened with 24/7, on the fly and in real time.
• Research isn’t exclusively an academic venture – industry and non profits are in the game.
• We can now know ‘everything’ at a granular level using new digital, wearable technologies.
• Promising data anonymity may not be realistic.
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 7
The Apple Watch Use Case• NIH-funded Research
• Participant ‘free-living’ activity is recorded for 7-days using:
• A wearable camera called SenseCam
• An accelerometer and ActivePAL
• A Global Positioning System (GPS) location tracker
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 8
Wearable GPS, accelerometer and camera image courtesy of B. Lewars National Cancer Institute – J. Kerr, PI, Validating Machine-Learned Classifiers of Sedentary Behavior and Physical Activity Grant # R01CA164993
Social Media Methods
Social networks are used to observe patterns and predict behaviors
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 9
Sensing Methods
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 10
Passive, Pervasive, UbiquitousWith permission of Dr. Todd Coleman, UC San Diego Professor of and CORE Advisor
Commercial Products
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 11
New challenges when products are used as research tools
New Methods Produce Granular Data
• Volume
• Personal and Private
• Lacking data management standards
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 12
National Cancer Institute – J. Kerr, PI, Validating Machine-Learned Classifiers of Sedentary Behavior and Physical Activity Grant # R01CA164993
Ethical Challenges in the Digital Age
• Informed Consent: How can we make consent more informed?
• Risks and Benefits: How should the probability and magnitude of benefits or harm be determined?
• By-Catch: What about the rights of by-catch (i.e., audio and image recording)?
• Data Management: What standards for data storage, security and sharing should we use when not under HIPAA?
Exploring challenges …
MobileImagingSensingSocialTrackingEthicsMISST-E
Against a Complicated Landscape
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 14
NPRM for Revisions to the Common RuleHHS Announces Proposal to Improve Rules Protecting Human Research Subjects
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Empirical 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
Nebeker, C. et al. (2016 ) Engaging participants to inform the ethical conduct of mobile imaging, pervasive sensing and location tracking research, Translational Behavioral Medicine: Practice, Policy and Research doi:10.1007/s13142-016-0426-4
Nebeker, C., Murray, K.E., Holub, C., Haughton, J., and Arredondo, E. (forthcoming). Bridging the digital and cultural divide in mHealth: Concerns of ethnically diverse participants and recommendations for researchers and institutional review boards
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):118-137Dunseath, S., Bloss, C., Weibel, N., Nebeker, C. (forthcoming).
• Funding Sources• Level of
Support• Research
Themes• Institutions• Investigators
Ecosystem
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Formative Research with IRBs
• Capacity Overload• Lack of Expertise• Arbitrary and Inconsistent Decisions• Lack of Evidence Base• Unfamiliar with MISST Tools/Methods
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)
Stakeholders Shaping 21st Century Research Ethics
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE 18
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.
CORE MethodologyStakeholder-engaged Participatory Research Approach
IRB Researchers
+
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
CORE FeaturesStakeholders in MISST
ecosystem have access to…
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
Engaging Participants as Research Partners – Bridging CORE with BRIC
IRB Researchers
+
Copyright 2016 The Regents of the University of California. All rights reserved.thecore.ucsd.edu @UCSDtheCORE
Participants
+
Building Research Integrity and CapacityBRIC for Communities
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
What do researchers look like?
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Like This?
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Or This?
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Who are Community Health Workers (CHWs)/ Promotores de Salud?
…lay members of communities who work either for pay or as volunteers in association with the local health care system in both urban and rural environments and usually share ethnicity, language, socioeconomic status and life experiences with the community members they serve.
USDHHS. Community Health Worker National Workforce Study. Washington, DC: USDHHS, Health Resources and Service Administration; 2007.
Promotor(a) Community Health Advisor Lay Health Advocates
Outreach EducatorsPatient NavigatorResearch CHW/Promotora
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Role of CHWs/Promotores in ResearchThe intent of community engaged research is to transform research from a relationship where researchers act upon a community to one where researchers work with community members to:
• define the questions and methods
• implement the research
• disseminate the findings
• apply findings
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Role of CHWs/Promotores in Research•Numbers (in 2000)
•US: ~ 86,000•California: ~8,000
•Gender•Female: 82%
•Ethnicity•Latino/Hispanic: 35%•Non-Hispanic White: 39%
•Age •30-50: 55%
USDHHS. Community Health Worker National Workforce Study. Washington, DC: USDHHS, Health Resources and Service Administration; 2007.
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
C3 Report• Since 1998, new roles
• Implementing Individual and Community Assessments
• Participating in Evaluation and Research
• Need for professional development• Reduce threats to data fidelity• Increase research integrity
USDHHS. Community Health Worker National Workforce Study. Washington, DC: USDHHS, Health Resources and Service Administration; 2007.
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
• What competencies do Research CHWs/Promotores need to carry out their work?
• How should these competencies be assessed?
• Does BRIC training improve learning about research when compared to a control condition (i.e., mental health training)?
USDHHS. Community Health Worker National Workforce Study. Washington, DC: USDHHS, Health Resources and Service Administration; 2007.
Building Research Integrity & Capacity
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Building Research Integrity and CapacityBRIC Online: http:bric.ucsd.edu
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
BRIC Modules• Module 1: Introduction: What is Research?
• Module 2: Research Design
• Module 3: Elements of Research
• Module 4: Methods of Information Collection
• Module 5: Handling Information
• Module 6: Introduction to Human Research Ethics
• Module 7: Research Risks and Benefits
• Module 8: Informed Consent in Research
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Capacitación en Ética y Estándares de Investigación: Una Guía Interactiva para Promotores
Selección y Asignación Aleatoria
Selección Aleatoria Asignación Aleatoria
• El proceso de selección de un grupo de individuos a partir de un grupo mayor de participantes en un estudio.
• Cada persona tiene la misma oportunidad de ser seleccionado, lo que permite que cada uno tenga la misma oportunidad de participar.
• Un procedimiento utilizado en experimentos para crear grupos de estudio con características similares de manera que los grupos sean equivalentes al inicio de la investigación.
Elementos de la Investigación
Personas Elegibles
Asignación Aleatoria a Intervenciones
Intervención A Intervención B Intervención C
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
BRIC RCT Results• BRIC (intervention) vs. mental health training (control)• N = 43; South Bay San Diego
• Selection criteria:• CHW/Promotor(a)• Interest in learning research ethics• Spanish fluency
• Assessment• Research Competencies• Knowledge• Community Examples
BRIC vs. Control Group Mean Scores
0
10.3
20.5
30.8
41
BRIC Control
40.54139.4
36.3
Pre Post
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Project BRIC Early Adopters• DOR: CaPROMISE/Interwork Institute, SDSU, RCT focusing on special needs
youth• NCI - U54: MCC/Institute of Behavioral and Community Health, SDSU.Cancer
research foci on Latino community health• NCI and CTRI: PIC-Health, Pacific Islander Community Health, CSU San Marcos
and Rawmana Fitness• NCI: Hawaash pilot study, City Heights/Somali Refugee CBPR study on nutrition• NIH: ESPINA – UC San Diego and Cimas del Equador study of pesticide
exposure on child/adolescent development • NIDDK OBY25 – UC San Diego and 4 global sites to gather data on kidney
disease and intervention feasibility
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Democratization of Research
IRB Researchers
+Participants
+
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Bridging CORE and BRIC = Participants as Partners
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Next Steps …
Copyright 2016 The Regents of the University of California. All rights reserved.bric.ucsd.edu @UCSD_BRIC@cnebeker
Join the CORE Network:
thecore.ucsd.edu/network
thecore.ucsd.eduthecore-platform.ucsd.edu@[email protected]
View CORE Tutorial:
bit.ly/COREtutorial
Copyright 2016 The Regents of the University of California. All rights reserved.