Shaping Ethics in the Digital Age - Connected and Open Research Ethics (CORE)

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

http://thecore.ucsd.edu

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


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



http://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



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.



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


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



Sensing Methods


Passive, Pervasive, UbiquitousWith permission of Dr. Todd Coleman, UC San Diego Professor of and CORE Advisor


Commercial Products


New challenges when products are used as research tools


New Methods Produce Granular Data

• Volume

• Personal and Private

• Lacking data management standards


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


NPRM for Revisions to the Common RuleHHS Announces Proposal to Improve Rules Protecting Human Research Subjects



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



Formative Research with IRBs

• Capacity Overload• Lack of Expertise• Arbitrary and Inconsistent Decisions• Lack of Evidence Base• Unfamiliar with MISST Tools/Methods



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


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

+



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



Engaging Participants as Research Partners – Bridging CORE with BRIC

IRB Researchers

+


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?



Like This?



Or This?



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



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



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%




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




• 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)?


Building Research Integrity & Capacity



Building Research Integrity and CapacityBRIC Online: http:bric.ucsd.edu




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



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



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



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



Democratization of Research

IRB Researchers

+Participants

+



Bridging CORE and BRIC = Participants as Partners



Next Steps …



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.

http://thecore.ucsd.edu/network


http://thecore-platform.ucsd.edu

mailto:[email protected]?subject=

Education

Shaping Ethics in the Digital Age - Connected and Open Research Ethics (CORE)