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Bioethical Issues in Genomics and Electronic Health Records
Wylie Burke MD PhDDepartment of Bioethics and Humanities
University of Washington
2013-14 Presidential ChairUniversity of California San Francisco
The challenge…ethically and scientifically
“…big data becomes transformative
when disparate datasets can be linked
at the individual person level… [BUT]
big biomedical data are scattered
across institutions and intentionally
isolated to protect patient privacy.”
Weber et al JAMA 2014
Blurring the line between clinical care and research
Clinical information research Transparency /choices for opting out Justification for using health information Adequacy of confidentiality protection
Research information clinical care Therapeutic misconception Premature translation Participant rights
UCSF CT2G Working Group on Clinical-Research Interface (Koenig/Somkin)
Trust
Context specific… Whom do you trust to do what?
Who would you trust to handle your
money?
Take care of your child?
Use your personal health information?
Kohn M. Trust Oxforf Univ Press
Public campaigns against research use of newborn screening samples
http://www.cchfreedom.org/issue.php/14#.U01sHtyuJTk
“Information commons” policy questions
ConsentHow much choice can and should patients have? Can health data be uploaded without consent?
GovernanceWho decides about data access? On what basis?
Identification of use and mis-use:What kinds of audit trails are in place? Can mis-use be identified, with appropriate consequences?
CommunicationWhat information is owed to people whose data are included?
EngageUC: Engaging University
of California Stakeholders for
Biorepository Research
Daniel Dohan PhDElizabeth Boyd PhDBarbara Koenig PhD
Jen Hult, MPHSarah Dry, MD
Arleen Brown MD
What do Californians want from UC for biorepository research?
Deliberative Community Engagement Two events held, each with 27 random selected
deliberants, 4 days face-to-face, in LA (June 2013) & SF (September 2013)
Education: Briefing book, website, expert talks Deliberation: Facilitated small/large group
discussions, develop recommendations Recommendations: Endorse agreements,
identify disagreements, present results to other stakeholders
Areas of strong agreement (partial list)
Meaningful involvement of community in oversight
Public education and communication Monitoring and consequences for mis-use Clear consent forms, using simple
language
Areas of persistent disagreement (partial list)
How community should be represented Whether leftover samples can be used
without consent Scope of data-sharing
Methods development for ethical policy-making
Meaningful ways to engage public discussion
Innovative stewardship models
Mechanisms for accountability