This document discusses several bioethical issues related to genomics and electronic health records. It touches on the challenges of linking disparate health datasets while protecting patient privacy. It also examines the blurring lines between clinical care and research when using individuals' health information. Specifically, it raises questions around informed consent, transparency, justification for using data, and ensuring adequate confidentiality. The document also explores issues of trust in different contexts and public concerns about the use of newborn screening samples in research. Finally, it discusses developing policy around "information commons" and engaging stakeholders to help shape biorepository research standards.

1. Bioethical Issues in Genomics
and Electronic Health Records
Wylie Burke MD PhD
Department of Bioethics and Humanities
University of Washington
2013-14 Presidential Chair
University of California San Francisco

2. 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

5. 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)

6. 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

7. Public campaigns against research use
of newborn screening samples
http://www.cchfreedom.org/issue.php/14#.U01sHtyuJTk

8. “Information commons” policy questions
 Consent
How much choice can and should patients have?
Can health data be uploaded without consent?
 Governance
Who 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?
 Communication
What information is owed to people whose data
are included?

9. EngageUC:
Engaging University
of California
Stakeholders for
Biorepository
Research
Daniel Dohan PhD
Elizabeth Boyd PhD
Barbara Koenig PhD
Jen Hult, MPH
Sarah Dry, MD
Arleen Brown MD

10. 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

11. 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

12. Areas of persistent disagreement
(partial list)
 How community should be represented
 Whether leftover samples can be used
without consent
 Scope of data-sharing

13. Methods development for
ethical policy-making
 Meaningful ways to engage public
discussion
 Innovative stewardship models
 Mechanisms for accountability