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