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Data Warehouse and Incidental Findings_Slides_AC_2-21-14


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Research Ethics Forum
Is Keck Ready to be a 21st Century Academic Medical Center?
Topics: Data warehouses, incidental findings, secondary findings

1. What makes this lecture valuable and helpful?
Clinical and translational research—from basic understanding of disease etiology to evaluation of clinical practices and population health—will increasingly depend on analyzing “big data” drawn from the extensive information gathered from clinical care and research interventions and stored by medical centers. When combined and organized into registries, repositories, databases, and “data warehouses,” such compilations of data and biological samples have the potential to accelerate a wide range of research. As the Keck Medical Center prepares to establish such a data warehouse, all medical practitioners at Keck will in effect become part of the center’s research enterprise.

2. What does it teach viewers and how does it help them do their research?
Viewers of this “Ethics Forum” will learn about the steps underway at Keck to establish a data repository to facilitate research and about how people using that repository—just as researchers using existing registries—will face questions about having identifiable versus anonymized samples, about the debate over using “opt out” versus “opt in” to enroll patients into clinical databases, and about the dilemmas that can arise when researchers return the results of research studies (as opposed to validated clinical test results) to patients or turn up a finding that was not merely incidental to the purpose of the study they were conducting but actually unanticipated as a possible result.

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Data Warehouse and Incidental Findings_Slides_AC_2-21-14

  1. 1. IS KECK READY TO BE A 21ST CENTURY ACADEMIC MEDICAL CENTER? Research  Ethics  Forum   Friday,  February  21,  2014     12:00  PM  -­‐  1:00  PM       PANELISTS   Stephen  B.  Gruber,  MD,  PhD,  MPH     Director,  USC  Norris  Comprehensive  Cancer  Center     Professor  of  Medicine,  KSOM     Joshua  Lee,  MD   Chief  InformaPon  Officer,  Keck  Medicine  of  USC     Senior  Vice  President  for  USC  Health       MODERATOR   Alexander  M.  Capron     Director  of  Ethics,  ECDE,  SC  CTSI     Professor  of  Law  and  Medicine,  KSOM              
  2. 2. TERMINOLOGY •  Data  Warehouse   o  o  o  o  Clinical  records   Research  records   Biological  samples   Return  of  results   •  Types  of  Incidental  Findings   o  o  An=cipatable  vs  Unan=cipatable  (based  on  current   scien=fic  knowledge)   Secondary  finding  (ac=vely  sought        but  not  primary   finding)  
  3. 3. QuesPons?   SC  CTSI   hGp://sc-­‐   (323)  442-­‐4032   info@sc-­‐