Utah Resource for Genetic

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• Utah Resource for Genetic
• and Epidemiologic Research
• (RGE)
• Jahn Barlow, MPA
• Director

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Utah Resource for Genetic and Epidemiologic
Research

• 1982 Executive Order of Governor established RGE
• A data resource for the collection, storage,
  study and dissemination of medical and related
  information for the purpose of reducing morbidity
  
• 2003 Utah State Code 26-15, modified to increase
  confidentiality of familial and other information

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Utah Population Database (UPDB)

• University of Utah research resource
• Over 30 years of research
• Over 9 million records
• 78 approved projects

http//www.hci.utah.edu/groups/ppr/
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Sources for Data
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UPDB Resource

• Conduct studies that require individual and
  familial data
• Family histories
• Genealogy records from the Family History Library
• Family reconstitution
• Create maternal and paternal birth histories
• Link across generations
• As many as 11 generations for some families

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Utah Family, Circa 1900
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3
10
2
12
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F
M
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1
4
Father (F), Mother (M) and children by birth
order Married 1853, 12 Children, 3 Infant deaths
(6, 9, 11)
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Utah Family in UPDB
Maternal side
Paternal side

• Spans 11 generations from 1807 to 2005
• Couple (in picture) 4,289 descendants (3,821
  living)
• Paternal side 6,510 descendants (5,714 living)
• Maternal side 19,350 descendants (16,973 living)

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UPDB Sources of Medical Information

• Utah Cancer Registry (UCR) state wide since 1966
• NCI Seer registry since 1973
• 88 link 64 in 2 or more generation families
• Cancer Data Registry of Idaho statewide since
  1969
• Cause of death on Utah death certificates
• Birth details on Utah birth certificates
• Utah Birth Defects Network (1994 forward)
• 99.7 link and 70 with one or more grandparents
  in UPDB

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UPDB Sources of Medical Information

• New collaboration with Utah Department of Health
• Health claims dataset from 1996 to present
• Hospital Inpatient Discharge 2.7 million
• Ambulatory Surgery- 2.5 million
• Emergency Department Encounters- 6.3 million

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Sources of Medical Information

• Research Infrastructure - Master Subject Index
• U of U Health Sciences Center (UUHSC)
• Matched over 1.0 million (70) patient
  demographic records from the Enterprise Data
  Warehouse (EDW)
• 23 projects
• Huntsman-Intermountain Cancer Care Program
• Agreement signed 2007
• Linking 5.3 million patient demographic records
  in the Intermountain Enterprise Data Warehouse to
  UPDB

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Access to UPDB

• Approval of the RGE Review Committee
• Representatives of the data contributors
• Veto authority over use of their data
• University faculty knowledgeable about UPDB and
  genetic research
• Approval of the Institutional Review Board(s) of
  the sponsoring institution(s)
• Data Transfer Agreement for researchers not
  affiliated with the University of Utah

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RGE Review

• Appropriate Use of the Data
• Is the data available from the sources requested?
• Bona Fide Research (not just clinical care)
• Scientific Justification
• Privacy and Confidentiality

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RGE Review

• Identifying Data
• De-identification data more difficult to achieve
  with familial studies
• Publication Review
• Justification for access to identifying data
• Requires an investigator affiliated with a Utah
  institution of higher education or a Utah
  non-profit medical research institution
• Personnel with access to identifying information
  should be kept to the minimum necessary to
  accomplish the project

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RGE Review

• Procedures for Contacting Individuals
• Initial contact by a third party (treating
  physician, data contributor or RGE)
• Request permission to release name and contact
  information to researcher
• Only individuals diagnosed with a disease or
  condition are contacted for genetic studies
• Unaffected family members are recruited through
  the probands

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RGE Review

• Data Security Administration
• What department or group will have administrative
  responsibility for the computers on which UPDB
  data will be stored?
• Where will the computers be physically located?
  (building and room number)
• Who within the department or group has managerial
  responsibility for the physical and technical
  security of these computers?
• What are the back-up policies for these
  computers? (Where are back-up copies of the data
  stored, including any off-site storage?)
• If any data is to be transferred, what is the
  method for transmittal?

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RGE Review

• Standard Procedures for Data Security Physical
  Security
• Inform RGE in writing of any changes in the
  administrative responsibility or the physical
  location of the computer(s) on which UPDB data is
  stored
• Report any suspected or known security breach of
  computers housing UPDB data to RGE within 24
  hours
• Submit to unannounced audits of UPDB data on
  project computers
• Obtain permission from RGE before transferring
  any UPDB data outside of the performance site(s)
• House computers, data files, remote terminals,
  computer tapes and printers in a secured facility
  (locked rooms accessible only by authorized
  personnel). Storage of UPDB data on laptops,
  compact disks, or other portable storage devices
  is prohibited.

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RGE Review

• Standard Procedures for Data Security Personnel
• Maintain a current list of all personnel with
  access to UPDB data
• Submit an updated list of such personnel to RGE
  at least annually
• Require that all personnel with access to UPDB
  data sign and submit RGE Confidentiality
  Agreements
• For each user of the data, authorize a unique
  user name and password which allows access only
  to files and records for which the user has been
  approved
• Ensure that data access is revoked for personnel
  no longer working on the project

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RGE Review

• Standard Procedures for Data Security
  Identifying Data
• All identifying information stored electronically
  will be kept separate from other project
  information
• ID numbers replace identifying information when
  labeling specimens for laboratory work and for
  the use of protected data by collaborators at
  other institutions

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RGE Review

• Relationships with for-profit companies
• Who is sponsoring the research?
• Projects supported by for-profit companies must
  have provision for a principal investigator at
  the University of Utah
• Do any personnel have any relationship with a
  for-profit company that might have an interest in
  the research?
• No direct access to UPDB data by a for-profit
  company
• No identifying information can be provided to a
  for-profit company
• No contact of individuals by a for-profit company
  or its employees

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RGE Review

• Data returned to RGE by the project
• Names and addresses
• Birth and death dates/places
• Family relationships
• Flag indicating if a biospecimen has been
  collected
• No medical or health information

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RGE Review

• Plan for Disposition of Data
• Destroy data
• Return data to RGE for long-term storage