Tue Ses 2 - caBIG Annual Meeting 2008 DSIC OCTRI_panel by xiagong0815


									A Data Sharing Use Case: Oregon
Clinical and Translational Research
Institute (OCTRI)

Data Sharing and Intellectual Capital (DSIC) Panel
Shannon McWeeney, PhD (OCTRI)
Pierre La Chance (OCTRI)
Lewis Frey, PhD (Huntsman Cancer Institute)
Sarah Greene, MPH (Group Health Center for Health Studies)
Kerry Rowe, PhD (Intermountain Healthcare)

Moderator: Paul K. Courtney, MS (Booz Allen Hamilton)

caBIG 2008 Annual Meeting
June 24, 2008
OCTRI Overview

Oregon Clinical and Translational Research Institute (OCTRI)

    •   CTSA partnership between Oregon Health & Science University (OHSU) and
        Kaiser Permanente Center for Health Research (KPCHR)
    •   Public/Private Partnership
    •   Affiliation with Kaiser Permanente Northwest (Oregon, Washington, Hawaii)
        OCTRI provides:
    •   Centralized resources for translational research (space, equipment, funding,
        professional resources)
    •   Educational resources to promote translational research
    •   Coordinated core research tools (bioinformatics, biostatistics, core labs, translation
        of research into practice and policy, community research opportunities,
        administrative/compliance support)
    •    Funding to promote translational research with emphasis on multidisciplinary
    •   Development of Virtual Data Warehouse (VDW)
Virtual Data Warehouse (VDW)

   What is the VDW?

• Provides, for research use, access to clinical data generated from
  OHSU and KPNW clinical facilities as well as data previously collected
  for research purposes
• VDW is the process by which clinical and research data from OHSU
  and KPNW are extracted by staff at the respective institutions and
  combined (if appropriate) into a dataset for provision to an investigator
  for a research project with appropriate IRB and Privacy Board (HIPAA)
• Rationale: In competitive funding climate, VDW is a more efficient
  infrastructure that can be easily adapted to evolving compliance
  mandates to allow us to handle information safely

      Future                     Integratable and shareable across CTSA

                   Shareable across Institutions in compliance with governance rules

                          KP                                          OHSU
                                            Integrated Data           Only
                          Programs to acquire identifiable data, meta data,
                                    and deidentified data cubes

                     KP Local Only                            OHSU Local Only

      Data Warehouse

      OPS Data

      OPS level Data
VDW Data Sharing Issues

• IRB issues (i.e. inclusion in informed consent re.
  data release, OR genetic privacy law, etc.)
• Privacy/Confidentiality issues
• Proprietary issues (public vs. private institution)
• Security (how is data transferred to requestors?)
• Sponsor data restrictions
• Multi-site patient identification
The Cancer Connection

• OCTRI – OHSU Cancer Institute Integration has been a
  focus since the CTSA award was announced
• KPNW has strong oncology program, as well as key
  role in Cancer Research Network (CRN)
• Excellent use cases of VDW in cancer already: CRN
  Cancer Counter
• Potential for integration/evaluation of caBIG tools and
  frameworks in CTSA
   • Overlay of DSSF on OCTRI example
The DSIC Framework as Decision Tool

                                                                                                                                                                                        Specific permission required
                                                                                                                                                                                           for any redisclosure.

                                                                                                                         Is data contributed to                                            May be released with
                                                                                                                         the dataset subject to
                                                                                                                          sponsor restrictions
                                                                                                                                                                                           appropriate security/
                                                                                                                            on redisclosure?                                                   protections.

                                                                                                                                                                                          May be shared without
   PHI is defined at 45 C.F.R.                Does the dataset
   § 160.103:                                                                                                       No privacy concerns unless
                                              exclude all PHI (is
   http://tinyurl.com/33q2cl     ?                                           Y                                     state law or institutional policy
                                                it completely
                                                                                                                  is more restrictive than HIPAA.

                                                                                                                                                                                      Project-specific IRB
                                                       N                                                                                                                              approval required.
                                                                                                                                                       Prospective collection
                                                                                                                                                       or consent restrictions
                                                                                                                                                       apply to retrospective
   An LDS is defined at 45
   C.F.R. § 164.514(e)(2):                     Does the dataset                                                             What human
   http://tinyurl.com/37zhmx.    ?            qualify as a limited           Y
                                               dataset (“LDS”)?                                                          restrictions apply?
                                                                                                                                                   Retrospective use of
                                                                                                                                                     data with no links;
                                                                                                                                                  or data collected under
                                                                                                                                                    ambiguous or silent
                                                                                                                                                   consents (vis. re-use)        IRB approval or exemption may be
                                                                                                                           No human subjects
                                                                                                                            or no engagement                                       required depending on level of
                                                                                                                           per OHRP guidance                                         identification and nature of
                                                       N                                                                                                                         agreements among data providers
                                                                                                                                                                                            and recipients.

                                                                                                                           No IRB review/

   NOTE: Although HIPAA
   arguably doesn’t regulate             Significant privacy concerns.
   genetic information, SNP          Subject authorization and contractual
   data even without names              restrictions are likely needed.
   or other direct identifiers
                                                                                                                  Characterize the type of data
   is considered identifiable
                                                                                                                    included in the dataset.
   and requires special
   protection even if no
   authorization is required..
                                                                                                           L1, L2, L3                                 L4
                                                                                                Raw, Normalized, or Segementation        Biomarkers, Molecular Targets

                                                                                                                                                Significant IP concerns. Release will require
                                                                      No IP concerns. Project publication policies may
                                                                                                                                               strict protections and may be delayed to secure
                                                                      require credit/acknowledgements to the project.
caBIG™ Data Sharing and Security Framework


    Economic/Proprietary/IP Value                     PrivacyConfidentiality//Security                                       IRB/Institutional Restrictions                                                     Sponsor Restrictions
       (Need for Protection from                              Considerations                                               (Human Subjects Considerations                                                        (Grant or Contract
     Institution or PI Perspective)                         (Legal/Regulatory)                                                         – Ethical)                                                              Terms and Conditions)

   Examples: is the data subject to a restrictive                                                                      Do your Institution's or IRB's policies or the applicable
                                                      Do federal or state law or your institution's                                                                                               Do terms and conditions in any sponsored agreements
    license? Is it related to an invention report                                                                    informed consent documents explicitly or implicitly restrict
                                                       policies prohibit or restrict disclosure?                                                                                               prohibit or restrict disclosure outside institution or to caGRID?
  you have or intend to file with your institution?                                                                       or permit disclosure (e.g., “no commercial use”)?

                                                                 De-Identified/                                                      Explicit Permission
                   None/Low                                    Anonymized Data                                           NA             for Registry                                         Possibly               No Restrictions
                                                                      Set                                                              Participation

                                                                                                                                                                                                                    Delays or Other
                    Medium                                                                                                            Policy Limitations                                                              Moderate
                                                                    Data Set

                                                                                                                                       Explicit Consent                                                               Classified
                       High                                     Identifiable Data                                                        Limitations/                                                               Research/Major
                                                                                                                                         Restrictions                                                                Restrictions

                                                       Oregon Privacy Law issue

              ALL of the following:                                                   ANY of the following:                                                                         ANY of the following:
              - no IP value                                                           - moderate IP value                                                                           - high IP value
              - low sensitivity data                                                  - moderate sensitivity data (e.g., LDS)                                                       - high sensitivity data (e.g., PHI)
              - no IRB restrictions                                                   - limited institutional or IRB policy restrictions                                            - significant IRB/consent restrictions
              - no sponsor restrictions                                               - moderate sponsor restrictions                                                               - major sponsor restrictions

                                                                                                                                                                                     Standardized Click-Through Terms and
                                                                                                Standardized Click-Through
                      General Website Terms of Use                                                                                                                                    Conditions or Individually Negotiated
                                                                                                   Terms and Conditions
                                                                                                                                                                                      Bi-Lateral or Multi-Lateral Agreement
OCTRI Discussion

• Request context
   • Annotations on top half of slide reflect preparatory research which
     can be grid-enabled
   • IRB-approved protocols
• Definitions
   • De-identification
        Issues: Which elements & by what method
        VDW        Extraction (by query)
• Historic context
   • Use of agreement on green-level data is historical due to non-NIH
     funding/proprietary model
• Variations
   • Biospecimens
   • Pharma sponsored data/specimens

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