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Integrating a Federated Healthcare Data Query Platform With Electronic IRB Information
Systems
Shan HeIPHIE 2010
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Background
• Clinical research – Investigating new approaches to
treatment, cure and prevention of diseases
– Important in improving the quality of heath care
• Breakthroughs in basic research• Translate basic research
breakthroughs to clinical practice – Require clinical research involving
human subjects
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Human Subject Protection
• Department of Health and Human Services’ Protection of Human Subjects (Title 45 CFR part 46, Common Rule)
• Food and Drug Administration’s (FDA) Protection of Human Subjects Regulations (Title 21 CFR part 50)
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HIPAA Privacy Rule
• Protected Health Information (PHI)– Individually identifiable health information that
is transmitted or maintained in any form or medium (electronic, oral, or paper) by a covered entity or its business associates
• Limited access to PHI– Authorization from research subject– Waiver or alterations of Authorizations by an
IRB/Privacy Board
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HIPAA Privacy Rule and Research
• Clinical researchers require access to many sources of health information (e.g. archived medical records, epidemiological databases, tissue repositories)
• The Privacy Rule requires covered entities to obtain additional documentation from researchers before disclosing health information to them, and to scrutinize researchers' requests for access to health information more closely.
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Institutional Review Board
• IRB--committees that have been formally designated to review, approve and monitor any research involving humans
• The Common Rule requires IRB to conduct continuing review of research to ensure compliance of regulations
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Problem Statement
• Major challenges for IRBs during oversight of human subjects protection– Bureaucratic and time-consuming
review procedure– Difficulty of adequate continuing review
to ensure investigators comply with their approved protocols
– More complicate process of obtaining ethics review for multi-site studies
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Current Challenges
• Investigator– IRB application: inclusion and exclusion
criteria not explicit enough for IRB to make a decision
– Data request: separately submitted to a clinical data source administrator
• Data Provider– Required to make sure the investigator has
obtained IRB approval (and what has been approved)
• IRB– No control over the actual data access
process
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System Proposal
• Integrated system which interconnects a federated healthcare data query platform with electronic IRB systems– streamline the clinical research process– speed research initiation– increase efficiency and patient privacy
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Federated Healthcare Data Query Platform
• Researchers require data drawn from multiple sites and multiple data sources
• Federated Healthcare Data Query Platform– Virtually integrate disparate data sources– Provide a unified query interface– A example: Federated Utah Research and
Translational Health e-Repository (FURTHeR)
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FURTHeR Overview
• Data sources to be integrated:– University of Utah Healthcare– Intermountain Healthcare– Salt Lake City Veterans Administration Medical
Center– Utah Department of Health– Utah Population Database (UPDB, an extensive
genealogic and demographic resource)
• Query interface (MyRA)– Aggregated count query– Detailed, federated results joining the query
results from each data source
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FURTHeR Security
• Protects patient health information and limits accessibility to authorized entities to ensure privacy
• A federated security model is complex– Confidentiality (e.g. message
encryption)– Integrity (digital signature)– Federated authentication– Federated authorization
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Federated Authorization
• Most complex component– Users from different institutions have
different roles; Each role has different defined privileges
– Simple role-based access control is not adequate for the federated query service to make the right authorization decision
– Regulatory compliance (protocol-specific authorization)
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System Architecture
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Implementation
• Service-Oriented Architecture (web service interface of ERICA)
• Message communication between FURTHeR and ERICA – Use the standard clinical study
information content currently being developed by HL7 Regulated Clinical Research Information Management (RCRIM)
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Discussion
• Integration with multiple electronic IRB systems– Implementation challenges
• Not the only safeguard mechanism to ensure information security and patient privacy– Other security steps should be
implemented together with IRB system integration
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Discussion
An obstacle for study investigators is the inability to recruit enough participants (public concern about privacy issues)
• The integrated system could provide the general public with an access interface to regulatory information of studies– Enhance public trust– Improve study enrollment
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Acknowledgments
• Committee– Dr. Scott Narus (PhD Committee Chair)
– Dr. John Hurdle– Dr. Jeffrey Botkin– Dr. Lee Min Lau– Dr. Julio Facelli
• Public Health Services research grant UL1-RR025764 from the National Center for Research Resources
• Contact– Shan He
Department of Biomedical Informatics, University of Utah [email protected]
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