CTSI Core Leaders Retreat 1 Committee on Human Research (CHR) Issues for Core Laboratories UCSF CTSI Core Leaders Retreat Elizabeth Tioupine, CIP Human Research Protection Program (HRPP) University of California, San Francisco November 6, 2007

CTSI Core Leaders Retreat2 Main CHR Issues Affecting Cores Does the Core itself need CHR approval? Does the Core itself need CHR approval? Does the investigator have appropriate CHR approval? Does the investigator have appropriate CHR approval? How does HIPAA and restricted access to identifiers affect the work Cores do for researchers? How does HIPAA and restricted access to identifiers affect the work Cores do for researchers? What do Cores need to do to maintain subject privacy and confidentiality of data? What do Cores need to do to maintain subject privacy and confidentiality of data?

CTSI Core Leaders Retreat3 Why Would a Core Need to Have its Own CHR Approval? The Core needs to have its own CHR approval that addresses receipt, processing, storage and distribution of identifiable data and specimens The Core needs to have its own CHR approval that addresses receipt, processing, storage and distribution of identifiable data and specimens Investigator Data & Raw Specimens In Core Receives Processes Stores Distributes Investigator Data & Assay Results/ Processed Specimens Out

CTSI Core Leaders Retreat4 Types of CHR Approval CHR reviewed and approved – will have a hyphenated approval number starting with “H” with date of approval (1 year approval) CHR reviewed and approved – will have a hyphenated approval number starting with “H” with date of approval (1 year approval) Exempt Certification – will have 8 digit number (3 year approval) Exempt Certification – will have 8 digit number (3 year approval) No CHR approval needed – when study doesn’t qualify as human subjects research based on CHR decision tree (PI may present Self- Certification Form for Sponsors) No CHR approval needed – when study doesn’t qualify as human subjects research based on CHR decision tree (PI may present Self- Certification Form for Sponsors)

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7 Definitions “Coded” “Coded” Data and specimens are associated with a unique code number; identifiers are retained separately and securely Data and specimens are associated with a unique code number; identifiers are retained separately and securely “De-identified” or “Anonymized” “De-identified” or “Anonymized” Data and specimens have been stripped of identifiers; no code exists to link specimens to identifiers Data and specimens have been stripped of identifiers; no code exists to link specimens to identifiers

CTSI Core Leaders Retreat8 18 Protected Health Identifiers Names Names Dates* Dates* Postal Address* Postal Address* Phone Numbers Phone Numbers Fax Numbers Fax Numbers Addresses Addresses Social Security Numbers Social Security Numbers Medical Record Numbers Medical Record Numbers Health Plan Numbers Health Plan Numbers Account Numbers Account Numbers License/Certificate Numbers License/Certificate Numbers Vehicle ID Numbers Vehicle ID Numbers Device Identifiers/Serial Numbers Device Identifiers/Serial Numbers IP Address Numbers IP Address Numbers Biometric Identifiers Biometric Identifiers Facial Photo/Images Facial Photo/Images Any Other Unique Identifiers Any Other Unique Identifiers *with some exceptions

CTSI Core Leaders Retreat9 Verification of CHR Approval The Core should request the CHR approval # and date of approval The Core should request the CHR approval # and date of approval If a project does not meet the definition of human subject research, the Core could ask the PI to submit the PI Self Certification Form If a project does not meet the definition of human subject research, the Core could ask the PI to submit the PI Self Certification Form Ultimate responsibility for obtaining appropriate CHR approval rests with Principal Investigator Ultimate responsibility for obtaining appropriate CHR approval rests with Principal Investigator

CTSI Core Leaders Retreat10 Working with Identifiable Specimens Request that specimens be labeled with a code, not direct identifiers Request that specimens be labeled with a code, not direct identifiers If you must receive identifiable specimens, assign a code number and remove direct identifiers as quickly as possible If you must receive identifiable specimens, assign a code number and remove direct identifiers as quickly as possible Store identifiable specimens securely Store identifiable specimens securely Store identifiers and code key securely and separately from research data Store identifiers and code key securely and separately from research data

CTSI Core Leaders Retreat11 UCSF Resources Committee on Human Research: Committee on Human Research: UCSF Guide for Research Use of Human Biological Specimens: y05.pdf UCSF Guide for Research Use of Human Biological Specimens: y05.pdf y05.pdf y05.pdf UCSF IT Security: UCSF IT Security: Enterprise Information Security: Enterprise Information Security: Cell Culture Facility – Linda Reilly: Cell Culture Facility – Linda Reilly: Neurosurgery Tissue Core – Cynthia Cowdrey: e_facility.html Neurosurgery Tissue Core – Cynthia Cowdrey: e_facility.html e_facility.html e_facility.html UCSF AIDS Specimen Bank – Yvonne DeSouza: UCSF AIDS Specimen Bank – Yvonne DeSouza: