Committee on Human Research (CHR) Issues for Core Laboratories

1. Committee on Human Research (CHR) Issues for Core Laboratories UCSF CTSI Core Leaders Retreat Elizabeth Tioupine, CIP Elizabeth.tioupine@ucsf.edu 415-514-9246 Human Research Protection Program (HRPP) University of California, San Francisco November 6, 2007 CTSI Core Leaders Retreat

2. Main CHR Issues Affecting Cores • Does the Core itself need CHR approval? • Does the investigator have appropriate CHR approval? • 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? CTSI Core Leaders Retreat

3. 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 Investigator Data & Raw Specimens In Core Receives Processes Stores Distributes Investigator Data & Assay Results/ Processed Specimens Out CTSI Core Leaders Retreat

4. Types of CHR 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) • 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) CTSI Core Leaders Retreat

5. CTSI Core Leaders Retreat

6. CTSI Core Leaders Retreat

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

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

9. Verification of CHR 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 • Ultimate responsibility for obtaining appropriate CHR approval rests with Principal Investigator CTSI Core Leaders Retreat

10. Working with Identifiable Specimens • 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 • Store identifiable specimens securely • Store identifiers and code key securely and separately from research data CTSI Core Leaders Retreat

11. UCSF Resources • Committee on Human Research: 476-1814 http://www.research.ucsf.edu/chr/index.asp • UCSF Guide for Research Use of Human Biological Specimens: http://www.research.ucsf.edu/chr/Guide/UCSFBiospecimenGuideMay05.pdf • UCSF IT Security: http://security.ucsf.edu/EIS/home.html • Enterprise Information Security: 514-3333security@its.ucsf.edu • Cell Culture Facility – Linda Reilly: 476-5247 http://www.ccf.ucsf.edu/ • Neurosurgery Tissue Core – Cynthia Cowdrey: 476-9760http://neurosurgery.medschool.ucsf.edu/neurosurgery_research/core_facility.html • UCSF AIDS Specimen Bank – Yvonne DeSouza: 476-2513http://ari.ucsf.edu/programs/asb.aspx CTSI Core Leaders Retreat