1. UNM Virtual Human Biospecimen Repository -- Pitfalls and the Possibilities UNM Biocomputing Conference April 22, 2005 Philip J. Kroth, M.D., M.S.

2. Overview Why build the UNM Tissue Repository? What is the UNM Tissue Repository? What are the key regulatory issues? What is the proposed pilot project structure?

3. Why Build the UNM Tissue Repository? Linking clinical, genetic, and demographic information with human biospecimens significantly increases their value for research Supports growing regulatory and privacy requirements Can facilitate more efficient use of a very scarce and valuable resource

4. What is the UNM Tissue Repository? Virtual database of (eventually) all human biospecimens at UNM HSC Structured and coded (using SNOMED) in a standardized manner to facilitate: –Queries across UNM institutional boundaries to find tissue available for research –Linking with other databases including clinical data Designed to be consistent with the National Biospecimen Network Blueprint

5. Regulatory Issues Human Tissue Oversight Committee Human Research Review Committee Four defined types of tissues: –Type A Excess tissue alternatively prepared for possible future diagnostic purposes. (No IRB oversight or consent status as tissue prepared for diagnostic studies only.) –Type B Excess tissue alternatively prepared for a known HRRC- approved active research project with HRRC-approved consent status. –Type C Excess tissue alternatively prepared for unknown future research project with Tissue Repository consent of patient. –Type D Excess tissue alternatively prepared for unknown future research project with waiver of informed consent, waiver of HIPAA authorization, Tissue Repository as honest broker for identifiers and dispensed as de-identified samples.

6. Proposed Pilot Project Structure Oracle Database Server TissueMetrix PC Workstation Pilot Year-1 Web-Based Queries Potential Future Expansion Potential Cerner Clinical System UNM Tumor Registry SEER Data Velos Cancer Trial Tracking System Tri-Core Labs Others?

7. For More Information http://hsc.unm.edu/som/research/htr/

8. Questions?

9. UNM Virtual Human Biospecimen Repository -- Pitfalls and the Possibilities UNM Biocomputing Conference April 22, 2005 Philip J. Kroth, M.D., M.S.