1. Practical Issues and Logistics- Tissue Resources and IRB/HIPAA William E. Grizzle Department of Pathology University of Alabama at Birmingham wgrizzle@uab.edu

2. Practical Issues and Logistics- Tissue Resources and IRB/HIPAA Tissue Collections-Maximized -Rapid -According to Specifications -Uniform Collections -Quality Control -Cost Effective

3. Practical Issues and Logistics- Tissue Resources and IRB/HIPAA Tissue Collections -Fresh -Paraffin Blocks -Frozen -Paraffin Slides -Fixed -Frozen Sections -Tissue Arrays -Whole Blood -Serum -Saliva -Plasma -Urine Pellets -Buffy Coat -Urine Supernatant

4. Practical Issues and Logistics- Tissue Resources and IRB/HIPAA >200 Patients per Week > 500 Specimens per Week

5. Practical Issues and Logistics- Tissue Resources and IRB/HIPAA 1) Relationship of tissue resource personnel to the patient- the source of the tissues 2) Informed Consent 3) Confidentiality 4) Security of Information

6. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA Relationship of tissue resource personnel to the patient. In general, personnel managing the Tissue Resource and those collecting tissues have no direct relationship with those patients from whom tissues are obtained

7. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA Lack of a relationship may cause problems 1) No direct access to patients 2) Identification of patients/tissues of interest 3) Cold contact 4) Efficiency of collection of informed consent and HIPPA authorization 5) Patient’s physician may object to contact

8. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA Identified Tissue and Information Bank or Tissue Resource Limited Data Set De-identified Anonymized Patient ‘s Remnant Diagnostic or Therapeutic Tissue and Protected Health Care Information IRB and HIPPA IRB IRB and HIPPA

9. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA Regulations of IRB and HIPPA Too Much Too Little Research What are the ethics of not performing research??

10. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA INFORMED CONSENT IF TISSUE IS ANONYMIZED SHOULD INFORMED CONSENT REQUIRED??

11. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA Informed Consent-Research Performed Using clinical protocol operative model non-operative diseases-type II diabetes role of autopsy Informed Consent-Research Affecting Populations and/or Families cystic fibrosis sickle cell anemia type II diabetes

12. Lack of a relationship may cause problems INFORMED CONSENT FOR WHAT TISSUES/ACTIONS? WHEN TO OBTAIN? WHO WILL OBTAIN CONSENT? WHERE WILL IT BE OBTAINED?

13. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA INFORMED CONSENT To obtain blood/bodily fluids To investigate inheritable disease For recontact For negative concerns of populations

14. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA WHEN TO OBTAIN INFORMED CONSENT ON ADMISSION AT CLINIC IMMEDIATELY PREOPERATIVE POST OPERATIVE AFTER DISCHARGE

15. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA OBTAINING INFORMED CONSENT ON ADMISSION GREATEST ACCESS TO PATIENTS MOST EFFICIENT # POINTS OF ADMISSION TRAINING OF PERSONNEL

16. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA OBTAINING INFORMED CONSENT ON ADMISSION CHAOS, INTAKE OF PATIENTS RAPIDLY PATIENTS VERY BUSY WITH HIGH VOLUME OF INFORMATION PATIENTS AND FAMILIES UPSET COSTS SHIFTED TO MEDICAL CENTER

17. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA OBTAINING INFORMED CONSENT AT CLINIC MAY BE CALM TIME PATIENTS FOCUSED ON DISEASE SPACE A PROBLEM TISSUE RESOURCE PERSONNEL ARE GUESTS TOO MANY CLINICS AT SAME TIME

18. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA OBTAINING INFORMED CONSENT IMMEDIATELY PREOPERATIVE STRESS HIGH SPACE CONSTRAINT, TISSUE PERSONNEL ARE GUESTS TIME CONSTRAINT ONLY OPERATIVE PATIENTS

19. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA OBTAINING INFORMED CONSENT POST- OPERATIVE OR WHEN AVAILABLE MILD SEDATION PATIENT FOCUSED TIME PRIOR TO DISCHARGE PATIENT LOCATION (1 HR/ PATIENT) CONSENT ONLY PATIENTS ACCESSED

20. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA CONFIDENTIALITY PERSONNEL NEED TO COLLECT PHI ON PATIENTS SIGN CONFIDENTIALITY AGREEMENT INFORMATICS SYSTEM PROVIDE ONLY DE-IDENTIFIED OR LIMITED DATA SET

21. SECURITY NEED ACCESS TO PHI PREVENT UNAUTHORIZED ACCESS TO PHI AUDIT TRAIL KEEP DATABASE STRUCTURE SECURE Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

22. SECURITY CONTROL AND MONITOR ALL ACCESS LIMIT AND MONITOR WRITERS TO DATABASE LIMIT AND MONITOR THOSE WHO CAN CHANGE STRUCTURE OF DATABASE

23. Practical Issues and Logistics-Tissue Resources and IRB/HIPAA SECURITY ON LINE (INTERNET) ALWAYS LIMITED HOURS NEVER USE SERVER AS CONTROL CRYPTOGRAPHIC APPROACH

24. Practical Issues and Logistics- Tissue Resources and IRB/HIPAA William E. Grizzle Department of Pathology University of Alabama at Birmingham wgrizzle@uab.edu