1. Recent Changes in the IRBs and in OPRS at UCLA Roberto Peccei Vice Chancellor for Research February 7, 2006

2. In the area of research involving human subjects the main goal of my office is - to make the IRB process more efficient for investigators -while maintaining the highest level of protection for research subjects - and remaining fully compliant with Federal regulations and local laws This requires a difficult, but necessary, balance between competing interests and is often the cause of significant frustrations for faculty

3. UCLA Institutional Review Boards carry a large workload (~ 10,000 transactions/year) To decrease the individual workload in each IRB in August 2004 we moved from 3 IRBs to 5 IRBs, thereby allowing increased specialization - MIRB1: general biomedical research - MIRB2: cancer, infectious diseases, AIDS - MIRB3: neuroscience and psychiatry - SGIRB: health services research - NGIRB: ethnographic research Change has been very positive, but some issues still need to be resolved

4. Workload of IRBs is very large and varies both among the Boards and in time

5. Move to 5 IRB was accompanied by an increase in overall direct staff support from 12 to 15, but a decrease in staff support per IRB from 4 to 3. This has not worked well, resulting in large staff turnover and delays in protocol approvals

7. Real effort made to eliminate protocol approval tails, but this is an ongoing struggle

8. Three parallel efforts underway to help reduce existing stresses in the system: i.Adoption of a webIRB protocol system aimed at streamlining the submission, review, and approval of human subject research protocols, eliminating the large paper burden and legacy systems that slow down the present process. [Unfortunately, have encountered difficulties with chosen software vendor. Nevertheless, hope to be able to roll out system this summer]

9. ii.Reorganization of the Office of Research, leading to the appointment of Rick Greenwood as Assistant Vice Chancellor for Research- Administration. -Rick will have direct administrative oversight over the functioning of both OPRS and ORA -I will remain the Institutional Official for both Human Research Subject Protection and for Animal Research, dealing with compliance issues

10. iii.HPRB has agreed to allow the use of outside IRBs to review UCLA research protocols in some specific circumstances - Pediatric oncology trials [program is underway using central NCI IRB ] - Pilot will start in the spring allowing the use of commercial IRBs for some industry sponsored Phase III and Phase IV clinical trials - Modalities are being developed to allow RAND-UCLA Health Services research to be reviewed by a single IRB [UCLA or RAND]

11. Want to mention three additional developments which also will help i.Structure of OPRS office has been re- organized about 10 months ago after resignation of Steve Peckman. Human subject protection side now has 3 Asst. Directors, reporting to Judy Brookshire: - Farida Lada, responsible for MIRBs - Allison Orkin, responsible for GCIRBs and WebIRB development - Bette Okeya, responsible for adverse events and audits and investigations

12. ii.An Executive IRB has been established to help resolve cases where, after various rounds (> 3), an investigator and an IRB have not been able to resolve differences. - Executive IRB convened after written appeal to VCR - Composed of Chairs and Vice Chairs and appropriate others - Role of Executive IRB is advisory to the original IRB

13. iii.UCLA’s Human Subject protection programs will undergo an external review this calendar year - Review will be performed by a (relatively new) national accreditation Board AAHARP, which functions similarly to the AAALAC Board, which accredits research with animals -Will need extensive internal review and documentation of our Human Subject protection processes this Spring