HSRO Update

1. HSRO Update August 23rd, 2006

2. Update • Policies and Procedures • Staffing Changes • State of the UM IRBs • Eprost Re-deployment

3. HSRO Policies and Procedures • Updates online to SOPs • Reviewed and accepted by OHRP • Ongoing updates to include FDA topics such as combination products etc. • Ad Hoc Polices and Procedures Review Committee – Quality Improvement

4. Staffing Updates • Amanda Coltes-Rojas, Associate Director for Regulatory Affairs & Educational Initiatives, is responsible for oversight of the regulatory staff. • Evelyne Bital, Assistant Director for Privacy and Regulatory Affairs, is responsible for all HIPAA-related issues for research and for implementation of regulatory compliance. • Marisabel Davalos, Assistant Director for Educational Initiatives, is responsible for providing ongoing human subjects education to the research community. • Zuny Fernandez, Assistant Director for Business & Operations, will oversee the pre- and post-board operations and assist with eprost re-deployment. • Lucia Verdaguer will supervise the pre-board staff; Natalie Francis will supervise the post-board staff. • Meghan Stein and Jesse Leins have taken responsibilities as IRB Regulatory Analysts. • Simonnette Thompson has been hired as an IRB Coordinator.

5. U Operational Model for Human Subjects Research Office IRB Chairs Dr. Ofelia Alvarez Dr. Charles Carver Dr. Thomas Sick Assistant Provost for IRB Affairs Dr. Stephen Richman Vice Provost Dr. Myron Rosenthal Associate Director for Business and Finance Vanessa Leyton Kelly Insignares, CIM Executive Director HSRO Associate Directorfor Regulatory Affairs and Educational Initiatives Amanda Coltes-Rojas M Human Subjects Research Protection Program Office Of Research Compliance Office of Research Training & Education Ethics Program, Privacy Office, Ancillary Committees Office Manager Kenia Viamonte Information Technology Associate Director IV – TBA - 04/06 A03 – Sr. Staff Associate – A. Dufau Privacy & Regulatory Affairs Assistant Director – Evelyne Bital Marisel Valdes –Sr. Staff Assistant Daniel Auguste – Sr. Staff Assistant Receptionist – Mireya Diaz De Arce – Sr. Staff Associate Y. Fraga – Staff Assistant Assistant Director for Business and Operations – Zuny Fernandez IT / Educational Trainer – TBA – 4/06 Software Spec. - A. Boloix Software Spec. – TBA TBA – Staff Associate Educational Initiatives Assistant Director – Marisabel Davalos PRE BOARD POST BOARD A01 – Supervisor – L. Verdaguer A01 – Coordinator IV – D. Stoutt A01 – Coordinator IV – A. Clasca A01 –Coordinator IV – S. Thompson A01 – Coordinator IV - TBA Paul Neil – Staff Associate A01 –Supervisor – N. Francis A01 – Coordinator IV – E. Cepero A01 –Coordinator IV – TBA A01 – Coordinator IV - TBA A01 – Vivienne Carrasco – Sr. Regulatory Analyst A01 – Sonya Hadrigan – Sr. Regulatory Analyst A01 – Meghan Stein - Regulatory Analyst A01 –Jesse Leins – Regulatory Analyst A01 – TBA – Regulatory Analyst CONFIDENTIAL August 2006

6. UM IRB • Medical Board A – Chair, Dr. Tom Sick • Medical Board B – Chair, Dr. Ofelia Alvarez • Social Behavioral Board – Chair, Dr. Charles Carver • Meetings every week for Bio- Medical • Meetings twice a month for SBS

7. Eprost – Re-deployment • Facts to consider: • Will require the completion of eprost smartforms for all submissions including WIRB • Quarterly reports to be submitted as notifications • Annual CR – requires smartform and WIRB form • Multi-site clinical pharmaceutical studies will continue to be sent to WIRB at this time • Require smartform and WIRB form for processing • All protocols will need to be entered/completed in the system – now, or at continuing review or at the time of amendment

8. Eprost Plan • Adrian Boloix • Eprost System Administrator