Transcript HSRO Update
HSRO Update August 23rd, 2006 Update Policies and Procedures Staffing Changes State of the UM IRBs Eprost Re-deployment 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 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. UM Operational Model for Human Subjects Research Office Vice Provost Human Subjects Research Protection Program Dr. Myron Rosenthal Assistant Provost for IRB Affairs Kelly Insignares, CIM Office Of Research Compliance Dr. Stephen Richman Executive Director Office of Research Training & Education IRB Chairs HSRO Ethics Program, Privacy Office, Ancillary Committees Dr. Ofelia Alvarez Dr. Charles Carver Associate Director for Business and Finance Vanessa Leyton Office Manager Kenia Viamonte Associate Director for Regulatory Affairs and Educational Initiatives Amanda Coltes-Rojas A03 – Sr. Staff Associate – A. Dufau Assistant Director for Business and Operations – Zuny Fernandez PRE BOARD Marisel Valdes –Sr. Staff Assistant Daniel Auguste – Sr. Staff Assistant Receptionist – Mireya Diaz De Arce – Sr. Staff Associate Y. Fraga – Staff Assistant POST BOARD A01 – Supervisor – L. Verdaguer A01 –Supervisor – N. Francis A01 – Coordinator IV – D. Stoutt A01 – Coordinator IV – A. Clasca A01 – Coordinator IV – E. Cepero A01 –Coordinator IV – TBA A01 – Coordinator IV - TBA A01 –Coordinator IV – S. Thompson A01 – Coordinator IV - TBA Privacy & Regulatory Affairs Assistant Director – Evelyne Bital Educational Initiatives Dr. Thomas Sick Information Technology Associate Director IV – TBA - 04/06 IT / Educational Trainer – TBA – 4/06 Software Spec. - A. Boloix Software Spec. – TBA TBA – Staff Associate Assistant Director – Marisabel Davalos 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 Paul Neil – Staff Associate August 2006 CONFIDENTIAL 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 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 Eprost Plan Adrian Boloix – Eprost System Administrator