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HSRO Mission

HSRO Mission. Protecting the safety, rights, and welfare of human research participants through: Regulatory Compliance Collaboration

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HSRO Mission

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  1. HSRO Mission Protecting the safety, rights, and welfare of human research participants through: Regulatory Compliance Collaboration Providing administrative support and guidance to the IRB while collaborating with Investigators, key study personnel, and other supporting institutional bodies toward a common goal of protecting human research participants.

  2. COMMON HSRO-IRB PROBLEMS • Increasingly complex federal, state and local regulations • Documentation requirements have increased 3. Numbers of active studies increased 4. Training expectations for IRB members, HSRO staff and investigators have increased 5. IRB service is costly to departments and may be unrewarding to individual members 6. Retention issues - investigator frustrations de-motivate HSRO staff and IRB members 7. Sponsor expectations/requirements increasing

  3. COMMON PERCEPTION OF IRB BUDGET HSRO-IRB represents a ‘cost’ rather than a ‘revenue generator’ BUT … consideration must be given to: • Revenues lost because sponsors are unwilling to condone problems • Costs to investigators due to lost time and inefficiency • Costs to the institution when the ability of faculty and students to conduct research is impaired

  4. PROMISES TO OHRP 1. create data base a) define number of active protocols, b) track protocols – names, approval and expiration dates 2) suspend all expired protocols – no exceptions a) triage for subject safety b) warning letters • ensure regulatory compliance • corrective action plan – expedited reviews • policies and procedures—required by OHRP – valuable to investigators

  5. COMMITMENTS AND GOALS • Recruit and train new HSRO staff • Establish 'pre-board' and 'post-board' administrative- operational teams and procedures to support IRB functioning, make recommendations to IRB members and communicate with investigators • Eliminate backlog from earliest to present • Develop IT system (Eprost) a) new forms b) training c) help desk • Education programs 6. Implement a revenue system for HSRO/IRB 'work'

  6. Plan Objectives • Align and ensure activities are compliant with regulatory, funding, and any other applicable governing / funding / regulatory bodies • Align HSRO activities with the institutional goals and objectives related to the research enterprise • Focus and apply HSRO resources on activities that advance programs for human subjects protection = the institutional vision • Implement customer support services to the institution and develop credibility as we create the “role model for IRB administration”

  7. Operational Model for Human Subjects Research Office Assistant Provost for IRB Affairs Dr. Stephen Richman Executive Vice President and Provost Dr. Tom LeBlanc Executive Director for HSRO Business / Operations Kelly Insignares Vice Provost Dr. Myron Rosenthal Directorfor Regulatory Affairs and Educational Initiatives Judith Aguirre IRB Chairs Dr. Ofelia Alvarez Dr. Stephen Sapp Dr. Thomas Sick M Human Subjects Research Protection Program HSRO / IRB Mission U Office Of Research Compliance Office of Research Training & Education Ethics Program, Privacy Office Ancillary Committees A01 – Mike Bingham – Asst Mgr III- eff. 11/05 A01 – Evelyn Bital - Mgr IV – eff. 11/1/05 A01 – Amanda Coltes-Rojas - Mgr IV – eff. 11/1/05 A01 – Marisabel Davalos- Mgr IV – eff. 2/1/06 A01 – TBA – Asst. Mgr. III – eff. 7/05 Educational Initiatives Associate Director IV –Julia Beutler– 11/05 A01 – Coordinator IV Associate Director IV – Vanessa Leyton - 12/05 Operations and Finance PRE BOARD POST BOARD Associate Director IV – TBA - 09/05 Privacy & Regulatory Affairs Pre Board Review Manager – effective 10/05 – Z. Fernandez A01 – Coordinator IV – effective 8/05 – J. Addison A01 – Coordinator IV – V. Carrasco – effective 10/05 TBA – Sr. Staff Associate Paul Neil – Staff Associate Post Board Review Manager – effective 10/05 – S. Hadrigan A01 – Coordinator IV – L. Verdaguer – effective 8/05 A01 – Coordinator IV – N. Francis – effective 11/05 #027697 – TBA –Coordinator IV #026505 – Dena McCarthy Information Technology IT Asst. Mgr III - TBA DB Tech Spec. - C Estevez DB Tech Spec. – TBA Sr. Staff Asst. – Elvia Molina Office Manager Kenia Viamonte Marisel Valdez – Staff Asst. Daniel Auguste – Staff Asst. Receptionist – Mireya Diaz De Arce – Sr. Staff Associate Danny Mercado - Temp CONFIDENTIAL 01/06

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