HSRO MissionProtecting the safety, rights, and welfare of human

research participants through: Regulatory Compliance

CollaborationProviding 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.

COMMON HSRO-IRB PROBLEMS

1. Increasingly complex federal, state and local regulations 2. Documentation requirements have increased3. Numbers of active studies increased4. Training expectations for IRB members, HSRO staff and investigators have increased5. IRB service is costly to departments and may be unrewarding to individual members6. Retention issues - investigator frustrations

de-motivate HSRO staff and IRB members

7. Sponsor expectations/requirements increasing

COMMON PERCEPTION OF IRB BUDGET

HSRO-IRB represents a ‘cost’ rather than a ‘revenue generator’

BUT … consideration must be given to:

1. Revenues lost because sponsors are unwilling to condone problems

2. Costs to investigators due to lost time and inefficiency

3. Costs to the institution when the ability of faculty and students to conduct research is impaired

PROMISES TO OHRP

1. create data basea) define number of active protocols, b) track protocols – names, approval and

expiration dates2) suspend all expired protocols – no exceptions

a) triage for subject safetyb) warning letters

3) ensure regulatory compliance4) corrective action plan – expedited reviews5) policies and procedures—required by OHRP –

valuable to investigators

COMMITMENTS AND GOALS

1. Recruit and train new HSRO staff 2. Establish 'pre-board' and 'post-board' administrative-

operational teams and procedures to support IRB functioning, make recommendations to IRB members and communicate with investigators

3. Eliminate backlog from earliest to present 4. Develop IT system (Eprost)

a) new forms b) training c) help desk

5. Education programs6. Implement a revenue system for HSRO/IRB 'work'

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”

Operational Model for Human Subjects Research Office

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

Executive Vice President and Provost

Dr. Tom LeBlancHuman Subjects Research Protection

Program

HSRO / IRB MissionU

M

Executive Director for HSRO Business /

Operations

Kelly Insignares

Vice Provost

Dr. Myron Rosenthal

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

Associate Director IV – Vanessa Leyton - 12/05

Operations and Finance

01/06

Office Manager

Kenia Viamonte

Director for Regulatory Affairs and Educational

Initiatives

Judith Aguirre

Assistant Provost

for IRB Affairs

Dr. Stephen Richman

Marisel Valdez – Staff Asst.Daniel Auguste – Staff Asst.

Receptionist – Mireya Diaz De Arce – Sr. Staff AssociateDanny Mercado - Temp

Educational Initiatives

Associate Director IV –Julia Beutler– 11/05

A01 – Coordinator IV

Associate Director IV – TBA - 09/05

Privacy & Regulatory AffairsPre 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

CONFIDENTIAL

PRE BOARD POST BOARD

Information Technology

IT Asst. Mgr III - TBADB Tech Spec. - C Estevez

DB Tech Spec. – TBA Sr. Staff Asst. – Elvia Molina

IRB Chairs

Dr. Ofelia Alvarez Dr. Stephen Sapp

Dr. Thomas Sick

Office Of Research Compliance

Office of Research Training & Education

Ethics Program, Privacy Office

Ancillary Committees