REGULATORY SUPPORT AND ADVOCACY CORE

UIC CTTS

Specific Aim #1

Coordinate and simplify regulatory compliance tasks for clinical and translational investigators at UIC and affiliated institutions.

Monday, A ugust 24, 2009 2

Specific Aim #2

Expand research participant advocacy services to maximize participant safety and ensure the integrity of UIC clinical and translational research involving human subjects.

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Challenges

• Administrative structures that are silo based or decentralized (Departments, IRB, Contracts)

• Inadequate resources, bottle necks (typists and receptionists, copying)• Current economic realities

• Risk adverse nature of universities

• Lack of incentive for facilitating research

• Complexity and breadth of clinical and translational research

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Approach

• Support for PI’s (Concierge based support, educational programs)

• Meeting with stakeholders to identify opportunities• IRB

Contracts

Steering Committee

• Benchmarking regulatory processes, increasing accountability

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Accomplishments

• Recruited core staff

• Developed an administrative structure

• Attended IRB meetings

• Provided training on regulations to the Intensive Summer Program for Clinical and Translational Research Methods and CIC staff

• Created outreach activities/PR materials• Presentations to departments• Brochure and web page

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Submission Summary2008 2009 Total

Submission Number 44 35 79

Application TypeHealth/Biological

Social/Behavioral

Human Embryonic Stem Cell

Center

Other

21

11

0

0

11

22

6

1

6

1

43

17

1

6

12

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College/Department Utilization

• Dentistry

• Emergency Med

• Endocrinology

• GI Surgery

• Hepatology

• Infectious Disease

• Internal Med

• Nephrology

• Nephrology - pediatric

• Neurology

• Nursing

• Ob-Gyne

• Oncology

• Ophthalmology

• Pharmacognosy

• Psychiatry - pediatric

• Physical Therapy

• Public Health

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Stein/Goldstein Meetings with IRB

• Recommended trying a commercial IRB for phase III clinical trials

• Attained agreement to have coordinators attend IRB meetings

• Met with Vice Chancellor for research to problem solve

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Accomplishments

• Consulted on subject safety issues

• Completed risk assessments

• Evaluated data safety monitoring plans, data monitoring committees, and safety reports

• Evaluated adverse events (AEs)

• Evaluated unanticipated problems involving risks to subjects

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Not there yet

• Latency to IRB approval, beginning study

• Increase in clinical and translational studies• Pediatric

• Comparative Effectiveness Studies

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Intermediate goals

• Facilitate IRB and contracting issues for multi site studies

• Develop working relationships with other CTSA in Chicago and nationally (September 2010)

• Provide financial resources to investigators (E.g., budget planning, tracking)

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