Download - REGULATORY SUPPORT AND ADVOCACY CORE
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.
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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
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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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