Regulatory Support and Advocacy Core (RSAC)
Index
Core Description
Services Provided
Core Members
Steering Committee Members
Announcements
Other Resources
For Questions or Services
Dr. Mark Stein, Director
Dr. Stein is a clinical psychologist, researcher, Professor, and Director of the Regulatory Support and Advocacy Core. Dr. Stein has written more than 100 articles, co-edited the text book Attention Deficits and Hyperactivity in Children and Adults (Marcel Dekker, 2000), and has participated in numerous clinical trials of ADHD medications. His reserach has emphasized diagnosis of ADHD, genetics, thyroid, and psychopharmacology. Current research is on pharmacogenetics, dose response effects of medication, predicting response to methylphenidate and atomoxetine, and sleep problems.
CORE DESCRIPTION
The CCTS Regulatory Support and Advocacy Core (RSAC) offers a variety of services to assist investigators with the administrative activities involved in meeting the regulatory requirements for research involving human subjects. The RSAC serves as a liaison between the IRB, investigators, and research staff, both at UIC and CCTS partner organizations. The Core’s aim is to provide centralized, accessible regulatory support, advice and guidance.
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Services provided
The RSAC offers following services:
1. Concierge services that include a coordinated and simplified
approach to regulatory compliance tasks:
• Clarify regulations
• Customized action plan for IRB submissions
• Review of protocol, informed consent, HIPAA, and submission documents
• Completion of IRB submission documents, if necessary
• Will attend IRB meeting when your protocol is reviewed to answer questions, clarify information or contact the Investigator
• Track protocol progress through regulatory process
2. Research Participant Advocacy
• Consult on subject safety issues
• Complete a risk assessment
• Evaluate data safety monitoring plans, data monitoring committees, and safety reports
• Evaluate adverse events (AEs)
• Evaluate unanticipated problems involving risks to subjects
3. Education and training programs on regulatory topics
• Core members are available to speak to departments and research programs about the regulatory core services and regulatory requirements.
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CORE MEMBERS
Burton Andersen, MD, Research Participant Advocate
Contact: 312-996-1596
Lynn Podraza, Regulatory Knowledge and Support Coordinator
Contact: 312-996-2102
Email: podrazal@uic.edu
Sandra Rahbe, Regulatory Knowledge and Support Coordinator
Contact: 312-996-0996
Email: srahbe@uic.edu
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STEERING COMMITTEE MEMBERS
Mark Stein, PhD
Professor, College of Medicine, Chair
*Burton Andersen, MD
Professor and former Head of Infectious Disease Section, Dept of Medicine
Linda Bressler, Pharm D
Associate Professor, Dept. of Pharmacy Practice
Susan R. Goldman, PhD
Distinguished Professor of Psychology and Education
*Jay Goldstein, MD
Professor of Medicine, Vice Head for Clinical Affairs
Lisa Anderson-Shaw, PhD, MA, MSN
Director, Clinical Ethics Consult Service, Assistant Clinical Professor
Mary Lou Schmidt, MD
Associate Professor of Pediatrics, Head, Division of Pediatric Hematology/Oncology College of Medicine
Lynda Slimmer, PhD, RN
Associate Department Head, Department of Medical-Surgical Nursing (College of Nursing)
Clare Tessman, BA
Head Coordinator, Psychiatry Clinical Trials
Annette Valenta, PhD
Professor and Head, Biomedical and Health Information Sciences, College of Applied Health Sciences
Christine Wu, PhD
Associate Dean for Research, Professor, College of Dentistry
*Larry Danziger, Pharm D
Interim Vice Chancellor for Research
*James Fischer, Pharm D
Director of OPRS
Howard Gordon, MD
Associate Professor, Health Promotion Research, Department of Medicine
Rebecca Ann Lind, Ph.D.
Assistant Vice Chancellor for Research
* Ex Officio
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Announcements
RSAC staff members are available to speak about the Core to your department or research program, on request.
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Other Resources
OPRS Home page
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/index.shtml
OPRS Getting Started Page
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/getting_started.shtml
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For Questions or Services
If you have general questions, contact us at CCTS-Reghelp@uic.edu.
To request a consultation, please click the icon below for the application for services. This is a Word document. Please save it and send it via e-mail to Irene Ziaya at iziaya1@uic.edu. If you have any questions, please call Irene Ziaya at 312-413-7316.
