UIC Center For Clinical And Translational Sciences

Index

Core Description
Services Provided
Core Members
Steering Committee Members
Announcements
Other Resources
For Questions or Services

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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 the 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

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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

Emily Anderson, PhD
Project Director, Illinois Prevention Research Center

Lisa Anderson-Shaw, PhD, MA, MSN
Director, Clinical Ethics Consult Service, Assistant Clinical Professor

Rebecca Ann Lind, Ph.D.
Assistant Vice Chancellor for Research

Linda Bressler, Pharm D
Associate Professor, Dept. of Pharmacy Practice

*Larry Danziger, Pharm D
Interim Vice Chancellor for Research

*James Fischer, Pharm D
Director of OPRS

Susan R. Goldman, PhD
Distinguished Professor of Psychology and Education

*Jay Goldstein, MD
Professor of Medicine, Vice Head for Clinical Affairs

Howard Gordon, MD
Associate Professor, Health Promotion Research, Department of Medicine

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

* 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.

The OPRS website now includes a directory of research studies at UIC that are actively enrolling subjects. The listing will help guide individuals who are interested in participating in clinical or social-behavioral research at UIC. The directory listing will contain the protocol title, enrollment contact information, and three keywords. To visit website for the directory click here.

If you have a research study that you would like to have listed on the website, please fill out the form entitled "Type 12: Research Directory Listing" here and email it to uicirb@uic.edu with the subject heading RESEARCH DIRECTORY. OPRS will verify the information on the form and will post the study to the directory. It is the responsibility of the PI to inform OPRS when enrollment is completed, so the study can be removed from the registry. PIs will also have the option of listing their study by checking a box on the new initial and continuing IRB application forms.

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Other Resources

Research Services:
Obtaining Research services within UIMCC

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

Lay Language Link:

Are you trying to translate language from your research protocol into lay language for an IRB submission?  The link below goes to a site at the University of Michigan where you will find a Simplification Guide to Medical Terms that has suggestions for common medical terms that may need translation. 

http://www.med.umich.edu/irbmed/guidance/guide.htm

OVCR Quality Improvement Program Toolbox has templates you can use
 
Are you the PI or coordinator of an Investigator-Initiated research study?  If so, take a look at the OVCR website for their Quality Improvement Program. Ensuring that research studies comply with the principles of Good Clinical Practice and applicable government regulations requires planning and documentation.  In industry-sponsored studies, appropriate documentation forms may be provided.  PIs of Investigator-Initiated studies sometimes struggle with documentation.  The OVCR Quality Improvement Program has created a good Toolbox of standard tracking forms that will help you capture essential information in an organized fashion.
 
http://tigger.uic.edu/depts/ovcr/research/QIP/toolbox.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, along with your protocol and any other completed IRB submission documents, to Irene Ziaya , Investigator Interface Coordinator at iziaya1@uic.edu. If you have any questions, please call Irene Ziaya at 312-413-7316.

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