Click here to download the entire policies and procedures manual.
Table of Contents
Official Signature Page
Martin Lispky, M.D., Regional Dean – Institutional Officer
Thornton Kline, Jr., M.D. – Institutional Review Board Chair
Joe G. N. “Skip” Garcia, M.D. – Vice Chancellor for Research (UIC)
Section 1: INTRODUCTION
1.1 Purpose and Scope
1.2 Mission Statement
Section 2: IRB COMPONENTS AND ROLES
2.1. COM-R IRB Introduction and Purview
2.1.6. Organizational Chart
2.2. Role of the IRB
2.3. Compensation for IRB Members
2.4. The Role of the Chair
2.5. Frequency of IRB Meetings
2.6. Quorum and Voting Procedures
2.7. Confidentiality
2.8. IRB Determination According to Federal Regulations
2.9. Undue Influence of IRB Reviewer
Section 3: THE RESPONSIBILITIES OF RSS OFFICE
3.1. The Research Support Services Specialist (IRB Administrator):
3.2. IRB Minutes and Records:
3.3. Internal Auditing to Insure FWA Compliance
3.4. IRB Roster and Resumes:
Section 4: GETTING STARTED IN THE SUBMISSION PROCESS
4.1. Other Committee Reviews
4.2. IRB Submission Process
4.3. Independent Decision Concerning Research Activity
4.4. Determining . . . Engaged or Not Engaged in Research
4.5. Levels of IRB Review
4.6. Other IRB Issues
4.7. IRB Decisions and Actions
4.8. Required Educational Training
4.9. Developing the Protocol
4.10. Recruitment Process and Documents:
4.11. Informed Consent / Assent/ Parental Consent Process and Documents:
4.12. Research in the COM-R Clinics:
4.13. FDA Regulated Studies
4.14. Industry Funded Research – IRB Charges:
Section 5: PRINCIPAL INVESTIGATOR RESPONSIBILITIES
5.1. General Guidelines.
5.2. Understanding “Privacy” and “Confidentiality”:
5.3. Conflict of Interest Reporting:
Section 6: ETHICAL PRINCIPALS AND THE LAW
6.1. Ethical Principles:
6.2. The Belmont Report:
6.3. FWA and OHRP Oversight:
6.4. Conducting Research in Illinois:
6.5. Requirements for Other Disclosures to Subjects:
6.6. Laws That Apply to Research at COM-R:
Section 7: GLOSSERY