Springfield Committee for Research
Involving Human Subjects
Under Construction
For policy information regarding human subjects protection at SIU School of Medicine, please contact the SCRIHS staff at 545-7602. As content is added, links are shown in blue.
Southern Illinois University School of Medicine (SIU-SOM)
Policies and Standard Operating Procedures (SOPs)
TABLE OF CONTENTS
(Version Date - 10/10/2012
IRB Operations and Training
- Determination of Activities That Require IRB Review
- IRB Membership
- IRB Member and Consultant Conflict of Interest
- Human Subjects Protections Training
- Generation, Use and Revisions of SOPs
- External Research and IRB Reliance
Types of IRB Reviews
- Initial Full Board Review
- Initial Expedited Review
- Exempt Review
- Continuing Review
- Cancer Cooperative Groups LTFUP - Continuing Review
- Amendments
- Unanticipated Problems and Adverse Event Reporting
- Protocol Deviations, Violations and Exceptions
- HIPAA Compliance
- Subject Concerns/Complaints
- Noncompliance
- Termination and Suspension of Research
- Conduct of IRB Meetings
Special Requirements
- Informed Consent
- Protection of Vulnerable Subjects
- Medical Devices
- Humanitarian Use Device (HUD)
- Emergency Use
- Expanded Access Program (EAP) for Drugs
- Data and Safety Monitoring Plans
- NCI Pediatric CIRB Review
- Surrogate Consent
Recordkeeping and Reporting
- Minutes of IRB Meetings
- Inspections by Regulatory Agencies
- Mandated Reporting to External Agencies
- Study Closure
- IRB/SCRIHS Recordkeeping
Monitoring and Assessments
- Human Subjects Research Compliance Review
- PI Self-Assessment Review
- Administrative Assessment Review
Coordination
- Affiliated Hospitals/IRB Coordination
- Office of Compliance/Conflict of Interest/IRB Coordination
