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Springfield Committee for Research
Involving Human Subjects

 

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 - 11/22/2013)

IRB Operations and Training

  1. Determination of Activities That Require IRB Review
  2. IRB Membership
  3. IRB Member and Consultant Conflict of Interest
  4. Human Subjects Protections Training
  5. Generation, Use and Revisions of SOPs
  6. External Research and IRB Reliance

Types of IRB Reviews

  1. Initial Full Board Review
  2. Initial Expedited Review
  3. Exempt Review
  4. Continuing Review
  5. Cancer Cooperative Groups LTFUP - Continuing Review
  6. Amendments
  7. Unanticipated Problems and Adverse Event Reporting
  8. Protocol Deviations, Violations and Exceptions
  9. HIPAA Compliance
  10. Subject Concerns/Complaints
  11. Noncompliance
  12. Termination and Suspension of Research
  13. Conduct of IRB Meetings

Special Requirements

  1. Informed Consent
  2. Protection of Vulnerable Subjects
  3. Medical Devices
  4. Humanitarian Use Device (HUD)
  5. Emergency Use
  6. Expanded Access Program (EAP) for Drugs
  7. Data and Safety Monitoring Plans
  8. NCI Pediatric CIRB Review
  9. Surrogate Consent

Recordkeeping and Reporting

  1. Minutes of IRB Meetings
  2. Inspections by Regulatory Agencies
  3. Mandated Reporting to External Agencies
  4. Study Closure
  5. IRB/SCRIHS Recordkeeping

Monitoring and Assessments

  1. Human Subjects Research Compliance Review
  2. PI Self-Assessment Review
  3. Administrative Assessment Review

Coordination

  1. Affiliated Hospitals/IRB Coordination
  2. Office of Compliance/Conflict of Interest/IRB Coordination