Topical Guidance Fact Sheets

Human Subjects Committee (IRB) General Jurisdiction & Oversight

• Jurisdiction of the HSC 
• Activities that Require HSC Review
• Determination of Not Human Subjects Research
• Determination of Quality Assurance or Quality Improvement
• Case Reports & HSC Approval
• Secondary Analysis of Previously-Collected Data or Specimens

Human Subjects Committee (IRB) Review

• Federal Criteria of Human Subjects Research
• Types of HSC Review - Quick Reference
• Selecting an HSC Application Form
• Exempt Research
• Expedited Research
• Investigator Initiated Clinical Trials

Informed Consent

• Legally Effective Informed Consent
• Informed Consent Checklist
• Phone Consent
• Consent of Non-English Speaking Subjects
  > Instructions for Using Short Form Consent Documentation
• Consent Without Subject's Signature
• Consent Involving Surrogate Decision Makers

Collaborative Research

• Collaborative Research and IRB Reciprocity
• Special Arrangements for KUMC (KU Med) - KULC (KU Lawrence) Collaboration