Policies and Guidelines

Policies

• Upstate IRB Guidelines & Policies text
• Clinical Trials Registration Policy text
• NCI Central IRB (CIRB) Guidelines (text alt)
• Notifying the IRB of Adverse Events (text alt)
  • Adverse Event Flow Chart text
• Emergency Use of an Investigational Drug or Biologic (text alt)
• Emergency Use of Unapproved Medical Devices (text alt)
• Protocols Involving Ionizing Radiation Exposure to Human Subjects (text alt)
• HIPAA and Research (text alt)
• Conflict of Interest Policy for IRB Members (text alt)

Guidance

• Research with Children
  • SOP for Obtaining Consent from Subjects who Enrolled as a Minor (text alt)
• SOP for Establishing Legal Guardianship for Pediatric Subjects (text alt)
• Continuing Review Guidelines (text alt)
• 5-Year Renewal Guidelines (text alt)
• Guidelines for Genetic Testing (text alt)
• Requesting an IND Consult from the FDA (text alt)
• Requesting Medical Records from UH for Research Purposes text
• Assessing Capacity to Consent for Research (text alt)
• Guidelines for Scientific Reviewers (text alt)

Exemption from IRB Review

• Request Exemption from IRB Review (text alt)
  • Sample Data Abstraction Form (text alt)
• Request Exemption from IRB Review for Case Reports (text alt)

Quick Reference - How to:

• Submit a Study for Review (text alt)
• Submit an Amendment for Review (text alt)