IRB Toolkit

IRB Application Forms and Templates

Human Subject Research Determination: As of 09/12/2022 determination requests are to be submitted through Infoed. See Guidance.

Application Forms & Checklist 

• Anonymous Survey Application
• Retrospective/Archival Study Application
• Minimal Risk Study Application
• Clinical Trial/Full Board Application
• IRB Submission Checklist
• Study Abstract

Managing Approved Studies

• Personnel Change Request Form
• Change Request Form
• Protocol Violation/Deviation Form
• Research Report For Renewal or Closure (login required)
•  Adverse Event (login required)
• Change Request Form (login required)

Recruitment & Consent Forms Templates

• Telephone Recruitment Script
• California Experimental Subject Bill of Rights (Required if study meets the state definition of "medical experiment.")
  • English
  • Spanish
  • Other Translations
• Consent Templates
  • (See Guidance for developing the Informed Consent Document)
  • (See Lay Terms for Preparing Consent Documents)
  • Clinical Trials
  • Minimal Risk Studies
  • Anonymous Survey
• Assent Templates (for minors)
  • Blood Draw
  • Bone Marrow
  • Oncology Treatment
• Authorization for Use of Protected Health Information (HIPAA)
  • Standard
• Waiver of Consent/HIPAA authorization: Form

Protocol Template

• Protocol Template (Clinical)
• Protocol Template (Non-Clinical)