IRB Toolkit

The LLUH IRB must POSTPONE the iRIS Go-Live date of October 15, 2020 until further notice due to an unforeseen technical issue with the new system. Effective immediately, we will resume accepting IRB submissions via email per the standard process. We apologize for any inconvenience this may have caused. If you should have any questions, please do not hesitate to contact Amy L. Casey, Director, Human Research & Compliance at acasey@llu.edu

IRB Application Forms and Templates

Human Subject Research Determination: Form

Application Forms & Checklist 

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

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)
  • Adult [Standard][Dependency Treatment]
  • Minors [Standard][Dependency Treatment]
• Waiver of Consent/HIPAA authorization: Form
• Authorization for Case Studies

Protocol Template

• Sample Protocol Outline

iRIS Training

• Training Video for Investigator/Study Personnel in accessing and submitting through iRIS. *COMING SOON*