LSUHSC-NO’s Human Subject Protection Program and Institutional Review Board (IRB) are responsible for reviewing all research projects involving the use of human subjects, with the purpose of protecting the rights and welfare of individuals participating in those projects. It is the policy of LSUHSC-NO that all projects involving human beings and/or information or tissue collected from human beings must be presented to the IRB for a determination as to whether: 1) The project is human subjects research, 2) The human subjects research project can be given Exempt status under the Federal regulations, or 3) The human subjects research project must have IRB review, approval, and continued oversight.

IRB Policies and Procedures

• IRB Policies and Procedures Guidebook

IRB Forms

There are now three versions of the IRB Application Form. Instructions given in How to Submit will show you how to start the application process and will clarify which version (1, 2 or 3) of the IRB Application Form is appropriate for your research.

1. Exempt Research Application

   • Information Sheet for Exempt Research

2. Minimal Risk (Expedited) Research Application

   • Information Sheet for Expedited Research

3. Greater than Minimal Risk (Full Board Review) Research Application

   • Information Sheet for Full Board Review

As part of the application process, the following forms must be completed for all studies:

• The Demographic Form

• Addendum - Conflict of Interest Attestation  [Note: This form must be completed by all study team members.]

Other IRB forms that may be required during the application process include:

• Addendum - Additional Personnel

• Waiver of Informed Consent, Waiver of HIPAA Authorization, and Waiver of Documentation of Informed Consent

• Consent Form Template   

       ○  Consent Form Instructions

• Non-English Speaking Subjects Short Form Instructions

  • English Version

  • French Version

  • Spanish Version

  • Vietnamese Version

Other IRB forms:

• Adverse Event Reporting Forms

  • Local Serious Adverse Event

  • Non-Local Serious Adverse Event

• IRB Re-Approval Form

• Notification of Protocol Deviations/Violations Form

Human Subjects Protection ─ Links to Training Resources

• Collaborative Institutional Training Initiative (CITI)
  • Instructions for CITI
• NIH-IRB Self-Tutorial on Human Subjects Protection

LSUHSC-NO Human Subjects Protection Program – Emergency Readiness

• HSPP - Emergency Readiness Plan
• Emergency Notification Letter for Subjects - Template

Other Useful Links

• AAMC Research Compliance Resources
• The Belmont Report
• ClinicalTrials.gov
• Code of Federal Regulations

• Food And Drug Administration (FDA)

• Office of Human Research Protections (OHRP)

• Requirements

• Joint Informed Consent Template