Recently Updated Pages
1.21 Post-Approval Monitoring of Research
Last Revised: 11/17/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...
1.31 Observers at IRB Meetings
Last Revised: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s...
1.32 Confidentiality of the Review Process
Last Reviewed: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’...
Noncompliance
Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a gui...
IRB Conference Content
2025 Ethical Study Design IS Good Science (Susan Fish) The AI Middle Game: From Panic to Prop...
1.27 Research Personnel Qualifications and Responsibilities
Last Revised: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the qualifications...
Community Partners
All individuals that work on human subject research projects must complete human subject research...
Mental Health Considerations
Explanation of Risks Be clear in application and ICD about risks associated with mental health a...
Emergency Preparedness Resources
Emergency Preparedness / Continuity of Operations Plan (EP/COOP)
E-Signature Instructions
The e-signature function in RSS is a way to electronically sign consent forms. It can be used if...
Informed Consent Resources
RSS Training for Consent Forms Consent Forms 101 Creating a Consent Form Functions within a...
Office Hours
IRB Office Hours We can be reached by phone (402-559-6463) or by email (irbora@unmc.edu) Mon-Fri ...
Relevant Links & Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...
RSS Guides
Guides to assist with RSS procedures: If there is a topic that does not appear below, please cont...
Short Forms
A Short Form may be used when a subject/LAR who cannot understand English is unexpectedly encount...
Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...
6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use
Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe...
8.6 Study Hold, Suspension, and Termination
Last Revised: 1/20/2023 1.0 Purpose The purpose of this policy is to describe the process for stu...
8.5 Noncompliance by the IRB or Other Components of the HRPP
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for revi...
8.4 Review of Noncompliance by the PI, Study Team, and/or Subjects
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for revi...