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Noncompliance
Noncompliance Guide (11/20/2025) Noncompliance Corrective Action Plan (CAP) Guide (11/25/2025...
Community Partners
All individuals that work on human subject research projects must complete human subject research...
IRB Training Videos
Below are training topics related to the IRB, its history, and its function. Please let these vid...
Investigator Toolkit
Advertisement Policy Cheat Sheet Am I Doing Human Subject Research? Assembling you Research Team ...
IRB Conference Content
2024 2024 IRB Conference Introduction (Bruce Gordon) 2024 IRB Conference Conclusion (Bruce Go...
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)
HRPP Investigator Guidance Series
This page serves as a hub for all of the Investigator Guidance Series documents. Each document is...
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...
Training
SPAdmin offers a number of formal and informal educational opportunities for departmental adminis...
4.4 Research Involving Children
Last revised: 9/3/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
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...
5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities
Last Revised: 11/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
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...