Institutional Review Board (IRB) Guidebook
This guidebook includes all of the information previously found on the Institutional Review Board (IRB) webpage.
After clicking into a topic, navigation within the book or page can be found on the left side of your screen. Above the page lists your current location within the content structure. If needed you will find a search function at the top of the page which may also be used for fast navigation.
The FAQ page will assist in directing you to the appropriate section of the guidebook based on your question.
If you have any questions, please contact us at 402-559-6463 or by email at irbora@unmc.edu
Introduction
Mailing Address: Institutional Review Board University of Nebraska Medical Center 98783...
IRB News & Updates
New Biomedical/Social Behavioral IRB Application Rollout Oct 30th, 2025 The new version of the Bi...
Does My Project Require IRB Review?
The IRB has multiple tools to assist investigators in determining whether their project is Human ...
Which Application Do I Use?
There are eight applications to choose from depending on the type of research that is planned. Pl...
IRBs & Submission Deadlines
IRBs IRB-01 (Adult) OHRP IRB Registration # IRB00000670 Meets the first Thursday of each month...
Report a Research Problem or Complaint
Report a problem Report a problem securely and confidentially through the UNMC Human Subjects Res...
Forms
The following sections (located in the menu below will assist researchers by providing various to...
Existing paper protocols
NOTE: THE PAPER FORMS ON THIS PAGE ARE ONLY TO BE USED FOR STUDIES THAT HAVE NOT BEEN TRANSFERRED...
Miscellaneous
Title Version Format Investigator Assessment Checklist for Regulatory Documentation 4/24/2...
Recruitment templates
Whenever possible, the layout of advertisements must conform to UNMC's institutional requirements...
Short Forms
A Short Form may be used when a subject/LAR who cannot understand English is unexpectedly encount...
Subject's Rights & Responsibilities
Research Questions: Amheric - Research Questions & Rights and Responsibilities English (UNMC) Eng...
General Information
Frequently Asked Questions (FAQ)
Below are a number of commonly asked questions. The questions will either provide an answer or wi...
FWAs - Federalwide Assurance (member roster)
Federalwide Assurance UNMC operates under Federalwide Assurance (FWA) in accordance with 45 CFR 4...
IRB Chairs
The Institutional Review Board (IRB) is composed of members from a variety of scientific discipli...
IRB Fees
In line with most other academic medical centers and universities, the Office of Regulatory Affai...
IRBs & Submission Deadlines
Information regarding IRB Board meetings and Submission deadlines can be found on the IRB & Submi...
Office Hours
IRB Office Hours We can be reached by phone (402-559-6463) or by email (irbora@unmc.edu) Mon-Fri ...
Guides
The goal of the IRB Education Program is to facilitate research involving human subjects from ini...
Emergency Preparedness Resources
Emergency Preparedness / Continuity of Operations Plan (EP/COOP)
Informed Consent Resources
RSS Training for Consent Forms Consent Forms 101 Creating a Consent Form Functions within a...
Mental Health Considerations
Explanation of Risks Be clear in application and ICD about risks associated with mental health a...
Noncompliance
Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a gui...
Relevant Links & Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...
RSS E-Signature Instructions
The e-signature function in RSS is a way to electronically sign consent forms. It can be used if...
RSS Guides
Guides to assist with RSS procedures: If there is a topic that does not appear below, please cont...
Investigator Toolkit
Cheat Sheets & SOPs
Advertisement Policy Cheat Sheet Central IRB (cIRB) Cheat Sheet Compensation Cheat Sheet Consent ...
IRB Application Guide
IRB Application Guide
Miscellaneous
Assembling your Research Team IRB Acronyms and Definitions Informed Consent Resources Other Insti...
RSS Assistance
E-Signature Instructions RSS Guides
Policies
Procedures
The IRB is committed to making the submission process as smooth as possible. In this section, you...
Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please conta...
Emergency Treatment
The contact list for Emergency Treatment authorization can be found here in RSS. Under certain ci...
Exempt Studies
It is understood this project will be conducted in full accordance with all applicable HRPP Polic...
Incidents (Non-compliance/Problems)
Per HRPP policy 8.4 non-compliance (NC) involving the PI and/or study personnel must be promptly ...
Protocol Deviations
A Single Subject Protocol deviation is a change in an IRB-approved protocol which is permitted fo...
Single & Central IRB
RSS For applications with due dates on or after Jan 25, 2018, and contract solicitations publish...
Glossary
Cede Review An institution agrees to transfer IRB review and oversight authority for specified re...
sIRB - What is Single IRB?
Single IRB is a model of IRB review that is intended to streamline and reduce administrative burd...
sIRB - UNMC process
A helpful guide for starting an sIRB Request can be found here: Starting an sIRB Request The UNMC...
sIRB - Submission deadlines
Click here to be redirected to the page for sIRB Submission Deadlines for New Submissions, Previo...
sIRB - Reliance
Reliance refers to an arrangement where an IRB allows another IRB to perform review and approval ...
sIRB - Fees
For information regarding the fee schedule for Single IRB studies, please contact sirb@unmc.edu. ...
cIRB - What is Central IRB?
The UNMC IRB uses the term “central IRB” or “cIRB” to indicate that the reviewing IRB (i.e., the ...
cIRB - UNMC Process
Note: When requesting cIRB review, study teams must satisfy the requirements of each IRB and the ...
cIRB - Reliance
When requesting to rely on an external IRB, the UNMC IRB will assess the external IRB’s qualifica...
cIRB - Fees
Please visit our IRB Fees page located here.
cIRB - Forms & Links
Note: the UNMC IRB cannot answer questions related to external IRB processes or applications. Con...
SROC
In accordance with all Federal Guidelines, the University of Nebraska and Board of Regents policy...
Chairs and Administrator
Iqbal Ahmad, PhD Chair, SROC 402-559-4091 Email IRB Analyst III, SROC 402-559-3779 Email
Committee
In 2008, the Human Embryonic Stem Cell Research Advisory Committee of the National Research Counc...
Forms
Scientific Research Oversight Committee (SROC) Submission Form for Stem Cell Research SROC Ap...
Training
The topics found below will provide various learning resources for common IRB items.If there is a...
CITI Training
What is CITI? Collaborative Institutional Training Initiative (CITI) certification is an insti...
Community Partners
All individuals that work on human subject research projects must complete human subject research...
IRB Conference Content
2025 Ethical Study Design IS Good Science (Susan Fish) The AI Middle Game: From Panic to Prop...
IRB Training Videos
Below are training topics related to the IRB, its history, and its function. Please let these vid...