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
Congruency, Consent, and Recruitment Materials Dec 13th, 2024 In order to assure that subject inj...
Frequently Asked Questions (FAQ)
Below are a number of commonly asked questions. The questions will either provide an answer or wi...
HRPP (Human Research Policy & Procedures) Manual
The purpose of this policy and procedure is to provide a basic description of UNMC’s Human Resea...
Does my project require IRB review?
To help you determine if your project constitutes Human Subject Research and requires IRB review,...
Which application do I use?
There are eight applications to choose from depending on the type of research that is planned. Pl...
Submission deadlines
IRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Change...
Report a research problem or complaint
Report a problem Report a problem securely and confidentially through the UNMC Human Subjects Re...
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 medi...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please co...
Emergency Treatment
The contact list for Emergency Treatment authorization can be found here in RSS. Under certain c...
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...
Submission Process
Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by em...
Education & Resources
The goal of the IRB Education Program is to facilitate research involving human subjects from ini...
HRPP Investigator Guidance Series
This page serves as a hub for all of the Investigator Guidance Series documents. Each document is...
Investigator Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR: 2...
Mental health considerations
MENTAL HEALTH CONSIDERATIONS FOR RESEARCHERS DECEMBER 2023 EXPLANATION OF RISKS: Be clear in a...
Miscellaneous Resources
Below investigators will find a variety of resources that may assist with research goals: Allowa...
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...
Consent Forms
Capacity to consent Assessment of capacity to consent to participate in research Consent Form R...
E-Signature Instructions
The e-signature function in RSS is a way to electronically sign consent forms. It can be used if...
IRB Training Videos
Below are training topics related to the IRB, its history, and its function. Please let these vid...
RSS Training
Guides to assist with RSS procedures: If there is a topic that does not appear below, please cont...
Virtual Training/Office Hours
IRB Office Hours We can be reached by phone (402-559-6463) or by email (irbora@unmc.edu) Mon-Fri...
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...
FWAs - Federal Wide Assurance
The UNMC IRB Federal Wide Assurance documents can be found here: Adult IRB Roster -2025 (FWA00002...
Miscellaneous
Title Version Format Investigator Assessment Checklist for Regulatory Documentation 9/17/2007...
Recruitment templates
HRPP policy to review: #3.5 Subject Recruitment Through Advertisements Recruitment Type Format ...
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...
Single & Central IRB
For applications with due dates on or after January 25, 2018, and contract solicitations publishe...
Glossary
Cede Review An institution agrees to transfer IRB review and oversight authority for specified r...
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
The UNMC sIRB Process is captured in the diagram below. Contact sirb@unmc.edu with any UNMC sI...
sIRB - Submission deadlines
sIRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Chang...
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
In line with most other academic medical centers and universities, the Office of Regulatory Affai...
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...
IRB Staff
This section will detail contact information for both IRB Staff and IRB Chairs.