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Institutional Review Board (IRB) Guidebook Guides

Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...

Updated 6 days ago by Robert A Lewis

RSS Guides

Institutional Review Board (IRB) Guidebook Guides

Guides to assist with RSS procedures: If there is a topic that does not appear below, please cont...

Updated 6 days ago by Robert A Lewis

RSS E-Signature Instructions

Institutional Review Board (IRB) Guidebook Guides

The e-signature function in RSS is a way to electronically sign consent forms. It can be used if...

Updated 6 days ago by Robert A Lewis

IRB Training Videos

Institutional Review Board (IRB) Guidebook Training

Below are training topics related to the IRB, its history, and its function. Please let these vid...

Updated 6 days ago by Robert A Lewis

Informed Consent Resources

Institutional Review Board (IRB) Guidebook Guides

RSS Training for Consent Forms Consent Forms 101 Creating a Consent Form Functions within a...

Updated 6 days ago by Robert A Lewis

HRPP Investigator Guidance Series

Institutional Review Board (IRB) Guidebook Policies

This page serves as a hub for all of the Investigator Guidance Series documents. Each document is...

Updated 6 days ago by Robert A Lewis

HRPP (Human Research Protection Program) Policies

Institutional Review Board (IRB) Guidebook Policies

The purpose of this policy is to provide a basic description of UNMC’s Human Research Protection ...

Updated 6 days ago by Robert A Lewis

Office Hours

Institutional Review Board (IRB) Guidebook About

IRB Office Hours We can be reached by phone (402-559-6463) or by email (irbora@unmc.edu) Mon-Fri ...

Updated 6 days ago by Robert A Lewis

IRB Fees

Institutional Review Board (IRB) Guidebook About

In line with most other academic medical centers and universities, the Office of Regulatory Affai...

Updated 6 days ago by Robert A Lewis

Frequently Asked Questions (FAQ)

Institutional Review Board (IRB) Guidebook About

Below are a number of commonly asked questions. The questions will either provide an answer or wi...

Updated 6 days ago by Robert A Lewis

FWAs - Federalwide Assurance (member roster)

Institutional Review Board (IRB) Guidebook About

Federalwide Assurance UNMC operates under Federalwide Assurance (FWA) in accordance with 45 CFR 4...

Updated 6 days ago by Robert A Lewis

Recruitment templates

Institutional Review Board (IRB) Guidebook Forms

Whenever possible, the layout of advertisements must conform to UNMC's institutional requirements...

Updated 6 days ago by Robert A Lewis

Short Forms

Institutional Review Board (IRB) Guidebook Forms

A Short Form may be used when a subject/LAR who cannot understand English is unexpectedly encount...

Updated 6 days ago by Robert A Lewis

IRBs & Submission Deadlines

Institutional Review Board (IRB) Guidebook About

IRBs IRB-01 (Adult) OHRP IRB Registration # IRB00000670 Meets the first Thursday of each month...

Updated 6 days ago by Robert A Lewis

Glossary

Institutional Review Board (IRB) Guidebook Single & Central IRB

Cede Review An institution agrees to transfer IRB review and oversight authority for specified re...

Updated 2 weeks ago by Robert A Lewis

IRB News & Updates

Institutional Review Board (IRB) Guidebook

New Biomedical/Social Behavioral IRB Application Rollout Oct 30th, 2025 The new version of the Bi...

Updated 3 weeks ago by Robert A Lewis

sIRB - Submission deadlines

Institutional Review Board (IRB) Guidebook Single & Central IRB

Click here to be redirected to the page for sIRB Submission Deadlines for New Submissions, Previo...

Updated 3 weeks ago by Robert A Lewis

Introduction

Institutional Review Board (IRB) Guidebook

Mailing Address: Institutional Review Board University of Nebraska Medical Center 98783...

Updated 3 weeks ago by Robert A Lewis

8.1 Review of Adverse Events and Adverse Device Effects

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 3/24/2026 1.0 Purpose The purpose of this policy is to describe the process for rep...

Updated 3 weeks ago by Robert A Lewis

5.3 Use of a Remote Consent Process

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 1/14/2026 For an abbreviated version intended for investigators, coordinators, and ...

Updated 3 weeks ago by Robert A Lewis