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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 videos serve as a training tool for those new to the IRB and research fields. If you need individual assistance with specific issues, or for general information, plea...

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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 the consent process is conducted in person (face to face) or remotely (telephone or video as approved by the IRB). RSS e-signature can only be used for certain st...

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 contact irbora@unmc.edu Adding Personnel Adding Documents to an Application Completing a Completion Report Consent Forms 101 Creating a Consent Form Creating and navig...

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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 an abbreviated version of one of our HRPP Policies intended for investigators, coordinators, and other study team members. This page is a good starting point for ...

Community Partners

Institutional Review Board (IRB) Guidebook Training

All individuals that work on human subject research projects must complete human subject research training. Faculty, students, or employees of UNMC, NM, CHMC, UNO, BMC, or another academic partner institution are required to take CITI training. Community partn...

sIRB - What is Single IRB?

Institutional Review Board (IRB) Guidebook Single & Central IRB

Single IRB is a model of IRB review that is intended to streamline and reduce administrative burden on IRBs reviewing multisite studies. In a single IRB model, one IRB serves as the reviewing IRB or “IRB of Record” and the participating site (pSite) IRBs serve...

sIRB - UNMC process

Institutional Review Board (IRB) Guidebook Single & Central IRB

A helpful guide for starting an sIRB Request can be found here: Starting an sIRB Request The UNMC sIRB Process is captured in the diagram below. View diagram as text Step One: Request Determination Lead Site submits sIRB request through RSS sI...

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, Previously Tabled Protocols and Requests for Change

sIRB - Reliance

Institutional Review Board (IRB) Guidebook Single & Central IRB

Reliance refers to an arrangement where an IRB allows another IRB to perform review and approval of a study. The UNMC IRB uses the term “single IRB” or “sIRB” to indicate that UNMC is serving as the reviewing IRB (i.e., the IRB of record) of a multisite study...

cIRB - What is Central IRB?

Institutional Review Board (IRB) Guidebook Single & Central IRB

The UNMC IRB uses the term “central IRB” or “cIRB” to indicate that the reviewing IRB (i.e., the IRB of record) of a multisite study is external to UNMC. The UNMC IRB has contracted with two commercial IRBs, Advarra and WCG. In addition, the UNMC IRB partners...

cIRB - UNMC Process

Institutional Review Board (IRB) Guidebook Single & Central IRB

Note: When requesting cIRB review, study teams must satisfy the requirements of each IRB and the funding agency or sponsor (as applicable), prior to initiating the research. For assistance on how to start a cIRB application, please find the guide here: How To...

cIRB - Reliance

Institutional Review Board (IRB) Guidebook Single & Central IRB

When requesting to rely on an external IRB, the UNMC IRB will assess the external IRB’s qualifications in accordance with HRPP Policy 1.4 (UNMC Ceding Review to an External Central IRB). The UNMC IRB may request information related, but not limited, to: SMART...

cIRB - Forms & Links

Institutional Review Board (IRB) Guidebook Single & Central IRB

Note: the UNMC IRB cannot answer questions related to external IRB processes or applications. Contact the external IRB's helpdesk or designated representative directly for assistance. For questions regarding UNMC cIRB processes or applications, please contact ...

cIRB - Fees

Institutional Review Board (IRB) Guidebook Single & Central IRB

Please visit our IRB Fees page located here.

sIRB - Fees

Institutional Review Board (IRB) Guidebook Single & Central IRB

For information regarding the fee schedule for Single IRB studies, please contact sirb@unmc.edu. For information regarding other IRB Fees, please visit that page here.

Chairs and Administrator

Institutional Review Board (IRB) Guidebook SROC

Iqbal Ahmad, PhD Chair, SROC 402-559-4091 Email IRB Analyst III, SROC 402-559-3779 Email

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Committee

Institutional Review Board (IRB) Guidebook SROC

In 2008, the Human Embryonic Stem Cell Research Advisory Committee of the National Research Council and Institute of Medicine published Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research. Section 2.0 (page 11) describes th...

Forms

Institutional Review Board (IRB) Guidebook SROC

Scientific Research Oversight Committee (SROC) Submission Form for Stem Cell Research SROC Application for Continuing Review SROC Request for Change in Protocol

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