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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 ...

Updated 8 months ago by Robert A Lewis

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 ...

Updated 8 months ago by Robert A Lewis

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.

Updated 8 months ago by Robert A Lewis

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 ...

Updated 8 months ago by Robert A Lewis

sIRB - UNMC process

Institutional Review Board (IRB) Guidebook Single & Central IRB

The UNMC sIRB Process is captured in the diagram below. Contact sirb@unmc.edu with any UNMC sI...

Updated 8 months ago by Robert A Lewis

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 burd...

Updated 8 months ago by Robert A Lewis

Recruitment templates

Institutional Review Board (IRB) Guidebook Forms

HRPP policy to review: #3.5 Subject Recruitment Through Advertisements Recruitment Type Format ...

Updated 8 months ago by Robert A Lewis

Community Partners

Institutional Review Board (IRB) Guidebook Training

All individuals that work on human subject research projects must complete human subject research...

Updated 9 months ago by Robert A Lewis

Investigator Resources

Institutional Review Board (IRB) Guidebook Education & Resources

Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR: 2...

Updated 9 months 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 r...

Updated 9 months ago by Robert A Lewis

Submission Process

Institutional Review Board (IRB) Guidebook Procedures

Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by em...

Updated 9 months ago by Robert A Lewis

Emergency Treatment

Institutional Review Board (IRB) Guidebook Procedures

The contact list for Emergency Treatment authorization can be found here in RSS. Under certain c...

Updated 9 months ago by Robert A Lewis

Adverse Event Reporting

Institutional Review Board (IRB) Guidebook Procedures

Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medi...

Updated 9 months ago by Robert A Lewis

Incidents (Non-compliance/Problems)

Institutional Review Board (IRB) Guidebook Procedures

Per HRPP policy 8.4 non-compliance (NC) involving the PI and/or study personnel must be promptly ...

Updated 9 months ago by Robert A Lewis

Protocol Deviations

Institutional Review Board (IRB) Guidebook Procedures

A Single Subject Protocol deviation is a change in an IRB-approved protocol which is permitted fo...

Updated 9 months ago by Robert A Lewis

ClinicalTrials.gov (CT.gov)

Institutional Review Board (IRB) Guidebook Procedures

Check back to this page for more updates regarding clinicaltrials.gov information. Please co...

Updated 9 months ago by Robert A Lewis

Exempt Studies

Institutional Review Board (IRB) Guidebook Procedures

It is understood this project will be conducted in full accordance with all applicable HRPP Polic...

Updated 9 months ago by Robert A Lewis

CITI Training

Institutional Review Board (IRB) Guidebook Training

What is CITI? Collaborative Institutional Training Initiative (CITI) certification is an insti...

Updated 9 months ago by Robert A Lewis

Funding

Research Handbook

Announcements Internal & External Funding Upcoming internal funding announcements are share...

Updated 1 year ago by Max V. Kuenstling

Table of Contents

HRPP Policies and Procedures

Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progr...

Updated 1 year ago by Robert A Lewis