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NOTE: THE PAPER FORMS ON THIS PAGE ARE ONLY TO BE USED FOR STUDIES THAT HAVE NOT BEEN TRANSFERRED TO THE ELECTRONIC SYSTEM (I.E. THEY ARE STILL IN PAPER FORMAT). FORMS FOR EXISTING PAPER PROTOCOLS ONLY Title Version Format 1. CR Biomedical Research 06/13...

A Short Form may be used when a subject/LAR who cannot understand English is unexpectedly encountered, there is not sufficient time to develop and obtain IRB approval for a complete ICF written in language understandable to the subject/LAR, AND the research pr...

Research Questions: Amheric - Research Questions & Rights and Responsibilities English (UNMC) English (UNO) Spanish (UNMC) Spanish (UNO) Rights of Research Subjects: English English (CHMC) French Somali Spanish Rights and What to know: French Karen Interpretat...

Whenever possible, the layout of advertisements must conform to UNMC's institutional requirements regarding the use of logos and brands. Please see the UNMC Brandwise site for available templates to assist with this. For more information on what information ma...

The UNMC IRB Federal Wide Assurance documents can be found here: Adult IRB Roster -2025 (FWA00002939) Pediatric IRB Roster -2025 (FWA00002939)

Title Version Format Investigator Assessment Checklist for Regulatory Documentation 9/17/2007 Word Investigator Assessment of IRB 9/7/2007 Word

Below are a number of commonly asked questions. The questions will either provide an answer or will link to the appropriate section of the guidebook. The Page Navigation found in the upper left side of the page can be used to scroll directly to the answer need...

IRB Office Hours We can be reached by phone (402-559-6463) or by email (irbora@unmc.edu) Mon-Fri 7am-5pm. The IRB offers two virtual learning/training sessions each month. 2nd Monday of every month 9-10 AM (Zoom link) 4th Thursday of every month 2-3 PM (Zoom ...

Cede Review An institution agrees to transfer IRB review and oversight authority for specified research to another institution’s IRB (reviewing IRB). cIRB <<<< insert definition >>> Lead Site <<<< insert definition >&g...

Deron Anderson, MS IRB Analyst 402-559-5845 Email Megan Berger, BS, MEd IRB Analyst & Education Coordinator 402-559-6044 Email Erika Boohar, BA IRB Analyst 402-559-3853 Email Kristi DeHaai, MS, CIP IRB Analyst ...

The Institutional Review Board (IRB) is composed of members from a variety of scientific disciplines and individuals from the community who assist investigators in the protection of the rights and welfare of human subjects. Executive Chair Bruce Gordon, MD E...

Introduction IRB News & Updates FAQ HRPP Policies Does my project require IRB review? Which application do I use? Submission Deadlines Report a research problem or complaint Procedures Adverse Event Reporting Clinicaltrials.gov Emergency Treatment Exem...

2025 Ethical Study Design IS Good Science (Susan Fish) The AI Middle Game: From Panic to Proportionate IRB Oversight (Tonya Ferraro) Integrating IRB Review Into US Special Pathogens Research Efforts (Kristi DeHaai & Abby Lowe) Informed Consent: Why We ...

In line with most other academic medical centers and universities, the Office of Regulatory Affairs and the IRB charges an initial submission and an annual continuing review fee for commercial and industry sponsored protocols. New Pricing Guidelines (effective...

Advertisement Policy Cheat Sheet Am I Doing Human Subject Research? Assembling your Research Team Demographic Recruiting Numbers Form SOP Direct Invitation Policy Cheat Sheet E-Signature Instructions Informed Consent Resources IRB Acronyms and Definitions IRB ...

Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a guide for study teams when deciding what constitutes noncompliance, when it needs to be reported, and how to report it. The following Noncompliance Guide will explain...