• Academic & Research Services

    Academic & Research Services

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  • IRB reviews a wide variety of research involving human subjects.

    IRB reviews a wide variety of research involving human subjects.

  • FDA regulations require IRB review for all drug and device studies.

    FDA regulations require IRB review for all drug and device studies.


To view the latest updates from the IRB, visit our Updates Page


IRB Office Hours

January 19th, 2024

2nd Monday of every month 9-10 AM via Zoom
4th Thursday of every month 2-3 PM via Zoom

RSS Office Hours: 4th Friday of every month 3-4 PM via Zoom

Additional information can be found on our Education page here.

August 17th, 2023

The Office of the Vice Chancellor for Research and Office of Regulatory Affairs want to inform human subjects researchers about a temporary policy change.

Why it Matters: Over the next couple of months, temporary onboarding and training demands for new IRBORA staff may lead to a delay in timelines for IRB review and other ORA processes. The VCR and ORA recognize the potential impacts this could have on studies and have implemented a temporary policy change to lessen their effect and provide another option for studies.

What’s New: This policy change is currently in effect and provides an option for certain study teams to use Advarra [advarra.com] or WCG [wcgclinical.com] as a Central IRB (CIRB).

  • This change applies to new investigator-initiated studies where the Principal Investigator is from UNMC, Nebraska Medicine, Children’s Hospital & Medical Center, or the University of Nebraska—Omaha.
  • This is a temporary change from the policy requiring local IRB review for UNMC investigator-initiated studies.
  • This option will be in place until November 1, 2023 unless extended further by the VCR Office/ORA.
  • Study teams are still encouraged to use the UNMC IRB, as this change only provides the option to use a Advarra or WCG as the IRB of record.

What to Do: Investigator teams seeking to use one of these commercial IRBs as the IRB of record are required to submit a CIRB application to the UNMC IRB in addition to the application required by the commercial IRB.

Studies should be aware of the following costs associated with using an external IRB:

  • A one-time, $1,500 fee for UNMC review of CIRB studies to ensure compliance with local institutional guidelines.
  • Any additional fees charged by external IRBs for review and use of their services

As a reminder: any human subjects research, whether reviewed by the UNMC IRB or by an external IRB, must adhere to all UNMC HRPP Policies, and must have the approval of all other relevant institutional committees.

For more information, visit the UNMC CIRB website or contact IRBORA@unmc.edu with any questions.

Bruce Gordon, MD
Assistant Vice Chancellor for Regulatory Affairs
Executive Chair, UNMC IRBs

Russell J. McCulloh, MD
Associate Vice Chancellor for Clinical Research
Institutional Official, UNMC IRBs

UNMC expanding support for ClinicalTrials.gov registrations

June 30th, 2023

The UNMC Office of the Vice Chancellor for Research and the Office of Regulatory Affairs are updating and expanding support for UNMC’s investigator-initiated studies registered on ClinicalTrials.gov.

To assist UNMC investigators in meeting the complex registration and reporting requirements in ClinicalTrials.gov, the two offices are rolling out an enhanced record monitoring and communication plans that will take effect on July 1.

Key enhancements include:

  • Investigators and institutional leadership now will be kept apprised of records with update or reporting problems.
  • For any studies experiencing issues with their ClinicalTrials.gov listing, UNMC’s ORA will provide a timeline for correction and assistance as needed.
  • A CITI training course is available to UNMC and University of Nebraska at Omaha learners, which provides video instructions for registering, uploading documents and submitting results in ClinicalTrials.gov
  • IRB protocols linked to ClinicalTrials.gov records are easily identified via color-coded icons in RSS. Red icons indicate records with problems, and green icons indicate records that currently are compliant.

Over the next few months, additional support and resources will be provided through UNMC’s ORA, including expanded ClinicalTrials.gov information on the UNMC IRB website, a new decision-making tool for determining registration requirements and timing and more robust processes for record management and closure.

The goal is to bring studies registered on ClinicalTrials.gov through UNMC into full compliance with federal regulations, while reducing the complexity and burden of this process on investigators.

The National Institutes of Health and U.S. Food and Drug Administration have increased their enforcement efforts against reports of registration and reporting failures. Penalties can include substantial monetary fines and the suspension of funding for an investigator or the institution.

However, by collaborating with UNMC’s ORA and following the updated process, UNMC and its investigators can achieve full compliance and avoid these consequences.

ClinicalTrials.gov, launched in 2000, serves as a publicly accessible registry for clinical trials. The database provides the public with clinical trial information, while offering researchers access to valuable study data, promoting transparency and informed decision-making in clinical research.

Please email the Office of Regulatory Affairs for more information.

cIRB webpage update

March 6th, 2023

The cIRB page of the IRB website has recently been reworked. Please feel free to visit the page for updated information as well as a list of helpful forms and links. Keep an eye out for upcoming changes to the sIRB information available on the website!

If you have any questions, please email sirb@unmc.edu or call 402-559-6463.