IRB UPDATES

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

Congruency, Consent, and Recruitment Materials

Dec 13th, 2024

In order to assure that subject injury language in the consent forms matches that in contracts, UNeHealth or SPA will begin conducting congruency checks.  The congruency check is an institutional requirement and is a requirement for accreditation of our Human Research Protection Program.  

Research teams should ensure a copy of the consent form is either developed or uploaded in RSS. The Office of Regulatory Affairs will notify SPA/UNeHealth of the requirement for a congruency check.  If a discrepancy is found, SPA/UNeHealth will reach out to study teams directly to correct the consent form.  Research teams will need to revise the consent developed in RSS or upload a copy of the revised consent (if relying on an external IRB) to RSS.

Congruency checks apply to studies that are conducted at UNMC, Nebraska Medicine, and Children's Nebraska that are:

1. Commercially funded
2. Grant/Foundation/Consortium (other than NIH) funded 
3. DoD funded 

Congruency checks are NOT required for:

1. NIH funded studies
2. Cooperative Groups studies, such as the Children's Oncology Group
3. Departmentally funded studies
4. CCTR funded studies
5. Studies conducted at UNO

CIRB Consent Forms

For studies relying on an external IRB for oversight (CIRB studies), the Office of Regulatory Affairs will be reviewing consent forms to verify the required UNMC local consent language has been appropriately inserted into the consent.  The required language is available on the UNMC IRB website (https://www.unmc.edu/irb/singlecentral/central_irb/cirb_forms_and_links.html).  This review will also look for any consent language required by the UNMC Conflict of Interest Committee, as applicable.  

CIRB Recruitment Materials

For studies relying on an external IRB for oversight (CIRB studies), the Office of Regulatory Affairs will begin reviewing recruitment to verify the materials conform to UNMC HRPP policies 3.5 and 3.6 .  For existing studies, any new recruitment materials should be submitted as a change request.  For new studies, recruitment materials should be uploaded to RSS at the time of initial submission.

Fee Increase

July 31st, 2024

To align with other academic medical centers and universities, effective September 1, 2024, the Office of Regulatory Affairs and the IRB will increase the IRB review fees for the initial review of protocols where UNMC relies on a commercial IRB. This will apply only to protocols submitted on or after September 1, 2024.

• Central IRB initial review fee (UNMC relying on a commercial IRB) will increase from $1500 to $3000. This is a one-time fee.

All investigators involved in research projects relying on a commercial IRB should include the IRB review fee in their grant or contract budget. A funding account must be provided at the time of IRB submission.

If you have any questions, please contact the Office of Regulatory Affairs at irbora@unmc.edu.

Advarra Submissions

July 2nd, 2024

Effective immediately, UNMC site submissions to Advarra may begin as soon as a study has been assigned a UNMC IRB number in the RSS system.  Previously, Advarra required an Acceptance letter from the Office of Regulatory Affairs in order for study teams to begin the submission process with Advarra.  Study teams will be required to provide Advarra with a copy of the "New Protocol" email as documentation of having a UNMC IRB number.

Emergency Preparedness (EP/COOP)

May 16th, 2024

We would like to remind clinical researchers about our Emergency Preparedness & Continuity of Operations Plan (EP/COOP), which is designed to:

• Detail how decisions on altering or halting ongoing research might affect studies, investigators, and current/potential subjects.
• Establish a framework to restore essential functions to UNMC’s Human Research Protection Program (HRPP), Institutional Review Board (IRB), and ORA during emergencies.
• Complement the broader UNMC/NM enterprise-wide COOP.

The plan is available here:
https://guides.unmc.edu/books/hrpp-policies-and-procedures/page/emergency-preparedness-continuity-of-operations-plan-%28epcoop%29

IRB Office Hours

January 19th, 2024

Intended for questions regarding research projects, filling in an application, policies, regulations, etc.

2^nd Monday of every month 9-10 AM (Zoom link)

4^th Thursday of every month 2-3 PM (Zoom link)

-Please direct questions regarding office hours to the IRB Education Coordinator, Megan Berger: mberger@unmc.edu or 402-559-6044

-We would like to remind everyone that IRB staff are available for assistance outside of office hours. If you ever need help outside of the designated office hours, please do not hesitate to reach out to an analyst or our main email, IRBORA@unmc.edu. We are happy to assist you via email, phone call, or video conference call during normal work hours.

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