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IRB reviews a wide variety of research involving human subjects.
FDA regulations require IRB review for all drug and device studies.
To view the latest updates from the IRB, visit our Updates Page.
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.
- 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.
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 firstname.lastname@example.org or call 402-559-6463.
Reminder regarding Protocol Approval Expiration
January 17, 2023
Investigators and research teams are reminded that annual continuing review is required for research originally approved by the convened IRB (protocols designated FB) as well as most research approved before 2019. As always, reminders will be sent to the PI and the Lead Coordinator and/or Regulatory Contact 60 days and 45 days prior to approval expiration.
If Continuing Review is not submitted and re-approved by the IRB by the expiration date all human subject research activities must stop. This includes new subject accrual, as well as follow-up of existing subjects and data analysis.
If continuation of research activities is in the best MEDICAL interest of already enrolled subjects (that is, the research presents the potential for direct benefit to subjects) you may submit the “Request to Continue Treatment for Enrolled Subjects on Approval Expired Studies" form, available in RSS.
If a Continuing Review application is not submitted within 30 calendar days, the study will be closed, and re-activation of a closed protocol will require submission of a new IRB application.
If all study activities, including all follow-up and data analysis, are completed, and all ClinicalTrials.gov reporting requirements have been met, you must submit a Study Completion Report, available in RSS.
Research which qualifies for Expedited Review (protocols designated EP) and some FB research that is in data analysis or clinical follow-up may not require annual continuing review. The initial approval letter, or a subsequent communication from the Office of Regulatory Affairs, will notify you if CR is not required.
If your research does not require annual CR you must still complete an annual Demographics form. If this form is not submitted within 20 days the protocol will be closed as above.
If you require assistance, please contact us at IRBORA@unmc.edu, or at (402) 559-6463