• 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.

IRB UPDATES

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

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.

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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

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Consent regarding Human Biological Materials

August 26, 2022

Investigators are reminded that obtaining blood samples or other biological specimens for research, whether from a patient or from an employee or other normal volunteer, for use now or in the future, requires IRB approval and written informed consent. This includes drawing blood as “controls” for in vitro assays, unless those assays are performed solely for clinical purposes (and usually in a CLIA certified laboratory).

The IRB is happy to work with you to develop protocols to encompass a number of different activities involving collection of samples from human subjects, and to discuss further.  Please contact us.

Conducting human subject research without IRB approval and informed consent, including obtaining blood or other biospecimens for any research purpose, is serious non-compliance and may be reported to HHS, FDA, NIH, or other Federal authorities."

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cIRB Application Update

June 24, 2022
1. 
The CIRB application has been updated to include a contact information sheet which can be automatically generated in RSS. This contact sheet includes the Rights of Research Subjects and Research Questions.

a. Check the box next to personnel you would like to list on the Contact Information sheet.

        6/24/22 IRB update 1
b. When all personnel have been selected, click “Save” and the page will refresh.

c. Select “Contact Information Sheet” from the left side menu to generate a pdf that includes a list of authorized personnel and the last 2 pages appended to any consent form.

        6/24/22 IRB update 2
2. Additional questions have been added to the CIRB application:

a. “Does this study involve an investigational drug or device?” If yes, prompted for IND/IDE#.
b. “Will subjects age 18 years of age or younger be included in this research?” If yes, prompted to enter age range. 
c. “Method of Subject Identification and Recruitment” section added for consistency with other IRB applications and to ensure UNMC investigators are following UNMC policies.
d. “Process of Informed Consent” section added for consistency with other IRB application and to ensure UNMC investigators are following UNMC policies.

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