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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
(last updated 2/9/22)
February 9, 2022
The request to voluntarily defer the start of new protocols and pause face-to-face research activities is now lifted. Investigators should continue to use remote visits, when and where feasible, and review all subjects for potential exposures or risk before any scheduled face-to-face visit. Location or timing of visits may still be impacted by changes in Nebraska Medicine or other clinical facility changes and/or staff shortages.
Demographic Data Requirement Update
January 10, 2022
The Vice Chancellor of Research and the IRB now require that all human research studies provide demographic data (gender, race, and ethnicity) of all enrolled subjects, at time of annual review. This information will be submitted as part of the Continuing Review form, for studies requiring continuing review. For studies not requiring Continuing Review, PIs and Lead Coordinators will receive an email directing him/her to a new Demographics form which has been generated in the FORMS section of your application in RSS.
In accordance with Health and Human Services Regulations for Protection of Human Subjects (45 CFR 46), an Institutional Review Board (IRB) composed of members from a variety of scientific disciplines and individuals from the community, assists investigators in the protection of the rights and welfare of human subjects.
The University of Nebraska Medical Center (UNMC) IRB was established to assure the protection of all human subjects in research projects conducted by anyone on the premises of UNMC, Nebraska Medicine, Nebraska Medicine - Bellevue, Children’s Hospital & Medical Center (CH&MC), and the University of Nebraska at Omaha (UNO). In addition, the IRB has oversight for all research that is conducted elsewhere by faculty, students, staff, or other representatives of these institutions.
The IRB also serves to facilitate valuable human subject research, as well as, protect the investigator and the institutions through a comprehensive review process. All human subject research projects must be reviewed and approved by the IRB prior to initiation and then conducted in full compliance with the federal regulations and institutional policies.