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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.
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Consent Form Readability Standards
In response to Common Rule requirements, beginning October 31, 2019, consent forms must satisfy minimum readability standards; specifically, the Flesch Kincaid reading level and Flesch Reading Ease.
Please see more about readability standards and how to get started or contact the Office of Regulatory Affairs with questions.
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.