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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.
NOTE: Upcoming IRB changes to impact application process
Investigators should expect to see significant changes in the look, feel and content of the on-line IRB Application within the next few months. Some of the changes come in response to the upcoming revisions in the Common Rule, the overarching Federal Policy governing human subjects research in the United States. Other changes are part of a multi-faceted effort on behalf of the ORA and the IRB to reduce burden on investigators and on the ORA staff, and to facilitate the review and conduct of ethical research within the Organization.
Expect further information, and details regarding training opportunities for the new process, in the near future.
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.