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    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.

UPDATE Regarding COVID-19

Updated: FAQs and Guidance for Investigators and Research Coordinators

All remaining human subject research IRB protocols which were halted due to the pandemic can apply to restart. Investigators must first complete and submit a Research Safety Plan using this link.

Once received, the plan will be reviewed by the Human Subject Research Safety Review Committee assembled for this purpose. The investigator may be asked for clarification or additional information, or may be asked to modify their plan. The plan must be approved before the research will be allowed to proceed. The person completing the form will receive an email confirming the form was successfully submitted.

The plans will be evaluated in the order that they were received. The number received will impact how quickly the investigators receive a response.

Once the committee has approved the plan it will be passed onto the IRB for final review; the IRB will release consent pending any requirement for submitting an IRB protocol modification for review and approval through the RSS portal.

 

Bruce Gordon, MD

 

 


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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.