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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 6/24/22)
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.
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.
2. Additional questions have been added to the CIRB application:
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.
Financial Interest Disclosure
June 21, 2022
As of June 21, 2022, PIs and Faculty Advisors must personally complete the Financial Interest Disclosure questions at the time they are signing section I of the application. Though other research personnel may collaborate on completing other sections of the IRB application, no one other than the individuals signing the application will have the ability to answer the financial disclosure questions. This change applies not only to new applications but also to approved applications when a change request is initiated.
Revised Paper Continuing Review Forms
June 17, 2022
The continuing review applications for existing paper applications have been revised. These forms have been revised to remove personnel changes from the continuing review so that the continuing review and personnel changes on paper applications are handled like the electronic applications in RSS. These forms can be found on the IRB website: https://www.unmc.edu/irb/procedures/forms/paper-protocols.html
RSS New Application Update
June 8, 2022
All IRB applications begun after today will no longer require certification and signature by a Resource Reviewer.
Investigators are reminded that they are still responsible for assuring that there are adequate resources available to conduct the research, and to protect the rights and welfare of human subjects.
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.