What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is an administrative body charged with the protection of the rights, safety, and welfare of human subjects in research. The IRB is charged with the responsibility of reviewing and approving, prior to its initiation and thereafter on an ongoing basis, all research (whether funded or not) involving human participants. The IRB has the authority to approve, disapprove, monitor, suspend, terminate, and/or require modifications to all human subjects research activities that fall within its jurisdiction under the federal research regulations and institutional policy.
Institutional Review Boards are charged with ensuring that:
Creighton University Institutional Review Boards
Creighton University IRB (CU IRB) is responsible for all human subjects research conducted by CU faculty or students or occurring on a CU campus. CU IRB has two review boards, a Biomedical IRB (IRB-01) and a Social and Behavioral IRB (IRB-02). Creighton’s IRBs operate under Federal Wide Assurance (FWA) FWA00001078. A Federal Wide Assurance is an assurance of compliance provided from an institution to the federal government, attesting that the institution will abide by the federal human subjects research regulations.
Members are appointed to the CU IRBs by the CU Institutional Official, Julie Strauss-Soukup, PhD. Current membership rosters for CU IRBs can be found here. CU IRB meeting schedules and submission deadlines are located here.
Submitting to the IRB
The CU IRB uses InfoEd, an electronic submission system, for all IRB submissions. Before you can submit a protocol to the IRB using InfoEd you will need to set up an InfoEd profile. If you do not have an InfoEd profile, please contact Rosa Seiffert at RosaSeiffert@creighton.edu or 402.280.3074 for assistance. In preparation for setting up your InfoEd account and profile please have ready your CU NetID, a copy of your current signed and dated resume or CV in PDF format, and a copy of your current professional license if you are a professional license holder. For additional information , please see the IRB Instructions page for information on how to access and submit through InfoEd.
I have an IRB question. Who should I contact?
o Ethan R. Ankrum: EthanAnkrum@creighton.edu
o Betsy Dancisak: BetsyDancisak@creighton.edu
o Meg Rayner: MegRayner@creighton.edu
Standard IRB Turnaround Times
The IRB will typically complete its initial review of IRB submissions according to the timelines below. While we endeavor to complete our review well ahead of these expected turnaround times, a faster review will not always be possible. Therefore, we encourage investigators to be aware of anticipated turnaround times and to communicate with the IRB office if priority review is requested to meet deadlines associated with a grant application, course requirements, etc. Please note that priority review is never guaranteed.
In addition, anticipated turnaround times apply to complete submissions only. If your submission is missing required information or requires revision it will be returned to you with comments via the InfoEd platform. In these cases, turnaround time calculations begin once your complete/revised submission has been successfully returned to the IRB. During periods of the academic year when the IRB is reviewing a higher-than-average volume of submissions, the IRB will post revised expected turn around times to this website. If you believe that your submission is not adhering to the turnaround times below, please contact the IRB at irb@creighton.edu or 402.280.2126.
o This includes submissions with revised investigators brochures or other updated drug or device information, revisions to biomedical protocols that may increase risks to subjects or others.
IRB Office Contact Information
Location: Dr. C.C. and Mabel L. Criss Health Sciences Complex I, Room 133
Phone: 402-280-2126
Fax: 402-280-4766
Email: IRB@creighton.edu
Creighton University Earns Full AAHRPP Accreditation
Creighton joins an elite group of organizations in achieving full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). In achieving full AAHRPP accreditation, Creighton University has demonstrated its commitment to rigorous standards that help protect research participants while ensuring that society continues to reap the benefits of research.