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 Betsy Dancisak: BetsyDancisak@creighton.edu
o Meg Rayner: MegRayner@creighton.edu
Standard IRB Turnaround Times
The IRB aims to complete its initial review of complete IRB submissions (no missing documents or information) consistent with or faster than median turnaround times for Association for the Accreditation of Human Research Protections (AAHRPP) accredited programs, which are listed 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 a notice about expected turnaround 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.
Initial Applications (Quality Improvement (QI), Not Human Subjects Research (NHSR), or Exempt submissions): Within 12 business days.
Initial Applications (Expedited Studies): Within 17 business days.
Initial Application (Full Board Greater than Minimal Risk Studies): Are due to the IRB two weeks prior to the dates of the next convened IRB meeting. The IRB meeting schedule and information on full Board submission deadlines can be located here. Protocols received within one week prior to the next meeting may be added to the meeting agenda at the discretion of the IRB Director and IRB Chair. Protocols received with less than one week prior to the meeting agenda will be added to the meeting agenda for the following month. Please understand that compliance with the human research regulations requires that Board members have adequate time to read and evaluate submissions prior to the date of the convened meeting.
Modifications (NOT REQUIRING Scientific Review): Within 5 business days.
Modifications (REQURING Scientific Review): Within 12 business days.
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.
Reportable New Information (Subject Death, Hospitalization, or Other Serious Adverse Events (SAEs)): Within 48 hours.
Reportable New Information (Other): Within 5 business days UNLESS the RNI submission is limited to a single site visit monitoring report, in which case the report must be submitted within 30 days.
Closure (Routine Study Closeout): Within 5 business days.
Continuing Review (Expedited Studies subject to FDA regulation ONLY): Within 7 business days.
Continuing Review (Full Board Greater than Minimal Risk Studies): Are due to the IRB office no later than 30 days prior to the date of expiration for the IRB protocol to ensure that continuing reviews can be added to the next regularly scheduled IRB meeting. Late-submitted requests for continuing review may lead to a lapse in IRB approval. If IRB approval is permitted to lapse, no study activities other than those necessary to protect the rights, safety, and welfare of subjects will be allowed to continue and study enrollment must be stopped until IRB approval has been restored.
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.
