IRB Application Process
All research conducted at Saint Xavier University which involves human or animal subjects must first be reviewed by the Institutional Review Board (IRB). The mission of IRB is to assure that ethical guidelines for research are followed. IRB reviews each research proposal and will either approve the proposal or make a formal request for changes to meet ethical guidelines for human subjects research stated by the Collaborative Institutional Training Initiative (CITI), National Institutes of Health (NIH), and/or American Psychological Association (APA). In cases of animal or other sensitive research, the proposal will be reviewed by the entire IRB committee. The committee consists of faculty members representing all four schools, the broader professional community, and the general public.
Applications for review of proposed human subjects research are accepted by the IRB at any time. During the academic year, complete applications are reviewed by the committee with goals of two-week turn-around times for applications qualifying for expedited review and four-week turn-around times for applications requiring full review. Applications received outside the academic calendar year are reviewed as time permits. All applicants should use the IRB Application Form (DOC) and make sure to complete the key steps in preparing an IRB application noted on this page. Applicants are encouraged to consult other pages of the IRB website as well as handbooks for additional guidance on the design of research projects involving human subjects and the preparation of related IRB applications that entail the use of appropriate templates (consent forms, parent permission, institutional agreements, etc.)
Complete IRB applications (including accompanying documents) should be submitted via email (as a single Word document) to firstname.lastname@example.org in the Office of Academic Affairs. The application will be logged and forwarded to the IRB Chair/Co-Chair. Additionally, you will need to print a hard copy of the signature box page of the main application form and any administrator consent forms, collect the required signatures, and bring or mail these items to the Office of Academic Affairs (Warde Academic Center, Room A209) on the Chicago Campus. Complete submission instructions may be viewed on the Helpful Hints web page. If you are a student, your faculty sponsor is responsible for reviewing and signing your application forms for IRB review (and the consent form, if applicable) prior to submission to the IRB.
After an initial review of the research protocol, an IRB member will contact the researcher to inform him or her of the following:
The IRB may request additional information regarding the nature of the research protocol, or may require changes in the informed consent procedures or content. Proposals are classified and processed by the IRB as exempt, as expedited review, or as requiring full review based on the level of risk to human subjects, and on the adequacy of the information and consent provided to the proposed research subjects. The result of a review is either approval, non-approval, or a written request for changes. Any changes made in response to such a request must be submitted in writing (email to email@example.com or deliver to the Office of Academic Affairs) and will be processed through the full review track.
Via email, you will receive a formal letter from the IRB indicating their review of your proposal, and you may begin data collection upon notification that your proposal has been approved by the IRB.
The IRB is committed both to facilitating research and to assuring that all research at SXU meets federal guidelines protecting the rights of human subjects. Please feel free to contact any IRB member should you have any questions. If you desire further information, you may request a copy of the Belmont Report (PDF) and/or of the Federal Regulations from the Office of Academic Affairs (45 CFR 46) (PDF).
In compliance with Sections 115 and 103.b.3-5 of 45 CFR 46, the IRB maintains records of IRB operations, applications to the IRB, and decisions related to those applications. Records related to IRB applications that are not approved are kept for 3 years after the date on which the decision was rendered, and records pertaining to IRB applications that were approved are kept for 3 years after the conclusion of the study. More information on the IRB and its procedures can be found in Section 2.2.12 of the Faculty Handbook.
Key Steps in Preparing an IRB Application:
- Complete the IRB Application Form (DOC) (with all appropriate signatures). Once submitted, an IRB member will review and decide whether the proposal should undergo an exempt, expedited, or full review process.
- Outline your description of proposed project in the application form.
- Attach any auxiliary materials (the questionnaire you plan to use, permission letters from data collection sites, certification for CITI or NIH training) to the above documents.
- If submitted by a student or adjunct faculty member, the application form should be reviewed and signed by a faculty sponsor. The sponsor should receive copies of all correspondence between the IRB and the investigator.
- Faculty sponsors or researchers and all other project personnel, including student researchers or assistants, must complete CITI or NIH Certification: (1) Send an electronic copy of the completed IRB application (DOC) and all auxiliary materials to firstname.lastname@example.org. (2) Deliver a hard copy of the signature page to the Office of Academic Affairs in the Warde Academic Center, Room A-209. (3) When appropriate, obtain a letter of agreement from a gatekeeper at the institution that hosts your research and deliver it as a part of application package to the Office of Academic Affairs.
- Applicants should allow ample time for processing, as IRB committee members’ schedule,
the volume, and complexity of proposals fluctuates, and revisions and multiple rounds
of review may be necessary. However, within 2 business days of submission of a complete, clearly assembled application, applicants should receive an email from the IRB Chair/Co-Chair acknowledging receipt
of the complete IRB application and assigning a tracking number that should be used
in all correspondence related to the application. Be aware that incomplete applications will not be reviewed, and target processing timelines only commence with receipt of a complete IRB application. If the IRB reviews an application and requires revisions to it, the relevant processing
timeline starts over upon the IRB's receipt of the revised application. Applicants
are encouraged to contact the IRB concerning the status of their applications if either
an acknowledgement of receipt coupled with issuance of a tracking number has not been
received within two business days of application submission, or following issuance
of a tracking number, the IRB has not made follow-up contact at the end of the relevant
processing period (2 weeks for expedited review and 4 weeks for full review). Be aware that data collection may not begin prior to receipt of IRB approval.