Institutional Review Board

Frequenty Asked Questions

What is the role of the Institutional Review Board?

The Institutional Review Board (IRB) at Saint Xavier University (SXU) consists of members from each School and department within the University along with a community representative. The role of the IRB is to review in advance all research proposals involving human subjects data, and to monitor the progress of projects that have been reviewed by the IRB. The purpose of IRB review is to insure that the rights of human subjects are protected. The mandate of the IRB is to monitor and review all research conducted by SXU faculty, students and staff that compiles and analyzes data gathered about human subjects. In addition, the IRB reviews research conducted by parties not affiliated with the University, but which uses SXU students, faculty or staff as research subjects.

When must my proposal be submitted?

In all cases, it is the responsibility of the researcher to request and receive permission to proceed as a result of IRB review and prior to the initiation of any data collection from human subjects. Failure to obtain IRB review prior to data collection may result in adverse consequences to the researcher and/or to the University.

Why must research proposals be submitted for IRB Review?

Federal Regulations (Code of Federal Regulations, chapter 45, Section 46.11 6) and University policies require that all proposals for research involving human subjects be submitted for prior review to the Institutional Review Board (IRB). The United States Department of Health and Human Services (HHS) requires all researchers conducting human subjects research to provide prospective subjects with informed consent.

Who must submit research proposals for IRB Review?

Every researcher (e.g., students, faculty, staff, administrators) who is involved in collecting data from people or about people that will be used for purposes of generalization must submit their research proposal for review, even if the research is being conducted off campus. When faculty require students to conduct research or interviews as part of their class assignments, the faculty member may request a blanket exemption from full review that covers the class project and therefore requires submission of only one set of IRB forms.

What research must be submitted for IRB review?

The ultimate purpose of IRB review of research protocols is to verify that the rights and confidentiality of human subjects are protected. Research involving human subjects includes, for example, data collected from social surveys and interviews, participant observation, psychological experiments, observation, classroom surveys, evaluation research, market surveys, telephone and mail surveys, focus groups and generalizations from available records. All stages of research and data collection involving human subjects, including pre-tests and pilot studies, as well as the final data collection are subject to the review process.

What forms must be completed to request an IRB review and where do I obtain these forms?

The Request for Ethical Review of Research on Human Subjects application form may be downloaded from the IRB Forms web page. It requires applicants to provide basic contact and logistical information as well as a description of the research to be conducted. Additionally, applicants will need to attach supporting documents, including informed consent letters/forms and data collection instruments.

How does the IRB review process at SXU work?

The complete application (including accompanying documents) should be submitted via email (as a single Word document) to irb@sxu.edu in the Office of Academic Affairs. The application will be logged and forwarded to an IRB 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 mail these items to the Office of Academic Affairs 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/her of the following:

The IRB reviewer may request additional information regarding the nature of the research protocol, or may recommend changes in the informed consent procedures or content. Proposals are classified as either 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. If necessary, the proposal will be passed on for full review by the entire IRB. The result of a full review is either a verification or a written recommendation for changes. Any changes made in the light of those recommendations must be submitted in writing and will automatically receive a full review.

Via e-mail, 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 reviewed and 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 and/or of the Federal Regulations from the Office of Academic Affairs.

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