Role of the Institutional Review Board

The Institutional Review Board (IRB) at Saint Xavier University is established in compliance with Title 45, Part 46 of the Code of Federal Regulations (Rev. June 18, 1991). The role of the IRB is to review all proposals for research involving human subjects prior to commencement of such research, and to monitor the progress of projects which have received IRB approval. The purpose of IRB review is not to place obstacles in the path of legitimate research, but rather to ensure that the rights of human research subjects are fully protected.

The Code of Federal regulations defines research as "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR 46.102d). In effect, human subjects research is any activity involving the collection of data about living individuals for the purpose of generalization, including pre-tests and pilot studies (45 CFR 46 102f). It not only includes faculty research, but also student research involving human subjects (for example master's theses and class projects involving surveys or human subjects experiments). Examples of human subjects research include, but are not limited to, psychological experiments, comparative studies of teaching outcomes, ethnographic research or anthropological field work, sociological surveys and interviews, biological experiments, medical clinical trials, classroom surveys, evaluation research, market surveys, telephone and mail surveys and focus groups.

The mandate of the IRB is:

1. to monitor and review all research conducted by Saint Xavier University faculty, students and staff that compiles and analyzes data gathered from or about human subjects, and
2. to monitor and review all human subjects research conducted at Saint Xavier by parties not affiliated with the University which uses Saint Xavier students, faculty or staff as research subjects.

Only two categories of human-data collection are excluded from institutional review:

1. administrative record-keeping and information processing activities, such as maintaining transcripts, registration records, or billing files; and
2. service activities which do not have a research component, such as educational tests, diagnostic evaluations, counseling files, or student advising files.

However, the subsequent aggregation of administrative records or service/clinical files for the purpose of generalization is accordingly viewed as human subjects research and must apply for IRB review. Persons who are not sure if they are required to apply for IRB review should contact the IRB Chair or Co-Chairs for further information.

The IRB at Saint-Xavier adheres to federal IRB membership regulations (45 CFR 46.107), which require the IRB to have:

1. at least 5 members, with varying backgrounds to promote complete review of research activities;
2. a diversity of race, gender, and cultural backgrounds;
3. a balance of qualified persons on both sexes;
4. at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas; and
5. at least one member who is not otherwise affiliated with the institution.

Saint Xavier University endorses and complies with these regulations. Saint Xavier's IRB includes at least three full- time faculty members from a variety of scientific disciplines, at least one member who is not affiliated with the University, and at least one member whose primary concerns are in nonscientific areas. The membership reflects a balance of gender, race, and areas of specialization. The IRB meets as needed during both the academic year and the summer, but must convene at least once each academic year. Telepresence is an acceptable form of attendance for IRB members, and such attendance counts towards quorum. In accordance with Section 45 CFR 46.107.e, no member of the IRB may participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Accordingly, any department chair serving on the IRB will recuse him- or herself from the review of any proposed research project involving one or more faculty members from the chair's department, aside from the provision of information requested by the IRB. Any other IRB member who also happens to be from the same department as an IRB applicant is eligible to participate in all discourse and voting concerning a proposal from said department, provided that the IRB member has no other conflict of interest with respect to the proposal.