Concordia University Chicago (CUC) recognizes its ethical, legal, and federally mandated responsibilities to safeguard the rights and welfare of human subjects in all research conducted by its students and personnel. Its ethical responsibilities are guided by the principles outlined in the Belmont Report of respect for persons, beneficence, and justice. Concordia’s federally mandated responsibilities come from the Department of Health and Human Services (DHHS), and are outlined in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46). These regulations mandate that all institutions engaged in research with human subjects provide the dual protections of Institutional Review Board (IRB) review and informed consent from the participants.
The ethical and federally mandated responsibilities mentioned above serve as the foundation for an agreement between Concordia University Chicago and the DHHS’s Office for Human Research Protections (OHRP) called a Federalwide Assurance (FWA). Concordia University Chicago has filed and received approval of its FWA from OHRP. This assurance (FWA #00018965) covers research conducted by CUC-affiliated students and personnel.
The CUC Institutional Review Board reviews all research involving human subjects conducted by either Concordia students or personnel. The IRB was established by the Board of Regents to comply with the standards for research set by the OHRP and is described in section 4.00.101 of the University’s Administrative Policies and Procedures Manual.
The IRB for the University is sponsored by the Office of Planning and Research and is headquartered on the River Forest campus. Members of the IRB, appointed by the University President, represent the interests of the University and the broader community. They possess varied backgrounds and expertise, and include at least one member not affiliated with the University. The IRB meets once a month, and minutes of its meetings are filed in the Office of Planning and Research.
It is the responsibility of individual investigators to familiarize themselves with the policies and procedures set forth in the IRB Manual. The University regards any infringement of these policies and procedures as a serious breach of professional standards. The University’s willingness to defend researchers in litigation depends on strict adherence to policies and procedures regarding IRB approval.
Members of the Concordia community may bring issues of general policy regarding human subjects in research to the attention of the IRB. Questions should be sent in writing to the Chairperson of the IRB. Interpretation of applicability of IRB rules and regulations are solely the legal right and responsibility of the IRB.
Should you need immediate assistance with an issue related to the IRB, call or email any of the following people:
Amanda Maddocks, Chair of the IRB
Director of Academic Research
Planning and Research Associate
Senior Vice President for Planning and Research