Academic Research

Do I Need IRB Review?

The IRB reviews and approves all “research” involving “human subjects” that is carried out by Concordia students or personnel. The following definitions and guidelines are provided to help investigators determine if their work requires IRB review and approval.

Definitions

Research — Federal regulations (CRF Title 45, Part 46, 2009) define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition excludes instructional activities that are not designed to contribute in any way (e.g., through presentation or publication) to generalizable knowledge. Also excluded are activities related to routine course or program development/evaluation.

Human Subject — Federal regulations (CRF Title 45, Part 46, 2009) define a human subject as “a living individual about whom an investigator (whether a professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

In making a determination about whether an activity constitutes research involving human subjects, ask yourself the following questions:

1) Will the data collected be publicly presented or published?

AND

2) Do my research methods involve a) direct and/or indirect interaction with participants via interviews, assessments, surveys, or observations, or b) access to identifiable private information about individuals, e.g., information that is not in the public domain?

If the answer to both of these questions is “yes,” a project is considered research with human subjects and is subject to federal regulations. It thus requires a thorough review via one of the review mechanisms discussed in the IRB Manual. The type of review required depends on the nature of the research project. Consult the sections on full board, expedited, and exempt review to make this determination.

Activities That May Not Require Review

The following activities do not typically require review because they do not satisfy the definition of “research”—in other words, the investigator answers “no” to the first question above. Most often the following activities are thought of as learning experiences only, since the information gathered will not be used as actual “data” for publication or presentation. However, information obtained via any of these activities would be considered research if it were incorporated into a publication or presentation that would be used to contribute to generalizable knowledge.

Classroom Projects

In many academic programs, a knowledge of research methods/methodology is vital to a well-rounded education. Instructors may encourage their students to design small projects simply to teach them how to properly conduct research. In most cases, the data will not be used to contribute to generalizable knowledge and may not require IRB review. However, they must be registered using the Faculty Assurance Form for Classroom Projects and submitted to the IRB. For more information, email the IRB: IRB@CUChicago.edu

Program Evaluations

Investigators may gather data from human subjects through direct or indirect interaction for purposes of program evaluation. The information they collect will not be used to contribute to generalizable knowledge, rather the results will be used to improve or develop an internal program.

Investigators are strongly cautioned to consider whether or not the information collected for a classroom project or program evaluation will be used to contribute to generalizable knowledge; the investigator must decide in advance, as it is not possible to retrospectively review and approve a project once data collection has begun. If an investigator is unsure about how the data will be used, it is better to err on the side of caution and submit an application for review.

Even when projects do not qualify as “research,” as defined by federal regulations, they must be conducted with the utmost regard for University policies, ethical standards, and the welfare of human participants.

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: