Scope

Activities that fit the definition of research with human subjects include, in general:

• Research with humans or human tissue
• Surveys of human subjects
• Review of human subjects' records
• Courses in research methods and class assignments that involve research with human subjects
• Pilot studies and feasibility studies (including single subject studies)
• Research using data on human subjects gathered in earlier projects

In general, always assume that your project needs to be submitted to the IRB. We will let you know if it is not deemed to be human subjects research, or if it falls into a special category like translational research or quality improvement.

Click here to review the categories of human research review.

Please note: “Exempt” does NOT mean that IRB does not review your project. It means that the project is reviewed by our administrator, not the board, and does not require board oversight.

If you are not sure whether your project constitutes human subjects research, please ask!

Generally, it is not the charge of the IRB to comment upon the scientific merit of proposals submitted for review except where the scientific merit of the research, or lack thereof, increases either the risks to the subject (directly or indirectly) or the research burden to be borne by the subject. However, if we see a glaring issue or something that does not follow accepted research practices, we will let you know. If we see room for improvement in your study that pertains to how you communicate with your subjects or keep their data safe, we will let you know.

For projects with a student as PI, the research design and scientific merit must be vetted thoroughly by the faculty member or advisor who will serve as their project Co-PI. You can read more about that in the information for faculty section.

In such cases, the investigator may be referred to his/her advisor (in the case of a student) or to institutional experts for further guidance.

Institutional Review Boards exist to ensure compliance with Federal research rules. Federal IRB guidelines do not include concepts like “mission fit” for research. It is not the purview of the IRB to determine whether a project adheres to synodic or other religious beliefs. However, if a project presents the possibility of strain on the institution by creating risk for subjects that are part of the Concordia community, the IRB may deliberate, ask questions of the researcher, or request changes be made to the research to better protect participants.

We often field questions about the kinds of research the CUWAA community is “allowed” to do. Generally, Concordia researchers enjoy academic freedom to research what they are interested in. Faculty must follow the Academic Freedom Policy (available in the Faculty Handbook) when doing research, and students are encouraged to follow similar guidelines. Please reach out to us if you are unsure.

In general, a researcher’s job is to do excellent research and take good care of their research participants. The IRB’s job is to ensure that research is done ethically according to Federal guidelines. Use your best judgement and consider best practices when it comes to your research. For example, if you are not sure what to include in your survey for demographic questions (like gender), refer to Federal census categories . Using the most common categories for surveys will help you collect better data and have stronger research overall.