Do I need IRB approval?

St. Catherine University is committed to safeguarding and respecting the rights and welfare of human subjects involved in research. In order to carry out this obligation, the University, through its Institutional Review Board (IRB), is responsible for conducting initial and continuing review of all research that involves human subjects. Investigators cannot begin research with human subjects until a complete application has been submitted to the IRB, reviewed and approved.

One of the most challenging aspects of Human Subjects Protection is determining what constitutes "human subjects research" in order to determine what requires IRB review. Trying to decide, for example, whether a faculty member needs IRB approval in order to conduct a classroom assessment or a student needs IRB approval to conduct a survey for a course project can be confusing. Fortunately, we can help!


To determine what constitutes human subjects research, consider:

1. Is it Research?

For purposes of IRB review, "research" is defined as "a systematic investigation designed to develop or contribute to generalizable knowledge." (45.CFR 46.102).
Activities that meet this definition constitute "research" whether or not they are supported or funded by an external agency. Some "programs" and "projects" may also include research activities, particularly if there will be an assessment or evaluation. Projects at the undergraduate or graduate level such as thesis, honors, or seminar projects may also be considered "research."

2. Are Human Subjects Involved?

For purposes of IRB review, a "human subject" is defined as "a living individual about whom an investigator conducting research obtains (1) data through interaction or intervention with the individual or (2) identifiable private information." (45.CFR 46.102)

View the decision chart to determine whether your work is human subjects research!

What else should I consider?

Determining whether something is research that involves human subjects can be surprisingly complicated and depends on a variety of factors. There are a number of questions to think about as you determine whether you will need IRB approval:

• Do you intend to collect information and then present it to a public audience or at a conference?
• Do you intend to publish findings or disseminate information based upon your work?
• Will you be conducting interviews, surveys or focus groups?
• Will you need access to sensitive data or records?
• Is there any way to link the data you plan to collect with identifying information?
• Are you seeking grant funding?

If the answer to any of these questions is "yes" your work may require IRB review.

If you suspect that your research might constitute human subject research, please contact John Fleming, the Acting IRB Chair to discuss the specific circumstances of your project. The IRB Chair is happy to help you determine whether or not your work will require IRB review. It is usually better to err on the side of caution if you will be working with human subjects to ensure both their protection and your own!