Project Review : Northern Kentucky University, Greater Cincinnati Region

Please note, information on this website is intended for general IRB guidelines.
Please contact our office for more detailed clarification and interpretation of the regulations as it relates to your project if needed.

Does my Project Require IRB Review and Approval?

THERE ARE TWO MAIN QUESTIONS TO ANSWER THAT WILL HELP TO DETERMINE IF IRB REVIEW IS REQUIRED:

Is it research?
Does it involve human subjects?

Click here to view the NKU IRB Human Subjects Research Decision Tree.

Helpful definitions to determine if IRB review is required:

Research

Research means a:

systematic investigation, including research development, testing, and evaluation
designed to develop or contribute to generalizable knowledge.

Human Subjects

A living individual about whom an investigator (whether professional or student) conducting research obtains:

Data through intervention or interaction wtih the individual or
Identifiable private information

Intervention/Interaction

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Identifiable/Private Information

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

Still not sure?

NKU IRB has developed two tools to help you determine if the project requires IRB oversight.

Tool 1: Human Subjects Research Determination Diagnostic Survey

Tool 2: Quality Improvement Determination Diagnostic Survey

Contact the IRB office with any questions at irb@nku.edu or 859-572-5168.

Okay, my project meets the federal definition of human subjects research, now what?

After determining that your project requires IRB review, the next step is to determine which IRB review level best fits your project. In the Mentor IRB system, you will be prompted to select an appropriate review category, however, the IRB can change the determination if needed.

This diagnostic tool can help determine the review type.

Review Level

Exempt - Less than minimal risk - Exempt review categories
Expedited - No more than minimal risk - Expedited Categories
Full Board - More than minimal risk - Full Board Examples