Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors. The federal definition of research is:
“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.”
The NKU IRB office is frequently asked to make a formal determination that a project falls outside of the federal definition of research. Often, IRB review of these projects isn’t required; however, formal IRB determinations that the projects do not require IRB oversight are requested in anticipation of such documentation being required for journals, conferences, funding sources and others.
The materials below are intended to assist study teams in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected. To address the issue of documentation, the NKU IRB has developed a tool that can provide self-certification that the project does not require IRB review and oversight and also an abbreviated formal certification if needed.
This tool allows study teams to make the decision about whether their project meets the definition of human subjects research under the Common Rule (45 CFR 46) or if the project falls into the quality improvement category independent of the IRB. If, based on the questions and responses in the completed tool, the project does not constitute human subjects research, the tool provides a certification. If the PI would like a formal certification, one can be requested in the Mentor system. Instructions for how to request formal certification are provided within the self-certification tool.
If completion of the tool indicates the project may require IRB review, any indication of certification from the tool is considered invalid. In this case, the NKU IRB should be contacted for further guidance or an initial review application submitted in Mentor IRB.
This decision tree provides an additional resource for assistance in determining whether a project constitutes human subjects research (and subsequently requires IRB review) or quality improvement/program evaluation. The decision tree forms the basis for the questions in the IRB QI/Program Evaluation Self-Certification Tool (see above), but it does not provide a certification upon completion.
This table, created by University of Wisconsin-Madison Health Sciences IRB, is intended to help determine whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected. Please contact the NKU IRB with any questions or for assistance in making a determination.