Determining whether a project constitutes human subjects research as defined by federal regulations is a multi-step process. A project may be excluded from or not meet the federal definition of “research”, or it may be research but does not include “human subjects” as that term is defined by federal regulations. See HRP-310 – WORKSHEET – Human Research Determinations for definitions.

If you have a project that you believe does not meet the definition of “research” or does not include “human subjects” and you would like to participate in the pilot for the Not Research (NR)/Not Human Subjects Research (NHSR) Self-Certification Tool, please email the IRB Directors at irbdirector@hsirb.wisc.edu.

The NR/NHSR Self-Certification Tool* is designed to assist study teams in determining whether a project requires submission to the IRB. If the project involves some characteristics of a research project that involves human subjects, or if regulations require IRB determinations (e.g., HIPAA, FDA, single IRB), the Tool will direct you to obtain IRB review. If the project does not meet the definition of “research” or does not include “human subjects”, the Tool will provide you with a determination confirming this. This determination may be used as documentation that the project does not constitute human subjects research and further IRB review is not required.

Projects That Are Not Appropriate for the NR/NHSR Tool

If you believe your project qualifies as Quality Improvement/Program Evaluation, use the QI/Program Evaluation Self-Certification Tool instead.

This tool is not intended for FDA regulated studies. For guidance on whether your study is FDA regulated, see HRP-306 – WORKSHEET – Drugs and Biologics or HRP-307 – WORKSHEET – Devices and consult with the UW’s FDA Regulated Research Oversight Program. It is your responsibility to obtain IRB review if you are conducting FDA regulated research.

Research of a graduate student involving human participants for inclusion in a master’s thesis or doctoral dissertation must be approved or determined to be exempt by a UW-Madison IRB before beginning the research. See Student Research, Advisor, & Course Instructor Responsibilities for more information.

A journal or conference may not accept a self-certification as proof your project does not require IRB approval. Before conducting your project, consider whether self-certification will suffice for your intended purposes and, if not, you will need to submit an application in ARROW to obtain a formal IRB determination.

*This tool was adapted with permission from University of Pittsburgh, Office of Research Protections, HSR Determination Tool. We thank the University of Pittsburgh for generously sharing their materials and guidance with us.