Human Subjects Protocols

Created 9/21/16; reviewed 9/16/19

A human subjects protocol is needed when research at the University of Wisconsin-Madison involves human participants. The purpose of a protocol is to protects the rights and welfare of individuals participating as research subjects.

Similar to animal use protocols, human subjects protocols are submitted via ARROW (Application Review for Research Oversight at Wisconsin). The Institutional Review Board (IRB) that reviews our protocols on campus is the Education and Social/Behavioral Science (ED/SBS) IRB.

A great place to start is by contacting the ED/SBS IRB Office. Send an email to one of the staff members listed on their web site. They may suggest that you stop by their office in Lathrop Hall to discuss your research plans.

Another way to get started is to click on the topics in the ED/SBS IRB Office KnowledgeBase. It includes information for New Researchers (outline of the steps for getting started), IRB Reviews (meeting dates, review processes, modifications), IRB guidance documents, ARROW FAQs, and the link to log in to ARROW.

Once you start your protocol in ARROW, add Marilyn Larsen as a point of contact so she is able to edit the application, if needed, and receive email notifications about its submission.

Note: PIs for human subjects protocols do not need to be faculty members but must have approved PI Status for human subjects protocols, which is different than PI status for submitting grant proposals. Complete the Request for Approval to Serve as Principal Investigator (PI) on a University of Wisconsin-Madison Human Participants Study form. A link to the form is on the Principal Investigator Status for UW-Madison Studies Involving Human Participants web page.

A list relevant policies is on the Human Subjects Research Protection Program (HRPP) Policy Index web site.

For comments or suggestions regarding this page, contact Marilyn Larsen.