UW-Madison requires all individuals engaged in human subjects research that fall under the purview of its IRBs to be listed as part of the study team. Individuals who generally fall under UW-Madison IRB purview are individuals conducting human subjects research as UW-Madison faculty, staff, or students or under an appointment or affiliation with the Madison VA Hospital, University of Wisconsin Hospital and Clinics or University of Wisconsin Medical Foundation.

Individuals who fall under UW-Madison IRB purview are generally considered study team members engaged in human subjects research if they:

• design research
• direct research or serve as the principal investigator for the study
• enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects)
• make decisions related to eligibility to participate in research
• conduct study procedures
• analyze or report research data
• analyze or report adverse events

For additional details on what constitutes engagement in human subjects research, please see HRP-311 – WORKSHEET – Engagement Determination.