Key Personnel Guidance
Version Date: August 3, 2011
The 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. In addition, any other individual for whom the UW-Madison will serve as the IRB of record should be listed as part of the study team.
Individuals are considered 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
The ARROW SmartForm application requires the identification of several roles for study team members, including individual(s) who will serve as the Point(s) of Contact, and those who will be able to edit the application and receive automated emails about the application’s status and requests for action from the IRB, and those who will only have the ability to read the application. The Point(s) of Contact for the study should be the individuals to whom IRB correspondence and questions about the study are primarily directed, such as study coordinators, regulatory specialists, or administrative support staff, and are the only other people, as from the Principal Investigator (PI), who can submit materials to the IRB. Prior to the implementation of electronic submission, the IRB Offices only accepted materials signed by the PI to help ensure the PI was aware of and agreed with the materials submitted to the IRB. To keep this principle intact but to provide more flexibility in the electronic environment, a restriction was placed on who can submit materials to the IRB to allow the Point(s) of Contact to submit materials to the IRB.