The Personnel Update function allows for the following:

• Removing personnel
• Adding personnel
• Revising study team member roles
• Revising who has edit access to the application

The Principal Investigator (PI) and all points of contact (POCs) may use the Personnel Update function.

The Personnel Update can be used when a study is:

• Approved or Approved with No Continuing Review
• Expired or Closed
• Exemption Granted
• Reliance Approved

Yes. Everyone on the study team must have current human subjects research and, if applicable, Good Clinical Practice (GCP) training in order to complete a Personnel Update. Study teams will be blocked by ARROW from completing a Personnel Update until all study team members have the required training.

No. The activity form will not automatically check for financial conflicts of interest (COI). It is the study team’s responsibility to accurately answer the COI questions in the activity form prior to adding new study team members. Study teams will be blocked by ARROW if the answers to the questions indicate that a study team member has a financial conflict. If study teams provide incorrect or inaccurate responses to these questions and a study team member with a conflict is added via the self-service activity, this may be considered noncompliance.

No. Changes in PI must still be submitted with a change of protocol.

Yes. When a Personnel Update is completed, your application will reflect whatever revisions to study personnel you have made. Completion of a Personnel Update will also log in the history tab and you will receive a notification from ARROW.

Yes. Study teams can still update personnel as part of regular change of protocol. Please note, however, that you cannot use the Personnel Update function when a change of protocol is open. Personnel can join a study prior to IRB approval of the change of protocol under the following circumstances:

• A change of protocol which includes the new personnel has been submitted to the IRB for review;
• The personnel do not have a financial conflict of interest related to the study as defined under the Conflict of Interest Policy;
• The personnel have completed the required human subject protection training as defined under HRPP Education and Training or by Madison VA requirements (for information about VA training, contact Mina.Herreman@va.gov);
• The personnel have completed appropriate HIPAA Privacy Rule training and/or Good Clinical Practice training, if applicable;
• The personnel have received study-specific training and can adequately perform their study-related role(s); and
• The personnel are engaged in human subject research under UW-Madison, UWHC, UWMF or Madison VA appointment or as a UW-Madison student.

No. When a UW-Madison IRB serves as the reviewing IRB for external personnel or sites, those personnel cannot be added or removed via the Update Personnel activity. Please contact the Reliance and Navigation Team (irbreliance@wisc.edu) for assistance in determining whether and how to list external personnel in your application.

No. While you can update personnel as part of a regular change of protocol, you cannot use the separate Personnel Update function if a change is already open.

Yes.