Key questions about the self-service update personnel functionality are addressed below. If you have questions about how to use this functionality, please see this how-to guidance or email email@example.com for help.
What updates to the study team can be made with the Personnel Update?
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
Who can use the Personnel Update?
The Principal Investigator (PI) and all points of contact (POCs) may use the Personnel Update function.
When can the Personnel Update be used?
The Personnel Update can be used when a study is:
- Approved or Approved with No Continuing Review
- Expired or Closed
- Exemption Granted
- Reliance Approved
Does the Personnel Update check for training?
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.
Does the Personnel Update check for conflicts of interest?
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.
Can the PI be changed with the Personnel Update?
No. Changes in PI must still be submitted with a change of protocol.
Does completing the Personnel Update automatically update the application?
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.
Can I still make updates to personnel with a change of protocol?
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.
Can I add study team members from external institutions or sites with the Personnel Update?
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 (firstname.lastname@example.org) for assistance in determining whether and how to list external personnel in your application.
Can I complete a Personnel Update when a change of protocol is under review?
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.
Can I complete a Personnel Update when a continuing review application is open?