Principal Investigator Changes and Personnel Updates Guidance

Version Date: February 2020

The purpose of this document is to provide guidance to research teams regarding requirements for informing the Health Sciences IRBs (HS IRBs) of changes in Principal Investigator (PI). This guidance also discusses updates to study team members as well as their roles.

NOTE: For exempt studies, updates to personnel are not required except when a) a study team member has a new conflict of interest and b) when the Principal Investigator is changing. To make either update, please submit a change of protocol.

Change in Principal Investigator (PI)

Given the level of responsibility they assume, the HS IRBs generally require permanent changes of PI to be reviewed by the convened IRB as full changes of protocol. This allows the IRB to determine whether they meet the requirements in the Principal Investigator Status for UW-Madison Studies Involving Human Participants policy.

In the following cases, however, permanent changes to PIs may be reviewed as expedited changes:

The new PI should not assume responsibility for the study prior to IRB approval of the change unless the departure of the former PI was unexpected and/or a gap in study leadership would increase risks to subjects enrolled in the study.

When to Submit a Change of Protocol or New Information Report for PI Changes

Changes to Study Documents for PI Changes

When a PI change occurs, the research team should consider whether study documents are affected by this change, such as the consent and authorization forms or study protocol. If the subjects are still participating in a research study, the IRB recommends research teams provide a written update to these participants, such as an information sheet or letter, to inform them of the change in PI and to update them regarding changes in relevant telephone numbers (e.g., for study-related questions) and addresses (e.g., to withdraw authorization). Example letter informing participants of change in PI.

Updates to Study Team Members Other Than the Principal Investigator (PI)

Beginning in February 2020, PIs and their points of contact (POCs) can add and remove study team members as well as change their roles via the self-service Update Personnel activity in ARROW. For instructions on using this Update Personnel activity, please see this how-to guidance. NOTE: For changes in PI, a change of protocol is still required.

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