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
In the following cases, however, permanent changes to PIs may be reviewed as expedited changes:
- The study is permanently closed to enrollment and open only for long-term follow-up.
- Study activities are limited to data and/or biospecimen analysis.
- The study was initially reviewed under expedited procedures and continues to meet criteria for review under expedited procedures.
- The study was determined to be excused from continuing review.
- The sole purpose of the IRB application is to document approval of a grant.
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
- If the change in PI is permanent: Changes in the PI should be submitted to the IRB prior to the new PI assuming oversight of the study. If the PI is leaving the UW-Madison/UWHC/UWMF/Madison VA (hereafter referred to as the UW), the change must be submitted no later than 14 business days prior to the departure of the former PI. If the former PI is leaving the institution but will remain a study team member, please contact the Reliance and Navigation Team (firstname.lastname@example.org) to discuss what additional steps may need to be taken to ensure appropriate IRB oversight is in place.
- If a temporary change in PI is needed: Temporary changes in PI may be needed if the PI cannot provide oversight of a research study due to emergent circumstances (e.g., a sudden leave of absence) or a planned absence (e.g., parental leave, sabbatical or military service) lasting 6 weeks or longer.
- For temporary leaves lasting less than 6 weeks, the PI is responsible either for ceasing study activities or ensuring oversight of these activities is delegated to a qualified member of the study team. The study team does not need to inform the IRB in these cases.
- For temporary leaves lasting more than 6 weeks, the study team is required to submit a New Information Report to the IRB that:
- specifies the anticipated length of absence;
- confirms one of the following:
- no study activities will occur during the PI's leave;
- only activities involving data or sample analysis will occur during the PI's leave; or
- identifies who will assume PI responsibilities for the study during the leave.
- The New Information Report should be provided to the IRB as soon as possible, preferably before the PI takes leave. If the PI cannot return from leave as planned or changes their role after the leave ends (e.g., becomes a sub-investigator), a change of protocol to formally update the PI for the study would be required.
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.
- Removing personnel: Study teams must remove study team members who fall under UW-Madison IRB purview within 6 weeks of their departure from the study team, regardless of their role.
- If personnel leaving the UW will no longer be engaged in human subjects research for a study, these personnel should be removed using the self-service activity.
- If personnel leaving the UW will continue to be engaged in human subjects research for a study, the HS-IRBs cannot automatically remain the IRB of record for these personnel. The study team must contact the Reliance and Navigation Team (email@example.com) to discuss what additional steps may need to be taken to ensure these personnel continue to have appropriate IRB oversight for their study activities.
- Adding personnel affiliated with the UW: Personnel must be added to the study team before they can begin any study activities. Personnel can only be added if they:
- Do not have a financial conflict of interest related to the study as defined under the Conflict of Interest Policy;
- Have completed the required human subject protection training as defined under HRPP Education and Training Policy or by Madison VA requirements (contact the Madison VA Research Office for information about VA training requirements);
- Have completed appropriate HIPAA Privacy Rule training and/or Good Clinical Practice training, if applicable;
- Have received study-specific training and can adequately perform their study-related role(s); and
- Are engaged in human subject research under a UW-Madison, UWHC, UWMF, or Madison VA appointment or as a UW-Madison student.
- Adding personnel not affiliated with the UW: 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.