In the following limited cases, permanent changes to PIs may be submitted as expedited changes:
Prompt reporting of PI changes is required to ensure adequate oversight is in place for the conduct of the protocol and the protection of human subjects. 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 a gap in study leadership would increase risks to subjects enrolled in the study.
Reporting Requirements for PI Changes
- If the current PI is leaving the UW-Madison/UW Health/Madison VA: Changes in the PI should be reported to the IRB prior to the former PI leaving the research study, if at all possible. In all cases, a PI change must be submitted no later than 14 business days after the departure of the former PI.
- If the current PI is not leaving the UW-Madison/UW Health/Madison VA and the change in PI is permanent: Changes in the PI must be reviewed and approved by the IRB prior to the new PI assuming oversight of the study.
- 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) for a month or longer.
- For shorter periods of leave or vacation (i.e., one month or less), the PI is responsible either for ceasing study activities or ensuring oversight of these activities is delegated to an appropriately qualified member of the study team.
- For periods of leave that will be a month or longer and presumed to be temporary, the study team is required to submit a New Information Report to the IRB that:
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 or changes his or her 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.
- specifies the anticipated length of absence;
- confirms that if the leave is longer than expected or details of the planned absence change, a second New Information Report will be submitted
- confirms one of the following:
- no study activities will occur during the PI's leave;
- confirms that 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
Changes to Study Documents for PI Changes
When a PI change occurs, the research team should consider whether study documents were affected by this change, such as the consent form, HIPAA form 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
Removal of Study Team Members Other Than the Principal Investigator (PI)
Study teams must remove study team members who fall under UW-Madison IRB purview within one (1) month of the their departure from the study team, regardless of their role. Study teams should use the “Remove Study Team Members” activity in ARROW to remove personnel; a personnel change is NOT required when personnel are being removed. See How to Remove Study Team Members
for instructions on how to use the "Remove Study Team Members" activity.
Addition of Study Team Members
- For personnel affiliated with the UW-Madison/UW Health/Madison VA, a personnel change should be submitted to the IRB prior to or at the time when the new personnel will engage in human subjects research. Personnel can join a study prior to IRB approval of the personnel change under the following circumstances:
The IRB's review of the request to add personnel is to ensure the above conditions have been met. Failure of a study team to ensure key personnel have met the requirements noted above before engaging in human subjects research may be considered noncompliance.
- A personnel change 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 (contact the Madison VA Research Office for information about VA training requirements);
- 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, UW Health, or Madison VA appointment or as a UW-Madison student.
- For personnel NOT affiliated with UW-Madison/UW Health/Madison VA AND for whom the HS-IRBs have already agreed to serve as the IRB of record, the same guidelines described above should be followed.
- For personnel NOT affiliated with UW-Madison/UW Health/Madison VA AND for whom the HS-IRBs have NOT already agreed to serve as IRB of record, the personnel cannot engage in human subjects research activities until a change of protocol to add the institution or individual to the study has been reviewed and approved by the HS-IRBs.
- In the case of research studies where direct interaction with subjects does not occur, personnel changes can be batched and submitted to the IRB on a quarterly basis. The study team is still responsible for ensuring all of the conditions outlined in point 1 of this section, other than submission of a personnel change within 1 month, have been met. This exception to the 1 month submission time frame only applies to the following application types available in ARROW: 1) Non-Exempt Medical Records Review (unless the application involves contacting subjects for information) or 2) Reading Center/Statistical Data Analysis Center (SDAC)/Analysis center for data, specimens and/or images.
Changes to the Roles of Current Study Personnel
The study team must report significant changes in study team roles within 14 business days of those changes. Significant changes are defined as:
- Changes in who serves as point of contact as listed in the General Information section of the initial review application in question 1.6 and 4.4
- Changes in study team roles as listed in the General Study Information section of the initial review application in questions 4.1-4.3
When Current Study Personnel Leave UW-Madison/UW Health/Madison VA
Additional steps may need to be taken when current study personnel leave UW-Madison/UW Health/Madison VA (including graduating students).
- If personnel leaving UW-Madison/UW Health/Madison VA will no longer be engaged in human subjects research for a study, these personnel can be removed as described above.
- If personnel leaving UW-Madison/UW Health /Madison VA 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 HS IRBs Reliance 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.