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Personnel Change Guidance
The purpose of this document is to provide guidance to research teams regarding requirements for informing the Health Sciences IRBs (HS IRBs) of addition and removal of study team members as well as changes in study team member roles. This guidance applies to all studies except exemptions; personnel changes are not required for project that have been determined to be exempt from further IRB review. This guidance also describes the differences in the requirements for changes in Principal Investigators (PIs) compared to those of other study team members.
Version Date: September 29, 2017
Change in Principal Investigators (PIs)Some of the key responsibilities PIs assume for a human subjects protocol include:
- Ensuring compliance with the principles of the Belmont Report and adherence to the regulations outlined in the Common Rule (45 CRF 46), the Food and Drug Administration (when applicable), and the VA regulations (when applicable)
- Ensuring all study team members, including the PI, complete human subjects protection training and, if applicable, HIPAA Privacy Rule training and Good Clinical Practice Training prior to engaging in human subjects research
- Providing adequate training for and oversight of study personnel
- In the case of clinical research, ensuring the protocol procedures comply with Good Clinical Practice requirements
- Ensuring compliance with the Conflict of Interest Policy
In the following limited cases, permanent changes to PIs may be submitted 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
- Studies determined to be excused from continuing review under institutional policy.
- IRB applications limited to approval of grants.
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.
The New Information Report should be provided to the IRB as soon as possible, preferably before the PI takes leave. A second New Information Report should be submitted to the IRB when the PI resumes his or her role as PI. 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.
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:
- confirms 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 ChangesWhen 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:
- 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.
- Do NOT add personnel who are not affiliated with UW-Madison/UW Health/Madison VA AND whose study activities will be overseen by their own IRB.
- External personnel who are NOT engaged in research do NOT need to be as personnel. If those individuals need access to ARROW, please see this guidance: Accessing ARROW for Administrative Personnel at UW-Madison Not Engaged in Human Subjects Research
- 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 PersonnelThe 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 VAAdditional 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 (firstname.lastname@example.org) to discuss what additional steps may need to be taken to ensure these personnel continue to have appropriate IRB oversight for their study activities.