- UIC OVCR requires that a qualified PI who demonstrates a willingness to fulfill his or her responsibilities be assigned to each protocol at all times. An individual may be the PI for more than one protocol.
- The department head has a direct responsibility to monitor individuals in their department and to ensure that continuity exists with their PI role.
- IRB approval is required prior to the appointment of another PI. IRB approval is required prior to closure of a research protocol.
- Instructions for Planned Temporary Events: (1) The PI must either submit a final report or amendment to change the PI. If a final report is not appropriate, the PI is responsible for seeking out and coordinating communication with a new proposed PI. PIs are encouraged to seek the assistance of their department chair and colleagues in this process. If the PI is a student, the faculty advisor must be involved in the PI selection process and may also be selected as the new proposed PI. (2) Submit an amendment to change the PI 30-60 days in advance of the temporary event. (3) The PI must communicate their temporary absence to key research personnel and, if applicable, their faculty advisor, and must orient the new PI. (4) Once the absence is over, submit another amendment to change the PI again back to the original PI.
Examples of temporary events include, but are not limited to:
||Extended Jury Duty
|Family and Medical Leave
||Any other temporary event where the PI is unwilling or unable to fulfill his or her responsibilities for an extended period of time
|Leave of Absence
|Extended Sick Leave
- Instructions for Unforeseen Temporary Events: (1) The PI should immediately contact their department head to identify an appropriate proposed PI or to assess whether the research is appropriate for the submission of a final report. (2) The PI or their representative, such as the department head or key research personnel, must immediately call UIC OPRS and speak with the appropriate IRB coordinator or IRB Assistant Director so that UIC OPRS can advise on the matter and be alerted to the submission so it can be processed as quickly as possible due to the emergency circumstances. (3) The PI is responsible for quickly orienting key research personnel and the new PI.
- Instructions for Permanent Events: (1) When applicable, PIs are responsible for submitting a final report in advance of IRB approval expiration; PIs who are leaving UIC but not closing the research must submit an amendment to appoint another PI well in advance of their departure. PIs are encouraged to seek the assistance of their department chair and colleagues in this process. If the PI is a student, the faculty advisor must be involved in the PI selection process and may also be selected as the new proposed PI. Students who are graduating must either submit a final report or submit an amendment to the IRB to assign another PI to the study, such as the faculty advisor. (2) Submit an amendment to change the PI or final report 30-60 days in advance of the permanent event. Documents that contain the PI contact information, such as the protocol, informed consent, parental permission, assent, advertisement/s, and/or recruitment material/s, must also be updated with the new PI information and submitted with the revised PI amendment so that all documents coordinate. (3) The PI must communicate their temporary absence to key research personnel and, if applicable, their faculty advisor, and must orient the new PI. Examples of permanent events include, but are not limited to:
||Moving overseas indefinitely
|Transferring to another school
||Leaving UIC for another position
|Indefinite break from studies at UIC
|No longer enrolling at UIC
Students who are graduating must either submit a final report or submit an amendment to the IRB to assign another PI to the study, such as the faculty advisor. Faculty advisors are responsible for finding an appropriate PI for students who do not follow this procedure and for preparing and submitting the amendment for a change in PI or a final report.
Non-compliance with this Policy:
- If a PI is not assigned to a study due either to an unwillingness or an inability to perform his or her responsibilities and the IRB has not approved another PI, the consequences are:
- All research activities must stop, including recruitment, research interventions or interactions, data sharing/reporting, data collection and analysis of identifiable data;
- no new subjects may be enrolled;
- The research may continue only after an amendment is submitted to change the PI and written approval from the IRB is received. The appropriate party may also file a final report when applicable.
- The appropriate party may also file a protocol exception.
- The absence of a PI, to the extent that the PI is unable or unwilling to perform his or her responsibilities for any reason, must be reported to UIC OPRS as a serious adverse event within 5 business days of the absence via submission of the Prompt Reporting form.
- Within 10 business days of the absence, procedures to close the research will be established and the following information must be provided to UIC OPRS:
- Number of currently enrolled subjects;
- List of subjects for whom stopping research will cause harm; and
- Assessment for each of the risk of stopping study activities and the need to continue any research interventions; OR
- A signed assurance that no subjects are currently enrolled in the research or are at risk if research interventions are stopped.
- The department head has a direct responsibility to monitor individuals who are leaving and to ensure that continuity exists with the PI role. The faculty advisor also has a direct responsibility to report this serious adverse event. Key research personnel are also responsible for monitoring and reporting to OPRS when a PI is no longer willing and able to perform his or her responsibilities for an extended period of time, such as an individual who leaves the institution.
- Faculty advisors are responsible for submitting amendments, responding to OPRS correspondence, submitting protocol exceptions, and finding an appropriate PI for students who do not follow this procedure, which may be the faculty sponsor.
- Department heads take over the responsibilities of employees who leave without following the terms of this policy and procedure and are responsible for submitting an amendment to assign another PI to the study.
- Allowing IRB approval to lapse at the completion of the research is never acceptable. The PI must submit a final report requesting that the research protocol be closed.
- The lack of a PI represents non-compliance and is referred to the IRB according to the UIC HSPP policy, Handling Complaints and Allegations of Potential Non-Compliance with Human Subject Protection Regulations for consideration of whether the non-compliance is serious or continuing.
- Specifically, the IRB chair or designee makes a determination of whether the absence of a PI represents serious or continuing non-compliance.
- If the chair or designee determines that the lack of PI represents possible serious or continuing non-compliance, it is referred to the convened IRB for a final determination.
- The compliance determination is communicated to the investigator by e-mail and campus mail. Serious or continuing noncompliance is reported to the applicable federal regulatory agencies, agency heads, sponsors and institutional officials in accordance with the UIC HSPP policy and procedure on reporting, Reporting of Unanticipated Problems, Suspensions, Terminations, and Non-Compliance.
- The OVCR QIP may perform audits on protocols that do not have a PI to ensure that research activities stopped on the date that the PI was absent in the following circumstances:
- At the specific request of the IRB;
- As periodic spot audits, as described in the UIC HSPP policy OVCR Quality Improvement Program – Monitoring and Auditing.