New IRB requirement for amendments that change the Principal Investigator of a study
New Requirement for VCU IRB studies: All amendments submitted on or after March 15, 2021 that propose to change the Principal Investigator (PI) on a VCU IRB study will be required to have the new PI complete the PI Change Instrument and upload a copy of the completed responses.
The PI Change Instrument can be found in the IRB section of OVPRI’s Forms page, under “Supplemental Submission Forms.”
This requirement does not apply to external IRB studies where VCU is deferring review to another IRB. When external IRB studies are changing the VCU Principal Investigator, contact the IRB Reliance for details on how to best proceed: firstname.lastname@example.org
As a reminder, PIs who are separating from VCU/VCUHealth should refer to this blog post about what actions need to be taken with the IRB prior to separating: https://blogs.vcu.edu/humanresearch/2020/07/01/reminder-for-researchers-separating-from-vcu/
The PI Change Instrument is a new tool in REDCap that will guide a study’s new PI in certifying to the responsibilities that the previous PI certified at the time the study was initially approved. The new PI must be the one completing this Instrument.
The IRB is requiring use of the REDCap PI Change Instrument because it is important for the new PI to be aware of what they are taking on when they agree to be the PI, and the RAMS-IRB system does not have a mechanism for documenting that the new PI certified to all of the responsibilities listed below:
- Confirming that they are eligible to serve as the PI of a human subjects research study;
- Agreeing to abide by the PI Statement of Responsibilities outlined in WPP #: IX-1;
- Agreeing to assume full responsibility for the conduct of the study, and for the protection of the rights and welfare of human subjects involved in this research;
- Assuming responsibility for ensuring all study personnel complete CITI training; and
- If the study involves the VCU IRB serving as the IRB of record for another site, agreeing to the PI responsibilities that are outlined in the Institutional Authorization Agreement
The REDCap PI Change Instrument also contains a helpful checklist of what other edits might need to be made in amendments along with changing the study PI.
Use of this tool is anticipated to help streamline the IRB review process for PI change amendments because investigators and study teams will know up-front what the IRB will be looking for and can include more of the necessary information on the first submission. Having a more complete submission is anticipated to reduce both the number of questions that IRB reviewers need to ask and the time it takes to complete the review of these amendments.