Reminder: Researchers Separating From VCU Must Close or Amend Studies Prior to Separation
IRB Requirements for Separating PIs
A Principal Investigator (PI) who is leaving the institution and who no longer meets the PI eligibility requirements may not continue to serve as Principal Investigator on research conducted under the VCU IRB approval.
When a PI is planning to separate from VCU, they must address any studies they have with the IRB, regardless of review level (exempt, expedited, or full board), and regardless of whether those studies are active or expired. There are two options:
- Amend the study to designate a new PI, and obtain approval for this change PRIOR to the separation date
OR - Request closure of the study with the IRB, if the conditions for closure are met, and obtain acknowledgement of the closure PRIOR to the separation date
Either option requires the PI to submit the amendment/closure request AND receive approval of the amendment/closure request PRIOR to their separation date. This means PIs should allow ample time (at least 2-4 weeks) for review and approval of the amendment/closure request.
Instructions For Amending or Closing an IRB Study
If the separating PI elects to amend their study to designate a new PI, the separating PI must submit an amendment to their study in RAMS-IRB that includes a copy of the completed VCU PI Change Instrument (available under “Supplemental Submission Forms” on the IRB Forms page). Instructions for how to submit an amendment in RAMS-IRB can be found in the Navigating RAMS-IRB to Create an Amendment to a Study gif guide.
If the separating PI elects to close their study with the IRB, then the separating PI must submit a closure request in RAMS-IRB. Studies are only ready to close if ALL the following criteria are met:
- The research is permanently closed to enrollment at the site(s) under the VCU IRB approval
- All interactions/interventions with subjects, or access to subjects’ identifiable private information (including identifiable biological specimens) for the purpose of research data collection is complete
- All use, study, and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete
NOTE: Multi-center studies where VCU is not the lead site may close with the VCU IRB even if research activities are still taking place at other non-VCU sites, provided that the conditions above are met at the VCU site.
Instructions for how to submit a closure request in RAMS-IRB can be found in the Navigating RAMS-IRB to Create and Submit Closure Requests gif guide.
Other Guidance For Separating PIs
Separating PIs are reminded that they must comply with the following additional policies when separating from VCU:
- The PI is responsible for abiding by the sharing plan that was outlined in the IRB approved submission, even after closure with the IRB
- The PI is responsible for abiding by the VCU Research Data Ownership, Retention, Access, and Security policy
- The PI is responsible for abiding by any records retention requirements, which at minimum require data to be retained for 5 years following closure of the study. Additional records retention requirements may apply, such as for FDA-regulated studies, or studies that use HIPAA-regulated data. See Written Policy and Procedure XII-1 for more information on records retention requirements.