SOP 005: Principal Investigators Transitioning Research To and From WVU

Human Subjects Research Coming to WVU from Another Institution (PI begins employment with WVU)

A PI who moves human subjects research to or from WVU when external institutions are involved must review and follow this policy for each of the scenarios:

• The incoming PI submits a written request to irb@mail.wvu.edu to consult with WVU OHRP staff regarding opening a research study at WVU.
• WVU OHRP staff may request a phone call/virtual meeting with the PI, the previous institution, or both.
• The incoming PI notifies the WVU Office of Sponsored Projects if the research is funded and whether any primary or subawards will be reassigned to WVU from another institution.
• The incoming PI, after consulting with WVU OHRP staff (and if applicable, the previous institution’s IRB), submits a new, initial protocol to WVU’s electronic IRB submission system. The type of protocol (Flex, Exempt, Expedited, Full Board, CIRB) will depend upon the nature of the research being conducted at WVU, research funding (if any), and whether other institutions are engaged in human subjects research.

Human Subjects Research Going to Another Institution from WVU (PI leaves WVU and the study IS NOT under the Single IRB Mandate)

• The departing PI submits a written request to irb@mail.wvu.edu to consult with WVU OHRP staff regarding moving the research from WVU to the new institution. WVU OHRP staff may request a phone call/virtual meeting with the PI, the new institution, or both.
• The departing PI notifies the WVU Office of Sponsored Projects if the research is funded and whether any primary or subawards will be reassigned from WVU to the new institution.
• The departing PI, after consulting with WVU OHRP staff and their new institution’s IRB, submits an amendment in WVU’s electronic submission system to change the PI on the study from that of the departing PI to an authorized WVU employee who can serve as the new WVU PI. This ensures the continuity of the research until the departing PI obtains IRB approval, if applicable, at their new institution.
• The departing PI is completely removed from the protocol in WVU’s electronic IRB submission system.
• If the research is not continuing at WVU, the new PI of the WVU protocol closes the protocol within six (6) months of the departing PI’s separation from WVU. Protocols not closed by the new PI within six (6) months may be closed administratively by WVU OHRP and/or the IRB.
• If the research is continuing at WVU, no additional action is required, and the research continues under the new PI and operates under WVU OHRP SOPs. If the departing PI and new institution are involved in the research, the new institution is responsible for the oversight of the research activities at their site.
• Departing PIs may continue to collaborate on research at WVU after their departure by obtaining authorization/approval from their new institution’s IRB and providing documentation of this approval to WVU IRB.

Research Going to Another Institution (PI separates from WVU and the study IS under the Single IRB Mandate)

• The departing PI submits a written request to irb@mail.wvu.edu to consult with WVU OHRP staff regarding moving the research from WVU to the new institution. WVU OHRP staff may request a phone call/virtual meeting with the PI, the new institution, or both.
• The departing PI notifies the WVU Office of Sponsored Projects if the research is funded and whether any primary or subawards will be reassigned from WVU to the new institution
• For research that falls under a single IRB mandate, WVU OHRP operates under SOP 010 Single IRB Reliance. The departing PI will follow this process for moving their research to the new institution.

Research Involving Special Circumstances

• Under special circumstances, alternative arrangements to this policy may be approved on a limited case-by-case basis or by prior agreement.
• PIs who leave WVU and do not follow institutional policy and guidance regarding properly notifying WVU OHRP and moving their research may have their protocols at WVU assigned to an authorized PI who is willing to assume this responsibility or closed administratively without further notice.