Procedural Guidelines for Principal Investigators (PIs) Leaving the University of Pennsylvania

A PI who is leaving Penn and desires to transfer a grant to another institution is responsible for ensuring that the following actions occur:

• PI, in consultation with the Business Administrator (“BA”), must determine if the transfer is permissible per sponsor requirements.
  • PI/BA may consult with the Office of Research Services (“ORS”) for assistance with making the determination.
• If the transfer is permissible, the PI must inform the Department Chair of the request to transfer the grant.
• The Department Chair and as necessary, the Dean, will recommend on a case-by-case basis whether the grant may transfer with the PI. If a grant is broadly dispersed, such as to a Center or there are other PIs on the same grant, other Department Chairs or Deans may be consulted.
• If a transfer is not approved by the Department Chair or Dean, Penn may nominate a new PI.

Once a grant transfer is approved, the following issues must be addressed:

• To assist in the relinquishment process, the PI must notify the BA that the transfer of the grant has been approved by the school (“Relinquishment Form”).
• The PI must submit to ORS for approval a formal written request for the grant transfer.
• For NIH grants, the PI must complete form PHS 3734.
• The BA is responsible for assisting the PI with preparation and submission of the Relinquishment Form.
• An equipment list should be included as part of the Relinquishment Form.
• ORS will endorse the Relinquishment Form on behalf of the University.

• The PI, in consultation with the BA, must prepare and timely submit all required progress, programmatic, or technical reports to the sponsor.
• The PI must prepare and submit timely final invention statements to ORS for signature after verification by PCI.
• The PI, in consultation with the BA, must review all expenditures to assure appropriate allocation of expenses in preparation of the close-out.
• Funds may not be obligated after the termination date of the relinquishment.
• All expenses must be authorized, allowable, and necessary.

The PI must ensure that all effort reporting is completed.

Subawards must be handled as follows:

• The BA must notify ORS at least 45 days in advance of the transfer to properly close out the subawards.
• The BA will work with subawardees to ensure that all required reports ae submitted to ORS.
• ORS will modify and /or terminate any subawards dependent on the transferring funds.

The BA will determine disposition of staff receiving salary support from the grant and:

• Determine payroll for the staff (vacation, severance, etc.) against the award.
• Contact the Division of Human Resources regarding staff terminations as necessary.

ORS will prepare and submit final financial reports and invoices and/or final vouchers for the grants being transferred.

ORS is responsible for arranging to send to the Sponsor or transferee institution the unobligated balance on the award within 120 days of the relinquishment if necessary.

ORS will prepare and submit sponsor-owned equipment reports in cooperation with the PI and the department.

Research materials are defined as the record of data or results that embody the facts resulting from scientific inquiry in physical and/or electronic form and include, but are not limited to:

• Research proposals, protocols, grant application, progress reports
• Laboratory notebooks and records, clinical trial records, email, computer files
• Cell lines, chemical compositions, specimens, animals
• Publication materials (e.g., abstracts, theses, oral presentations, internal reports)

The PI and the Department Chair must identify the types of Research Materials related to the PI’s research.  The PI must prepare a written inventory of the research materials, including their location, which must be certified by the PI in writing. To the extent reasonably possible, the Department Chair, in collaboration with the PI, must identify any missing Research Materials based on the written inventory.

Subject to the limitations below, the Department Chair, in consultation with the PI and other institutional offices and officials as necessary, may determine which research materials may transfer along with the grant on a case-by-case basis.

• Ownership of research materials is addressed under the Patent and Tangible Research Property Policies and Procedures of the University of Pennsylvania” (“Patent Policy”) and may also be covered by agreements between Penn and third parties, including but not limited to licensing, sponsored research, and material transfer agreements (“MTA”). Determining whether original Research Materials may be transferred requires consideration of various factors including intellectual property protection, sponsor requirements and other legal concerns. Depending on the types of agreements and funding mechanisms involved, disputes and questions regarding missing, ownership, and/or permissibility of transfer of research materials may need to be referred to ORS, PCI, the Dean and, if not resolved, OGC.
• PCI should be consulted prior to authorizing the transfer of original laboratory notebooks and other documents containing data or information in their original form (i.e., which are not copies or reproductions) to protect any patent filings arising from the research. In accordance with Section 4.1 of the Patent Policy, the transfer of Tangible Research Property such as biological materials, chemical moieties, and other unique research products, may require an MTA.

• The University is ultimately responsible for producing original Research Materials for a variety of reasons, including but not limited to litigation and allegations of misconduct or fraud. Accordingly, it must be understood that Penn retains the right of access to all Research Materials for a reasonable cause after reasonable prior notice to the transferee institution at the time of the requested access.
• For records involving human research protocols which may contain Protected Health Information (PHI), the PI is responsible for compliance with all applicable Penn policies, laws and regulations and other legal requirements pertaining to PHI. Contact the appropriate entity privacy officer for guidance if needed.

• The Department Chair should indicate where the Research Materials will be located – either within the department or in other locations at Penn.
• The Department Chair should decide whether the PI may make and retain copies of the Research Materials.
• The Department Chair determines archiving, custody within Penn, sharing, storing and destruction measures and responsibility for costs.

• The PI in consultation with the BA must complete a full inventory for all equipment used for the grant.
• The BA will coordinate with the PI, in consultation with ORS as necessary, to reconcile equipment inventory in Ben Assets to determine the proper ownership of the equipment and what equipment must be transferred in accordance with Sponsor requirements (the equipment list should be included as a part of the relinquishment statement, as required by the Sponsor).
• The PI in consultation with the BA will review with the Department Chair the list of equipment, funding sources, and equipment that must be transferred per sponsor requirements.
• The Department Chair, in consultation with the PI is responsible for making decisions regarding discretionary transfers of equipment.
• For equipment purchased with grant funds in whole or in part for the current segment
  • The BA will submit appropriate paperwork to ORS for review and approval prior to transfer of the equipment.
  • The BA must contact the Property Management Group to update the inventory and determine if there are any maintenance contracts on any equipment that must be cancelled.
• For equipment owned by Penn or purchased from previous awards
  • Equipment purchased at Penn in prior competing segments of an award remains the property of Penn and cannot be transferred without the Department Chair’s prior approval, who may consult with the Dean in making a determination under this section.
  • The decision whether to keep the equipment involves consideration of several factors, including but not limited to need and cost, possible shared use of the equipment, whether the transferee will purchase the equipment at fair market value, and how the equipment will be packed and shipped.

The Department Chair is responsible for signing all equipment transfer forms.

• If the grant involves intellectual property, the PI/BA must complete the final invention statement and submit it to ORS to be signed on behalf of Penn.
• The PI must obtain an MTA to transfer Research Materials if applicable
• ORS will ensure an MTA is obtained if applicable.
• If there was an MTA for use at Penn, this may be transferrable, or the PI may need to request a new MTA for the transferee institution.
• The PI/BA should consult with PCI to assure that the proper licenses are negotiated, if applicable.
• If it appears that a patent will be filed by Penn, as well as by the transferee institution where the research will be completed, PCI may need to negotiate an inter-institutional agreement.
• If Research Materials are needed for patent prosecution, PCI should identify what original Research Materials must remain at Penn and specify which other Research Materials should be copied and retained by Penn prior to the transfer.

• The PI/BA must contact EHRS if the grant being transferred involves chemicals, radioactive materials, biohazards, or select agents.
• If chemicals, radioactive material, biohazards, or select agents were used in the lab, EHRS will determine the best procedures for further use in the lab as well as disposal of any materials necessary.
• When the proper management of hazardous materials at close-out requires the services of EHRS or an outside contractor, the responsible department may be charged for these services.
• EHRS is not responsible for costs incurred by individuals or departments as a result of lab close-out or transfers, or a regulatory agency mandated removal of hazardous materials.
• When hazardous materials will be transferred to another institution, the PI/BA must meet all regulatory requirements for shipping.
• A PI/BA should contact EHRS for assistance with shipping biological, chemical, or radioactive materials.

A PI who uses animals in teaching or research must notify ULAR and the OAW/IACUC of their intent to leave the institution at least 90 days prior to their date of departure if they still have animals on study. This notification should include a plan for the management of the investigator’s colony before and after his/her departure. Research or teaching animals must either:

1. Be shipped to an approved research or teaching institution;
2. Be transferred to the approved IACUC protocol of another Penn PI; or
3. Study completion and humane euthanasia by the PI or ULAR as described in the IACUC approved protocols or ULAR policies prior to the PI’s departure from Penn.

Federal regulations require that every research or teaching animal in any Penn campus be assigned to an approved Penn IACUC protocol and under the oversight of an eligible Penn faculty member or otherwise IACUC-approved researcher (see https://iacuc.upenn.edu/iacuc-documents/policies/principal-investigator-policy-protocols). At all times it is essential that the PI or a designated Penn faculty member or other designated individual remain accessible to ULAR to make treatment and study completion decisions. It is the outgoing PI’s responsibility to ensure that both ULAR and the OAW knows the contact information for the new PI who will assume responsibility for the research or teaching animals. All fees associated with the animals of a departing investigator (e.g., per diem, testing, transport, etc.) are the responsibility of the investigator and the department. Before leaving campus, the PI and department must also ensure that grant or other funds remain available to pay per diem and other service fees for any animals that remain at Penn beyond the PI’s departure date. Any animals without a listed contact person or not on an approved Penn IACUC protocol may be transferred to a ULAR holding protocol and/or final determination under the authority of the institutional Attending Veterinarian.

The PI/BA must notify ULAR at least 90 days in advance if animals will be shipped to another institution. This 90-day window is REQUIRED in order to allow ULAR adequate time to complete the exportation documents (e.g., health reports, USDA forms, etc.) and coordinate the shipping schedules.

The transfer of animals to another institution may require additional institutional review and approval, as follows:

• Unique and/or proprietary mammalian models, such as the mouse and rat, may require the execution of an MTA approved in advance by ORS and the transferee institution. (https://researchservices.upenn.edu/systems/research-inventory-system/material-transfers/)
• Shipments of animals that involve radioactive or biohazardous materials, e.g., ABSL2, etc., require review and approval by EHRS. Depending on the agent/material that renders the animals ABSL2, they may have to be packed by laboratory staff under the supervision of the Export Coordinator. Also, any animal shipment must be done under the terms and conditions approved by APHIS and the USDA.

This additional institutional review and approval may add to the timeline required for export.

Procedures

• The PI/BA is responsible for following the ULAR “Procedures for Shipping Rodents to Other Institutions”.
• The PI/BA must submit a “Rodent Import/Export” form (https://ular.upenn.edu/forms-landing/) to ular-rodent@lists.upenn.edu.
• Health reports will be submitted to the transferee institution by ULAR Diagnostic Services.
• Once the transferee institution approves the health reports and sends a formal written, electronic approval to receive the animals, ULAR Diagnostic Services will process any required paperwork. If the receiving institution’s veterinarian requires additional testing, this will add to the timeline of the process.
• If the animals are to be exported to an institution outside the US, USDA forms and/or health certificates may be required, and this adds to the timeline required for the export. Because of the time-sensitive nature of these documents, it is essential that the PI or the contact person listed on all of the required forms be accessible (on the Penn campus) to sign the USDA form before it is forwarded by ULAR to the USDA veterinarian in Harrisburg, PA. It is also essential that the number of animals listed on the USDA-stamped form match the number of animals shipped. If the numbers do not match, access to the destination country may be denied by the Customs officials or veterinarian at the point of entry.
• ULAR Diagnostic Services ensures that animals are appropriately packed for shipping and arranges transportation with an approved courier.
• Any requested animal exports that occur after the PI and/or designated laboratory contact have left the institution are subject to delay or cancellation if the animals cannot be positively identified by ULAR Diagnostic Services staff.
• Once all animals have been transferred to the transferee or other designated institution, the PI/BA should contact the OAW to request that the IACUC protocol(s) be terminated.
• Prior to transfer, the PI/BA should give the OAW/IACUC a specific date when protocol termination may occur.
• The IACUC protocol must remain active if animals remain at Penn after the PI leaves, which should only be for a brief period of time (e.g., to allow for a project to reach its endpoint, within a few weeks). At all times, the animals must be under the oversight of an eligible Penn faculty member or otherwise IACUC-approved researcher, as designated by the PI and communicated to ULAR and the OAW/IACUC.
• The PI remains responsible for full compliance with federal animal welfare regulations, policies and University guidelines while his/her animals remain at Penn.

If animals are transferred to another location on the Penn campus or to another protocol, the PI must submit the applicable request to transfer form and/or relocation form (https://ular.upenn.edu/forms-landing/) five days prior to their requested transfer date. Once the PI has obtained approval from ULAR, ULAR will note this in the chart and ensure that all of the appropriate records accompany the animals.  Depending on the original housing location of the animals and the destination location, the animals may require health monitoring testing or housing in the ULAR quarantine facility. Sampling for pinworms, as well as associated testing fees, are the responsibility of one of the laboratories involved. If quarantine is required, the fees associated with this service are also the responsibility of the investigator and department.

Contact the IRB with any human subjects protections questions.

When transferring PHI obtained in research to another institution, the PI is responsible for ensuring that any transfer, storage, or future use is consistent with the subject’s signed authorization or the conditions under which a HIPAA waiver was granted. If the transfer, storage, or future use is not consistent with the subject’s signed authorization or the conditions under which a HIPAA waiver was granted, this may require re-authorization or an updated HIPAA waiver. Please contact the IRB with any questions.

Active human subjects research may only be conducted under the oversight of a present PI. If an active protocol is being transferred to a new PI at Penn, please ensure that a modification to change the PI submitted to the IRB prior to the PI’s departure from Penn.