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Research Conduct and Compliance Office

Checklist for Investigators Leaving the University

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Investigators leaving the University should consult with the relevant administrator(s) for their school and department to plan the relocation. Contact the Office of Research4 if you need assistance in identifying these individuals.

General Procedures for Closing Laboratories.
Radiation-Producing Devices and Materials
Studies Using Animal Subjects
Studies Using Recombinant DNA
Studies Using Human Subjects
Studies Conducted Under a University-based, Sponsor-Investigator Investigational New Drug (IND) or Investigational Device
Studies Approved by the Human Stem Cell Research Oversight Committee (hSCRO)
Fiscal Matters
Intellectual Property and Rights in Data

General Procedures for Closing Laboratories

• Transfer data and related records to the University as described in the “Guidelines on Research Data Management” at http://www.provost.pitt.edu/documents/RDM_Guidelines.pdf.
• Develop an inventory of remaining chemical substances. Dispose of all unwanted chemicals through the Department of Environmental Health and Safety’s (EH&S)1 Chemical Waste program. Prior to transferring any usable chemicals to internal colleagues, forward the comprehensive chemical inventory to EH&S for review and approval. Highly toxic materials and chemicals which are on the Department of Homeland Security’s Chemicals of Interest list should not be transferred. (http://www.dhs.gov/xlibrary/assets/chemsec_appendixa-chemicalofinterestlist.pdf).
• It is not permissible to transfer Drug Enforcement Administration (DEA) controlled substances to another investigator. EH&S should be contacted for information regarding transfer of controlled substances to a reverse distributor.
• EH&S1 must be contacted for the disposal of large volumes of chemicals before separating from the University. Once the faculty member has separated from the University, the respective Department will be billed for chemical disposal.
• An online request for moving or relocating laboratory equipment must be submitted to Surplus Property at http://www.bc.pitt.edu/1click/. Prior to relocation, equipment scheduled for delivery to Surplus Property or another laboratory must be cleaned and disinfected according to protocols listed in the EH&S Safety Manual (http://www.ehs.pitt.edu/assets/docs/moving-lab.pdf).
• Countertops, chemical fume hoods, and any other potentially contaminated surfaces in the vacated laboratory must be cleaned. All waste must be properly discarded. EH&S1 can provide further details about the required procedures.
• Biological safety cabinets must be decontaminated by a qualifi ed vendor prior to being moved. Laboratory personnel are NOT permitted to perform or certify the decontamination of a biological safety cabinet (BSC) that is being moved. A qualifi ed vendor must be contacted to conduct and document the decontamination process of the BSC prior to moving the BSC or closing the lab 1.
• A formal decommissioning plan must be developed with EH&S 1 prior to vacating a BSL-3 laboratory.
• Remove regulators from all compressed gas cylinders, replace the protective cap, and ensure proper labeling of each cylinder. Contact the gas distributor to have the gas cylinders removed.

1Contact Environmental Health and Safety Office at (412) 624-9505 or safety@ehs.pitt.edu

Radiation-Producing Devices and Materials

• If any radiation-emitting equipment (e.g., x-ray device) will be removed, relocated, or discarded, the Radiation Safety Office2 must be notified.
• If any radioactive material is stored in the laboratory, the Radiation Safety Office2 must be contacted, to coordinate its removal, transfer, or disposal.
• If any departing personnel hold Access Cards to secured areas containing radiation-emitting devices (e.g., gamma irradiators, gamma knife), the Radiation Safety Office2 must be informed of the individual’s departure. Access Cards cannot be transferred to another investigator; they must be returned to the Radiation Safety Office upon departure of the initially assigned holder.

2Contact Radiation Safety Office at (412) 624-2728 or radsafe@pitt.edu

Studies Using Animal Subjects

• All Institutional Animal Care and Use Committee (IACUC) protocols for which the departing investigator is designated the Principal Investigator (PI) must be terminated, or an alternate PI should be designated via a protocol modification form. The IACUC Office3 can provide further details about these procedures.
• Prior to terminating IACUC protocols, all animals assigned to those protocols must be euthanized as specified in the protocol, transferred to another investigator’s protocol, or exported to the institution to where the PI is relocating. Animals can only be transferred if they have not, as yet, undergone manipulation, or the recipient protocol specifies the same manipulation procedures as the original protocol. If the animal is a proprietary model, which the University purchased or received from a third party, check with the Office of Research4 to determine whether the University can transfer the animals to a third party. To transfer animals within University of Pittsburgh laboratories, the PI must download (from http://www.dlar.pitt.edu) and complete an “Animal Transfer and Movement Approval Form” and submit it to transfer@dlar.pitt.edu. To export rodents to another institution, the PI must download (from http://www.dlar.pitt.edu) and complete a “Rodent Import/Export Application” and submit it to import@dlar.pitt.edu. For further information regarding the transfer or export of animals, contact the Division of Laboratory Animal Resources (DLAR).5
• If any departing personnel hold Access Cards to secure animal housing facilities, the DLAR5 must be informed of the individual’s departure. Access cards cannot be transferred to another investigator; they must be returned to the DLAR upon departure of the initially assigned holder.

3Contact the IACUC Office at (412) 383-2008 or iacuc@pitt.edu
4Contact the Office of Research at (412) 624-7400 or offres@offres.pitt.edu
5Contact the DLAR at (412) 648-8950 or dlar@pitt.edu

Studies Using Recombinant DNA

• All protocols approved by the Institutional Biosafety Committee (IBC) for which the departing investigator is designated as the PI must be terminated, or an alternate PI should be designated via a protocol modification form. The IBC Office6 can provide further details about these procedures.

6Contact the IBC Office at (412) 383-1768 or ibo@pitt.edu

Studies Using Human Subjects

• PIs leaving the institution are responsible for notifying the Institutional Review Board (IRB)7 well in advance of their departure so that arrangements can be made to either close the study or name another appropriately qualified individual currently at the institution to serve as the PI.
• Tissue transfer must be carried out as described in the “Management and Use of Human Biological Materials for Research Purposes” at http://www.ooas.pitt.edu/content.asp?id=2007.
• Research drug supplies should be disposed of as indicated by the sponsor of the study. If no such agreement exists, the investigator should contact the Investigational Drug Service (http://druginfo.infonet.upmc.com/ids.htm) for instructions on drug disposition.

7Contact the IRB Office at 412-383-1480

Studies Conducted Under a University-based, Sponsor-Investigator Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application

• If the departing investigator is currently the sponsor of an IND or IDE application, the application should either be withdrawn (if clinical studies being conducted under the application have been completed or will be terminated) or transferred to another University investigator (if clinical studies being conducted under the application will continue at the University). The Office for Investigator-Sponsored IND and IDE Support (O3IS)8 can provide further detail about these procedures.

8Contact the O3IS Office at (412) 383-1502

Studies Approved by the Human Stem Cell Research Oversight Committee (hSCRO)

•All hSCRO-approved protocols, including protocols that do not require Committee approval, for which the departing investigator is designated the PI must be terminated, or an alternate PI should be designated via a protocol modi cation form The hSCRO Office9 can provide further details about these procedures.

9Contact the hSCRO Office at (412) 383-2826 or escro@upmc.edu

Fiscal Matters

• With respect to all  scal matters, and research grant and contract matters arising from the departure of an investigator and the potential need to notify sponsors of a change in PI, the department research administrator should contact the O ce of Research to complete necessary paperwork4. The Office of Research will also assist with any needed Material Transfer Agreements (MTAs) to transfer University research materials. No University research materials may be taken to a new institution without an approved MTA in place. Permission of Chair or Institute Director is required for the relinquishment of any grants, or the transfer of any data, equipment or materials.

4Contact the Office of Research at (412) 624-7400 or offres@offres.pitt.edu

Intellectual Property and Rights in Data

• For investigators with invention disclosures, patent applications in prosecution or those receiving proceeds from licensing of intellectual property, please contact the Office of Technology Management10 to provide contact information and a point of contact for the technology transfer office at the new institution.
•The University of Pittsburgh retains ownership of the research data generated by University faculty. Data access, retention and transfer is addressed in the University of Pittsburgh Guidelines on Research Data Management document available at http://www.provost.pitt.edu/documents/RDM_Guidelines.pdf.
•For information on transferring copies of data, the department research administrator should obtain Chair or Institute Director approval and then contact the Office of Research to obtain a data use agreement when required.

10Contact the Office of Technology Management at (412) 648-2206