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Exit Process

Principal Investigators (PIs) with active research projects who end their employment with ISMMS, whether through resignation, retirement or termination must complete the PI Exit Checklist and submit it to Sponsored Projects Accounting (SPA). Refer to the PI Exit Checklist as well as the information on this page for the close out and/or transfer process.

Formal Written Notification

Formal written notification is required at least 6-weeks prior to the intended departure date.

Transferring Research Funds

Grants and Awards

All federal awards/grants are awarded to the ISMMS, not directly to the Principal Investigator (PI). The policies and procedures for transferring a project/grant or award to another PI or institution vary from funding agency to funding agency. Principal Investigators leaving ISMMS must contact their assigned GCO Grants Specialist for assistance in transferring or terminating grants/awards. It is recommended that principal investigators begin the transfer process at least 60 days in advance of their departure.

Subcontracts/Subawards

Refer to the guidelines outlined in the PI Exit Checklist.

Industry Sponsored Research

Investigators are required to consult industry sponsors as they have final approval over a change of PI and/or institution. Since the contract is with ISMMS, when a PI leaves the institution, an amendment to the contract will need to be executed for a PI change or termination of the study. Amendments to Clinical Trial Agreements handled by FACTS should be submitted through MediTract.

Human Subject Research Transfer Process

IRB

Refer to the guidelines outlined in the PI Exit Checklist.

Transferring Human Subject Research Data

Consult with PPHS (212-824-8200) regarding the HIPAA requirements for the transfer of human subject research data. Please see Transferring Materials, Samples and Data below for additional instructions applicable to all forms of data.

Transferring Human Subject Specimens

Consult with MSIP regarding a MTA for the transfer of human biological specimens/samples which includes blood, tissue, urine, saliva, RNA/DNA etc. Approval for such transfer must be provided by PPHS prior to any transfer of human subject specimens.

ClinicalTrials.gov Records

Principal Investigators who are the record owner of studies registered on ClinicalTrials.gov, must notify ORS in order to transfer, complete or terminate ClinicalTrials.gov study records. Click here to notify the ORS.

IND/IDE Sponsors

Principal Investigators who are the sponsor of an IND or IDE application can reach out to the ORS for guidance.

Investigational Drug Service (IDS)

The transfer of investigational products (e.g. drugs, biologics, etc.) must have written approval from the sponsor and the IRB, along with proper temperature control and monitoring during transport. Contact Ivy Cohen (non-oncology clinical trials) at (212) 241-2493 or Grace Jiang (oncology clinical trials) at (212) 824-8820 for more information.

Animal Research Transfer Process

Institutional Animal Care and Use Committee (IACUC)

Investigators with animal protocols MUST develop a transition plan with IACUC, GCO, CCMS and SPA to close the protocol, or transfer the protocol to another ISMMS Investigator via an amendment. For more information, contact IACUC.

Center for Comparative Medicine and Surgery (CCMS)

Investigators with animals MUST develop a transition plan with CCMS to ensure that all colonies and charges are adequately addressed. Contact the CCMS Import/Export Coordinator at (212) 241-4297 to initiate the transfer of animals to the new institution, or to another investigator at ISMMS. To schedule a consult or for other inquiries, contact (212) 241-3008.

Material Transfer Agreements (MTA)

Principal Investigators who will transfer materials (e.g., human, animal, cell lines compounds, and other biological materials) and/or data  must complete a Material Transfer Agreement. For more information, contact Mount Sinai Innovation Partners (MSIP).

Grants and Contracts Office (GCO)

Investigators with animals MUST develop a transition plan with GCO to ensure that all charges are adequately addressed. Contact the GCO office at (212) 824-8300 for assistance with closing out and transferring grants.

Finance Department

Investigators with animals MUST develop a transition plan with GCO to ensure that all charges are adequately addressed. Contact the Finance Department at (646) 605-4023 for assistance with closing out all grants and associated fund accounts.

Transferring Materials, Samples and Data

Research material, samples and data may be transferred to an outside institution but must only be transferred under a Material Transfer Agreement (MTA) and/or a Data Transfer Use Agreement (DTUA). A new MTA or DTUA is required for the transfer and use of Mount Sinai materials, samples, or data to a third party.

Consult with Mount Sinai Innovation Partners (MSIP) regarding the requirements specific to your research. Principal Investigators should also consult with the Grants and Contract Office (GCO) regarding the terms of ownership and use in cases where the data was received from a third party via a DTUA negotiated by the GCO.

Laboratory Close-out

Refer to the PI Exit Checklist, for laboratory closure and decommissioning guidelines. Mount Sinai follows the principles of “cradle to grave” management for all research laboratory materials. As such, laboratories working with radioactive material, chemicals, hazardous material, recombinant DNA, biological specimens are required to notify appropriate departments well in advance of the transfer from ISMMS (listed below) and are financially responsible for ensuring the safe disposal of all materials.

Contacts:

Transferring Equipment

Principal Investigators transferring assets from ISMMS to another institution are required to follow the procedures outlined in the Financial Memorandum No.101A and the Finance Policy on Fixed Asset Control.

All equipment sent to another facility must be decontaminated. Contact the Biosafety and/or Radiation Safety Officer, and complete Form BSO2-Certificate of Decontamination.

For complete step-by-step guidance, refer to the PI Exit Checklist.

Questions – Contact the Sponsored Projects Accounting Department at (646) 605-4023.

Transferring Hazardous Materials

If hazardous materials (chemicals, select agents, biological materials, etc) are being shipped to a new facility, applicable shipping regulations must be followed. Please request assistance from EH&S by contacting AskEHS@mssm.edu.

Intellectual Property

Investigators with patents, patents pending, copyrights, license agreements, etc. should contact Mount Sinai Innovation Partners (MSIP).

Data Retention Policy

Refer to the Data Retention Policy in the Faculty Handbook.

Resources

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