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Preface
Acknowledgements
Introduction: Overview of the Office of Research
Setting up the office and research space
Obtaining regulatory committee approvals
Finding, obtaining and managing money
Being responsible
Leaving UCSF or Transferring Funds/Specimens outside of UCSF
Appendices
UCSF School of Medicine Clinical and Translational Research

THE OFFICE OF RESEARCH

NEW INVESTIGATORS: A QUICK GUIDE TO STARTING YOUR RESEARCH AT UCSF

Table of Contents

LEAVING UCSF OR TRANSFERRING FUNDS/SPECIMENS OUTSIDE UCSF

• What is the process for closing my research program at UCSF?
• How do I close my laboratory?
  •  Working with my Department
  •  Disposing of Hazardous Materials
  •  Managing Laboratory Equipment and Supplies
  •  Working with Moving Services
• How do I close my animal research studies?
• How do I close my human research studies?
• How do I transfer biological specimens and protocols to another institution?
• How do I close my fund accounts, grants, and contracts?
• How do I transfer the grant to another institution?


What is the process for closing my research program at UCSF?

If you decide to close your research projects or your faculty appointment has ended, you must notify the appropriate UCSF administrative and regulatory groups.

You must carefully coordinate with laboratory safety, laboratory staff, and regulatory committees to close your approved protocols and funding accounts. Work with your Department and your Department Safety Advisor (DSA) to create a checklist covering everything needed to properly close laboratory spaces, office spaces, research protocols, and funding accounts.

Do not assume that your approvals and accounts will automatically close when you leave!

For example, just closing your laboratory may require coordinating the:

•  Clearance of the physical space,
•  Decontamination due to hazardous materials,
•  Transfer of students to other faculty,
•  Meeting the ethical and regulatory requirements for closure of animal and human subjects research,
•  Transfer of materials to other investigators or institutions,
•  Coordinating shut down of phone, email, IT, web services and turning in keys, proximity cards, and ID cards to your Department.
•  Closing active protocols
•  Waste disposal
• 
Transfer of inventories (chemical, animal, etc)

In this example, you would need to communicate and coordinate with your DSA, the OEH&S, the technical committees, IACUC, LARC, CHR, OTM, and your Department who will then work with your funding agencies and sponsors.

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How do I close my laboratory?

As the PI, you are responsible for the clearance of your laboratory and the proper disposal of any remaining materials. Specific safety and hazardous materials containment includes:

•  Decontamination,
•  Waste disposal,
•  Equipment decontamination,
•  Equipment transport, and
• 
Any potential transport of hazardous materials to another site.

Notify your Department Safety Advisor (DSA) from the Office of Environmental Health and Safety (OEH&S) as soon as you know when you will be leaving. They will work with you to ensure that appropriate methods are used to clear your laboratory space, OEH&S will inspect your laboratory space for proper clearance.

Specific forms, guidelines, and services for closing your laboratory at UCSF include:

•  Working with your Department:
  •  Your payroll and your staff’s payroll closeout,
  •  Keys, email, identification/proximity cards, space closeout procedures,
  •  Closure of your fund accounts, and
  •  General moving guidance and coordination.
•  Disposing of Hazardous Materials (website of OEH&S forms)
  •  Laboratory Chemical and Supply Surplus Exchange Program
  •  Chemical Waste Removal Form
  •  Controlled Substance Disposal Form
  •  Laboratory Clean Out Request (chemicals)
  •  Radioactive Material Transfer Form
  •  Radioactive Waste Disposal Form
  •  Hazardous Materials Management Program
•  Managing Laboratory Equipment and Supplies:
  •  Laboratory Chemical and Supply Surplus Exchange Program
  •  Compressed gas cylinders (arrange for pickup of campus cylinders)
  •  Recycling (standard paper, glass, and plastic recycling)
  •  SEP (Surplus Equipment Program) – usable equipment donated to local high schools
  •  Storage and Surplus (Materiel Management recycles and disposes of surplus equipment)
•  Working with Moving Services:
  •  General Moving Services (discounts for moving to and from UCSF)
• 
Laboratory and equipment services: check with your Department

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How do I close out my animal research studies?

The first thing to do when closing out your animal studies is to make arrangements with LARC for the welfare of your animals. Call the LARC business office at (415) 476-2204 to find out if you have or will have any animals leftover. If so, you will need to transfer these animals to one of the following:

•  Another PI at UCSF;
•  You or another PI at another institution; or
• 
LARC.

In order to transfer the animals, please complete and submit for processing the Animal Transfer form which you can find on the LARC website.

Secondly,

•  If your are retiring your study or studies, inform the IACUC by telephone (476-2197), by e-mail (car@research.ucsf) or by writing to the IACUC at Box 0962 that you will be leaving the University and will be retiring your study or studies.
• 
If you are transferring a protocol or protocols to another PI, then you must write and personally sign a letter to the IACUC stating that you will be transferring your protocols. This letter must be co-signed by the PI who will be assuming the responsibilities for your protocol(s).

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How do I close my human research studies?

The first thing to do when closing your human research studies is to consider what is needed for the safety and well being of the human subjects. If human subjects are enrolled in the study, then you will either need to transfer the study to another PI or ask for CHR approval for a plan to take the subjects off the study. If you are using human data or biological specimens, then you need to make arrangements either to retire the study or transfer the data or materials.

•  To close the study:
  •  Complete all procedures, including all necessary follow-ups for subject safety.
  •  Please notify the CHR by telephone (476-1814) by e-mail at chr@research.ucsf.edu or by letter that you will be retiring your study. You can also use the Status Report Form to do this.
  •  Work with your department or unit to make sure the signed consent forms and any adverse event reports are available in case Legal Counsel needs them for audits. CHR maintains copies of CHR-approved applications, but does not keep individual subject information.
•  To transfer the study to another PI at UCSF:
  •  As the current CHR-approved PI, you must submit a letter signed by you to the CHR requesting that the study be transferred to another PI.
  •  Include with this letter a modification request that includes a revised CHR Cover Page and revised recruitment and consent documents, if any of these list your name. Be sure to delete your name and include the name of the new PI where appropriate. Please refer to the information about Modifications for details.
•  To take data or biological specimens with you, for studies that do not have subjects enrolled and if all follow-up has been completed:
  •  Make arrangements for the appropriate IRB approvals at your next institution or company and,
  •  Complete a Material Transfer Agreement to transfer human biological specimens (such as tissue, DNA, blood, serum).
•  To close the study completely and not keep any data or materials, simply notify the CHR by telephone (476-1814), by e-mail at chr@research.ucsf.edu or by letter that you will be retiring your study. You can also use the Status Report Form to do this.

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How do I transfer biological specimens and protocols to another institution?

The University of California has ownership of any materials received or developed while you were employed at UCSF. Therefore, any transfer of human or research biological specimens require that a Materials Transfer Agreement be used when shipping specimens. There are also procedures for transferring your current animal or human subjects research protocols to other institutions:

•  Animal Research:
  •  Leaving animals at UCSF (contact LARC)
  •  LARC – Transportation guidelines
  •  LARC - rodent shipment guidelines
  •  Material Transfer Agreements (forms)
•  Human Subjects Research:
  •  Leaving human samples (contact CHR)
  •  Material Transfer Agreements (forms)
•  Recombinant research materials
  •  Contact the UCSF Biological Safety Officer (for safety requirements)
  •  Importation and Exportation for Biological Materials (form)

Material Transfer Agreements (forms)

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How do I close my fund accounts, grants, and contracts?

Funding agencies and UCSF policies requires that your final project report be filed in a timely manner in order to close out accounts. Your accounts do not automatically close when the grant expires, when you run out of money, or leave UCSF. Your department will coordinate the closing of specific fund accounts with the various units of the Office of Sponsored Research once they have received the final project reports from you.

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How do I transfer the grant outside of UCSF?

Government and nonprofit grants can be transferred outside of UCSF but the Sponsor, your Department Chair, the Dean, and Contracts and Grants must approve the transfer. There are strict guidelines imposed by both funding agencies and the university to document the transfer of funds, Note: clinical trial balances and gift balances stay within your department. To request transfer of funds:

•  Contact your Department as soon as possible.

Read and follow the procedures in Procedure to Transfer a Grant.