Protocol Approvals

I. Overview

• All research with human embryonic stem cells (hESCs) must be compliant with the UCSD Guidelines for Human Embryonic Stem Cell Research.
  
  
• Investigators planning to conduct research involving hESCs must submit applications and obtain review and approval from the ESCRO, IRB, Biosafety Committees, and Conflict of Interest Office.
  
  
• If the project includes animal subjects, approval is required by IACUC.
  
  
• Additional approvals may be required for stem cells transferred to or from an outside institution or between UCSD laboratories (MTA, Purchasing, OCGA, or TechTIPS) or projects receiving external funds (OCGA or CTAS).
  
  
• There is no fixed sequence in which approvals must be requested, but research is not approved to begin until approvals have been obtained from all appropriate offices.

II. Checklist

Before you can begin research or teaching use with human embryonic stem cells, you must have approval from:

• ESCRO Committee
  (858) 822-5915, http://escro.ucsd.edu
  
  
• UCSD Human Research Protections Program/
  Institutional Review Board (IRB)
  (858) 455-5050, http://irb.ucsd.edu
  
  
• Institutional Biosafety Committee/
  Environmental Health and Safety (EH&S)
  (858) 534-3660, http://www-ehs.ucsd.edu
  
  
• Conflict of Interest (IRC)
  (858) 534-6465, http://ocga3.ucsd.edu

If the project calls for use of animal subjects, you must also have approval from:

• Institutional Animal Care and Use Committee (IACUC)
  (858) 534-6069, http://iacuc.ucsd.edu

If human embryonic stem cells are provided by a non-UCSD source, you must have:

• An MTA - Office of Contract and Grant Administration (OCGA)
  (858) 534-3330, http://ocga3.ucsd.edu
  OR
• A Purchase Agreement - UCSD Purchasing
  (858) 534-3084, http://www-bfs.ucsd.edu/pur

If UCSD-developed cells are sent outside UCSD or transferred between UCSD investigators, you must receive an evaluation from:

• TechTIPS
  (858) 534-5815, http://invent.ucsd.edu

If research with human embryonic stem cells is funded by a non-UCSD source, you must have approval from:

• Office of Contract and Grant Administration (OCGA)
  (858) 534-3330, http://ocga3.ucsd.edu
  OR
  
• The Clinical Trials Administrative Services and Research Compliance Office (CTAS)
  (858) 822-4653
  CTAS Intranet, a secure site for UCSD employees only:
  http://www-ucsdhealthcare.ucsd.edu/researchcompliance/

If research or training is funded by a department or gift funds, approval is required from the department business office and/or department Chair.

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For further guidance, see http://irb.ucsd.edu/hesc.pdf