IRB ADMINISTRATION
spacer
 
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
Menu spacer
 
spacer
 

UC Collaborative Research


 

UC COLLABORATIVE RESEARCH

To streamline IRB review of Multi-UC Campus research, UC Davis has entered into the following arrangements for UC collaborative situations: 

  • Multi-UC Campus Research at University of California Campuses and UC-Managed Laboratories:  UCLA, UCSF, UCSD, UCB, UCI, UCSB, UCSC, UCD, LLNL, LBNL
    This arrangement will allow research to be reviewed by a single UC IRB instead of multiple UC IRBs for research that is conducted at multiple UC campuses. This arrangement strictly applies to research eligible for expedited or exempt review. 
  • Multi-UC Campus Research at UC Berkeley, UC Davis, UC San Francisco and LBNL
    This arrangement applies to multi-campus research between UC Davis and UC San Francisco, UC Berkeley, or LBNL.  It will allow research to be reviewed by a single UC IRB instead of multiple UC IRBs.  This arrangement differs from the above arrangement in that it also applies to research eligible for full committee review as well as expedited and exempt review. 
  • UC Campus Research between UC Davis and Lawrence Livermore National Laboratory
    This arrangement applies to research between UC Davis and LLNL.  It will allow research conducted at both UC Davis and LLNL to be reviewed by either the UC Davis IRB or LLNL IRB.  This arrangement applies to full committee, expedited or exempt review.


RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR AND UC IRBs

Principal Investigator:

  • Principal Investigators must conduct the research in accordance with all applicable Federal and State Laws, University of California and UC policies and procedures, and with the terms of the UC Memorandum of Understanding.
  • Any proposed amendments to the protocol, annual renewals, and other required notifications must be submitted to the Reviewing IRB for approval. 

Reviewing IRB:

  • The Reviewing IRB will serve as the IRB of Record.
  • A UC IRB may refuse, on a case-by-case basis, to serve as the IRB of Record.
  • The Reviewing IRB will conduct initial and continuing reviews, review of modifications/amendments to approved research and unanticipated problems and adverse events. 
  • The Reviewing IRB will have the authority to suspend the research for failure to comply with conditions of approval or regulatory requirements.

Relying IRB:

  • A UC IRB may refuse, on a case-by-case basis, to rely on the review of another UC IRB. 
  • The Relying IRB will rely on the review of the Reviewing IRB.  It will not re-review the study.
  • The Relying IRB will advise the Reviewing IRB of any noncompliance issues.
  • The Relying IRB will send the Principal Investigator at its campus and the Reviewing IRB, a letter acknowledging the approval by the Reviewing IRB.


INSTRUCTIONS

To enter into such an arrangement, Investigators are first directed to the flow chart entitled Process for Relying on Another UC IRB and Points to Consider When Determining Which UC IRB Should Provide Review for information on which UC IRB will serve as the Reviewing IRB and which will serve as the Relying IRB.  Completion of the Notice of Intent to Rely Form is required by all collaborating parties.

(Link to Flow Chart Form) (PDF)

(Link to Notice of Intent to Rely Form)(DOC)

For questions regarding these collaborative arrangements, contact the IRB Director, Eric Mah, or IRB Assistant Director, Elodia Tarango, at 916-703-9157 and 916-703-9154 respectively.

 

spacer
Page Tools
Email this page
Print this page

Industry university collaboration guide
 
 
spacer



CTSC Building,
UC Davis Medical Center
2921 Stockton Blvd.,
Suite 1400, Room 1429
Sacramento, CA 95817
tel: (916) 703-9151
fax: (916) 703-9160
 
Office of Research Integrity, DHHS Home Page UC Davis Office of Research Homepage