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HIPAA FAQs

Overview of IRB Reliance Agreements

 

In order to help facilitate human research by allowing investigators to avoid duplicative IRB review while at the same time protecting the rights and welfare of human research participants, UCLA is willing to establish IRB reliance agreements for research involving collaborations between two or more institutions. IRB reliance agreements allow for only one IRB review for research procedures completed by all collaborating personnel.

 

NOTE: Such agreements are limited to IRB review, and do not include ancillary committee reviews such as radiation safety, biosafety, etc. and are unnecessary for research that qualifies as “exempt” under 45 CFR 46.101(b).

 

Reliance Agreements can be the following:

  • UCLA IRB serves as IRB of record for a study
  • UCLA relying on another IRB for a study
  • Reciprocal IRB agreement: UCLA either relying on or reviewing for partner IRBs for multiple studies

 

Please email irbreliance@research.ucla.edu with any questions.

 

Who approves UCLA IRB reliances?

 

The Institutional Official (IO) is vested with the authority to make the decision whether or not to review for or rely on another IRB. At UCLA the IO is the Vice Chancellor for Research. The IO is authorized to execute IRB reliance agreements on UCLA’s behalf and may delegate this authority.
 
Factors that the Institutional Official will consider when deciding whether a proposed reliance agreement is appropriate:

  • Whether other IRB's policies and procedures meet UCLA standards. If the other IRB is part of an AAHRPP-accredited HRPP, then it will be presumed that UCLA standards are being met. However, accreditation status does not in itself necessarily suffice as a basis for the IO decision; nor does not being accredited necessarily mean UCLA will not rely on another IRB. 
  • Risk level of study: Can the study be reviewed using an expedited review procedure (minimal risk) or does the study require review at a convened meeting of the full committee?  
  • Source of funding. Which institution is the prime grantee?  
  • Location of human research activities. If research activities are not the same at both or all institutions, where will most of the contact with the research participants occur? 
  • Personnel involved: Is PI able to provide appropriate coordination and oversight of the study activities? What is the expertise of the personnel? Where is the primary appointment of the PI? 
  • IRB expertise: Which IRB has the most appropriate expertise to conduct the review?
     

How is an IRB reliance agreement documented?

 

The UCLA OHRPP Director will ensure that any required IRB reliance agreement is appropriately signed by the lOs/Delegates for both or all institutions involved and is kept on file for reference and review.


The UCLA OHRPP will facilitate communication with the relying or reviewing institution about UCLA IRB actions on the Human Subjects Research that is subject to the IAA, in accordance with its specific provisions.

 

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Page Last Updated: May 15, 2018