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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, the UCLA IRBs are willing to rely on the review of another specified IRB in the limited circumstances described below. OHRPP has negotiated several IRB Reliance Agreements with other institutions that may be applicable when UCLA researchers are involved in collaborative research. 

 

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Four Types of Reliance Agreements

 

UCLA currently has the following  types of Reliance Agreements in place:

  • 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
  • UCLA IRB serves as IRB of record for a group of studies

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

 

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Who Decides Which IRB Reviews?


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 Memorandums of Understanding (MOUs) and/or Institutional Authorization Agreements (IAAs) on UCLA’s behalf and may delegate this authority. For minimal risk research, the UCLA IO has delegated this authority to the UCLA OHRPP Director/Associate Director.

 

In deciding whether or not to review for or rely upon another IRB, the IO/delegate will consider the following criteria:

  • 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?

 

The UCLA OHRPP Director will ensure that any required Authorization Agreement (IAA) 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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What is required when UCLA relies on another IRB

 

Step 1: Contact the OHRPP to confirm that a reliance is possible

 

Send an email to irbreliance@research.ucla.edu that includes the following information:

  • UCLA Principal Investigator’s (PI) name
  • Type of Study
  • Nature of research collaboration
  • Identify reviewing IRB site

 

Step 2: Obtain Institutional Reliance Agreement

 

Once the UCLA OHRPP confirms that UCLA is willing to rely, the UCLA PI should contact the reviewing PI to (a) confirm that their IRB is willing to review for UCLA and (b) obtain a copy of their IRB reliance agreement. The Agreement is called an IRB Authorization Agreement, or IAA, and is completed by each institution’s Institutional Official (IO). The UCLA OHRPP will obtain the IO’s signature on the agreement. This agreement formalizes the IRB reliance arrangement between institutions. Completion of Steps 3-5 below are also required in order for the UCLA PI to commence the study.

 

Step 3: Ensure consent documents include local requirements

 

Although the reliance on another IRB means that the UCLA IRB will accept the review of the science, procedures and methods as well as the consent documents of the reviewing IRB, minor changes and/or additions will likely be required to the recruitment and consent documents. See ICF Checklist for Collaborative Research.

 

Step 4: Register the reliance in webIRB

 

The OHRPP requires that each protocol that will rely on another IRB’s review be registered in order to collect necessary local context information (e.g., personnel, resources) necessary to fulfill institutional requirements of the reliance agreement and to be able to communicate information to other offices on campus (e.g., contracts and grants).

 

The abbreviated reliance registration is created when you select “UCLA to rely on another IRB” in Section 2.1. The OHRPP staff will issue an “External Review Accepted” notice when the OHRPP administrative review is complete.

 

Step 5: Obtain other necessary approvals (e.g. finalize contract with sponsor, ISPRC review, etc.)

 

IRB approval and may not be the only approval necessary to conduct this research. The relying investigator and/or relying institution remain responsible for determining that necessary approvals are in place before the research proceeds.

 

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Current MOUs in Place at UCLA


As of the posting of this webpage, UCLA has the following Memorandums of Understanding (MOUs) in place.

 

  • UC Memorandum Of Understanding (UC MOU)

     

    This UC Memorandum of Understanding (MOU) establishes a reliance agreement between and among the Human Research Protection Programs at the ten campuses of the University of California and the Lawrence Berkeley National Laboratory. This MOU describes the procedures for the reliance by an IRB at a UC campus or at the Berkeley Lab on the review and approval of human subject research, by an IRB at another UC campus.

     

    Click for procedures for the UC IRB Reliance MOU.

    The Online UC IRB Reliance Registry: All new reliance requests, renewals and amendments should be submitted via the online UC IRB Reliance Registry at: http://irbreliance.ucop.edu.

     

    First-time Users: All first-time users must register with the UC IRB Reliance Registry before they create a new reliance request.  

    For more information, contact irbreliance@research.ucla.edu.

  •  UCLA Clinical Translational Science Institute IRB Group 

     

    This MOU represents a reciprocal IRB agreement and, therefore, allows an IRB at any one of the institutions below to rely on one of the other institution’s IRB for review and approval of human subjects research for collaborative research, under certain specified conditions

     

    • Burns and Allen Research Institute at Cedars-Sinai Medical Center (Cedars-Sinai),
    • Charles R. Drew University of Medicine and Science (CDU),
    • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed),
    • UCLA, and
    • University of Southern California (USC) (added in Spring 2015)

     

    Additional information is available at the following links:

     

    For more information, please contact irbreliance@research.ucla.edu.

  • National Cancer Institute Central IRB (NCI CIRB)

     

    The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI) in consultation with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The CIRB enables an investigator to enroll patients into adult and pediatric NCI-sponsored clinical trials significantly faster than when employing traditional method of IRB review. The NCI CIRB will serve as the IRB of record for these studies. A detailed description of this process is available on the CIRB website link indicated above.

     

    At UCLA MIRB-2 will accept NCI CIRB review for all cooperative group cancer trials.

     

    For more information, call irbreliance@research.ucla.edu.

  • The UCLA-RAND Memorandum Of Understanding (UCLA-RAND MOU) 

     

    This MOU is a reciprocal agreement for research that falls within the scope of the UCLA-RAND Memorandum of Understanding (MOU) for Health Services Research. As the July 2006 announcement from the UCLA Vice Chancellor for Research and the RAND Corporation explains, the agreement stipulates that one institution - either UCLA or RAND, depending on the scope of the research - will serve as the sole reviewing institution for health services and related research that previously would have required review at both institutions.

     

    The "UCLA/RAND Memorandum of Understanding and Affiliated IRB Procedures: QUESTIONS AND ANSWERS" provides guidance to UCLA and RAND researchers who wish to use the IRB deferral mechanism to seek IRB review from solely the UCLA or RAND IRB.

     

    Click here for "Request to Defer Review of Human Subjects Research" Form.

     

    For more information please contact irbreliance@research.ucla.edu

  • Commercial IRBs (Western, Quorum, Copernicus, Chesapeake, Schulman)

     

    UCLA investigators may have the option of using Western IRB (WIRB) as an external IRB for

    • Phase III and IV
    • Industry-sponsored studies only.

     

    For details, please refer to Use of Western IRB at UCLA. Email irbreliance@research.ucla.edu with any questions.

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Page Last Updated: November 8, 2017