Research and Economic Development

IRB Reliance Agreements

A Reliance Agreement, also called an Institutional Authorization Agreement (IAA), is a document signed by two or more institutions engaged in human subject’s research. This agreement permits one or more institutions to cede review to or rely upon another IRB. In order to help facilitate human subjects research, UCR is open to establishing IRB reliance agreements for collaborative research with up to two institutions. This process will allow investigators to avoid duplicative IRB review while at the same time protecting the rights and welfare of human research participants. An IAA allows for one IRB review of all the research procedures completed by all collaborating personnel.

Prior to submitting an IRB application, researchers should check to see whether collaborating institutions/investigators are "engaged in research". Institutions/investigators not engaged in research do not need IRB review for their involvement in the project. If the institutions/investigators are engaged in research, please first reach out to the external IRB to see if they are open to a reliance agreement with UCR. If all involved parties agree, and each institution’s internal requirements are met, UCR may agree to one of the following arrangements:

  • The UCR IRB will Review for the other institution.
  • The UCR IRB will Rely on the other institution’s review.

Collaborative or cooperative studies involve investigators from up to two institutions working together to conduct a research project. Different research activities can occur at different sites or the study can be a single-site study that involves personnel from multiple institutions.

Multi-site studies use the same research procedures outlined in a single protocol that is carried out at multiple institutions (e.g., a clinical trial where participants will be enrolled at each participating site, or an educational intervention implemented at each participating site).

This page is designed to provide an overview of the IRB reliance agreement process at UC Riverside. If you need additional information, please contact irb@ucr.edu for assistance.

In This Section:

 

Terms and Definitions

  • Cede Review

    The act of transferring responsibility of IRB review to an IRB at another institution or an independent IRB.

  • Engagement in Human Subject Research

    Engagement in Human Subjects Research: The term used in Federal guidance to determine whether IRB oversight is required for a site or personnel participating in a research study or project.

  • External IRB

    An IRB unaffiliated with the institution or site being discussed. For example, any IRB that is not the UC Riverside IRB is considered an external IRB to UC Riverside.

  • Federalwide Assurance (FWA)

    A formal, written, binding attestation in which a research institution commits to DHHS that it will comply with the Federal Policy governing human subjects research.

  • Institutional Authorization Agreement (IAA)

    A formal, written agreement in which one institution agrees to serve as the IRB of record for a relying Institution. Agreements are generally used to cover a single research study, categories of research studies or research studies within a research program. If an IRB authorization agreement is needed, the IRB office facilitates the processing of such agreements.

  • Institutional Official (IO)

    The signatory on the Federalwide Assurance (FWA) filed with the Office of Human Research Protections (OHRP) to ensure compliance with regulations governing the protection of human subjects. OHRP requires the IO to be a high-level official who has the authority to represent the institution named in the FWA. The IO is the UCR official responsible for signing IAAs and IIAs on behalf of the institution.

  • IRB of Record (aka Reviewing IRB)

    An IRB that assumes IRB responsibilities for another institution or personnel not affiliated with an institution with an IRB. A formal agreement is typically required when an IRB agrees to serve as IRB of record for another institution or external personnel.

  • IRB Reliance / IRB Reliance Agreement

    IRB reliance is a term to describe partnerships or agreements among different IRBs to rely on each other to provide IRB oversight for research studies. An IRB reliance agreement may also be referred to as an Institutianal Authorization Agreement (IAA).

  • Local Research Context (aka Local Considerations)

    Knowledge of the institution and community environment in which human subjects’ research will be conducted. In order for an IRB to agree to serve as IRB of record for another institution or external personnel, it must have adequate knowledge of local context (e.g., state laws, understanding of cultural context) in order to do so.

  • Multisite Research

    Any research study or project involving sites or personnel outside of UCR qualifies as multisite research. All multisite research projects raise questions about whether sites or personnel are engaged in research and if so, how IRB oversight will be provided.

  • Non-Exempt Human Subjects Research

    A project that meets the federal definition of human subjects research and requires IRB review at the Expedited or Full Board level.

  • Relying Institution or Organization

    A relying institution or organization is one that is relying on or has ceded IRB review to another IRB for a specific study or set of studies. Relying on another IRB to provide IRB oversight also is referred to as ceding or deferring IRB review.

  • Reviewing IRB

    A Reviewing Institutional Review Board (or IRB) is responsible for overseeing all sites participating in a multi-site study. The Reviewing IRB can also be referred to as the IRB of Record, or the Single IRB (sIRB).

  • Single IRB (sIRB)

    A single IRB conducts reviews on behalf of all or some participating sites in a multicenter study.

  • SMART IRB

    A nationwide NIH-funded initiative supporting IRB reliance through a master IRB agreement and other tools. It is not an actual IRB. SMART IRB stands for Streamlined, Multisite, Accelerated Resources for Trials.

Documenting Reliance Agreements

Reliance Agreements with other UC Campuses

UC Riverside utilizes the online UCOP Reliance Registry for studies in which our investigators rely on another UC campus or Lawrence Berkeley National Lab for IRB review or vice versa by means of the Reliance Memorandum of Understanding and MOU Implementation Procedures.

Reliance Agreements through SMART IRB

The SMART IRB is a platform designed to ease common challenges associated with initiating multisite research.

Important note: SMART IRB is not an actual IRB that provides regulatory approval. Instead, the SMART IRB provides a roadmap for institutions to implement the Single IRB Review requirements. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS). For more information, visit SMART IRB.

Institutional Authorization Agreement (IAA)

A reliance agreement can be documented outside of any online platforms through an Institutional Authorization Agreement (IAA) form. An IAA is usually specific to a single study.

Typically, an IRB has its own short template IAA form, and simply requires the signatures of each institution's signatory authority. Some reviewing IRBs require the use of their IAA template instead of Riverside’s template. Researchers should check with the reviewing IRB to see which IAA template is required. Review by the UCR Legal Department may be required if the IAA includes contractual or legal terms.

Regulatory Requirements

NIH Policy

Effective January 25, 2018, the NIH requires the use of a single IRB (sIRB) for the review of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. This policy applies to sites in the United States only.

Revised Common Rule

The Revised Common Rule is a federal policy regarding Human Subjects Protection that applies to 20 Federal departments and agencies. Under the revised Common Rule, most U.S. government-funded cooperative studies that meet the criteria for non-exempt human subjects research, and involve more than one site, will require sIRB review. This requirement went into effect January 20, 2020.

Requesting a Reliance Agreement

UC Riverside Reliance Policy

When UC Riverside investigators are conducting collaborative, human subjects research (UCR allows Exempt, Expedited or Full board review), it may be possible to establish an Institutional Authorization Agreement (IAA) allowing one institution to rely on IRB review conducted by another IRB.

Activities that do not constitute human subjects research (‘Not Human Subjects Research' or 'NHSR'), are ineligible for a reliance agreement. In addition, UC Riverside does not execute reliance agreements with international institutions.

How to Initiate a Reliance Agreement

To request UCR establish a reliance agreement for a study, and prior to submission to the IRB, send an email to irb@ucr.edu to request a consultation. The Reliance administrators will:

  • Determine reliance eligibility
  • Provide guidance for how to submit to the IRB
  • Facilitate the best reliance option, if applicable

Include the following information in the email:

  • Study Title
  • HS # of UCR approved IRB application
  • Funding Source and Status of Funding (funded / pending funding)
  • Name of the UCR PI
  • List of institutions and collaborating investigators that are expected to rely on UCR IRB (or the name of the single investigator)
  • If another institution’s IRB will serve as the reviewing IRB, identify the reviewing institution
  • Copy of the protocol or study summary
  • A description of the activities to be conducted by the collaborating researchers

Investigator Responsibilities

Responsibilities of the UC Riverside PI when UC Riverside is the Reviewing IRB: In addition to the normal responsibilities, the UC Riverside PI is responsible for:

  • Communicating to the relying investigators that they must submit reportable events to their local IRB following local IRB reporting requirements, and
  • Actively communicating with study investigators at the relying campus sites to ensure post-approval activities take place, including submission of modifications and continuing review for the relying sites to UC Riverside IRB.

HIPAA when UC Riverside is the Reviewing IRB

If a waiver of HIPAA Authorization is requested, it may be issued by the UC Riverside IRB or the relying IRB. This will be communicated to the research team and other relevant individuals as necessary.

Responsibilities of the UC Riverside PI when Relying on an External IRB

In general, when relying on an external IRB, the UC Riverside PI must follow the reviewing IRB’s policies. All modifications, continuing review progress reports, and other required submissions should be reported to the IRB of record.

The UC Riverside IRB should receive a very limited number of submissions when it is not the reviewing IRB. The following must be submitted to the UC Riverside IRB in addition to any reporting required by the IRB of record:

  • Modification when there is a change in PI or Co-PI
  • Other Reportable Event when the IRB of record has made any of the following determinations:
    • Suspension
    • Serious Non-Compliance
    • Continuing Non- Compliance
    • Unanticipated Problems Involving Risk to Subjects or Others
  • Closure when the study is closed permanently at UC Riverside

In addition, if there is a change in research that impacts UC Riverside local context approval, please contact the UCR Reliance Team (irb@ucr.edu). These changes may require additional reporting to the UCR IRB. Examples include, but are not limited to:

  • Addition of Prisoners as research subjects.
  • New Exception from Informed Consent Requirements for Emergency Research (EFIC)
  • New or change to a Waiver of Consent or Waiver of HIPAA Authorization
  • Change to UCR required consent language

The UC Riverside PI is required to conduct the research in compliance with pertinent federal regulations, state law, University of California policies, and UC Riverside policies.

HIPAA when Relying on an External IRB

UC Riverside requires the use of a stand-alone document for obtaining HIPAA authorizations. As such, HIPAA authorization language cannot be embedded within the consent documents. Changes to the UC Riverside approved HIPAA Authorization will require negotiations with Mr. Paul Hackman, J.D., the UCR Chief Compliance and Privacy Officer.

If you will be obtaining a signed HIPAA authorization from your subjects, you may use the UC Riverside approved HIPAA Authorization found on the Research Integrity Forms page. If you will need a waiver of HIPAA authorization for all or part of your study (e.g., recruitment), a request will need to be made to the IRB of record.

Review Timelines

Turnaround time can vary for an agreement due to the negotiation process and possible legal counsel involvement. The responsiveness of the other site may also affect the turnaround time. Agreements can take a few weeks to several months to be fully executed.

Reliance Contact

For questions or additional information regarding the IRB reliance process, please contact irb@ucr.edu.

Reliance Fees

UCR Researchers should check with their external collaborators to determine whether any reliance fees will be applicable to their projects.