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. IRB reliance agreements allow for one IRB review of research procedures completed by all collaborating personnel.

Prior to submitting applications, 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 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.

Requesting a Reliance Agreement

To request UCR establish a reliance agreement for a study, send an email to irb@ucr.edu to request a consultation. Include the following information in the email:

• Study Title
• HS # of UCR approved IRB application (if applicable)
• 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

The Reliance administrator will:

• Determine reliance eligibility
• Provide guidance for how to submit to the IRB
• Facilitate in obtaining IRB Authorization Agreements, when applicable

UCR Investigator Responsibilities

There are two possible scenarios, depending on the PI's institutional affiliation.

a. Requests for UCR IRB to Review for Another Institution

(non-UCR PI has direct oversight of relying site)

In addition to the normal responsibilities, the UCR PI is responsible for:

• Providing the currently approved documents and the approval letter to relying investigators
• Submitting reportable events from relying sites to UCR IRB
• Communicating to relying investigators that they must submit reportable events to their local IRB following local IRB reporting requirements
• Actively communicating with study investigators at the relying campus sites to ensure post-approval activities take place, including submission of amendments and continuing review for the relying sites to UCR IRB

b. Requests for UCR to Rely on IRB Review from Another Institution

The UCR PI is required to conduct the research in compliance with UC/UCR policies, state law, and federal regulations.

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

The UCR IRB should receive very limited submissions when it is not the IRB of record. The following must be submitted to the UCR IRB in addition to any reporting required by the IRB of Record:

• Amendment/modification when there is a Change in PI or Co-PI
• Closure when the study is closed permanently at UCR
• Other Reportable Event when the IRB of record has made the following determination:
  • Suspension
  • Serious Non-Compliance
  • Continuing Non- Compliance
  • Unanticipated Problems Involving Risk to Subjects or Others

In addition, if there is a change in research that impacts UCR local context approval, please contact 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 or change to a Waiver of Consent or Waiver of HIPAA Authorization
• Change UCR required Informed Consent form language

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.

IRB Reliance Terms and Definitions

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.

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 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 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.

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 and 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 IRB 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.

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 IRB is the IRB that serves as the IRB of record for institutions or personnel not affiliated with an organization with an IRB. Also referred to as IRB of record.

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.