Collaborative Research and UC Davis IRB Review

Sites and personnel who are not part of UC Davis are not covered by UC Davis’ IRB review unless certain agreements are in place. If your project or study involves collaboration with any sites and/or personnel outside of UC Davis, you will need to work with the UC Davis IRB and the other individual/institution to ensure that all reliance issues are addressed. This process may be complex. Study teams conducting multisite or collaborative research should become familiar with IRB requirements for such studies, including what information needs to be included in the budget, IRB application, protocol, and how to address other IRB reliance issues.

When UC Davis agrees to be the IRB of record for an outside individual or institution a formal written agreement must be in place and on record with the UC Davis IRB. The agreement may be an Individual Investigator Agreement (IIA) or an IRB Authorization Agreement (IAA). UC Davis has several agreements in place including the UC Reliance Registry, Neuronext, IRBChoice and the NCATS National IRBRely agreement. If you are planning to participate in collaborative or multisite research, and believe an IRB authorization agreement might be appropriate, check with the UC Davis IRB at by emailing the name of the outside institution/individual and title of the research project to HS-IRBreliance@ucdavis.edu to see if we already have an agreement in place.  If we do not, we will provide a template agreement for you to share with your external collaborators.

Investigators and research staff are not authorized to sign IRB reliance agreements. Each agreement must be signed by the Institutional Official (or designee) of the relying site and by the Institutional Official (or designee) of the reviewing site. You should send completed UC Davis agreements signed by the relying institution to UC Davis IRB Administration. IRB Administration will determine whether the reliance can take place and will either sign the agreement or discuss the project with you.   Likewise, if a collaborator sends an IRB authorization agreement to you for signature, send the agreement to the UC Davis IRB Administration for review.

If my research is to be conducted at UC Davis and other UC institutions what steps do I take: UC IRB Reliance Registry for UC Collaborative Research

UC IRB Reliance Registry for UC Collaborative Research

UC Davis uses the online UC IRB Reliance Registry hosted by the UC Office of the President for all studies covered by the Memorandum of Understanding (MOU) between the UC Campuses.  The MOU allows a UC collaborative research study to be reviewed by a single UC IRB, rather than requiring IRB review at two or more UC campuses where the research will take place.  All new requests must be submitted via the online Reliance Registry, prior to protocol submission to the Reviewing IRB.  For more information about the registry and qualifying research please visit https://irbreliance.ucop.edu/site/about.

All PIs and research coordinators at all UC Campuses who intend to use the Reliance Registry must have an active account prior to creating a reliance request, otherwise there will be technical issues with completion of the reliance request. Follow these step-by-step instructions for registration to avoid potential problems.

To ensure compliance with federal regulations and UC requirements, do not share your account information with someone else.

Before creating a new reliance request, review Information about the overall process, glossary of terms and FAQ at https://irbreliance.ucop.edu/site/help.   Whether UC Davis is the IRB of Record (Reviewing IRB) or the Relying IRB, the investigator must submit to UC Davis IRB certain documentation. Please see information provided below:

  • New Reliance Request and IRB Review: The initial request must be started prior to submission to the IRB and requires signature from all PIs at participating campuses and agreement by participating IRBs.
  • Amendments/Modification to an Existing Study & Continuing Review:
    • When UC Davis is the Reviewing IRB, the PI should follow normal process for amendments and continuing review submissions. The reviewing PI is responsible for ensuring the Relying PIs have the most currently approved documents.
      • Research Personnel: Relying site research personnel should not be added to the UCD research personnel list. The PIs at the relying sites must consult with their local IRB regarding submission of a research personnel list to their local IRB.
    • When UC Davis is the Relying IRB, submit the revised documents (protocol, subject-facing materials, Investigator Brochure) when applicable and the Reviewing IRB approval letter via IRBNet.
      • Research Personnel: The complete list of UCD research personnel is not required for submission to the UCD IRB or the reviewing IRB.
      • Change in Co-PI: The On-line Initial Review Application must be updated. Contact the UC Reliance Coordinator for assistance.
    • Change In PI: When the PI is changed, the reliance must also be amended and the new PI must electronically sign the assurances. Contact the UC Reliance Coordinator for assistance in submission of a revised reliance and IRB amendment.
    • Consent Documents: Minor administrative changes in the approved consent form to reflect local requirements, such as the contact phone number and letterhead, do not require prior IRB review and approval. However, if a watermarked (approval stamp on the) consent is required, this must be submitted as an amendment to the reviewing IRB.
  • Reportable New Information: No matter whether UC Davis is the Reviewing IRB or the Relying IRB, the UC Davis PI must follow UC Davis policy regarding Reportable New Information using normal reporting procedures.
  • Closure Report/Termination of the Reliance: Normally, all relying sites are closed out permanently and the Reliance is terminated when the Reviewing PI submits a closure report to the IRB. However, it is possible to permanently close a relying site while keeping the Reviewing site open. For assistance with this type of submission, please contact the UC Reliance Coordinator.

Whether UC Davis is the IRB of Record (Reviewing IRB) or the Rely IRB, the investigator has specified responsibilities as defined in the MOU. The UC Davis PI, whether UC Davis is the Reviewing or Relying IRB, is required to:

  • Notify UC Davis IRB that the study will involve one or more UC campuses.
  • Ensure that the UC Davis personnel performing the study are qualified, meet UC Davis education/training requirements, and adhere to the provisions of the IRB-approved protocol.
  • Obtain any UC Davis ancillary approvals required for this project (for example, conflict of interest, stem cells, cancer center, biosafety, radiation, or pharmacy).
  • Accept responsibility for the conduct of the study at UC Davis, the ethical performance of the project, and the protection of the rights and welfare of the human subjects who are directly involved at UC Davis.
  • Upon the occurrence of a post-approval event requiring notification, report to UC Davis IRB, as detailed in HRP-103 Investigator Manual using HRP-214 Reportable New Information.

When UC Davis is the Reviewing IRB, the UC Davis Principal Investigator is also required to:

  • Submit an amendment to the UC Davis IRB for review and approval of any amendments to the approved protocol and communicate such changes to all study investigators.
  • Actively communicate with all study investigators at all relying campus sites to make sure that the necessary and required coordination of any research activities including notification of post-approval events takes place.
  • Inform all study investigators about changes after initial approve unless other arrangements have been made with UC Davis IRB.

When UC Davis is the Relying IRB, the UC Davis Principal Investigator is also required to:

  • Forward relevant information to the Reviewing PI before the study is submitted to the Reviewing IRB for initial review, amendment, and/or continuing review, such as but not limited to:
    • local ancillary review determinations (conflict of interest, stem cells, cancer center, biosafety, radiation, or pharmacy, etc.);
    • reports of adverse events, other safety information, and/or protocol violations or incidents.
  • Submit a “shadow file” to UC Davis IRB via IRBNet with the following items:
    • UC Reliance Registry Request Document
    • HRP-226 Administrative Approvals
    • UC Davis On-line Initial Review Application
    • Reviewing IRB Approval Letter
    • Approved Protocol
    • Approved Subject-Facing Materials (such as consent document, recruitment materials, surveys, etc.), when applicable
    • Investigator Brochure, when applicable
    • UC Davis ancillary committee approvals/determinations
  • Not modify the IRB-approved protocol or any attached materials without first obtaining review and approval from the Reviewing IRB.
  • Follow standard procedures of the her/his own IRB for the reporting of the post-approval events.
  • Follow the standards and guidelines of the HRPP of the Reviewing IRB for the reporting of any post-approval events, including adverse events, other safety information, and/or protocol violations or incidents. This is in addition to following UC Davis IRB requirements for reporting. Information about reporting requirements can be obtained from the Reviewing PI or the Reviewing IRB:
The MOU also defines the responsibilities of the IRB (see below).

The MOU also defines the responsibilities of all signatory IRBs. All IRBs whether they are a reviewing or relying IRB are responsible for:

  • Accepting or Declining a Reliance – The IRBs may decline, on a case-by-case basis, the reliance. If this occurs, UC Davis IRB will notify the UCD PI who requested the reliance and the reciprocal campus of its decision.
  • Cooperation and Communication – The Reviewing and Relying IRBs will cooperate fully. Relevant documentation to support review, compliance and oversight by the respective IRBs will be made available to the reciprocal IRBs upon request.
    • Consistent with 45 CFR 46, the Reviewing IRB will notify the Relying IRB(s) of its determination or review decision
    • The IRB shall use the UC IRB Reliance Registry as a communication tool between the Reviewing and Relying IRBs that a determination has been made in its review of a study subject to the MOU.
    • The IRBs will immediately report to each other any unanticipated problems involving risks to subjects or others or any incidents of serious and/or continuing noncompliance.
      • The Reviewing IRB is the institution responsible for reporting as required by government regulations.
      • The Relying institution shall be provided with an opportunity to review and comment on regulatory-required reporting prior to submission by the Reviewing IRB.
    • Local Ancillary Review Committees – The Reviewing and Relying IRBs will ensure that their respective PI(s) have completed required local ancillary reviews and Relying IRBs shall communicate relevant ancillary review committee determinations to the Reviewing IRB.

When UC Davis is the Reviewing IRB, the IRB is also responsible for:

  • Review and Oversight – UC Davis IRB will conduct initial and continuing reviews and will review amendments to approved protocols and reports of unanticipated problems and serious and/or continuing non-compliance for UC Davis site and all relying sites.
    • UC Davis IRB will review federally-funded grant applications or proposals.
    • UC Davis IRB has the authority to suspend or terminate the research.
  • The Approval Letter – UC Davis IRB shall make a copy of its Approval Letter available to the Relying IRB(s). This Approval Letter shall be uploaded to the UC IRB Reliance Registry.
  • Record Keeping – The Reviewing IRB will keep records of studies subject to the MOU. The records will include, at a minimum, the date the application is submitted, review determinations, dates of approval, location of research activity, and oversight actions.

If my research is being reviewed by an external IRB what do I need to submit to the UC Davis IRB?

First, you must establish a reliance by contacting HS-IRBreliance@ucdavis.edu. Once the reliance is completed, you will need to submit a record of the research to the UC Davis IRB. One purpose of this submission is to ensure that the research is registered with the UC Davis Health, when necessary.  Another purpose is for the UC Davis IRB Administration to conduct an administrative review to ensure that the research complies with local law and UC Davis requirements.

You will use IRBNet to submit a New Project. The following documents must be included in the New Project submission:

  • HRP-226 Administrative Approval Form
  • Initial Review Application
    • When asked “Are you relying on an IRB other than the UC Davis IRB?” mark “yes.” This will create a truncated version of the form.
  • Copies of the approved protocol, consent and other documents that were reviewed by the external IRB.

You will also be required to obtain all required ancillary approvals (e.g. radiation, conflict of interest and biosafety committees).

How do I decide which IRB procedures to follow?

When an investigator relies on an external IRB, the investigator must follow the reviewing IRB’s requirements for submitting, modifying, reporting, and continuing review of research. These requirements will likely differ from their local IRB’s requirements

In some instances, you will need to send documents to the lead investigator who will forward them to the IRB and other instances you will need to send information directly the external IRB. If you are the lead investigator relying on an external IRB, you may need to coordinate review activities with all of the study investigators to ensure submissions and reports are submitted in compliance with the external IRB’s requirements.  You might also have to forward approval documents to each investigator relying on the external IRB.

Will UC Davis charge when the research is industry sponsored?

UC Davis IRB Administration will charge for processing the reliance and for administrative review of the research when industry sponsored research is reviewed by an external IRB.  You must include a sponsor fee form when you upload your documentation into IRBNet.

Contact us

If you have additional questions about IRB reliance, contact the UC Davis IRB Administration at HS-IRBreliance@ucdavis.edu

IRB Reliance Terms and Definitions

Below find a list of common IRB reliance terms and definitions. If you have questions about any of these, please contact the IRB Education Team for assistance.

Engagement in research: Engagement in human subjects research is the terms used in the Federal regulations 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 an institution assures the Department of Health and Human Services (HHS) that it will comply with applicable regulations governing research with human subjects.

Individual Investigator Agreement (IIA): An agreement used when UC Davis agrees to serve as IRB of record for external personnel or collaborators engaged in human subjects research and who are not affiliated with an institution with its own IRB. If an individual investigator agreement is needed, the UC Davis IRB facilitates the processing of such agreements.

IRB Authorization Agreement (IAA): A formal, written agreement in which the reviewing IRB 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 all human subjects research under an organization’s Federalwide Assurance (FWA). If an IRB authorization agreement is needed, the UC Davis IRB facilitates the processing of such agreements.

IRB of Record: A reviewing IRB that assumes IRB responsibilities for another institution or personnel not affiliated with an institution with an IRB. A formal agreement is often required when 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 also may be referred to as an IRB authorization agreement (IAA).

Local Research Context: 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).

Multisite Research: A multisite project is a project that is being conducted at one or more sites other than the site at UC Davis with a principal investigator (PI) who is not the same as the PI at UC Davis. All multisite research projects raise questions about whether sites or personnel are engaged in research and if so, how IRB oversight will be provided.

NCI CIRB (National Cancer Institute Central Institutional Review Board): The NCI CIRB provides centralized IRB oversight for institutions conducting certain cooperative group oncology studies.

NCATS (National Center for Advancing Translational Sciences): Established by NIH in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.

Relying IRB or Organization: A relying IRB or organization is relying on or has ceded IRB review to another IRB to provide IRB oversight for a specific study or set of studies.

Research at an External Site: Research activities that involve collaboration with sites and/or personnel outside of UC Davis when the research activities are under the oversight of a UC Davis researcher. All research projects involving external sites raise questions about whether sites or personnel are engaged in research and if so, how IRB oversight will be provided.

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.

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