Single IRB and Reliances

An executed reliance agreement must be in place before UC Davis can serve as the IRB of Record or rely on an external IRB for studies being conducted by UC Davis faculty, students and staff. The UCD Reliance Team is responsible for working with external institutions to obtain a signed agreement.

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

Federalwide Assurance (FWA)

All institutions that are conducting federally funded research are required to have a Federalwide Assurance (FWA) on file. The FWA is an assurance to the U.S. Department of Health and Human Services Office for Human Research Protections that an institution agrees to conduct research in accordance to federal regulations. Additional information about the FWA is available at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html

Requirements for a Reliance

Not all studies are eligible for a reliance. The following minimum criteria must be meet:

• The study requires IRB review and approval through expedited or full board level review
• UC Davis and the collaborating sites (or single investigator) are engaged in the human subjects research

In addition to the criteria listed above, there may be additional requirements applicable to the study or collaborating site. These additional requirements will be identified after the IRB receives the submission or during consultation with the Reliance Team.

Some multi-site research that is funded or supported by NIH will be required to follow a single IRB plan. Please use this guide for UC Davis researchers to determine when the policy is applicable and to assist you in the grant application process. Contact the IRB Reliance Team well in advance of submission to the NIH to ensure the IRB agrees with the single IRB plan and to obtain specific advice regarding IRB submission.

UC Reliance Registry

This is open only to UC campuses and Lawrence Livermore National Lab. If the UC Reliance Registry will be used to request the reliance agreement, follow these instructions.

Investigator Responsibilities:

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

• Providing the currently approved documents and the approval letter to relying investigators.
• Submitting reportable events from relying sites to UC Davis IRB  following UC Davis IRB requirements.
• 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 UC Davis IRB, and providing the currently approved documents and the approval letter.

All Other Requests

Prior to submission to the IRB, send an email to HS-IRBreliance@ucdavis.edu to request consultation. The Reliance Team will:

• Determine eligibility
• Provide guidance for how to submit to the IRB
• Obtain fully executed IRB Authorization Agreements, when applicable

Include the following information in the email:

• Study Title
• Funding Source and Status of Funding (funded / pending funding)
• Name of the UCD PI
• List of institutions that are expected to rely on UC Davis IRB (or the name of the single investigator)
• Copy of the protocol or study summary
• A description of the activities to be conducted by the collaborating researchers

Clarification of what level of direct responsibility and oversight the UCD PI has over collaborating researchers. See table below:

Additional Documentation Required

The package to add the relying site must include a site submission form with applicable supporting documents that is completed by the relying investigator/PI.

• Site Submission Form – Minimal Risk Study
• Site Submission Form – Greater Than Minimal Risk Study

UC RELIANCE REGISTRY

This is open only to UC Campuses and Lawrence Livermore National Lab. If the UC Reliance Registry will be used to request the reliance agreement, follow these instructions.

Investigator Responsibilities:

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

• Following the UC Davis reporting requirements to UC Davis IRB and following the Reviewing IRB reporting requirements to the Reviewing IRB. This will require coordination with the PI at the Reviewing Campus.
• Conducting the research in accordance to the approved protocol.
• Obtaining required local ancillary approvals.

All Other Requests

If the study qualifies for a reliance agreement, submit the following to the IRB via IRBNet:

• Cover Sheet
• HRP-226 Administrative Approvals
• The Initial Approval Document from the proposed IRB of Record
• 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.
• The Protocol
• Consent Documents
  • UCD Required Consent Language
• Recruitment Materials
• UC Davis Ancillary Committee Approvals/Determinations
• Sponsor Fee Form (when applicable)

The Reliance Team will screen the submission. If an agreement can be executed, the Reliance Team will obtain the agreement. Otherwise the Team will reach out to the PI to obtain clarification or require revisions.

Please note that the following scenarios may result in UC Davis declining to rely. This is not a complete list and is intended only to provide examples of reasons UC Davis IRB will decline to rely on another IRB.

• The reviewing institution is non-U.S. (foreign)
• The proposed reviewing IRB is non-responsive to UCD IRB’s inquiries for information
• The proposed reviewing IRB does not have the expertise needed to conduct the review of the study
• The proposed reviewing IRB declines to serve as the IRB of record
• An agreement with the proposed IRB of record cannot be executed

Investigator Responsibilities:

When UC Davis IRB cedes review to another IRB, the UC Davis PI retains responsibility for

• Research Member Training
• Submitting Reportable Events to the IRB of record, in accordance to their policies
• Obtaining required local ancillary approvals

HIPAA

Identifiable health information held by a covered entity (hospital, physician) (PHI) is protected under the Federal Privacy Rule. In most instances, individuals cannot access the PHI for research purposes without an authorization from the individual or a waiver of authorization from an Institutional Review Board (IRB) or Privacy Board.

If you will be obtaining a signed HIPAA authorization from your subjects, you must use the UC Davis approved HIPAA Authorization found on our forms page here.

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. If the IRB of record does not review HIPAA waiver requests, complete and submit the following form as a part of your IRBNet submission.

• HRP-217
  Request for HIPAA Waiver of Authorization (09/23/17)

Fees may apply for single IRB review. Click here for more information.

Email: HS-IRBreliance@ucdavis.edu.

Below find a list of common IRB reliance terms and definitions. If you have questions about any of these, please contact the IRB Reliance 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, also referred to as a reliance. 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.

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.

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.