Office of Research Single IRB and Reliances - Office of Research

Single IRB and Reliances

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. UC Davis IRB may opt to serve as the IRB of Record for collaborating research sites (or single investigators) or rely on another IRB for certain studies.

If your study is federally funded, it may require single IRB review. Please contact the UC Davis IRB Reliance Team for assistance.

 

UCD Institutional Policy for Reliances found here:

  • HRP-058
    IRB Reliance When UC Davis Relies on an External IRB
  • HRP-059
    IRB Reliance When UC Davis is the IRB of Record

 

Requirements for a Reliance

The following minimum criteria must be met in order for a study to qualify for a reliance:

  • The study requires IRB review and approval through expedited or full board level review (Study was not determined to be “Exempt”)
  • UC Davis and the collaborating sites (or single investigator) are engaged in the human subjects research
  • The proposed institution/investigator are not international

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.

 

UCD to Review for Another Institution

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

  • Determine reliance eligibility
  • Provide guidance for how to submit to the IRB
  • Obtain 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

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

 

UCD PI has Direct Oversight of Relying Site activities and Personnel:

 

Normal Submission

 

UCD PI Does Not Have Direct Oversight of Relying Site activities and Personnel:

 

CORE Setup Submission

 

Designation of PI for IRB Purposes

The UCD PI is considered the PI for the relying site and is ultimately responsible for ensuring the research remains in compliance at all sites. The lead investigator at the relying site would not be considered a PI and is considered a relying investigator.

The UCD PI does not assume any responsibility for how the research is conducted at the relying site. The lead investigator at the relying site is considered a PI for IRB purposes and is responsible for the conduct of the research at her/his site.

Submission to the IRB

All packages are submitted under one IRBNet # using the normal submission process. The UCD PI is responsible for all submissions.

The IRB submission uses a specialized Multi-site feature requiring a CORE (study-wide documents) IRBNet # and linked, but separate IRB #s for each participating site, including UCD, for local context and localized documents.

This will require considerable coordination and internal IRB documentation in IRBNet #. The Reliance Team and/or the coordinating center will facilitate this process.

IRBNet Access for the Relying Investigator/PI

The Relying Investigator is not required to have full access to the study via IRBNet. However, the UC Davis PI is responsible for ensuring the relying site has the currently approved documents and approval letters, submitting reportable events from relying sites, and ensuring post-approval activities take place.

Relying PI is required to have full access to the study via IRBNet.

The Reliance Team will facilitate this process.

Funded Research

When research is externally funded, submissions to approve relying sites will be held until the Notice of Award or executed contract is received. The IRB is happy to accept an email from SPO or HS-Contracts stating that the above have been received to fulfill this requirement. The review of the research and UC Davis as a participating site may move forward without the above requirement having been met.

Documentation Required When Adding a Relying Site on IRBNet

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

 

UC Davis to Rely on Another IRB

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

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.

 

HIPAA

Please Note: To comply with CA laws UCD requires the use of a stand-alone document for obtaining HIPAA authorizations; HIPAA authorization language cannot be embedded within the consent forms. Changes to the UC Davis approved HIPAA Authorization will require negotiations with the Compliance Department.

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)

 

Reliances between UC Campuses: UC Reliance Registry

This is only for reliances with UC campuses or the Lawrence Livermore National Lab.

Follow these instructions when UCD will be reviewing for another UC Campus.

Follow these instructions when UCD will be relying on another UC Campus.

 

UCD Investigator Responsibilities

UCD is Asked to Review for Another Institution (non-CORE studies)

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.

UCD is Relying on Another Institution

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.
  • Tracking personnel in the study delegation log.  The log should be clear which personnel are on the study and when, which personnel are off the study and when, and their training.

 

Reliance Agreements

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

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.

 

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

 

NIH Supported or Funded Research

Some multi-site research that is funded or supported by NIH is 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.

 

IRB Fees

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

 

Reliance Team Contact

Email: HS-IRBreliance@ucdavis.edu.