Relying on Other IRBs

What Are IRB Reliances?

Current UCSF policy requires that all faculty and staff paid by UCSF for greater than 50% of their effort must have UCSF IRB approval before they begin research using human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, regardless of the site of the study activities.

However, in some cases, UCSF researchers may rely on another IRB to review their human research. UCSF has signed reliance agreements with the following entities on which the UCSF IRB can rely. UCSF will consider additional reliance agreements on a case-by-case basis. Please note that UCSF does not enter into reliances with international sites.

Current IRB Reliances

Please visit this page for more details. 

Various Consortia 
  • PPHNet
  • TrialNet
  • NeuroNext (Massachusetts General Hospital)
  • StrokeNet (University of Cincinnati)
  • TrialNet (Vanderbilt)
  • PETAL Prevention and Early Treatment of Acute Lung Injury (Vanderbilt)
  • PPHT Pediatric Pulmonary Hypertension Network (Reviewing IRB will vary)
  • CARRA Registry, IRBRely (Duke University)
  • Cancer Immunotherapy Trials Network CITN (Fred Hutch)
  • Rare Lung Disease Consortium RLDC (Cincinnati Children’s Hospital)
  • Health eHeart – UCSF is reviewing IRB for NIH and Boston University
  • IRBChoice (Vanderbilt)
  • RDCRC Rare Disease Clinical Research Consortium (Children’s National Medical Center)
  • UCDC (Children’s National)

Note: In general, UCSF cannot be considered the IRB of record for non-affiliated institutions or investigators. However, there are some limited exceptions when UCSF can serve as IRB of record.

Notes for UCSF PIs:

Requirements for relying on an external IRB

External IRBs that review for UCSF should obtain independent IRB accreditation or certification, such as AARPP or Care-Q. IRBs lacking such accreditation will be required to complete a checklist to ensure the IRB complies with federal human subject protection regulations.

When relying on an external IRB , the external IRB must agree to include certain required elements in the UCSF consent form. Use of the UCSF plain language consent form template is strongly recommended to ensure that all local requirements are met.  If the UCSF template cannot be used, the consent form must meet minimum local requirements. Please refer to the external IRB consent form checklist to ensure that the consent form complies with local laws and policies.

The following are considered best practices for relying on an external IRB.  Please contact the UCSF reliance team as soon as possible if the external IRB is not able to follow these processes. Deviations from these processes may result in significant delays.

  • After the UCSF HRPP gives permission to rely on the external IRB, the reviewing IRB will approve UCSF as a site and provide documentation of UCSF site-specific approval.
  • The UCSF HRPP will coordinate with the reviewing IRB via a single online system for any given study. For example, the UCSF HRPP will use IREx, SMART IRB, or the reviewing IRB’s local system for the study. The UCSF HRPP is not able to coordinate multiple online systems for a single study.
  • Reliance agreements must comply with UCOP requirements for indemnification, insurance, and governing law.
  • External IRBs that require indemnification agreements should provide a single blanket Letter of Indemnification (LOI) to cover all studies the IRB reviews for UCSF thereafter. The LOI should not have an expiration date and will not be renegotiated except under exceptional circumstances.

Note that UCSF HRPP may decline to rely on an external IRB.

Submit the study in iRIS 

When UCSF relies on another IRB, the UCSF PI must submit an abbreviated application in iRIS. The UCSF HRPP will first screen the study to ensure compliance with UCSF policies and local laws. The reviewing IRB will review for UCSF only after this screening is complete and a reliance agreement has been signed or agreed to for the study. If another site wishes to rely on the UCSF IRB, indicate this request in the IRB Application in iRIS.

External IRB Review Fees

IRBs may charge review fees, regardless of study sponsor, funding source, or type of research. IRB review fees are the responsibility of the study team(s).  The UCSF HRPP cannot assist with funding or negotiating external IRB review fees.  NIH policy allows for some single IRB review fees to be charged as direct costs.

Responsibilities of the Reviewing IRB

Review Submissions

The Reviewing IRB will conduct initial and continuing reviews, and will review amendments/modifications to approved protocol and unanticipated problems or adverse events that may arise.

Can suspend research

The Reviewing IRB will have the authority to suspend the research for failure to comply with conditions of approval or regulatory requirements.

Comply with notification requirements

The Reviewing IRB will notify the Relying IRB of any unanticipated problems, suspensions or terminations of research. The Reviewing IRB will notify the federal or funding agencies of these events consistent with their policies and procedures, copying the Relying IRB on any such correspondence.

Consider COIs and funding

The Reviewing IRB will consider conflicts of interest and confirm, where appropriate, that the application or proposal for human subjects research submitted to the federal Department of Health and Human Services matches the protocol submitted for IRB approval.

Serve as IRB of record

The Reviewing IRB will serve as the IRB of record. 

Responsibilities of the Relying IRB

The Relying IRB will rely on the IRB review of the Reviewing IRB. It will not re-review the study.  Another IRB may refuse, on a case-by-case basis, to serve as the IRB of record for another location or to rely on the review another IRB.

Required submissions to the UCSF IRB after approval by an external IRB

UCSF researchers must submit certain changes and status updates to UCSF IRB when relying on an external IRB.  Please refer to the complete list of required submissions below. 

Modifications

Please submit a modification request in iRIS when making any of the following changes:

Changes to the study status or IRB reliance status

  • Changes to the UCSF Principal Investigator
  • Additional funding
  • Changing the reviewing IRB
  • Change in study title

Changes to UCSF procedures or policies

  • Addition of UCSF Clinical Research Services (CRS) support
  • Addition of Zuckerberg San Francisco General as a site
  • Adding Academic Research Systems (ARS) services or changing the dates of the records you request from ARS
  • Adding or changing HIPAA determinations
  • Adding or changing EMR access
  • Addition of a patient care ward at UCSF only
  • Addition of MyChart recruitment
  • Adding or changing anything that requires UCSF Radiation Safety approval (attach the consent form if RSC provides new risk language)
  • Addition or revision or a Conflict of Interest management plan
  • Adding UK and/or EEA data or participants. Please see our guidance before submitting.

Changes to the study that impact California state or local laws. It is the PI’s responsibility to be aware of laws that impact the research. 

  • Adding a vulnerable population (not currently in the UCSF reliance application) 
  • Addition of a drawing / lottery to compensate study participants
  • Addition of study participants who are unable to consent for themselves
  • Addition of minors who will consent for themselves under California state law
  • Addition of prisoners as study participants
  • Incarceration of a currently-enrolled participant
  • Addition of oocyte procurement procedures
Study closure
Post-approval reporting

Local Context

  • UCSF Local Context: This document is intended for use by the reviewing external IRB. The information provided is intended to provide the reviewing external IRB with local context, laws and policies affecting human subjects research at this institution.

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