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. 

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:

Submit the study in iRIS 

When UCSF relies on another IRB, the UCSF PI must submit an abbreviated application in iRIS. See detailed instructions in the individual reliance descriptions below. If another site wishes to rely on the UCSF IRB, indicate this request in the IRB Application in iRIS.

If using consent forms in non-UCSF format

The UCSF IRB is willing to consider accepting and reviewing consent forms not written in the UCSF format in certain circumstances in which the form has been or will be approved by another duly constituted IRB. Use the Consent Form Checklist for Using a Non-UCSF Consent Form when modifying the consent forms, assent forms, information sheets and recruitment materials. See the Consent Guidelines page for more info.

Definitions 

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.

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

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.

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.

Responsibilities

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

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

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

     

    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.

    Last updated: May 16, 2022