UCI as the Reviewing IRB

Reviewing IRB: The “IRB of record” to which authority for IRB review and oversight has been ceded by another institution for an instance of research under an institutional authorization agreement or individual investigator agreement.

The Reviewing IRB is responsible for reviewing all IRB transactions for the Relying Institution. This includes, initial/continuing reviews, amendments to approved protocol, and unanticipated problems 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 federal or funding agencies of these events consistent with their policies and procedures and copy the Relying IRB on any such correspondence.

Single IRB (sIRB) Submission Process Overview

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2019-01-01

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2019-01-01

Step 1

Review the Relying IRB's Policy & Website for Reliance

Touch base with their sIRB contact to identify the workflow and submission requirements

Step 2

UCI Investigator Drafts Amendment

Revise the UCI protocol to reflect the sIRB request

Step 3

UCI Investigator Submits to Relying Investigator/IRB

PDF of revised UCI protocol
Relying site specific recruitment or consent/assent, as applicable
sIRB Agreement for signature

Step 4

Relying Investigator/IRB Sign sIRB Agreement

Relying IRB communicates any necessary revisions to Relying Investigator and/or UCI Investigator

Step 5

UCI Investigator Submits Amendment to UCI IRB

Site confirmed/acknowledged recruitment or consent/assent, as applicable
sIRB Agreement signed by Relying Investigator (& Relying IRB)

Step 6

UCI Approves & Signs sIRB Agreement

Step 7

UCI Investigator Communicates Approval to Relying Investigator/IRB

Eligibility: UCI as the Reviewing IRB

The UCI IRB complies with the following single IRB (sIRB) requirements:

Entity	Regulations or Policy	Exceptions
Human Health Services (HHS) & Signatories of the 2018 Common Rule	45 CFR 46.114 Cooperative Research Any institution located in the United States that is engaged in cooperative (non-Exempt) research must rely upon approval by a single IRB (sIRB) for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.	§ 46.114(b)(2) (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
UC Irvine	Human Research Protections (HRP) Policy #4 Cooperative Research When not otherwise federally mandated, UCI will consider being the IRB of Record for an external (non-UCI) IRB when human subjects research is conducted at more than one U.S. site and when at least one of the following is true: the research will primarily take place at UCI sites/facilities the UCI IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context *includes up to three (3) non-UCI entity conducting non-exempt human-subjects research for which the same research procedures as UCI are administered	1. Exempt research that qualifies for self-determination 2. Exempt research that requires IRB review Exception: UCI will consider serving as the IRB of Record for exempt research only if the UCI lead researcher has a dual affiliation with another site. 3. Investigator initiated clinical trial (IIT) that is greater than minimal risk.

UCI as the Reviewing HIPAA Privacy Board

The UCI IRB will consider serving as the HIPAA Privacy Board only when the External IRB/Site is within California and it does not have a privacy board. Exceptions may be considered.

During the review process, the UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. The non-UCI entity may use the Relying Site HIPAA Research Authorization template. Each institution will retain their own Privacy reporting responsibilities should a breach of privacy occur.

UCI requires the version of the SMART LOA or IAA that includes language acknowledging the request for UCI IRB to serve as the HIPAA Board, signed by the relying entity, with the request for UCI to serve as the IRB of record. All templates for sIRB agreements can be found on IRB Forms.

UCI sIRB Agreements

UCI requires the appropriate sIRB agreement, signed by the relying entities, with the request for UCI to serve as the Reviewing IRB.

Review the flow chart below to determine which sIRB agreement applies. All templates for sIRB agreements can be found on IRB Forms.

Important note:

When UCI is the Reviewing IRB, it does not utilize the SMART IRB Online Reliance System, but requires the execution of a SMART Letter of Agreement (LOA).

UCI IRB Submission Requirements

UCI IRB Review Submission Requirements

KRP User Guide

Requests for sIRB are submitted via an amendment to the UCI IRB approved study. Requesting an sIRB process during initial review are generally not permitted as it often protracts the initial IRB approval timeframe for the UCI site. However, exceptions may be considered.

The following requirements will need to be addressed via an amendment submission in Kuali Research Protocols (KRP):

1. Revise the KRP protocol (as applicable) to account for the sIRB request:

- Reviewing IRB Screener: Add a separate line for for each sIRB request (i.e., Relying Site or Relying Investigator)
- Sample Size: Account for any additional subject enrollment at the Relying Site
- Recruitment Methods: Account for any additional recruitment methods for the Relying Site
- Account for any additional consent methods at the Relying Site
- Project Locations: Specify the Relying Site
- Project Procedures: Explain the Relying Investigator's role/collaboration
- Project Procedures: Account for any alterations in the research procedures at the Relying Site
- Participant Compensation: Revised to account for any additional compensation methods at the Relying Site
- Confidentiality: Account for any additional data storage methods at the Relying Site

2. Attach the sIRB agreement [e.g., SMART IRB Letter of Agreement (LOA)] signed by Relying Investigator (& Relying IRB)

3. Attach the following documents (as applicable):

- UCI Consent/Assent Form that includes any Relying Site specific information or Relying Site Consent/Assent Form
- Evidence of Relying Site Ancillary Review:
  - Conflict of Interest (COI) Management Plan
  - Radiation Safety Committee (RSC)
  - Institutional Biosafety Committee (IBC)

External IRB Submission Requirements

External Site Rely Submission Requirements

Prior to initiating any request for an sIRB process, UCI Investigators should review the IRB's policy/website for reliance/cooperative research and touch base with the sIRB contact at the IRB.

The following sites have provided additional information regarding their sIRB processes, as it relates the UCI sIRB Process.

Children's Hospital Orange County (CHOC)

Submit the following documents in the CHOC's IRB system, after completing the registration process at CHOC:

A PDF of the revised UCI protocol reflecting the request for CHOC to rely (it does not need to be approved by UCI yet)
A completed SMART IRB Letter of Agreement (LOA) signed by the Relying Investigator
As applicable:

- If consent is obtained at CHOC, submit a CHOC consent/assent form (preferred) or UCI consent/assent with requisite CHOC language included (Review Consent Checklist: CHOC Local Context)
- If UCI is the HIPAA board and Authorization is obtained at CHOC, submit a Relying Site HIPAA Research Authorization

For additional information on how to obtain a signed LOA, please contact CHOC Office of Research Compliance: orc@choc.org

MemorialCare Health System (MHS)

If consenting at MHS, submit the UCI consent reflecting the MHS Consent Language must be submitted to MHS for approval prior to submitting the amendment at UCI

For additional information on how to obtain a signed Smart IRB Letter of Agreement (LOA), please contact:

MemorialCare Human Research Protections: MHSIRB@memorialcare.org and
Sharon Denham: SDenham@memorialcare.org and/or Teri Cilurso: TCilurso@memorialcare.org

UC Berkeley

UC Los Angeles

UCLA requires that the UCI IRB sign the SMART IRB Letter of Agreement (LOA) first, to document UCI's willingness to serve as the IRB of record.

UCI Investigator completes the LOA and obtains the Relying Investigator’s signature
UCI Investigator signs the LOA and attaches it to their amendment submission
UCI IRB signs the LOA
UCI Investigator downloads the LOA and emails irbreliance@research.ucla.edu to request UCLA IRB signature [CC: Relying Investigator (& their Coordinator)]
UCI Investigator attaches final signed LOA to their amendment submission
UCI Amendment is approved

For more information on the UCLA reliance process, visit: What is required when UCLA relies on another IRB

UC San Francisco

UCSF requires that UCI IRB sign the SMART IRB Letter of Agreement (LOA) before the Relying Investigator can apply in iRIS.

UCI Investigator completes the LOA and attaches it to their amendment submission
UCI IRB signs the LOA
UCI Investigator downloads the LOA and emails SingleIRB@ucsf.edu to request UCSF IRB signature [CC the Relying Investigator (& their Coordinator)]
UCI Investigator obtains the Relying Investigator’s signature and final signed LOA to their amendment submission
UCI Amendment is approved
Relying Investigator can apply in iRIS. Type in the word “paper” when prompted for a SMART IRB# because UCI does not utilize the SMART IRB registry

For more information on the UCB reliance process, visit: Relying on Other IRBs