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.

sIRB Eligibility

UCI as the Reviewing IRB for a non-UCI Entity

UCI will consider serving as the Reviewing IRB for a non-UCI entity (site or individual researcher) on a protocol by protocol basis for research where:

the UCI investigator is the prime recipient of the funding award, or
the research will primarily take place at UCI sites/facilities, or
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 conductinductin non-exempt human-subjects research for which the same research procedures as UCI are administered

AND

The Single IRB process is allowed, according to the flow chart below:

UCI as HIPAA Privacy Board

UCI IRB as the HIPAA Privacy Board for a non-UCI Entity

The UCI IRB will consider serving as the HIPAA Privacy Board only when the non-UCI entity 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.

sIRB Reliance 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).

Submit an sIRB Request

Submitting an sIRB Request to the UCI IRB

UCI prefers that requests for sIRB be submitted via a formal amendment to the UCI IRB approved study, not during the initial review of the study. Requesting an sIRB process during initial review often protracts the initial IRB approval timeframe for the UCI site. Exceptions may be considered.

The following revisions and documentation requirements will need to be addressed during the amendment, as applicable.

Provide a sIRB agreement signed by each non-UCI entity.
Revise the protocol to account for the research activities of the non-UCI entity as applicable:
- Subject Population: Revise to account for the subject enrollments at the non-UCI entity.
- Recruitment: Revise to account for any recruitment methods that are specific to the non-UCI entity.
- Consent Process: Revise to account for any consent methods that are specific to the non-UCI entity.
- Procedures: Revised to account for the non-UCI entity's role in the research and for any alterations in the research procedures that are specific to the non-UCI entity.
- Compensation: Revised to account for any compensation that is specific to the non-UCI entity.
- Confidentiality of Research Data: Revised to account for any data storage methods that are specific to the non-UCI entity.
If consenting at a non-UCI site, a revised UCI Consent / Assent Form that includes any non-UCI entity specific information in context of the research. UCI prefers that only the Lead Collaborating Researchers (LCRs) from each non-UCI entity be listed at the top of the UCI consent form. Do not list other non-UCI researchers from the non-UCI entity on the consent form.
- If consenting at MHS, a revised the UCI consent template with the MHS Consent Language inserted where applicable. The consent must be submitted to MHS for approval prior to submitting to UCI.
- If consenting/assenting at CHOC, a completed CHOC Consent Template. If UCI is the HIPAA board and Authorization is obtained at the non-UCI entity, a completed Relying Site HIPAA Research Authorization.
Provide the non-UCI entity’s conflict of interest management plan.
Provide the non-UCI entity’s RSC approval.
Provide the non-UCI entity’s IBC approval.