UCI as the Relying IRB
Relying IRB will rely on the review of the Reviewing (external) IRB. The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB.
Single IRB (sIRB) Submission Process Overview
Step 1
Review the UCI HRP Policy #4 & this Website
- UCI Investigator confirms Relying IRB eligibility criteria
Step 2
UCI Investigator Pre-Submission
- Initiate process to obtain other UCI regulatory committee/ institutional approvals (i.e., Radiation Safety Committee (RSC), Conflict of Interest Oversight Committee (COIOC)), as needed
- Industry Sponsored Clinical Trials:
- Confirm that the Sponsor/CRO has contracted with the External IRB to provide services for the study
- Confirm that the Sponsor/CRO will include the UCI IRB fees in the clinical trial budget
Step 3
UCI Investigator Submits a New sIRB Application
- Submit a new sIRB application in Kuali Research (KR) Protocols - See: UCI sIRB Submission Requirements
Step 4
UCI IRB Agrees to Rely
- UCI local context and consent form language confirmed
- Clearance Notice Issued
Step 5
UCI Investigator/Sponsor Submits to External IRB
- External IRB reviews UCI documentation
Step 6
External IRB Agrees to serve as Reviewing IRB
- sIRB Agreement signed by Reviewing IRB or Approval Letter documenting UCI as a Relying Site
- Release of UCI specific approved documents
Step 7
UCI Releases the Initial Reliance Approval & Study Documents
Eligibility: UCI as the Relying IRB
Eligibility: UCI as the Relying 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. |
Food and Drug Administration (FDA) | 21 CFR 56.114(b)(1) Cooperative Research FDA is proposing new regulations to require that any institution located in the United States participating in FDA-regulated cooperative research rely on approval by a single IRB for that portion of the research that is conducted in the United States. | § 56.114(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 AI/AN tribe). (ii) Research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required. *Rare* (iii) Research on drugs that is exempt from the requirements for an IND application under § 312.2(b). (iv) Research on medical devices that meets the abbreviated requirements under § 812.2(b) or that meets the requirements for exempted investigations under § 812.2(c), to the extent the exempted investigation would be subject to part 56. |
National Institutes of Health (NIH) | NOT-OD-16-094 Single IRB for Multi-Site or Cooperative Research An NIH-funded study being conducted at more than one U.S. site involving non-exempt human subjects research is subject to the NIH Single IRB policy and/or § 46.114. As of January 20, 2020, studies subject to § 46.114 must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multi-site, career development (K), fellowship (F) awards, and Other Transaction (OT) awards. | Exceptions to use of single IRB are rare. NIH Single IRB Policy exception requests not based on a federal/state/Tribal law, regulation, or policy require the review and approval of the NIH Office of the Director (OD). NIH will consider exception requests for studies subject to the NIH Single IRB Policy if they are NOT also subject to the revised cooperative research sIRB provision. For questions or requests for an exception to the NIH Single IRB Policy applicants/recipients should consult with their Program Officials (POs), and offerors with their Contracting Officials (COs). |
UC Irvine | Human Research Protections (HRP) Policy #4 Cooperative Research When not otherwise federally mandated, UCI will consider relying on an external (non-UCI) IRB for non-exempt human subjects research conducted at more than one U.S. site when at least one of the following is true: *the External IRB is AAHRPP accredited CARE-Q Certified, or the organization is actively seeking accreditation / certification *research is primarily conducted at another institution and the UCI investigator’s role does not include interaction or intervention with subjects *unless it is an IRB Organization, the institution maintains an OHRP-approved Federalwide Assurance (“FWA”) | 1. Exempt research 2. Investigator initiated clinical trial (IIT) that is greater than minimal risk |
UCI as the Relying Privacy Board
UCI as the Relying Privacy Board
When the UCI is the Relying IRB, it does NOT rely on the External HIPAA Privacy Board. Rather, the UCI IRB continues to serve as the HIPAA Privacy Board. Exceptions may be considered.
The UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. Each institution will retain their own privacy reporting responsibilities should a breach of privacy occur.
External sIRB Agreements
External sIRB Agreements
External Entity/IRB | sIRB Agreement Description |
---|---|
Advarra Institutional Review Board (IRB) | Advarra is an independent IRB that provides services for academic and non-academic institutions. UC has a Master Service Agreement with Advarra to serve as the IRB of record for eligible clinical trials. For these trials, the industry sponsor’s protocol has already received IRB approval from Advarra. |
Institutional Authorization Agreement (IAA) | An IAA is a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying Institution. When a non-UCI entity is an institution that does not have their own IRB and they do not participate with SMART IRB, an IAA may be utilized. |
National Cancer Institute (NCI) Central IRB (CIRB) | The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies opened in the Cancer Trials Support Unit (CTSU). • Early Phase Emphasis (EPE) – Phase 0, 1 or 2 studies • Late Phase Emphasis (LPE) – Phase 3 studies UCI has established a formal agreement with the Adult NCI CIRB, investigators who wish to participate in these Cooperative Group trials can take advantage of this single IRB review model. |
SMART IRB | SMART IRB provides a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, supporting and encouraging collaboration and harmonization across the nation. The following reliance agreements will be processed utilizing the SMART IRB agreement: • Children's Hospital of Orange County (CHOC) - MemorialCare Health System (MHS) - UCI IRB (CMU IRB Reliance) • NEALS - Northeast ALS Consortium • NeuroNEXT • StrokeNet • UC IRB Reliance • Other Single Institutional Agreements (e.g., Fountain Valley, Kaiser) |
WIRB Copernicus Group (WCG) IRB | WCG is an independent IRB located in Olympia, Washington that provides services for academic and non-academic institutions. UC has a Master Service Agreement with WCG IRB to serve as the IRB of record for eligible clinical trials. For these trials, the industry sponsor’s protocol has already received approval from WCG IRB. |
UCI Relying Submission Requirements
UCI Relying Submission Requirements
The following requirements will need to be addressed via a new reliance submission in Kuali Research Protocols (KRP):
1. Refer to the table below and submit either 'Register to Rely on a non-UCI IRB' or 'Screener to Rely on a non-UCI IRB'
Research that is supported, or otherwise subject to regulation by any Federal department or agency that is a signatory of the 2018 Common Rule (including FDA regulated research). Exceptions are noted below. Common Rule Exceptions [45 CFR 46.114(b)(2)] The following research requires UCI IRB review: (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. FDA Exceptions [21 CFR 56.114(b)(2)] The following research requires UCI IRB review: (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 AI/AN tribe). (ii) Research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required. *Rare* (iii) Research on drugs that is exempt from the requirements for an IND application under 21 CFR 312.2(b). (iv) Research on medical devices that meets the abbreviated requirements under 21 CFR 812.2(b) or that meets the requirements for exempted investigations under § 812.2(c), to the extent the exempted investigation would be subject to part 56. UCI Exception Investigator initiated clinical trials require UCI IRB review. |
|
*Need to determine sIRB eligibility for a specific study *An investigator has a Disclosable Conflict of Interest |
2. Attach the following documents (as applicable):
-
- IRB Approval Letter, with active approval date
- Protocol (when a Master Protocol is not available)
- Questionnaires/surveys/measures, etc.
- Sponsor Study Documents:
- Master Protocol
- Investigator’s Brochure
- Documentation from the Sponsor/CRO confirming that:
- the External IRB is providing IRB services for the study and
- the Sponsor/CRO will cover IRB review fees
- UCI Specific Documents:
- UCI Site Recruitment Materials
- Draft of External IRB Consent that Includes UCI Template Language
- UCI HIPAA Research Authorization Form
- FDA Documentation
- Evidence of UCI Ancillary Review:
- Conflict of Interest (COI) Management Plan
- Radiation Safety Committee (RSC)
- Institutional Biosafety Committee (IBC)
3. For SMART IRB or IAA, attach the External sIRB agreement
External IRB Submission Requirements
External IRB Submission Requirements
Prior to initiating any request for an sIRB process, UCI Investigators should review the External IRB's policy/website for reliance/cooperative research and touch base with the sIRB contact at the IRB.
All sIRB applications must address UCI Relying Submission Requirements.
Post-Rely Responsibilities
Post-Rely Responsibilities
Transaction | Submit to External IRB of Record | Submit to UCI IRB |
---|---|---|
Amendments | According to External IRB Policy | UCI Specific Changes: once approved by the External IRB, submit a UCI amendment request for the following local context revisions: 1. Adding new version of an approved consent form 2. Any change in the informed consent process (e.g., adding short form consent) 3. Adding translated HIPAA Forms or non-English speaking subjects as a new study population Note: Do not submit translated consent forms 4. Any change in Protected Health Information (PHI) 5. Any change in research site 6. Any change in a research team member’s disclosable financial interests 7. Adding new or revised recruitment materials 8. Change in Lead Researcher 9. Adding or removing Co-Researchers or Research Personnel (when adding individuals UCI IRB approval must be provided prior to the individual engaging in research activities) |
Renewals | Progress Report of Research Activities at UCI | 1. Renewal Letter Approval from the External IRB of Record 2. Routine monitoring reports, as applicable |
Reportable Events | According to External IRB Policy | 1. External IRB’s Potential Unanticipated Problem or Noncompliance Form 2. Serious and/or Continuing Noncompliance that occurred at the UCI site 3. Unanticipated Problem that occurred at the UCI site 4. Notification of a hold or a suspension by the FDA, a sponsor, or a DSMB possibly related to risk to human subjects |
Advarra: Reporting Requirements | ||
Advarra: SAE Reporting Guidelines | ||
WCG: Reporting Requirements | ||
WCG: Reportable Info Form | ||
Audits By External Entities | According to External IRB Policy | 1. Notify UCI IRB and Internal Audit Services in advance of any audit or non-routine monitoring of study records to be conducted by an external entity (e.g., FDA, OHRP, study sponsor, CRO). The IRB and/or Internal Audit Services may wish to send a representative to observe proceedings including the "exit interview." 2. Any audit or non-routine monitoring written reports must be submitted to UCI, Routine monitoring findings by study sponsor or CRO must also be submitted to UCI IRB for their review and records. 3. Reports that include significant findings (potential Unanticipated Problem, Serious or Continuing Noncompliance) must be reported. |
Study Closure | According to External IRB Policy | External IRB’s study closure report |