IRB reliance

What is IRB reliance?

IRB reliance is when an IRB agrees to rely on an external IRB for the review and approval of a study. For example, the VCU IRB typically relies on independent IRBs such as Advarra or WCG IRB for industry-sponsored research, and on the NCI Central IRB for cooperative group oncology studies.

As part of the IRB transformation process, VCU HRPP has expanded the types of studies that can utilize the IRB reliance process. Review the IRB review and reliance matrix that outlines which studies should be reviewed by an external IRB versus which should be reviewed by the VCU IRB.

IRB reliance is not limited to the use of independent (central) IRBs. IRB reliance can also be established between academic or health system institutions.  

Reliance arrangements may be put in place when:

• VCU has agreed to rely on the IRB of another institution or an independent IRB
• VCU has agreed to be a reviewing IRB for one or more other institutions/organizations
  • Note: during the transformation process, VCU is limiting the execution of agreements where VCU is the reviewing IRB (or, “IRB of Record”).

VCU HRPP does not execute IRB reliance agreements for exempt studies.

All ToolKit forms referenced below (HRP-xxx) can be found on the HRPP policies and guidance page.

How is IRB reliance documented?

To establish a reliance arrangement, the two IRBs must enter into a reliance agreement to document the arrangement. This agreement may be called a reliance agreement or an institutional authorization agreement (IAA). These agreements can be study-specific or a master agreement (i.e., an agreement that covers more than one study within VCU). Reliance agreements must be signed by an authorized institutional official (IO) or designee because the agreement is between institutions and not between investigators.

With which external IRBs does VCU currently have a master reliance agreement?

VCU currently holds master reliance agreements with the following external IRBs:

• Advarra IRB
• WCG IRB
• NMDP
• SMART IRB
• NCI Central IRB
  

How do I request a reliance arrangement if I want VCU to serve as the reviewing IRB?

During the transformation process, VCU is limiting the execution of agreements where VCU is the reviewing IRB (or, “IRB of Record”).

If you would like to discuss VCU IRB acting as the IRB of record for your multi-site study, please email IRBreliance@vcu.edu to set up an appointment with the VCU IRB reliance specialist. 

If an exception is made for your study, you will be asked to submit your study in RAMS-IRB, as usual. In the “Types of sites” section of the application, check “other non-VCU sites” and provide additional information.

Approving a study where VCU IRB will act as the IRB of Record is a two-step process:

Step one: The VCU IRB will review and approve the study at this site via the regular process.

Step two : The VCU IRB will review the addition of sites to the local study. To begin the process, the PI will need to submit an amendment via RAMS IRB and upload the following documents:

• • A completed Basic Site Information Form (HRP-811) for each site that will rely on VCU's IRB.
  • Site-specific informed consent form(s) and HIPAA authorization(s), if applicable.
  • The VCU PI must send HRP-103p to the PI at the relying institution.
  • The IRB reliance specialist will work with the VCU IRB analyst and PI to facilitate all the necessary IRB agreements.

How do I request a reliance arrangement if I want VCU to rely on an external IRB?

For all studies where VCU relies on an external IRB, you must submit an IRB Reliance Application via RAMS IRB and an application must be submitted to the external IRB (IRB of Record).

For the RAMS IRB Reliance Application:

• Create a standard new study application in RAMS IRB.
  
• At the IRB panel setup, check which IRB will be the IRB of record.
• Even though an external IRB will be the IRB of record, you must still upload the following documents to your RAMS IRB Reliance Application:
  • Study protocol (HRP-503, HRP-503A or HRP-508).
    • HRP-508 is a supplement to a separate sponsor protocol.
      • If utilized, both the separate protocol and HPR-508 must be uploaded.

• • Consent and assent forms
    • Must include a key information section
    • Must include VCU-approved injury language for greater than minimal risk studies
    • Must include VCU subject payment language if VCU pays the subject more than $50 per year
    • Must include mandatory reporting language, if applicable
    • Where VCU is responsible for contributing data to an NIH genomic data repository, must include a disclosure of that sharing

• • Separate HIPAA form, if not incorporated into the consent form
    • HIPAA language must include an “expiration date or event;” cannot include language “this authorization does not expire”
    • Must include all the required elements of a research HIPAA, per HRP-330

• • Site-specific recruitment materials
    • Generic recruitment materials that will be used by all sites do not require VCU review

• • Study approval letter from the IRB of record, if available
    • Your study may have an overarching IRB study approval letter as well as an IRB site approval letter. If so, both letters should be uploaded.
      
      
  • PI’s curriculum vitae and current CITI certificate
    
  • Memo from OSP verifying injury clause language in the consent, if an industry-sponsored study (PDF of final version)
  • For studies that rely on another academic institution or health system (not a commercial IRB), upload the IRB of record’s preferred local context form
• Confirm all institutional requirements outside of IRB review are met. To assist researchers in identifying when other institutional requirements may apply to their study, please see HRP-309 Ancillary Review Matrix.

When relying on a commercial IRB, such as Advarra or WCG, you will also submit the external IRB application via the commercial IRB’s system (e.g. CIRBI or Connexus, respectively). 

It is preferred that your reliance application is reviewed by the VCU reliance analyst before the study is approved by the external IRB, to ensure the consent form includes all the required VCU language. Some researchers find it time efficient to start the VCU and external applications simultaneously, but delay submitting to the external until after the initial VCU review. The reliance analyst will ensure the final consent includes all the required VCU language.

Cede Letter. Once the VCU application is approved for local considerations, RAMS IRB will send a system generated cede letter. If a cede letter is required beforehand, the study team should reach out directly to the reliance analyst with this request. The analyst will facilitate generating the letter.

When relying on an institutional IRB (for example an academic or health system IRB), the lead PI will likely submit the application to the IRB of record. For these studies, the VCU IRB reliance specialist will work closely with the PI and the external IRB to execute the necessary IRB agreements. SMART IRB, IREX are some of the external web-based portals that may be used to facilitate this process.

The VCU reliance application must be accepted and the external IRB must approve the study before study activities may begin at this site.

After my study is approved by an external IRB, what are my responsibilities?

Responsibilities with the external IRB

When your study is approved by an external IRB, you are responsible for following all of the policies of the reviewing IRB. These responsibilities may be outlined in the reliance agreement or the approval letter, but typically will include:

• Adhering to the study procedures approved by the reviewing IRB
• Submitting any changes for approval prior to implementation (amendments), including changes in study personnel
• Reporting all unanticipated problems and noncompliance within deadlines established by the reviewing IRB
• Reporting any changes in financial relationships that may be perceived as a COI
• Cooperating with any post-approval monitoring requests

Responsibilities with the VCU IRB

Even though your study is approved by an external IRB, you still have some responsibilities with the VCU IRB as listed in HRP-103. These include:

• Submit the following as amendments to your VCU submission:
  • PI and personnel changes to VCU for approval prior to submitting to the reviewing IRB (required because most reliance agreements require VCU to verify personnel qualifications and training)
  • Changes to HIPAA pathways
  • Changes to the consent form
  • Addition of drugs or devices
  • Change in research funding

• Submit a report on your VCU submission when:
  • The reviewing IRB determined that an unanticipated problem occurred at the VCU site
  • The reviewing IRB determined that noncompliance occurred at the VCU site
  • The sponsor has made an SAE report to the FDA.

• Close the study with the VCU IRB when the reviewing IRB closes the VCU site.

Matrix for IRB review and reliance