IRB reliance

What is IRB reliance?

IRB reliance is when an IRB agrees to rely on the IRB review and approval of another IRB. For example, the VCU IRB typically relies on the WCG IRB for industry-sponsored research and on the NCI Central IRB for cooperative group oncology studies.

IRB reliance is not limited to use of independent (central) IRBs. IRB reliance can also be established between institutions. A reliance arrangement is particularly useful when study sites are following the same study protocol or procedures. Reliance arrangements can also be useful when some of the study sites or partners do not have their own IRB.

Reliance arrangements may be put in place when:

• VCU has agreed to be a reviewing IRB for one or more other institutions/organizations
• VCU has agreed to rely on the IRB of another institution or an independent IRB

How is IRB reliance documented?

To establish a reliance arrangement, the participating institutions or organizations must enter into a reliance agreement to document the arrangement. This agreement may be called a reliance agreement or an authorization agreement. These agreements are most often study specific; however, some master agreements exist to document the reliance arrangement between institutions for any study. Reliance agreements must be signed by an authorized institutional official because the agreement is between institutions and not between investigators.

Has VCU signed any master reliance agreements?

Yes, VCU has signed several master reliance agreements:

• WCG IRB
• Schulman IRB
• NCI Central IRB
• IRBChoice
• SMART IRB

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

You should submit your study in RAMS-IRB as usual. You will make the request when completing the RAMS-IRB section for non-VCU sites.

Multicenter study: If the study is a multicenter study where all sites have their own PI and will follow a standardized protocol, your initial submission in RAMS-IRB should not identify any relying sites. The VCU IRB will approve the protocol and template forms, such as informed consent. After the initial submission is approved, you should submit an amendment to add non-VCU sites. The reason for adding sites via amendment after the initial protocol is approved is so that template forms can be approved before relying sites submit these forms with institution-specific information for IRB review. Otherwise, if the VCU IRB requires changes to any of the template forms, each site would need to make changes to the documents they had submitted for review.

• VCU PI-directed study with relying sites: When study procedures will occur at multiple sites and all study procedures are being directed by the VCU PI (i.e., no site PIs), requests for reliance from participating sites can be made at the time of the initial submission or via amendments.

What information needs to be provided by a relying site?

Relying sites must provide:

• VCU IRB of record local context form
• Any study documents that have been customized for the site (i.e., informed consent form)

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

First, you are strongly encouraged to contact IRBReliance@vcu.edu, before you proceed with any submission in RAMS-IRB to ensure that VCU is amenable to relying on the other IRB. Taking this step can save you time in the long run.

Once you have determined that VCU is willing to rely on the external IRB, you must submit an abbreviated submission in RAMS-IRB formally requesting the reliance. The submission will be reviewed for compliance with institutional requirements and other typical requirements of an external IRB, including:

• Determining the PI is qualified and has appropriate credentials and privileges to conduct the research
• Verifying that all research personnel have completed CITI human subjects training
• Verifying that a COI review has been completed and sharing any COI management plan with the external IRB
• Conducting HIPAA approvals
• Confirming that IBC and UIC approvals are in place, as needed
• Confirming that the Massey Cancer Center PRMC has approved the study, if applicable
• Confirming that an approved data security plan is in place for the study
• Verifying that the investigational drug pharmacy will be used or an approved management plan is in place

VCU charges a compliance review fee of $1,600 to conduct this internal review for industry-sponsored studies. There is no charge for this review for non-industry sponsored research.

When preparing the study submission, you should upload the following documents, as applicable:

• PI’s curriculum vitae
• Study protocol, if applicable
• Informed consent(s) and HIPAA authorizations that will be used at VCU
• Memo from OSP Red verifying injury clause language in the consent, if an industry-sponsored study
• Approval letter for the study from the external IRB
• External IRB of record local context form
• Verification of all applicable institutional approvals, such as IBC, data security plan approval, etc.

VCU will correspond with the PI and/or the external IRB to finalize the reliance arrangement and document the agreement.

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. 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
  • Addition of drugs or devices
  • Change in research funding
• Submit a report on your VCU submission when:
  • An unanticipated problem occurs at the VCU site
  • The reviewing IRB determined that an unanticipated problem occurred at the VCU site
  • The reviewing IRB determined that noncompliance occurred at the VCU site
• Close the study with the VCU IRB when the reviewing IRB closes the VCU site.

What should I do if my grant proposal requires a plan for Single IRB Review, or I am asked to collaborate on a grant that will propose Single IRB Review?

It is important to verify with the VCU IRB any plans for use of a single IRB before a grant proposal is submitted. If you are preparing a grant proposing that the VCU IRB serve as the reviewing IRB, it is particularly important to contact IRBreliance@vcu.edu at least two weeks before your proposal is due to ensure the VCU IRB is willing to serve. Similarly, if the grant will require that VCU rely on an external IRB, it is important to contact IRBreliance@vcu.edu in plenty of time to receive a response prior to the grant deadline.

IRBs may charge for the review of external site submissions, even on federally funded projects. Thus, it is important to consider potential IRB charges in grant budgets. If VCU is being asked to serve as the reviewing IRB, please be aware of charges that should be accounted for in your grant budget. A cost structure for the VCU IRB will be available soon. When another IRB will serve as the reviewing IRB, it will also be important to determine whether that IRB will change a fee for initial and ongoing reviews for the VCU site and account for these charges in your budget.

IMPORTANT UPDATE: The VCU IRB charges a fee for serving as the reviewing IRB in multisite, collaborative research. Please see the attached announcement for specific guidance on the new sIRB fees.