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 Western IRB for industry-sponsored research and on the NCI CentralIRB 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:
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.
Yes, VCU has signed several master reliance agreements:
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.
screenshot of RAMS-IRB Non-VCU Site Details page with an arrow pointing to the [View Image]
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.
Relying sites must provide:
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:
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:
VCU will correspond with the PI and/or the external IRB to finalize the reliance arrangement and document the agreement.
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:
Even though your study is approved by an external IRB, you still have some responsibilities with the VCU IRB. These include:
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.