IRB Reliance

A reliance agreement avoids duplicate IRB initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site research protocol. The reliance agreement details which organization does what tasks.

Once the agreement is executed, it can lessen the administrative burden and regulatory oversight of multiple institutions’ IRBs.

Institutions vary as to whether they will utilize reliance agreements. Many institutions will decide if they will allow a reliance agreement based on the research protocol being reviewed.

Some institutions have standing arrangements to utilize other IRBs for specific types of research. From a regulatory perspective, federal regulations allow for reliance agreements to be used for multi-site research.

Even when Texas A&M University-Corpus Christi’s IRB will not review a protocol, it is important that we have record of the research conducted at TAMU-CC that is under the jurisdiction of another IRB.

Although IRB review will be conducted elsewhere, there are other ancillary reviews that may need to occur at TAMU-CC (conflict of interest, export control, radiation safety review, etc.). Entering the protocol in iRIS will allow these reviews to occur.

Login to iRIS.

To begin this process, create a new protocol and select the type “External IRB Application”. The smartform will generate questions applicable to your research, depending on the category(ies) you select as your involvement. This type of submission goes through an abbreviated administrative review.

Reliance/cede requests are reviewed by an IRB staff through an administrative process. IRB staff will review the submission, obtain any/all additional information from investigators, determine whether the request can be accepted on behalf of TAMU-CC IRB, and obtain a determination from the other IRB whether the request can be accepted.

Once a determination is made by both IRBs, the request will be approved and any necessary reliance documentation will be executed by both IRBs.

Once a reliance agreement has been executed for TAMU-CC to rely upon (cede review to) another IRB, the TAMU-CC PI is responsible for obtaining all regulatory protocol information (approved protocol, approved consent documents, etc.) from the ‘overall PI’.

Any questions or required reporting will need to go through the PI at the reviewing IRB site.

You will no longer interact with the TAMU-CC IRB or TAMU-CC Office of Research Compliance for protocol issues related to that research.

The continuing review that occurs at the ‘providing’ site’s IRB will include TAMU-CC’s involvement in the research. Therefore, you will need to provide all necessary information for that IRB’s continuing review to the ‘overall PI’ at the site TAMU-CC is relying on.

A continuing review at TAMU-CC will not occur.

In order to allow another institution to rely on Texas A&M University-Corpus Christi’s IRB oversight you must have a protocol (either under IRB review or approved) in iRIS.

Contact IRB staff at irb@tamucc.edu to inquire about Texas A&M University-Corpus Christi’s IRB serving as the IRB of Record.

If you agree to be a principal investigator for a protocol that assumes responsibility for IRB review of other sites, your responsibilities increase.

Not only are you responsible for the IRB review/oversight/reporting of research activities conducted at TAMU-CC, you now become responsible for IRB review and reporting for the sites that are relying on the TAMU-CC IRB as part of your protocol. It is important that before you consider assuming this responsibility, you have the resources and infrastructure to do so.

This will likely depend on relationships with investigators at the other sites since you will need to depend on them to provide information about the research activities at their sites.

Once a reliance agreement has been executed for other sites to rely upon (cede review to) TAMU-CC IRB, the TAMU-CC PI is considered the ‘overall PI’ for the multi-site research protocol and obtains overall responsibility for the protection of human subjects for all sites. This includes the collection of all regulatory information needed by TAMU-CC IRB and the notification/communication for all IRB-related matters to all sites. For example, if a reportable event occurs at a relying site the PI at that site will need to inform you so you can report that to the TAMU-CC IRB.