Relying on Another IRB

IRB reliance or ceded IRB review is the act of transferring IRB review or oversight from one IRB to another. The IRB ceding review is called the relying IRB. The IRB of Record who is performing the IRB review on behalf of one or more institutions is called the Reviewing IRB (also referred to as the single IRB or central IRB).

As of March 2017, The National Institutes of Health (NIH) will require the use of a single Institutional Review Board (IRB) for non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The policy is available for review at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.

IRB reliance is also commonly used when the study is being conducted by one or more institutions.

A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site.

A reliance agreement avoids duplicate IRB initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site research protocol. 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.

Yes, TAMU-CC does agree to cede review to an external IRB, depending on the situation.

The first step is to complete a Request to Rely. This form will prompt you to provide information about the study, the funding source, and the IRB you are requesting TAMU-CC to rely upon.

Your information will be reviewed to determine if the TAMU-CC IRB is willing to cede review based upon the details provided. If it is determined TAMU-CC is willing to cede, you will be contacted about additional details and the type of agreement required. Legal counsel and the Institutional Official will be involved in the decision making process and in drafting the reliance agreement.

Yes. Many IRBs will charge a fee to cover costs associated with the IRB review process. This is your responsibility and should be considered when drafting your study budget.

Once a reliance agreement has been executed for TAMU-CC to 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 for protocol issues related to that research. You will be responsible for providing information needed at the time of continuing review or if any unanticipated problems occur.

The final Agreement will dictate any additional responsibilities the TAMU-CC PI will have.

No. The continuing review that occurs at the external IRB of record IRB will include TAMU-CC’s involvement in the research. Therefore, you will need to provide all necessary information for the external 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.

All unanticipated problems, deviations, suspensions and terminations, noncompliance, subject complaints, etc., should be reported to the ‘overall PI’ at the external institution that is acting as the IRB of Record. The overall PI will be responsible for reporting these to the external IRB. The external IRB of record IRB will notify the TAMU-CC IRB of any such issues.

The consent forms to be used at TAMU-CC will be reviewed and approved by the external IRB of record. However, they should include TAMU-CC-specific information (headers, HIPAA/privacy language, injury language, TAMU-CC researcher contact information, etc.).

Typically, what occurs is that the multi-centered protocol submitted to the external IRB of record includes template consent forms that get approved by the IRB of Record. Once approved, the templates are distributed to all relying sites for them to insert local information. The site-specific consent forms are then submitted as an amendment to the external IRB of record and approved for use. For details on this process, contact your IRB of Record.