Single IRB (SIRB) Review
Reliance Consultation RequesTThe basis for the Single IRB Model is to allow multiple institutions that are conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research at the sites individually. The Single IRB Model has been in use for many years, across a wide variety of studies and circumstances.
At the University of Utah, we feel that while Single IRB Review may help to streamline the study initiation process, it is important to understand all of the components of the Single IRB model that must be completed beyond just the IRB review. Efficient performance of all stages of study initiation and conduct will help to ensure multi-site research is effective and expeditious.
As with any study, the protocol must be developed and finalized. This is primarily the responsibility of the lead study team, although the participating study teams may also provide input as part of a collaborative effort.
When using a Single IRB model, it is important to ensure that the protocol includes a detailed recruitment plan, consent process, and data and safety monitoring plan. These details will not only help the Single IRB to have complete information for their review, but will also ensure that the Relying Site HRPP has enough information to determine if the study meets local requirements. The participating study teams may need to provide information about their local requirements, such that the protocol can address the needs at each site.
It is also valuable for the lead study team to develop a consent document that can be used for the study. Each participating study team may need to make minor changes to the consent document to accommodate local consent language requirements, so generally, the Single IRB will approve a consent document version for each participating site.
The Single IRB and the Relying Site HRPP are responsible for working together to come to a decision about relying on the Single IRB for any given study. This decision must be documented in writing via a Reliance Agreement. The Reliance Agreement outlines the obligations and responsibilities of both parties.
Reliance Consultation Request
If you would like to request that the University of Utah IRB (UUIRB) be the IRB for your study, or if you would like the UUIRB to defer review to another IRB, please complete a Reliance Consultation Request.
Initial Review includes the initial Single IRB review, as well as the initial review performed by the Relying HRPP. Each stakeholder has responsibilities during this stage.
The Lead Study Team is responsible for making the submission to the Single IRB, on behalf of all sites. The Lead Study Team may prepare the Single IRB application themselves, or may contract with another group such as a Clinical Trials Office or a Contract Research Organization to prepare the submission.
Additionally, the Lead Study Team becomes the primary liaison for communication between the Single IRB and the participating study teams.
During the Initial Review stage, the Participating Study Teams are responsible for completing all of the non-IRB requirements at their local institution. These are the Relying HRPP requirements which were mentioned earlier in this presentation.
The Participating Study Team is also responsible for communicating necessary information to the lead study team, so that the lead study team can evaluate the information and determine whether it should be submitted to the Single IRB for review. This could include site-specific differences in the recruitment or consent process, or other information that could affect IRB approval at that site.
Lastly, the Single IRB is responsible for the Initial IRB Review. The Single IRB must review and approve studies according to applicable regulations and policies. In order to do this for all of the participating sites, the Single IRB will consider and address the information that has been provided by the participating study teams and the relying HRPPs.
Many Single IRBs will also act as a Privacy Board for HIPAA determinations, such that the Relying HRPP does not need to fulfill this role. This is a role that will be defined in the Reliance Agreement.
The Single IRB must communicate with the lead study team about IRB-related decisions and determinations that are part of the initial review.
This includes continuing review, amendments, and reporting of problems and events. This includes audits, compliance, and safety monitoring as well.
The lead study team is responsible for much of this oversight, ensuring that the required submissions to the Single IRB occur on behalf of the entire study, while also ensuring the study is monitored appropriately.
The lead study team remains the primary liaison for communication between the participating study teams and the Single IRB, and must have a clear communication plan in place.
The participating study teams have similar responsibilities during stage 4. They remain responsible for managing all of the non-IRB, HRPP requirements at their institution, throughout the course of the study. And they must maintain adequate and clear communication with the lead study team to ensure that they have all single IRB approvals that they need and that the single IRB receives all relevant information about problems and events during the study. This is likely to include site-specific amendments to the protocol or consent document, changes that result from ongoing review by the relying HRPP (such as changes in conflict of interest management plans), and local problems and events.
The Relying HRPP also has ongoing review and oversight responsibilities during stage 4. The Relying HRPP continues to work with the participating study team to review and meet local requirements outside of IRB review. If any changes or concerns are identified through the Relying HRPP’s review, the Single IRB must be notified to determine if changes are needed to the protocol or consent documents. The Relying HRPP also continues to perform compliance monitoring of the research, according to their institutional policies.
Though the Relying HRPP is not required to make IRB determinations regarding problems, events, and non-compliance, they may need to provide valuable assistance to help resolve these concerns. The Relying HRPP and the Single IRB will maintain communication, such that they can both assist the participating study team in resolving and preventing future problems. It is important that all of these stakeholders work together to create solutions that are in the best interest of the research participants.
During this stage, the Single IRB continues to perform all of the standard IRB functions for review and approval of the research as it progresses. The Single IRB may work with the Relying HRPP to perform compliance monitoring and will continue to have open communication with each institution to ensure research is performed.