Single IRB-of-Record (sIRB) Process

Federally-funded cooperative (i.e, "multi-site") human research studies are required per the Common Rule (45 CFR 46.114) to utilize a single IRB-of-Record (sIRB) to streamline the review process for human participant protections and to avoid duplicate review by an institutional review board at each site. 

Under the sIRB model, an IRB at one of the collaborating institutions agrees to provide IRB oversight for all participating institutions via an authorization agreement (a.k.a. "reliance" or "collaborative" agreement) or a commercial IRB is contracted to provide the oversight functions for the project.  These agreements/contracts document the respective authority, roles, responsibilities, and communication plans among the IRB-of-Record (i.e., the "reviewing IRB") and the institutions relying on that IRB (i.e., "relying site" and "relying IRB") for project oversight. 

At U-M, authorization agreements are negotiated and officially signed by U-M's HRPP Director.  No one on the study team (or at the U-M IRB) has the authority to negotiate or sign the IRB Authorization Agreement.

sIRB Functions

The sIRB centralizes the regulatory review of the human research activities taking place at all of the participating sites for a project.  This includes the review and approval of the:

• Protocol for all sites
• Recruitment process and documents
• Informed consent process and documents
• Data management and security for the project
• Reports of serious or continuing noncompliance, unanticipated problems involving risks to participants or others (UaPs) and substantive subject complaints, including reporting to federal agencies when necessary.

Related oversight functions, such as ancillary committee reviews (e.g., conflict of interest review, verification of completed human subjects protections training) remain with the individual participating institutions.  The conduct and reporting of the research remain the study team's responsibility.

U-M sIRB Request Guidelines

Confirming the sIRB for a cooperative human research project is a pre-eResearch task!  Principal investigators (or a designated study coordinator) should contact the applicable U-M IRB to discuss the sIRB options when developing the research proposal and before naming the sIRB on a PAF or in the funding application.

There are three sIRB options for cooperative human research projects:

1. U-M serves as the sIRB
2. An external institution serves as the sIRB
3. A commercial IRB serves as the sIRB

Federal sponsors (e.g., NIH, NSF) generally require confirmation of the sIRB before awarding the grant/contract.  By following U-M's 8/3 week request timeframe and processes outlined below, you ensure that due notice is provided to the U-M IRB and that accurate siRB information is provided to the funding sponsor of the project. 

Requesting a U-M IRB To Be the sIRB

At least eight (8) weeks prior to proposal submission, use the UMICH Single IRB Review Core in MiCORES to request that IRBMED or IRB-HSBS be the sIRB for a proposed project.  By using the sIRB Core within the recommended eight week timeframe, you:

• Provide key study details to the U-M IRB;
• Accord the IRB the necessary time during the proposal development stage to validate U-M's capacity for the IRB review and ongoing oversight of the project, and to determine the resources that will be needed to serve as the sIRB; and
• Enable the IRB to provide sIRB budget information, as applicable, for the proposal or pending award.  (IRBMED only)

For instructions and details on how to use the UMICH Single IRB Review Core in MiCORES, review the sIRB/MiCORES Overview guide.

sIRB Evaluation Criteria

The U-M IRBs evaluate on a case-by-case basis whether they can effectively serve as the sIRB for a proposed multi-site project or if an external IRB should be used. The main evaluation criteria are:

• The risk level to the human subjects
• The number of collaborating institutions and the research activity to be conducted by those institutions
• The experience level of the U-M PI/study team
• The level of administrative resources available to the PI/study team to manage/coordinate the project
• Whether U-M PI is the direct recipient of the federal grant
• The adequacy of technology platforms to support the submission of information across participating sites
• What entity holds any associated investigational drug or device (IND/IDE) approval

The U-M IRBs reserve the right to decline being the sIRB on any project, but will provide support to the U-M study teams to locate an external IRB to act as the sIRB.

Requesting an External/Commercial IRB To Be the sIRB

At least three (3) weeks prior to proposal submission, email or call your U-M IRB to request ceding sIRB oversight to an external (e.g., another academic institution's IRB) or a commercial IRB. 

sIRB Fees

Commercial and some academic IRBs may charge fees for the initial review and ongoing IRB oversight activities.  Always verify any IRB fees with the external IRB for proposal /award budgeting purposes.

The NIH allows IRB fees as a direct cost on the proposal/award budget.  (See the PHS G.300 -  R&R Budget Form guide for details.)  Other federal sponsors may not allow these fees as a direct cost.  Always verify with your project’s sponsor how to budget/account for the IRB fee (if any).

For sponsored multi-site studies under IRBMED jurisdiction where U-M is the sIRB, IRBMED will recharge awarded projects for sIRB services.  See the IRBMED sIRB and Multi-site Research (MSR) Guidance webpage for details.  Currently, IRB-HSBS does not assess a fee for sIRB services for cooperative studies under IRB-HSBS jurisdiction where U-M is the sIRB.

U-M Study Team IRB Processes

The type of IRB application used for the sIRB review of a cooperative research study varies.

When U-M Will Be the sIRB

U-M sIRB Coordinators can assist you in selecting the appropriate type of IRB application to use, depending on whether U-M will be a coordinating center for the project (i.e., responsible for the overall data management, monitoring, and communication among all sites), the lead site for the project, or a participating site only.

When U-M is the Lead Site, the PI/Study Team is responsible for:

• Submitting the applicable IRB application to the U-M IRB for review, including materials for the relying sites;
• Working with the U-M IRB and collaborating investigators to identify study roles and responsibilities, and to develop the communication plan to be used with the relying sites;
• Working with the sIRB to provide all of the information necessary to establish authorization agreements with relying sites;
• Responding to questions from collaborating study teams, relying IRBs, and external institutions involved in the project;
• Providing relevant U-M policies and procedures, such as incident reporting requirements, to collaborating study teams;
• Providing copies of U-M approved study documents (e.g., protocol, consent forms, recruitment materials, survey instruments) to collaborating study teams; and
• Submitting amendments, scheduled continuing reviews, and AE/ORIO reports for the study.

When an external or commercial IRB will be the sIRB

The U-M study team will complete a Requesting Review by a Non-UM IRB (a.k.a. "ceding") application in the eResearch Regulatory Management (eRRM) system.  The external IRB usually will have an application process which the study team also must follow.

The "ceding" application provides the project information necessary for local (i.e., U-M IRB) review functions not handled by an external IRB, and for the administration of the research at the U-M performance site by the study team, such as:

• Local context information for sIRB review
• Ancillary Committee review (e.g., conflicts of interest, radiation safety, research pharmacy)
• Fulfillment of human subjects protections training for U-M personnel via PEERRS or other training equivalent
• Amendments (e.g., changes impacting ancillary review or decision to cede oversight, project holds/suspensions)
• Reporting AE/ORIOs for related serious adverse events that occur in U-M subjects, unanticipated problems that occur in U-M subjects, and serious and/or continuing non-compliance determinations regarding U-M participation
• Annual continuing review to track study status

Study teams must receive both the U-M acknowledgement letter for ceding oversight to the external sIRB and the external sIRB approval notice for the research project before beginning any research related activities.