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The NIH sIRB policy applies to:
Cooperative research where:
- International site(s) participate
- Individual IRB review is required by law (e.g., Native American or Alaskan Native tribal law)
- A federal agency determines and documents that the sIRB model is not appropriate
U-M IRB-of-RECORD PROCESS REFERENCES
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.
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:
- U-M serves as the sIRB
- An external institution serves as the sIRB
- 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.
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.
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.
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.
- 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.
A single IRB-of-Record (sIRB) is the institution review board that is designated (with negotiated terms via a formal service/authorization agreement) to act as the sole provider to conduct the initial, continuing, and any subsequent review of the research project to ensure human subjects protection regulations will be/are followed.
From U-M's perspective, an external IRB is any non-UM institutional review board. An external IRB can be an accredited commercial, central, other academic, or hospital-based IRB. When a U-M study team is not utilizing a U-M IRB for a non-exempt, multi-site human subjects research project, it will be using an external IRB.
A central IRB is an institutional review board that specializes in reviewing a specific type(s) of human subjects research; or is established to review projects funded by a specific agency. For example, the NCI Central IRB reviews projects sponsored by the National Cancer Institute.
An single IRB-of-Record (sIRB) may charge for their services on a cooperative or multi-site, non-exempt human research project. Estimated expenses are calculated on a case-by-case basis and, if allowed by project sponsor, listed as a direct cost in the budget for a funding proposal and award.
Common IRB services include, but are not limited to:
- IRB Reviews
- Initial review of the research protocol, investigator/site qualifications, informed consent plan and documentation, and subject recruitment materials
- Continuing/annual protocol review (regulatory requirement) for subsequent years of the project
- "Periodic" review of any incident reports (e.g., Adverse Events or ORIOs), as they are filed
- Amendments/modifications - changes to the study that require IRB review
- Administrative Services - letters, study changes not requiring IRB review, etc.
- Site/Project Closeout - review of the final status report, resolution of outstanding issues
- Other - services as applicable to the project, e.g., foreign language translation, etc.
Factors that impact the budget for sIRB services include the number of performance sites, level of risk to the participants of the research and/or to the institution, duration of the study, and more. See the External sIRB fee schedule -sample for an example.
Always contact your U-M IRB to determine the best option and requirements for the sIRB prior to submitting funding proposals for cooperative non-exempt human subjects research.
NIH uses the term "multi-site project" to describe a sub-set of cooperative non-exempt human research where the same research procedures (i.e., the “same protocol”) are conducted at two or more U.S. research sites under the control of a participating investigator at each site.
A multi-site project typically involves a lead site (lead PI) that manages the administrative functions of the project in addition to conducting the same research procedures as the participating sites. A multi-site project could be a clinical trial, an observational study, or a basic clinical research study.
A “cooperative” (or “collaborative”) project involves two or more U.S. research sites where each site is conducting a different part of a research protocol under the direction/control of the lead PI. An example would be a non-exempt study where U-M is the lead site and conducting the interaction/intervention with the human participants, but the analsyis of the data is being done by is an external institution/collaborator.
Under NIH and Common Rule sIRB guidelines, both multi-site and cooperative research projects may:
- Require the use of a single IRB for oversight.
- Have a lead site/PI who receives the grant or contract from a sponsor and then establishes a subaward or subcontract to each participating site.
- Require authorization (“reliance”) agreements to establish the contractual terms for IRB oversight and project management.
Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered by the NIH to be the “same research protocol,” even when variations due to local (research site) context exist. Per the NIH sIRB guidelines, non-exempt multi-site studies utilizing the same research protocol at each domestic (U.S) site are subject to sIRB regulations.
~ Definition paraphrased from the University of Washington.