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The NIH sIRB policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
- Domestic research only
- Non-exempt research only
The Common Rule sIRB policy applies to:
- Multi-site non-exempt studies
- Domestic research only
Cooperative research where:
- International site(s) participate
- Individual IRB review is required by law (e.g., American Indian 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
Effective as of January 20, 2020 - the single IRB-of-Record (sIRB) review requirement for all cooperative research projects sponsored by one of the federal Common Rule agencies.
Federally-funded cooperative (i.e., multi-site) human subjects research studies are required per the Common Rule (45 CFR 46.114) to utilize a single IRB-of-Record (sIRB) to streamline the human subject/participant protections review process and 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 an accredited commercial IRB is contracted to provide the oversight functions for the project. This legal contract documents the respective authorities, 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 signed by U-M's HRPP Director.
- 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 (see Study Team Process below).
Study teams - Always contact the applicable U-M IRB to discuss the sIRB options before you begin a funding application for a multi-site study involving human subjects research!
The U-M IRBs require lead time to evaluate whether U-M can serve as the sIRB (see criteria below).
If requesting a U-M IRB to the single IRB-of-Record, contact the IRB at least 8 (eight) weeks prior to the grant application submission date.
If requesting U-M to cede IRB oversight to an external IRB, contact the IRB at least 3 (three) weeks prior to the grant application submission date.
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)
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.
For NIH-funded multi-site research, the study team must designate the sIRB as part of the grant application at the time of proposal submission. IRB fees (if any) should be budgeted as direct costs on the proposal/award budget. (See the PHS G.300 - R&R Budget Form guide for details.)
For research sponsored by other federal agencies, the lead institution may propose the sIRB, but the funding agency officially will designate which institution will act as the sIRB.
Reminder: Contact a U-M IRB several weeks prior to the proposal submission date to determine whether IRBMED or IRB-HSBS can act as the sIRB for the project or whether U-M will rely on another IRB for oversight.
When U-M is the sIRB
The IRB process (e.g., IRB application type used) to establish projects where U-M will act as the sIRB vary depending on whether U-M will be a coordinating center (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.
- For IRBMED, see the Multi-Site Research (MSR) guidance for instructions
- For IRB-HSBS, contact Mary Donnelly, Single IRB Coordinator (email@example.com) for assistance
- 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 ceding to an external IRB
When ceding to an external IRB (whether commercial or other institutional partner), the U-M study team:
- Indicates the selected external IRB in the PAF/CTRF in the eResearch Proposal Management (eRPM) system.
- Contacts the external IRB to determine the IRB review fees for incorporation into the proposal budget. Commercial IRBs post their rates on their websites. Some academic IRBs may also charge a fee.
- Works with the external IRB and the applicable U-M IRB to request an IRB Authorization Agreement.
- No one on the study team (or at the U-M IRB) has the authority to negotiate or sign the IRB Authorization Agreement.
- Completes 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 Requesting Review by a Non-UM IRB (a.k.a. "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 contex 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.
U-M has master service agreements with two commercial IRBs:
All U-M units can utilize either of these external IRBs as the sIRB for the review of multi-site projects involving human subjects research.
In addition, Michigan Medicine has negotiated service agreements for U-M Medical School unit use of NCI CIRB (CIRB).
Master service agreements establish the terms and conditions for the IRB review, including the fees charged (if any) for the initial review, continuing review, and the review of AEs/ORIOs. When any of the U-M approved external IRBs are utilized as the sIRB, an individual Authorization Agreement may not be needed.
Reminder: Fees (if any) for external sIRB review should be budgeted as a direct cost on the proposal/award budget.
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 external (i.e., commercial or other academic) IRB may charge for services when designated as the single IRB-of-Record (sIRB) for a multi-site, non-exempt human subjects research project. Estimated expenses are negotiated on a case-by-case basis in the service agreement between U-M and the external IRB, and budgeted for as direct costs in the sponsor's (e.g., NIH) 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 subjects and/or institution, duration of the study, and more. See the External sIRB fee schedule -sample for an example.
The principal investigator is not authorized to sign the negotiated service agreement with the external IRB. As a financial transaction, the agreement must be signed by an authorized official from U-M Procurement Services and may require approval from the U-M Regents.
Always contact your U-M IRB to determine sIRB requirements prior to submitting funding proposals for multi-site, non-exempt human subjects research.