Guidance

SINGLE IRB (sIRB) AND MULTI-SITE RESEARCH (MSR)

Feb 8, 2021 12:45 pm

Updated February 8, 2021

Note:

  • If requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date.  See section “IRBMED as the sIRB (accepting oversight)” of this guidance for additional instruction.
  • If requesting IRBMED to cede oversight to an external IRB, complete an eResearch application “Request Review by non-U-M IRB” (i.e., ceding application) at least 3 weeks prior to the grant application due date.

Multi-site research (MSR) means, in general, that two or more participating sites utilize the same research protocol in the conduct of the research. However, not all participating sites may perform the same functions to support the conduct of the research. 

When the research is expected to follow a single IRB (sIRB) model because they are utilizing the same research protocol, one participating site agrees to be the IRB of record (reviewing IRB) and the other participating sites agree to cede IRB oversight (relying IRBs).  NIH defines protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes as the “same research protocol.” 

Roles and responsibilities of participating sites in multi-site research are defined in this guidance.

  1. Single IRB Policies
  2. IRBMED Accepts IRB Oversight (sIRB)
  3. IRBMED Cedes IRB Oversight to an External IRB
  4. U-M as a Coordinating Center
  5. Downloadable Multi-site Research Job Aids (including MiCORES)
  • I. Federal Single IRB Policies/Regulations

    Since 2018 (NIH policy) and 2020 (HHS regulations) applicable federally-sponsored multisite research projects using the same research protocol are required to utilize a sIRB review model for all participating institutions.  

    NIH Policy, effective January 25, 2018

    • Applies to: Domestic sites of NIH funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts or the NIH Intramural Research Program.  It does not apply to Foreign Sites, career development (K), research training (T) or fellowship awards (F) and noncompeting continuation awards. 
    • Exceptions: VA sites; international sites; sites involving tribal nations.
    • NIH FAQ's on the Single IRB Policy for Multi-Site Research

    Revised Common Rule Regulations, effective January 20, 2020

    • Applies to: All sites in the United States participating in a federally funded multi-site research study following the Common Rule requirements.
    • Exceptions: Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.
  • II. IRBMED Accepts IRB Oversight (sIRB)

    If requesting IRBMED to be the reviewing sIRB, contact IRBMED via MiCORES as soon as possible but at least 8 weeks prior to the grant application due date to seek authorization to commit IRBMED to this effort. 

    Completion of a request form in MiCORES using the Single IRB Review Core (“sIRB Core”) is required. The sIRB Core provides a single location where researchers can request that IRBMED be the sIRB of record for proposed multi-site human research. Initiate a request using the “U-M to be the Single IRB-of-Record” form. During the review of the information provided, the IRBMED will determine if it is appropriate for IRBMED to serve as the sIRB for the proposed project.  Evaluation criteria include:

    • Study design
    • What entity/individual holds any associated IND/IDE

    The number and location of participating sites

    If it is determined that IRBMED will not serve as the sIRB, the research investigators should consider whether another participating site will serve as sIRB or whether an independent IRB should be considered.  As applicable IRBMED will then provide a letter of support to rely on the external IRB for inclusion with the grant proposal.  Commercial IRB options will also be discussed. 

    If agreeing to be sIRB under a federal award, IRBMED will prepare a budget estimate for any applicable direct costs associated with its review of the multi-site components of the research.  Estimates are based on the number of sites and expected complexity of study oversight. 

    Contact irbmedreliance@umich.edu with any questions

    NIH Grant Proposals

    For NIH applicants, the single IRB plan is no longer required at the time of submission but a budget must be provided. However, the grant applicant must provide a statement naming the sIRB of record in the Just-in-Time submission prior to award.  Provide IRBMED the information as indicated above.

    AHRQ Grant Proposals

    For AHRQ applicants, if this is a research project that involves more than one institution and that will be conducted in the United States, a single IRB plan must be prepared unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. The single IRB plan will be developed by IRBMED.  Provide IRBMED the information as indicated above.

    Other Federal Agency Requirements

    Check the specific requirements associated with the grant application. Provide IRBMED the information as indicated above.

    Non-federal Grant/Contract Proposals for IRBMED as sIRB

    IRBMED will evaluate whether it will serve as sIRB on a study-specific basis. Provide IRBMED the information as indicated above.

    Further information for institutions participating in the SMART IRB agreement:

    RES_IRBMED_SMART IRB GUIDANCE COMPANION PIECE.DOCX

    Further information for institutions not participating in the SMART IRB agreement:

    RES_IRBMED_NON-SMART IRB GUIDANCE COMPANION PIECE.DOCX

  • III. IRBMED CEDES OVERSIGHT TO AN EXTERNAL IRB

    Ceding to an Independent (i.e., commercial IRB) under an existing Master Service Agreement. 

    U-M maintains Master Service Agreements with Advarra, Western IRB (WCG or WIRB), Ethical and Independent IRB (E&I), and NCI CIRB.  No advance notification is necessary to initiate ceding of IRB review to these organizations.  Complete the Ceding Application in eResearch.

    U-M research teams must complete the "Request Review by a Non-UM IRB" (Ceding) Application within eResearch to receive an Acknowledgement letter and complete the independent IRBs application.  Study teams must receive the U-M Acknowledgement letter and the independent IRB approval notice before beginning any research related activities.

    Ceding under the SMART IRB Agreement (e.g., ceding to an academic IRB)

    Ceding to an external (academic) IRB under the SMART IRB agreement requires submission of the eResearch ceding application.  Also, provide SMART IRB Letter of Acknowledgement and/or the local context form from the external IRB.  IRBMED will assess the appropriateness of ceding to this IRB for the designated study.  Unless mandated by policy, the IRBMED cannot guarantee its willingness to rely on an external IRB.

    Further information for institutions participating in the SMART IRB agreement:

    RES_IRBMED_SMART IRB GUIDANCE COMPANION PIECE.DOCX

    Ceding under No Prior Agreement

    Submit an eResearch ceding application for IRBMED to consider a request to cede outside of a Master Services Agreement or SMART IRB agreement.  These ceding requests will be assessed on a study-specific basis.

  • IV. U-M AS A COORDINATING CENTER

    A coordinating center is an entity that agrees to be responsible for coordinating administrative and/or collection activities for data, clinical protocols, or biospecimens associated with a multi-site research project.  

    When U-M is the coordinating center, the study team will complete a Multi-Site Research Application type in eResearch.  The IRB Application instructions for Multi-site Research provide specific guidance for completing the application.

    Note: Unless required by federal regulations, if U-M performs only coordinating center activities it does not necessarily require that IRBMED follow a sIRB model and/or provide IRB oversight for all participating sites.

  • V. Downloadable Multi-Site Research Job Aids (including MiCORES)

    Multi-site Research Documents for Study Teams

    MiCORES Learning Site (level 1 login required)

    • Overview of sIRB Core and MiCORES Account Registration:
    • MiCORES learning resources, how to training materials, and more

    Single IRB Review Core – Features and Guidelines (MiCORES)

Tags: Regulatory
Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By:bpsea@umich.edu
Last Updated: February 8, 2021 at 12:30 PM