Guidance

MULTI-SITE RESEARCH (MSR)

Jun 25, 2019 1:45 pm

Multi-site research (MSR) means that multiple participating sites are involved in supporting the conduct of the same research protocol. However, not all participating sites may perform the same functions to support the conduct of the research. Unique roles and responsibilities of participating sites are defined in this guidance.

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 are considered to be the “same research protocol.” 

Key Information:

  • 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 and a letter of support is required, contact IRBMED at least 3 weeks prior to the grant application due date.
  • 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: When 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.

  • Single IRB (sIRB) of Record Information

    Single IRB Policies

    In 2018 NIH policy and in 2020 HHS federal regulations require certain types of federally-funded research projects involving multisite research using the same research protocol to use a sIRB model to accomplish IRB review for all participating institutions.  See below for more detail on the policies and note the effective dates

    The 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.

    Please see the NIH FAQ's on the Single IRB Policy for Multi-Site Research

    The revised Common Rule, effective January 19, 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.

    NIH Grant Proposal Submissions

    See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and (for specific details) Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide. The information presented below is from this resource, but also includes University of Michigan specific information and links to useful resources.

    U-M is a participating site (not the lead site)

    If U-M will be a participating site for a study meeting the requirements of the sIRB Policy, requests for a letter of support to cede IRBMED oversight to an external IRB should be submitted to irbmedreliance@umich.edu at least 3 weeks prior to the external site’s grant submission due date.  The IRBMED cannot guarantee its willingness to rely on an external IRB without sufficient prior notice to evaluate the request.

    U-M is the lead site and IRBMED will serve as sIRB

    Required by NIH
    The NIH sIRB Policy requires the following new information in grant applications for multi-site research submitted after January 25, 2018:

    Human Subjects section

    A sIRB Plan including the following elements (this sIRB Plan is provided by IRBMED when IRBMED has agreed to be the sIRB):

    • IRBMED named as the sIRB of record
    • Indication that: (1) All sites, including any added after award, agree to rely on the sIRB; (2) Sites will sign a reliance agreement that will include a communication plan; (3) IRBMED will maintain records of the reliance agreements

    Budget and Budget Justification

    Any IRB fees that will be charged as direct costs, and any personnel costs directly related to managing the IRB arrangements. See the PHS G.300 – R&R Budget Form for information about where in the budget form to put this information.

    • IRBMED is developing fees that will be announced for inclusion in future grant submissions (anticipated release later in 2019)
  • IRBMED as the sIRB (Accepting Oversight)

    Single IRB Request – Grant Preparation

    Research investigators must contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date to discuss options for IRBMED review of a multi-site study where University of Michigan will either be the lead or participating site.  If it is determined that IRBMED will serve as the sIRB for all sites, IRBMED will provide the Investigator/Study Team with the sIRB plan to include with the grant proposal. 

    Completion of a single IRB request form is required.  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. Contact irbmedreliance@umich.edu with any questions.

    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.  IRBMED will then provide a letter of support to rely on the external IRB for inclusion with the grant proposal.   

    When will IRBMED act as the single IRB?

    During the review of a sIRB request, IRBMED will evaluate whether it is suited to serve as the sIRB for the proposed multi-site project on a case-by-case basis. 

    Evaluation criteria include:

    • The risk level/complexity of study design for the proposed research
    • The number of participating sites
    • The location of the participating sites
    • What entity holds any associated IND/IDE
    • Adequacy of technology platforms to support submission of information across participating sites

    IRBMED reserves the right to decline being the sIRB and will support research investigators to locate an external IRB to serve in that capacity.

  • Working with External IRBs (Ceding Oversight)

    If U-M will be a participating site for a study meeting the requirements of the sIRB Policy, a request for a letter of support must be submitted to irbmedreliance@umich.edu at least 3 weeks prior to the external site’s grant submission due date.  The IRBMED cannot guarantee its willingness to rely on an external IRB that has been selected without prior notice.

    If U-M will be a participating site and the study will be ceded to an independent (commercial) IRB or another academic IRB, see the information below.

    Independent (Commercial) IRBs

    U-M has finalized Master Services Agreements to permit ceding to several independent IRBs:

    • Advarra (formerly Shulman, Chesapeake, Quorum)
    • Western IRB (WIRB)
    • NCI CIRB (CIRB)

    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.

    For more information about working with one of the listed IRBs, click on the U-M Box link in the reference section below.

    Academic IRBs

    U-M does not have any master services agreement with external academic IRBs. These requests will be made on a study-specific basis. IRBMED has signed on to be a participating institution with the SMART IRB agreement and prefers to use that route for agreements if the academic IRB participates in it as well.

  • Templates and Documents

    For downloadable multi-site research templates and documents, follow this link:

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: June 25, 2019 2:30 PM