IRB Reliance Requests

Reliance is the process of using a single IRB for review of multiple sites or investigators at multiple institutions. One IRB agrees to oversee a research study on behalf of another institution.

Why does IRB Reliance Exist?

Using a single IRB cuts down on duplicate reviews for the same study, creates consistency in how participant protections are reviewed, and can speed up study startup by requiring less paperwork and fewer reviews.

Key Terms:

• Reviewing IRB: The institution that is responsible for overseeing a multi-site study, particularly when there is a reliance agreement between different institutions.
  • also known as the Single IRB, Lead IRB, IRB of Record, Central IRB
• Relying Site: The institution that chooses to have another IRB (the Reviewing IRB) oversee their research.
  • also known as the Relying IRB, Remote Site, Ceding IRB
• Reliance Agreement: The written document between institutions that indicates how one IRB will rely on another for the review and oversight of a research study.

The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all participating sites.

1. The Common Rule’s Cooperative Research Provision

• Effective Date: January 20, 2020
• Applies to: Federally funded cooperative research projects receiving initial IRB approval on or after January 20, 2020. That is, studies that involve more than one institution conducting research with human subjects (regardless if each institution is not carrying out the same human subject research activities).
• An example would be a non- exempt study where MUSC is the lead site and conducting the interaction/intervention with the human participants, but the analysis of the data is being done by an external institution/collaborator.
• Reviewing IRB: Will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution (subject to the acceptance of the Federal department or agency supporting the research).
• Exceptions to the Requirement: International sites; sites involving tribal nations; or studies that received initial IRB approval prior to January 20, 2020.
  
  

2. The NIH Single IRB Policy for Multi-Site Research

• Effective Date: January 25, 2018
• Applies to: NIH multi-site funded studies in which the sites are all using the same research protocol to conduct the same human subject research activities at each site. These will typically be clinical trials, but can include observational studies.
  • A multi-site NIH 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
• Exceptions to the Requirement: VA Sites; international sites; or sites involving tribal nations.
• Details: NIH Single IRB Policy for Multi-Site Research

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.

MUSC is willing to review requests for reliance on an external IRB as well as requests for MUSC to act as the IRB of record.

Typically, requests for reliance are submitted to our IRB when studies are in their planning stages (i.e. when a grant submission is being prepared or grant funds have just been awarded) or when studies are ready to be submitted for IRB review.

There are two important steps in the reliance process:

1. Determine whether MUSC or the external institutions/collaborators are considered “engaged” in human subjects research.

• If you are unsure if any of the collaborators are engaged in the research, please review the guidelines regarding Engagement of Institutions in Human Subjects Research.

• We have also created a helpful checklist to quickly determine if MUSC or the external institution is considered engaged.

Engagement Checklist

Please note: The final decision on engagement will be made by the IRB

2. Complete the Reliance Intake Form. Once submitted, the MUSC IRB Reliance Manager will review the information provided in the reliance request and will contact you with the next steps.

Reliance Intake Form