IRB Reliance Requests

Reliance is the process of using a single IRB for review of multiple sites or investigators at multiple institutions.

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.

The Two Policies

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.

  • Details:  The Revised Common Rule’s Cooperative Research Provision

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.

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 at two time points:

  1. When studies are in their planning stages, e.g. you are preparing a grant submission or have just been awarded grant funds but are not yet ready to submit your protocol for IRB review
  2. When studies are ready to be submitted for IRB review

In both of these scenarios, the first step in the reliance process is to complete a reliance intake form. The MUSC IRB reliance manager will review the information provided in the reliance request and will contact you with the next steps.

Relying or Reviewing?

Which type of study are you trying to submit? Select the link below for additional information and instructions.


For information on fees charged for studies where MUSC relies on an external IRB or when MUSC serves as the IRB of record, please view the IRB submission information.

Still Have Questions?

For more information, please see the single IRB frequently asked questions (FAQs).

Please contact the IRB Reliance Manager for questions about IRB reliance, including:

  • When reliance on external IRBs is allowable
  • How to request reliance on external IRBs
  • Relationships with external IRBs
  • Requesting MUSC IRB approval for non-affiliated investigators
  • NIH single IRB policy

Contact Us

Monica Baczko Pearl
IRB Reliance Manager

Maggi Lejeune
IRB Reliance Administrator

Related Links

Smart IRB

Click to visit the SPARCRequest website.