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).

  • 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 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.

  • Exceptions to the Requirement:  VA sites; international sites; or sites involving tribal nations. Details:  NIH Single IRB Policy for Multi-site Research

  • Details: NIH Single IRB Policy for Multi-site Research

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.

Fees

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

Summer Young, JD, MPH, CIP
IRB Reliance Manager

youngsn@musc.edu
843-792-4144

Related Links

Smart IRB

Click to visit the SPARCRequest website.