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Reliance Agreements

Reliance Agreement: Also known as an Institutional Review Board (IRB) Authorization Agreement (IAA). A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in human subjects research to delegate IRB review to an independent IRB or an IRB of another institution. Institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.

 Single IRB (sIRB): An IRB that oversees all sites participating in a multiple site (multisite) study.

Multi-site study/Cooperative research: A multi-site study uses the same protocol to conduct non-exempt human subjects research at more than one site. All sites will conduct study activities under the same research protocol.

Participating Site: A domestic entity that will rely on the sIRB to carry out the site’s IRB review of human subjects research for the multi-site study.

SMART IRB Reliance Agreement: The SMART IRB master reliance agreement was launched in 2016 to streamline the IRB review process for multi-site studies and eliminate the time and effort of negotiating IRB authorization agreements for each new study. It facilitates reliance for each study and defines the roles and responsibilities of institutions, IRBs, and study teams. About 800 institutions, including USC, have signed onto this agreement, and are actively using it as the reliance agreement for multi-site projects.  For a list of SMART IRB participating institutions click  https://smartirb.org/participating-institutions/

Policies and Requirements

Effective January 20, 2020, any institution located in the United States that is engaged in multi-site/cooperative research must rely upon approval by a single IRB (sIRB) for that portion of the research that is conducted in the United States.

NOTE: Studies that are cooperative in nature and were approved prior to January 20, 2020 (other than NIH funded projects) are not affected by the sIRB mandate and will continue to be governed by the “pre-2018” human subjects research regulations.

The single IRB (sIRB) mandate is an NIH policy effective January 25, 2018, that requires certain types of NIH-supported studies involving multiple sites where each site will conduct the same protocol involving non-exempt human subjects research to use a single IRB to accomplish IRB review and approval for all domestic participating sites. Single IRB is not required for international sites.

For more information: NIH Policy on the Use of a Single IRB (sIRB)

*Exceptions to single IRB regulations:

  • Research for which any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the context
  • Research that is governed by state or local laws or
    regulations (including tribal law passed by the official
    governing body of an American Indian or Alaska Native tribe).

Reliance Agreements

SMART IRB

USC is a participating institution in the SMART IRB master reliance agreement. USC uses the SMART IRB agreement as the basis of reliance for all studies where we serve as the sIRB. USC prefers to use the SMART IRB to rely on an external IRB. Any exceptions to using SMART IRB for the reliance agreement must be discussed with and approved by the USC IRB Reliance Team.

Below are the steps to create the reliance agreement on the SMART IRB platform: 

  1. Create a SMART IRB account by clicking “Request Investigator Access” link at https://smartirb.org/reliance/. Once the USC IRB Reliance Team receives the account request, they will activate your account. An email notification will be sent to you when your account is activated.
  2. Once your account is activated, log in to the SMART IRB website at https://smartirb.org/reliance/ and create the reliance request for the study. Review the SMART IRB Reliance Checklist before creating the reliance request. Guides and tutorials on how to create the reliance request are also available on this website at  https://smartirb.org/study-teams/.
  3. Enter the study details and the Relying Site(s) information. This includes the site PI information, site study activities, and uploading the USC IRB approved protocol and consent (if applicable). NOTE: The title of the reliance request should include the USC IRB number (HS-XX-XXXX/UP-XX-XXXX) AND have the same study title listed in iStar. The USC IRB Reliance Team will verify the information in the reliance request with the information in the iStar study application.
  4. The USC IRB Reliance Team will review the reliance agreement request and will move the reliance agreement forward to be completed by the Relying Site(s) or send it back for changes, if needed.
  5. It is recommended that the Relying Site Study Team contact their IRB to notify them of the reliance request. The Relying Site’s SMART IRB point of contact will receive the notification from SMART IRB to access the online system and enter their reliance decision. NOTE: Each Relying Site Study Team will also need to follow their institutional processes for relying on an external IRB.
  6. Once the Relying Site agrees to rely on the USC IRB, the USC IRB will complete the reliance agreement in the SMART IRB online system. If multiple sites are involved, a reliance determination may be made for all of the sites or an individual site, if needed.
  7. Once the reliance agreements have been completed for each site, the Overall PI will be emailed the determination letter for the reliance agreement. The determination letter should be uploaded to the iStar application.

NOTES:

  • The reliance agreement must be completed before the Relying Site is approved.
  • If LAC+USC Medical Center is a participating site and a letter of indemnification is requested from the reviewing IRB, they should remove the indemnification provision since the Los Angeles County Department of Health Services will not sign the letter.

Master Agreements

USC has executed broad reliance agreements with central IRBs and consortium groups. If you believe your study may fall under the scope of an existing master reliance agreement, or if you are interested in entering into a master reliance agreement with USC, please contact the IRB Reliance Team at reliance@usc.edu.

The USC IRB will review requests to serve as a sIRB as well as requests to rely on an external IRB. Typically, requests for reliance are submitted to our IRB at two time points:

  1. When studies are in the planning stages (e.g., grant submission)
  2. When studies are ready to be submitted for IRB review

The first step in the reliance agreement process is to complete a study application in iStar. The type of study application will depend on whether the USC IRB is serving as the sIRB or relying on an external IRB.

USC IRB Serving as the sIRB

All new NIH or other federally funded grant applications for non-exempt multisite research that require a plan for use of a single IRB.  For more information…

USC Relying on an External IRB

The USC IRB will be asked to rely on an external IRB for non-exempt research. For more information…