USC Reliance on an External IRB Review Process

1. Once you have received confirmation of USC’s willingness to enter a reliance arrangement, you should submit an eIRB application and choose the External IRB Review on the IRB Review Request page.

Plan ahead. When submitting an External IRB Review request, be ready to provide the following materials:

• External IRB approval letter
• IRB-approved protocol
• Documents provided by the External IRB for completion by the USC IRB (e.g., local context sheet, reliance agreement template, determination form, etc.)
• Consent form template approved by the External IRB (if applicable)
• HIPAA authorization (if applicable)

The USC IRB will complete an administrative review of the application for local context concerns and completeness. The USC IRB administrator will review the materials to ensure the following:

• The research is appropriate for submission to an External IRB and the PI meets the USC requirements to serve as PI on a research project.
• The application is complete and includes all required External IRB documents.
• The PI, co-investigators and key personnel have completed the required CITI human subjects training.
• All applicable ancillary review committees have completed and signed off on their reviews of the study.
• The Local Context form (if applicable) is complete, and all required local context language is included in the consent form.

2. When reliance is accepted, federal regulations require the relationship to be documented by a written agreement called a reliance agreement.

The IRB Manager will facilitate completion of the reliance agreement.  Investigators are not authorized to sign reliance agreements.  Each agreement must be signed by the  appropriate institutional official for each site.  Most institutions that have an IRB office will have an established process by which the site PI can formally request reliance.

Please be aware that reliance agreements can take a while to complete due to the complexity and institutional officials involved. 

3. Once the Reliance arrangement has been executed and the local context concerns have been met, the IRB administrator will return the study application pending activation in the eIRB system. The study team will be informed that all local context concerns have been met and the reliance agreement is complete. This authorizes the USC study team to submit the USC site to the External IRB as site.

Acknowledgement of a reliance request by the USC IRB is simply confirmation that reliance on the External IRB is appropriate. It is not an IRB approval. The study team is still responsible for obtaining USC IRB approval and cannot begin research until approval is granted.

4. Once the USC study team receives documentation from the External IRB that USC has been added as a site, this documentation along with the final approved versions of the consent and HIPAA should be uploaded into eIRB and returned to the USC IRB for review and acknowledgement/approval. The USC IRB will then issue a final acknowledgment/approval letter and the study team can begin enrolling.
5.  The IRB of record is responsible for providing the approval stamp for all documents approved by that IRB.

The USC IRB’s expiration date will be set to match the External IRB’s expiration date.

6. Once the USC IRB has acknowledged your request for reliance and the External IRB has approved your study, you are required to submit amendments, status updates and study closures to the USC IRB.

USC as the Single IRB Review Process

When preparing submissions for funding from NIH or one of the Common Rule Agencies, the following steps will help ensure a smooth IRB review process when USC is the prime awardee of funding:

1. Designate the single IRB of Record as part of the grant or contract application. Ensure that the USC IRB is willing and able to serve as the Reviewing IRB for the research (i.e., obtain a letter of support from the USC IRB as the Reviewing IRB for the cooperative research project).
   
   
2. Budget Accordingly. Assess any costs associated with using the single IRB, such as fees for USC or commercial IRB to serve as the single IRB. As per NOT-OD-16-109, primary activities should be charged as indirect costs if those activities are included in an organization’s Federally-approved indirect cost rate agreement. Secondary activities may be charged as direct costs, with appropriate budget justification.
   
   
3. The IRB Reliance Exchange (IREx) is a web-based portal designed to support single IRB review processes and dissemination of study documents. The University of South Carolina is a participating institution of IREx and this method should be utilized to complete many study related processes with Relying sites. 

Costs of Single IRB Review

Service Provided	USC IRB Fee
Initial Review (Full Board or Expedited Review)	$0 for USC site $1,500 per site for the external sites
Continuing Review (Full Board Review)	$0 for USC site $1,000 per site for external sites