USC Reliance on an External IRB Review Process

USC may rely on an external IRB that is currently registered with OHRP/FDA for review and approval of nonexempt human research if such reliance is a requirement of the research, or if it benefits USC, its investigators and/or its research participants.

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

Plan ahead. When submitting an external reliance request, be ready to provide the following materials:

• Documentation that the protocol has been reviewed and approved by the external IRB, (i.e. 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 sIRB (as applicable)
• HIPAA authorization

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 sIRB and by an 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 on the sIRB.

Please be aware that reliance agreements can take a while to complete due to the complexity and institutional officials involved. Platforms such as Smart IRB, have assisted in reducing the amount of time these agreements take but it is best to begin this process early.

3. Once the Reliance arrangement has been solidified and the local context concerns have been met, the IRB administrator will issue an acknowledgment, pending activation in the eIRB system. The study will move into the state of Reliance Acknowledged, Pending Activation. The study team will be issued an Initial Concurrence Letter from the IRB that all local context concerns have been met and the reliance agreement is complete. This letter authorizes the USC study team to submit the USC site to the main IRB to add USC as site.  Once approval of USC is gained from the Reviewing IRB, the documentation of this addition should be uploaded into the USC eIRB system along with the final approved versions of the consent and HIPAA.

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. You are still responsible for obtaining IRB approval from the external IRB and cannot begin research until approval is granted.

4. Once the USC study team receives documentation from the Central IRB that USC has been added as a site, this documentation will need to be uploaded into eIRB and sent back to the USC for review and acknowledgement. The USC IRB will then issue a final acknowledgment letter and the study will enter the final state of Acknowledged and the study team can begin enrolling.

5. Stamping: The IRB of record is responsible for providing the approval stamp for of all documents approved by that IRB.

Expiration Date: 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, there are still some things you are required to continue to submit to the USC IRB. Please submit amendments and/or updates to eIRB for the following:

• internal Study Personnel Changes to the USC IRB for administrative approval
• Changes which require revision to the HIPAA authorization
• Amendments when the reviewing IRB has approved a change to recruitment or study procedures that appreciably alters:
  • The inclusion of participants or changes to the study requiring special routing to:
    • Conflict of Interest Committee
    • Protocol Review Committee
    • Radiation Safety Committee
    • Institutional Biosafety Committee
    • Other ancillary committees that require re-review
  • The recruitment activities that were described in the initial application that require compliance with USC HRPP policies:
    • Students, trainees, and employees;
    • Persons with impaired decision-making capacity;
    • Non-English speaking subjects;
    • Children as subjects;
    • Prisoners as subjects.
  • Status Update
  • Closure Report after the IRB of record closes the study

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.  Identify an IRB  and ensure that the chosen IRB is willing and able to serve as the Reviewing IRB for the research (i.e., obtain a letter of support from the IRB identified as the Reviewing IRB for the cooperative research project). The Reviewing  IRB  may be USC IRB or an external IRB (either an accredited commercial or other academic IRB).  
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. Work with the Reviewing IRB and the Relying IRB to request an IRB Authorization Agreement (a.k.a. "reliance agreement"). This is the legal contract negotiated between the IRBs. No one on the study team has the authority to negotiate or sign the IRB Authorization Agreement.

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