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Requesting USC IRB to Act as the sIRB

Requesting USC IRB to Act as the sIRB

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The USC IRB will agree to serve as the single IRB (sIRB) when:

 

  • USC is the prime awardee of federal funding, and the research is multi-site or cooperative research
  • The study is not determined to be exempt
  • The study has no more than 4 non-USC Relying Sites located in the United States.
  • USC holds the IND on an investigator-initiated FDA regulated study. This will be agreed upon on a case-by-case basis since the FDA does not require a single IRB.

The USC IRB may NOT agree to serve as the sIRB when:

  • There are more than 4 non-USC sites involved in the research.
  • The external sites are international sites. International sites should obtain their own IRB approval.
  • The study is determined to be exempt. External sites should submit the study to their IRB for an exempt determination.
  • The study is a biomedical study that primarily enrolls minors or is a medical device study due to limited USC IRB resources.

NOTE: Single IRB does not apply to international sites. International sites should obtain their own IRB approval.

The Principal Investigator (PI) must contact the USC IRB Reliance Team at reliance@usc.edu and request confirmation that the USC IRB is able to serve as the single IRB of record BEFORE submitting the grant application to the funding agency and submitting the study to the USC IRB. The USC IRB prefers to use the SMART IRB agreement as the reliance agreement and will consider the use of an alternate reliance agreement on a case-by-case basis only when the SMART IRB agreement cannot be used.

A USC PI who agrees to become the Overall PI for multiple sites is responsible for the protection of human subjects for all Relying Sites in the study. Critical evaluation should take place to assure that the necessary resources and infrastructure are in place to support and lead a multi-site research project. Considerations include the management and collection of all regulatory information needed by funders/sponsors and/or regulatory bodies such as the FDA and a communication plan necessary to disseminate and receive all study-related matters between all sites.  

The USC Overall PI/Lead Study Team should review the following documents to understand the sIRB process and their responsibilities:

You must submit the study to the USC IRB via iStar for initial review and approval. See the Getting Started page on the HRPP website for more information. The submission should include the protocol, consent forms, recruitment documents, and any other study materials needed for USC IRB review (e.g., data collection sheets, questionnaires, drug package inserts/investigator’s brochure, device information, etc.).

NOTE: Participating sites should only be listed in the protocol and should NOT be added to the initial iStar study application. Once the study is approved, each participating site should be added via an individual amendment.

How do I name study documents?

All documents submitted to the USC IRB should be named as follows so the documents can be easily identified for each site.

Document Type_Version Date_Site Name
(for example: Protocol_MM/DD/YYYY_USC or ICF_MM/DD/YYYY_USC/Site Name)

After the initial study approval, the USC IRB will provide the Overall PI/Lead Study Team the reliance documents needed to add Relying Sites. If applicable, the USC IRB will also provide the USC Part 1 Main Informed Consent Template and USC Part 2 Site-Specific Information Template, Recruitment Template documents for revision by Relying Sites.

The USC IRB uses the SMART IRB platform to establish the reliance agreement with the Relying Site. Any exceptions to using SMART IRB must be discussed with the USC IRB reliance team. You will need to create the reliance agreement on the SMART IRB platform. The Relying Site must be a participant of the SMART IRB agreement so they can be added to the reliance request. Click here to see the SMART IRB website for more information on how to join and here on how to create a SMART IRB account and the reliance request.

The Relying Site should follow their institution’s procedures for relying on another IRB. Their IRB will need to conduct a review to ensure that all local requirements have been met. This is called a local context review. The Relying Site should contact their HRPP or IRB office for more information.

The USC Overall PI/ Lead Study Team should provide the Relying Site with the following documents for their local context review:

  • The USC IRB approval letter
  • The USC IRB approved protocol
  • The USC IRB approved consent template form (if applicable)
  • The USC IRB reliance documents for the relying site to complete
  • Any other reliance documents required by the USC IRB

The Overall PI/Lead Study Team will submit an amendment via iStar to add a Relying Site. Only one site should be added per amendment. The Overall PI/Lead Study Team will collect all necessary documents from the Relying Site for USC IRB review.

The amendment should include the following documents:

  • Completed USC Overall PI Communication Plan (only submit once)
  • Completed and signed USC IRB Local Context Form and IRB Implementation Checklist for the Relying Site
  • Relying Site’s local context edits to the Part 2 Site-Specific Consent Information Template and recruitment materials, if applicable
  • Relying Site’s HIPAA Authorization form, if it will be separate from the informed consent form
  • The SMART IRB Determination Letter or USC IRB Authorization Agreement signed by the Relying Site
  • Ancillary Committee approvals from the Relying Site (e.g., radiation safety review, review for research with bio-specimens, drug safety review, contracts, etc.), if applicable
  • Conflict Management Plan for Relying Site study team personnel. if applicable
  • Any other documentation from the Relying Site’s local IRB (e.g., ceded acknowledgment letter)

When a Relying Site is approved, the USC IRB will issue the following documents to the USC Overall Principal Investigator. These documents must be provided to the Relying Site for use.

  • Approval Letter for the Relying Site
  • Approved site-specific informed consent(s) and recruitment materials, as applicable
  • Any other IRB-approved documents
  • Fully signed IRB Authorization Agreement (IAA) when SMART IRB is not used for the reliance agreement