REQUEST TO RELY ON AN EXTERNAL IRB

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When is Reliance Appropriate?

• Request or requirement by the sponsor or funding agenc
• Study is part of an existing network, consortium, or agency which encourages or mandates single IRB revie
• Proposed external IRB has already reviewed the study or a similar stud
• IRB expertise concerns (e.g., special subject population, untypical research design, sensitive topics
• Efficiency considerations, especially for collaborative researc
• Feedback or request from Institutional Official, HRPP staff, IRB, etc
• Conflict of interest concerns (e.g., institutional conflict of interest)

HRPP Authority

HRPP reserves the right to deny the request for reliance. HRPP may do so if, among other reasons, it determines that the external IRB does not have sufficient qualifications or expertise, or that the protocol involves procedures or conditions that require specific knowledge of local context.

HSC allows the use of commercial IRBs (WIRB and Advarra) under specific conditions. HRPP will make the final determination as to whether a protocol is eligible for commercial IRB review, or if it must be submitted for local review by the HSC IRB. WIRB and Advarra will not review research on behalf of HSC without prior notification from the HSC HRPP that the study has been cleared for their oversight.

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Reliance Agreements

An IRB Authorization Agreement (IAA) or Reliance Agreement between the HSC HRPP and the institution of the External (Reviewing) IRB, delineating the responsibilities of the respective institutions, must be executed before the HRPP will approve reliance.

• HSC has executed master reliance agreements with the following IRBs. Under these agreements, all HSC investigators may request reliance on these IRBs for applicable studies.
  
  • National Cancer Institute Central IRB (NCI CIRB)
  • Prevention & Early Treatment of Acute Lung Injury Network Central IRB (PETAL cIRB)
  • WCG IRB (WIRB)
  • Advarra IRB

• If the Reviewing IRB intends to use either the SMART IRB or IRB Reliance Exchange communication platforms then the request for reliance may be approved under the SMART IRB reliance agreement, to which HSC is a signatory.

• HSC will enter into reliance agreements with other institutions on a case-by-case and study-by-study basis. In this situation, please attach the draft reliance agreement provided by the Reviewing IRB when submitting a Reliance Request application (see below).

Local Context Information

In addition to an executed reliance agreement, Reviewing IRBs often, but not always, require information about the Relying Institution, its IRB(s), and any local laws, regulations, or cultural issues that may impact the conduct of the study. This information is captured most commonly in a Local Context Questionnaire/Survey (LCQ/S) which the investigator at the Relying Institution is asked to complete and a Relying IRB administrator must sign.  

To assist the investigator in completing the LCQ/S, the IRB Office has compiled some of the most commonly requested information in the following document: LSUHSC Local Context Questionnaire Information. With this document as reference, investigators should complete the LCQ/S as fully as possible and attach it as part of the Reliance Request application

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How to Submit a Reliance Request

1. Log into Kuali Research (KR).
    
2. Under Protocol Type, select Reliance Request. Complete and submit the resulting form following instructions in the document HRP-2811: Reliance Request which is available on the Kuali Quickguides Webpage.
    
3. IRB Office staff will notify you of the reliance decision through the KR platform.
    
4. Key considerations:
   
   • The HSC HRPP will serve as the Privacy Board for reliance studies. Please use the Standard HSC HIPAA Authorization Form for the reliance study unless the Reviewing IRB has granted a waiver of HIPAA authorization. Please submit a completed HIPAA form when requesting reliance.
     
     
   • Use of the HSC consent form for reliance studies is optional. The consent document(s) approved by the Reviewing IRB may be used as long as the relevant information in the LSUHSC ICF Cover Letter Template is incorporated in the final consent document. Alternatively, the cover letter may be attached to the front of the ICF approved by the Reviewing IRB for consenting participants locally. Please submit a completed ICF Cover Letter when requesting reliance, and also to the Reviewing IRB.

Reliance Determination

1. If reliance is NOT APPROVED, submit the study to the HSC IRB for review. Instructions for submitting protocols in KR are available in Kuali Quickguides. Approval and maintenance of the study will follow standard HSC IRB policies and procedures.
    
2. If reliance IS APPROVED, submit the study and all relevant documents to the Reviewing IRB according to its procedures. The study may be initiated once the Reviewing IRB has approved the study and confirmation has been provided to the HSC HRPP.

Post-Approval Requirements

• Submit all relevant requests and information (e.g., request for research modification, continuing approval, study closure, reportable events, etc.) to the Reviewing IRB according to its procedures, AND
• Submit applicable information within 30 days to the HSC HRPP following the instructions provided in Kuali Quickguides for the specific type of post-approval action. The local study team can move forward with implementaiton of the approved changes prior to LSUHSC acknowledgment.  

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Additional Guidance & Resources

• Using the NCI CIRB
• Using the SMART IRB Platform
• Using the IRB Reliance Exchange (IREx) Platform
• LSUHSC Local Context Questionnaire Information

Applicable Forms & Templates:

• LSUHSC ICF Cover Letter Template 
• HIPAA Authorization Form