Institutional Review Board

SINGLE IRB & RELIANCE

Both the Office of Research Protections (OHRP) and the Food and Drug Administration (FDA) permit an IRB to rely on the review of another IRB. The two institutions enter into an agreement referred to as an IRB Reliance Agreement. These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties.  The NIH, study consortia and some funding agencies have increasingly encouraged the designation of central or single IRBs (sIRB) to serve as the Reviewing IRB for all participating sites in multicenter research studies.

LSUHSC-NO IRB is willing to serve both as the Relying Institution with another IRB as the Lead or as the Lead (Reviewing) IRB with other relying institutions. 

Note that exempt studies are not eligible for reliance. 

LSUHSC-NO IRB as the Relying IRB (External Reliance)

Where appropriate, LSUHSC-affiliated investigators may request the services of an external IRB for ethical review and oversight of research. Reliance may be appropriate for several reasons including:
 

 

External Reliance Agreements

 

How to Submit an External Reliance Request

  1. Log into Kuali.
     
  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. The reliance decision will be communicated through the Kuali platform.
     
  4. Key considerations:
    • The LSUHSC-NO IRB will serve as the Privacy Board for reliance studies. Please use the Standard LSUHSC-NO 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 LSUHSC-NO 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 or attached to the front of the ICF approved by the Reviewing IRB when consenting participants locally. Please ensure the ICF Cover Letter is uploaded and approved by the Reviewing IRB.

 

Reliance Determination

If the LSUHSC-NO IRB agrees to rely on the proposed reviewing IRB, submit the study and all relevant documents to the Reviewing IRB. Study activities may not begin locally until all of the following conditions have been met:

      1. The Reviewing IRB has approved the local PI/site.
      2. The local PI/site approval letter, along with all locally applicable approved documents, has been uploaded in Kuali.
      3. LSUHSC-NO IRB has provided acknowledgment of IRB of Record approval and all applicable documents.

 

If the LSUHSC-NO IRB does NOT agree to rely on the proposed reviewing IRB, it should be submitted directly to the LSUHSC-NO IRB for review if researchers still want to undertake the study. Instructions for submitting protocols in Kuali are available in Kuali Quickguides. Approval and maintenance of the study will follow standard LSUHSC-NO IRB policies and procedures.
 

LSUHSC-NO IRB as the Reviewing IRB

When requested to serve as the Reviewing IRB for a multi-center study, the LSUHSC-NO IRB prefers to establish reliance under the SMART IRB  or IREx Reliance Agreement platforms using either the SMART IRB or IRB Reliance Exchange (IREx). LSUHSC-NO and many other institutions are already signatories to the SMART IRB Reliance Agreement and its use obviates the need for establishing study-specific reliance agreements with each Relying Institution.  In the case where other institutions are not signatories to SMART or IREx, an Interinstitutional Agreement (IAA) may be utilized. 

 

Reliance Options when LSUHSC-NO is the Lead IRB 

In general, the LSUHSC-NO PI will first submit their study to the LSUHSC-NO IRB in Kuali. The protocol should be submitted with the proposed risk categorization and information about the proposed relying sites included in the submission.  Typically the LSUHSC-NO IRB must grant approval of the protocol before another institution will agree to cede oversight. If sites other than the original proposed relying sites are to be be included later, this can be accomplished with an amendment. 

1. Submit:

    1. the appropriate initial protocol (either Expedited or Full-Board) through Kuali for LSUHSC-NO IRB review and approval, making sure to answer the questions related to relying sites, or
    2. a modification to the approved protocol to request addition of one or more relying sites using the Amend function.

2. Once approved in Kuali, a member of the study team will need to log in submit the request for reliance and upload all approved documents. 

 

3. After the request has been submitted, a member of the LSUHSC-NO IRB staff will confirm all information is correct and that LSUHSC-NO is willing to act as the reviewing IRB.
 

4. After the sites agree to rely, a notification will be generated in IREx or SMART IRB.
 

5. Each time a change is made to the study or a renewal is approved, the research team is responsible for updating  the study accordingly.

  1. Submit:
    1. the appropriate initial protocol (either Expedited or Full-Board) through Kuali for IRB review and approval, making sure to answer the questions related to relying sites, or
    2. a modification to the approved protocol to request addition of one or more relying sites using the Amend function.
       
  2. Send the Single Study IAA and the Local Context Survey form to the PI at the Relying Institution for completion and processing.
     
  3. Submit the partially-executed IAA to the IRB Office for final signature by the LSUHSC-NO IRB Institutional Official (IO). A copy of the fully-executed document will be returned to researchers to upload in Kuali.
     
  4. The reliance determination will be communicated to researchers through the Kuali platform.

Post-Approval Requirements

 

Applicable Forms & Templates:

Resources