SINGLE IRB & RELIANCE


Both OHRP and the FDA permit an IRB the option to rely on the review of another IRB. When this is the intention, the two institutions enter into an agreement referred to variously as either an IRB Authorization Agreement (IAA) or 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 agreements can be for a single research study (i.e., Study-Specific IAA) or for multiple studies (Master IAA). The NIH, study consortia and some funding agencies have increasingly encouraged the designation of central or single IRB (sIRB) to serve as the Reviewing IRB for all participating sites in multicenter research studies.

The LSUHSC-NO (HSC) IRB is willing to serve as the Reviewing IRB (alternatively referred to as the Lead IRB or IRB of Record) for one or more Relying Sites. In this case, HSC will enter only into a study-specific Reliance Agreement. Conversely, HSC is willing to serve as the Relying Institution and enter into a Reliance Agreement to assign another IRB as the Reviewing IRB for multi-center research. In this case, the Reliance Agreement can be a Master IAA that applies to all human subjects research involving two or more sites, or it can apply to a single study. Increasingly, funding agencies and federal regulations are requiring a sIRB for multi-center research.
 

HSC is the Relying Institution

Please visit the Reliance Request page for more information about existing reliance arrangements and how to request reliance on an external IRB for applicable research studies.
 

HSC IRB is the Reviewing IRB

When requested to serve as the Reviewing IRB for a multi-center study, the HSC IRB prefers to establish reliance under the SMART IRB Reliance Agreement and using either the SMART IRB or IRB Reliance Exchange (IREx) communication platforms. HSC 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, although such an approach may be necessary in extenuating circumstances.

Reliance Options

The following options, in order of preference, are available to the investigator.

In general, the HSC PI will first submit his/her study to the HSC IRB in Kuali. Usually, the Reviewing IRB must grant approval of the protocol before another institution will agree to cede oversight. Other sites can then be added with an amendment. There are, however, exceptions where this can occur with initial approval of the study at HSC.

    Using IREx

  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. Once approved, a member of the IRB staff will create a record in IREx and request all participating sites to confirm their willingness to rely on LSUHSC-NO for IRB review.
     
  3. After the sites agree to rely, a member of the IRB staff will upload approval documents into IREx.
     
  4. Each time a change is made to the study or a renewal is approved, a member of the IRB staff will update the IREx study accordingly.
     

    Using SMART IRB

  1. Submit:
    1. the appropriate initial protocol (either Exempt, 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. Once the study/amendment is approved, a member of the study team will need to log into SMART IRB and submit the request for reliance. Detailed instructions can be found at https://smartirb.org/reliance/.
     
  3. After the request has been submitted in SMART IRB, a member of the IRB staff will confirm all information is correct and that LSUHSC-NO is willing to act as the reviewing IRB.
     
  4. Once all sites have agreed to rely, a member of the IRB staff will issue the study approval in SMART IRB.
     

    Not Using IREx or SMART IRB

  1. Submit:
    1. the appropriate initial protocol (either Exempt, 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 template 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. A copy of the fully-executed document will be returned to you.
     
  4. Submit a modification  to the approved protocol to request addition of one or more relying sites using the Amend function. This submission must include copies of the...
     
    1. fully-executed IAA,
       
    2. completed Local Context Survey form, and
       
    3. the applicable site documents listed in the Local Context Survey.
       
  5. IRB Office staff will notify you about the status of the modification/reliance request through the KR platform.
     

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