RELYING ON AN EXTERNAL IRB


Where appropriate, LSUHSC-NO-affiliated investigators may request the services of an external IRB for ethical review and oversight of research typically under the jurisdiction of the HSC-NO IRB. Reliance may be appropriate for several reasons including:

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

Reliance Agreements

An IRB Authorization Agreement (IAA) or Reliance Agreement between the HSC-NO 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-NO has executed master reliance agreements with the following IRBs. Under these agreements, all HSC-NO 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)
       
    • Western IRB (WIRB)
       
  • 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-NO is a signatory.
     
  • HSC-NO will enter into reliance agreements with other institutions on a case-by-case and study-by-study basis.

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.

Please consult the HRPP Policy on IRB Reliance for more information.


General Procedure

  1. Submit a request for reliance to the HSC-NO HRPP by completing one of the application forms listed below and following the instructions provided in the form.
  2. The HSC-NO HRPP will serve as the Privacy Board for reliance studies. Please use the Standard HSC-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 and also to the Reviewing IRB.
     
  3. Use of the HSC-NO ICF template 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 Templateis 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.
     
  4. If reliance is NOT APPROVED, submit the study to the HSC-NO IRB for review using standard protocol. Approval and maintenance of the study will follow standard HSC-NO IRB policies and procedures.
     
  5. If reliance IS APPROVED, submit the study and all relevant documents to the Reviewing IRB according to its procedures.
     
  6. The study may be initiated once the Reviewing IRB has approved the study and confirmation has been provided to the HSC-NO HRPP.
     
  7. Post-Approval Requirements:
  8. Study Closure:

Additional Guidance & Resources