Reliance Process

How to request use of an External IRB

  1. Complete the reliance request form on the Georgetown IRB website 
    • Request form
    • This is required regardless of if Georgetown has a Master Reliance Agreement with the desired external IRB.
      • This process should be completed for every distinct study.
  2. Georgetown IRB approval of request 
    • Upon initial review and approval of the reliance request form, you will be provided a “Reliance Confirmation Letter” for the specific study. 
    • With this confirmation letter, an IRB Authorization Agreement can be partially executed by the external IRB if appropriate. 
    • External IRBs with a Master Reliance Agreement with Georgetown do not require a separate IRB Authorization Agreement. 
  1. Creation of External IRB Submission in the Georgetown-MedStar IRB system
    • Please refer to “External Submission Guide” (WIP).
    • Partially executed IAA should be provided at this step to the Georgetown IRB for full execution. Submission will not be reviewed until IAA is fully executed. 
    • Georgetown “Reliance Confirmation Letter” must be attached for submission to be reviewed.
  2. Georgetown IRB Local Review
    • As part of Georgetown’s review, the study submission must include:
      • Multi-Site Protocol
      • Drafted Local Informed Consent Forms (ICFs)
      • Georgetown will review drafted ICFs for compliance with institutional requirements. Once approved, locally approved ICFs can be sent to the reviewing IRB.
      • CITI Training 
      • Drug/Device Documentation
      • Investigator Brochures and Package Inserts are required for all listed drugs or devices.
      • Conflict of Interest
        • Ensure conflict disclosures complete in GU-Pass or MedStar System for all local study team members. 
        • Required conflict disclosures must be incorporated in the ICF prior to approval.
      • Other Reviews
        • This includes applicable radiation safety, protocol review and monitoring committee review, etc. 
      • After Georgetown IRB has finished review, an “Institutional Clearance Letter” will be provided, verifying that the study is in compliance with all local institutional requirements. 
  3. Submit Georgetown Institutional Clearance Letter and locally approved ICFs to the Reviewing IRB
  4. Upload Reviewing IRB Site Approval Letter in the Georgetown-MedStar IRB System Submission
  5. Final System Approval in the Georgetown-MedStar IRB System