Office of Research Integrity and Assurance

GMU as Reviewing IRB

GMU Serving as the Single IRB

Introduction

Obtaining full IRB approval for projects where George Mason is serving as the Reviewing IRB (i.e., approval of the overall protocol and approval of each participating site(s)) occurs in approximately three steps. This page outlines our standard process for executing reliance and onboarding participating sites. However, some flexibility exists in this process (e.g., what documents are included in which modifications, number of modifications necessary, etc.), so please reach out to your assigned IRB Specialist if you have any questions.

Step 1: Initial IRB Review
Step 2: Execute Reliance Agreements
Step 3: Review of Participating Sites
Reliance Agreement Toolkit

Step 1: Initial IRB Review

  1. Submit your project in RAMP
    1. This submission will look very similar to a normal single-site study.
    2. Include a thorough description of activities happening at each site within the protocol
    3. Do not yet include participating sites on the “Sites” page or external study team
      members on the “Study Team” page. You will add these later via a modification and
      reliance agreements will be submitted during that review.
  2. IRB Review
    1. Once the IRB approves the study, you will be issued an initial approval letter. This letter indicates that the protocol and other study materials have been approved for use at GMU. This letter DOES NOT indicate that research activities may commence at external sites as Reliance Agreements and review of external sites are not typically executed in initial submissions.
    2. To request IRB review of participating sites and execute Reliance Agreements, you will next create a modification for the project in RAMP as detailed in Step 2.

Step 2: Execute Reliance Agreement(s)

  1. Open a modification in RAMP
    1. In the modification, include a draft version of the Reliance Agreement using GMU’s template. Fill out the blank sections as appropriate. The Reliance Agreement should not have any signatures at this stage. One Reliance Agreement should be uploaded per participating site.
    2. Add all participating sites to the “Sites” page, and add Site PIs to the External Study Team Members list and submit after you’ve ensured the rest of the submission is up to date.
  2. After submitting your modification:
    1. Once your assigned IRB Specialist has completed their pre-review, the Reliance Team will review the reliance components of the submission and ensure the RAMP application and Reliance Agreement have been completed accurately. We will communicate any necessary changes or clarifications via RAMP.
    2. Once the Reliance Agreement is complete and accurate, the Reliance Team will facilitate the execution of the reliance agreement via RAMP. At this stage, IAAs and LOAs will be signed by George Mason’s Signatory Official. Once signed, they will be returned via a comment in RAMP.
  3. At this stage, you will have all current GMU IRB approved documents. These may include, but may not be limited to:
    1. GMU signed Reliance Agreement
    2. Master consent form (if applicable)
    3. Recruitment materials (if applicable)
  4. Send all IRB approved study materials, the Institutional Profile Form, and Basic Site Information Form to your external collaborators
    1. Regarding the Consent form and HIPAA authorization, instruct participating sites to locate and delete George Mason’s language related to participant injury, Conflict of Interest/Financial disclosure/compensation, and HIPAA language, and replace it with their local required language (as appropriate)
    2. Your external collaborators will need share the partially executed reliance agreement and Institutional Profile Form with their IRB. The local IRB should be able to (a) complete the Institutional Profile Form and (b) obtain the signature of their institution’s Signatory Official on the reliance agreement
  5. Once signed by the external collaborator’s Signatory Official, upload the fully executed Reliance Agreement and the completed Institutional Profile Form to the RAMP modification submission.
    1. Note that at this point, while Reliance has been fully executed, the George Mason IRB Office has not reviewed or approved participating sites. Research activities at participating sites cannot occur until reliance agreements are fully executed and approval for the participating site(s) has been issued by the George Mason IRB.

Step 3: Review of Participating Site(s)

  1. If the participating site(s) will be enrolling participants locally, your collaborators should return the site-specific consent form(s) (with HIPAA authorization, if applicable) and recruitment materials. They should include their institution’s required local language and site PI contact information.
  2. Submit all site-specific documents in RAMP via the Sites page. Include any documents received from the participating site(s). These will be reviewed by the appropriate IRB Specialist.
  3. As reliance is fully executed, the IRB Office will now review participating sites, their activities, and if applicable, their site-specific documents. The IRB Office will then issue an approval letter which lists each external site.
  4. Throughout the life of the project, while George Mason is the IRB of Record, the George Mason PI maintains the responsibility of retaining all reliance documentation, submitting continuing reviews, modifications, and submitting any Reportable New Information that comes from the George Mason site or any other participating site(s).

Reliance Agreement Toolkit

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