Reliance on External IRBs

You may request that Rhodes College’s Institutional Review Board rely on an external IRB to review and approve your research project. Reliance can increase efficiency, but there is still a significant amount of work required to obtain IRB approval for a protocol or a specific site, and additional regulatory requirements apply.

Reliance—When one or more relying institutions choose to accept IRB review and oversight for a research project from another institution’s reviewing IRB. In these situations, the reviewing IRB provides IRB review and oversight for conduct of the research at the relying institution(s).

Reviewing IRB – The IRB that will be reviewing research from all participating sites

Relying institution – institution that agrees to accept IRB review and oversight from a reviewing IRB

How It Works

The Rhodes College IRB approves the use of an external IRB on a case by case basis.

Even if a reliance request is granted, the Rhodes College principal investigator and study team, Rhodes IRB, and involved institutions still retain considerable responsibility. When you rely on an external IRB, you must:

  • Comply with the Rhodes College IRB roles and responsibilities as outlined in the IRB handbook.
  • Obtain IRB approval for conduct of your research from the reviewing IRB and ensure all members of your study team are listed on the IRB documentation as required by the reviewing IRB.
  • Ensure the IRB-approved documents accurately reflect how you will conduct the research at Rhodes College
  • Follow the reviewing IRB’s policies and procedures, the IRB-approved documents and conditions of approval, and any applicable laws and regulations. For example, you are responsible for meeting the reviewing IRB’s expectations for:
    • reporting adverse events, deviations, noncompliance, and other problems to the reviewing IRB
    • updating personnel and enrollment status
    • submitting amendments
    • tracking subject enrollment and status
  • Ensure all members of your study team are appropriately qualified and have met standards for eligibility to conduct research, including completion of CITI ethics training

How To Submit a Request for External IRB Reliance

When you submit a reliance request, be ready to provide the following materials:

  • Documentation that the protocol has been reviewed and approved by the external IRB, unless reliance on a commercial/independent IRB is requested
  • IRB-approved protocol or other documentation of the research plan
  • Documents provided by the external IRB for completion by the Rhodes College IRB (usually a Reliance Agreement form to be signed).  You may also use the Reliance Agreement form approved for Rhodes College.

If the IRB determines that reliance is not appropriate, you must submit the study to the Rhodes College IRB for review.

Approval of a reliance request by Rhodes College IRB is only confirmation that reliance on the external IRB is appropriate. It is not an IRB approval. You are still responsible for obtaining IRB approval from the external IRB and cannot begin research until approval from the reviewing IRB is granted.

When reliance is accepted, federal regulations require the relationship to be documented by a written agreement called a reliance agreement.

Once the IRB has granted your request for reliance and the external IRB has approved your study, you are still required to continue to submit some items to the Rhodes College IRB. Please submit Amendments to report:

  • PI and personnel changes
  • Potential conflicts of interest, including institutional and potential financial interests, that could affect or be affected by the research