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Reliance on External IRBs

ORI

You may request MUSC Institutional Review Board rely on an external IRB to provide review and approval of your research project. Reliance can increase efficiency, but there is still significant work required to obtain IRB approval for a protocol or a specific site. Additional regulatory requirements also apply.

Words to Know

Reliance - An instance of IRB review 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). 

How it Works

The MUSC Human Subjects Office approves the use of an external IRB on a case by case basis.

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

  • 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 MUSC-affiliated locations.
  • 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 human subjects protection training, and disclosure of conflict of interest (PDF)

Step 1: Submit a Reliance Request

Request reliance on an external IRB by Submitting a Reliance Request via eIRB using the External IRB Pathway. 

Plan ahead. When submitting 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
  • MUSC standalone HIPAA authorization form, if you will enroll subjects
  • Confirmation of approval by any ancillary review committees (e.g. Scientific Review Committee, Radiation Safety, etc.)
  • Documents provided by the external IRB for completion by the MUSC IRB or HRPP (e.g. local context sheet, reliance agreement template, determination form, etc.)
  • Consent form (as applicable)

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

Approval of a reliance request by the MUSC IRB is simply 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 is granted.

Step 2: Complete the Reliance Agreement

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

The Human Subjects Office reliance team will facilitate completion of the reliance agreement. 

Please be aware that reliance agreements can take several weeks to complete due to the complexity and institutional officials involved. Platforms such as SmartIRB, StrokeNet, TINS and others have assisted in reducing the amount of time these agreements take but it is best to begin this process early. 

Step 3: Post-Reliance Reporting

Once the IRB has granted your request for reliance and the external IRB has approved your study, there are still some things you are required to continue to submit to the MUSC IRB. Please submit amendments to the reliance request to report:

  • PI and personnel changes
  • Changes which require revisions to the HIPAA authorization
  • Potential conflicts of interest, including institutional, and potential financial interests, which could affect or be affected by the research
  • Study closure
  • Annual status update