Process for Reliance On An External IRB

MUSC may rely on an external IRB, including the IRB of another institution or organization, or an independent (Commercial) IRB, for review and approval of nonexempt human research if such reliance is a requirement of the research, or if it benefits MUSC, its investigators and/or its research participants.

Note: Even if the study is ceded to another IRB, the PI of the research still has responsibilities to the MUSC IRB and MUSC as an institution. Please review these responsibilities and be clear on the requirements.

Criteria for Selecting an External IRB

MUSC will apply the following criteria in selecting an external IRB to conduct the review of MUSC protocols:

  • The external IRB is currently registered with OHRP/FDA
  • For commercial IRBs: the commercial IRB is AAHRPP-accredited
  • For non-commercial IRBs: the IRB is AAHRPP-accredited or determined as part of the administrative review to meet MUSC standards
  • The external IRB is located within the U.S. (MUSC IRB reserves the right to withhold any new research study from being sent to an external IRB)

Steps for Submitting an External IRB

Step 1: Submit a Reliance Intake Form in Redcap (Required)

MUSC has created a REDCap form to assist in managing the Reliance Requests. The Reliance Intake Form is required prior to the submission of an eIRB application or before making any commitment that MUSC will rely on an external IRB. The MUSC IRB will review your reliance request to determine whether we are willing to enter into a reliance agreement.

Be prepared to provide the following information on the intake form:

  • Identify who will act in the role of the Lead Study Team (e.g., your own study team, a coordinating center, or both). The Lead Study Team assumes additional responsibilities when single IRB review will be used.
  • Provide details about the study, including the study wide protocol and template consent document(s), which will help facilitate the discussion.

Submit a Reliance Intake Form

Step 2a. Submit an External eIRB application

Once you have received confirmation of MUSC’s willingness to enter into a reliance arrangement, you may submit a new eIRB application and choose the External IRB Pathway on the IRB review Request page.

Plan ahead. When submitting an external reliance request, be ready to provide the following materials:

  • Documentation that the protocol has been reviewed and approved by the external IRB, (i.e. Approval Letter)
  • IRB-approved protocol
  • Documents provided by the external IRB for completion by the MUSC IRB (e.g. local context sheet, reliance agreement template, determination form, etc.)
  • Consent form template approved by the sIRB (as applicable)
  • HIPAA authorization

The MUSC IRB will complete an administrative review of the external IRB application reviewing the application for local context concerns and completeness. The MUSC IRB administrator will review the materials to ensure the following:

  • The research is appropriate for submission to an external IRB and the PI meets the MUSC requirements to serve as PI on a research project.
  • The application is complete and includes all required external IRB documents.
  • The PI, co-investigators and key personnel have completed the required CITI human subjects training.
  • All applicable ancillary review committees have completed and signed off on their reviews of the study.
  • The Local Context form (if applicable) is complete and all required local context language is included in the consent form.
  • For industry sponsored studies, the contract between MUSC and the sponsor of the research is finalized and the sponsor’s commitment language regarding study related injury within the ICF has been verified.

Step 2b: Completion of the Reliance Agreement

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

The IRB Reliance Manager will facilitate completion of the reliance agreement.  Investigators are not authorized to sign reliance agreements.  Each agreement must be signed by the sIRB and by an appropriate institutional official for each site.  Most institutions that have an IRB office will have an established process by which the site PI can formally request reliance on the sIRB.

Please be aware that reliance agreements can take a while to complete due to the complexity and institutional officials involved. Platforms such as Smart IRB, have assisted in reducing the amount of time these agreements take but it is best to begin this process early.

Step 3a. Acknowledgement of the Reliance Arrangement via eIRB, Pending Activation

Once the Reliance arrangement has been solidified and the local context concerns have been met, the IRB administrator will issue an acknowledgment, pending activation in the eIRB system. The study will move into the state of Reliance Acknowledged, Pending Activation. The study team will be issued an Initial Concurrence Letter from the IRB that all local context concerns have been met and the reliance agreement is complete. This letter authorizes the MUSC study team to submit the MUSC site to the main IRB to add MUSC as site.  Once approval of MUSC is gained from the Reviewing IRB, the documentation of this addition should be uploaded into the MUSC eIRB system along with the final approved versions of the consent and HIPAA.

Acknowledgement 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.

Reliance on a Commercial IRB:  Submission Information

It is at this stage that the study team will submit the study information to the commercial IRB.  The study team will submit the required information to the commercial IRB via that IRBs standard system.

Step 3b. Final Acknowledgement of the Reliance Arrangement via eIRB

Once the MUSC study team receives documentation from the Central IRB that MUSC has been added as a site, this documentation will need to be uploaded into eIRB and sent back to the MUSC for review and acknowledgement. The MUSC IRB will then issue a final acknowledgment letter and the study will enter the final state of Acknowledged and the study team can begin enrolling.

Step 4: Stamping and Expiration Dates

Stamping: The IRB of record is responsible for providing the approval stamp for of all documents approved by that IRB.

Note: If MUSC chooses to remain the HIPAA Privacy Office, MUSC will stamp the HIPAA authorization.

Expiration Date: The MUSC IRB’s expiration date will be set to match the external IRB’s expiration date.

Step 5: Post-Reliance Reporting

Once the MUSC IRB has acknowledged your request for reliance and the external (reviewing) 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 eIRB for the following:

  • New MUSC study personnel are added to or removed from the study team
  • Changes which require revision to the HIPAA authorization
  • Changes to conflict of interest
  • Changes are made which affect local context / institutional policy / state law requirements
  • The reviewing IRB has approved a change to the study procedures or recruitment and is modified in such a way that additional institutional approvals are required from one of the following:
    • Conflict of Interest Committee
    • Protocol Review Committee
    • Radiation Safety Committee
    • Institutional Biosafety Committee
    • Other ancillary committees that require re-review
  • The recruitment activities that were described in the initial application that require compliance with MUSC HRPP policies:
    • Students, trainees, and employees;
    • Persons with impaired decision-making capacity;
    • Non-English speaking subjects;
    • Children as subjects;
    • Prisoners as subjects.

Please submit a status update to eIRB for the following:

  • Status update with the IRB of Record's Continuing Review attached.
  • Closure Report after the IRB of Record closes the study.

Fees

For information on fees charged for studies where MUSC relies on an external IRB or when MUSC serves as the IRB of record, please view the IRB submission information.