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Process for Reliance On An External IRB

Research Integrity

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 Selecting 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
  • MUSC standalone HIPAA authorization form, if you will enroll subjects
  • 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 (as applicable)

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.

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 Acknowledgement Pending Activation Letter from the IRB that all local context concerns have been met and the reliance agreement is complete, however, the study team needs to provide via eIRB the MUSC IRB with final documentation from the IRB of Record indicating the MUSC site has been added to the study and can begin enrollment.

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.

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 4: Post-Reliance Reporting

Once the MUSC IRB has acknowledged 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 and/or updates to eIRB for the following:·

  • 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
  • Any modifications for which changes the study in such a way that additional institutional approvals are required. (e.g. radiation safety, conflict of interest)
  • Annual status update
  • Study closure

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.