Process for Reliance On An External IRB

MUSC only needs to rely on an external IRB if the PI or institution is determined to be "engaged" in human subjects research. If you are unsure if MUSC is engaged in the research, please review the guidelines regarding Engagement of Institutions in Human Subjects Research.

We have also created a helpful checklist to quickly determine if MUSC or the external institution is considered engaged. 

Please note: The final decision on engagement will be made by the IRB. 

Engagement Checklist

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 reliance intake form:
  •  MUSC PI and study coordinator or regulatory contact
  • Study wide protocol and template consent document(s)
  • The external IRB and any other institutions involved in the reliance arrangement
• The submitted form will be reviewed by the MUSC reliance team and determined if reliance is appropriate. A notification of the decision will be sent via email to the MUSC PI and study coordinator/regulatory contact listed on the form. 

After receiving the confirmation email from the MUSC reliance team determining that reliance is appropriate, 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;

• Approval Letter(s) from the external IRB documenting that the protocol has been reviewed and approved
  • The approval letter(s) must not be expired and should show the current versions of the study documents being uploaded to the eIRB application
• Protocol approved by the external IRB
• Consent Form Template approved by the external IRB (as applicable)
• Reliance Documents provided by the external IRB for completion by the MUSC IRB
  • local context form, reliance agreement template, determination form, etc. if applicable
• HIPAA Authorization if the external IRB does not allow for the HIPAA and Consent form to be combined, or if MUSC will act as the Privacy Office for the study
• Other study documents approved by the external IRB such as questionnaires, advertisements, drug brochures, etc. as applicable to the study
• Consent Form Template(s) updated with MUSC Local Context Language
  • The consent form template provided by the external IRB/sponsor must be updated to include MUSC's local language
  • Depending on the nature of the study, some or all of the local language will be required to be included in the consent form
  • Review the following document to determine which language must be added to the form:

MUSC Local Context Language

The MUSC IRB will complete an administrative review of the external IRB application. The application will be reviewed 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 study personnel have completed the required CITI human subjects training. 
• The Local Context Form (if applicable) is complete and all required local language has been included in the consent form(s).
• 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.
  • The IRB administrator reviewing your application will ensure this step has been completed with ORSP.

The reliance arrangement must be documented using several forms. During the IRB review process, the Reliance Manager will reach out to the external IRB to obtain and complete the following documents:

Reliance Agreement

• The Reliance Agreement is a written document that allows institutions to delegate the review of  human subjects research to another institution's IRB.
  • Also known as an Institutional Authorization Agreement (IAA)
• The IRB Reliance Manager will facilitate completion of the reliance agreement. Investigators are not authorized to sign reliance agreements.
• MUSC has signed on to the SMART IRB reliance agreement. This allows for the use of a Letter of Acknowledgement rather than a full reliance agreement with institutions who have also signed on to SMART IRB.
• If an external IRB requires the use of their site-specific reliance agreement and/or is not a member of SMART IRB, the reliance agreement must be reviewed by MUSC's Legal department*.
• Each agreement must be signed by the 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 time to complete, especially when a legal review is required, due to the complexity and institutional officials involved. The Reliance Manager will begin the process of completing the reliance agreement early in the review process. 

Local Context Form

• The Local Context Form is a questionnaire that helps a reviewing IRB obtain information about a relying site's local laws and policies.
  
  • Also known as a Site Information Sheet, Local Site Profile, Site-Specific Information Form, etc.
• Not all institutions require a local context form. In some instances, when a master reliance agreement is in place, the external IRB will keep the MUSC local context information on file so as to not require a form for each study.
• The IRB Reliance Manager will complete any required local context forms. 
• In some cases, the local context form requires a signature from the MUSC PI. The Reliance Manager will reach out to the study team to obtain any information and signatures needed for the form. 

Once MUSC's review of the external application has been completed, the Reliance Agreement has been fully executed, the local context concerns have been met, and all MUSC ancillary approvals have been issued, the IRB administrator will issue an acknowledgement, pending activation in the eIRB system. The study will move into the state of "Reliance Acknowledged, Pending Activation". 

The IRB administrator will upload the fully executed Reliance Agreement and the Initial Concurrence of Reliance Letter from the MUSC IRB to the application. This Concurrence letter informs the study team of the following:

• The study has been reviewed by the MUSC IRB, all local context concerns have been met, and the reliance agreement is complete;
• The study team is authorized to submit the MUSC information to the external IRB to add MUSC as a relying site;
• The study team may not begin enrollment at MUSC until external IRB approval is issued, and the approval letter and documents are uploaded to the eIRB application;
• Indicates the roles and responsibilities of the institutions in the agreement.

Please note that 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. 

The MUSC study team is responsible for obtaining IRB approval from the external IRB and cannot begin research until approval is granted. It is at this stage that the study team will submit the MUSC study information to the external IRB via that IRBs standard system. 

If the external IRB requests any changes to the documents that have already been reviewed by the MUSC IRB, these changes must be submitted in eIRB for review prior to approval by the external IRB. 

Once the MUSC study team receives documentation from the external IRB that MUSC has been added as a site, this documentation will need to be uploaded into eIRB and sent back to the MUSC IRB for review and acknowledgement.

The study team will upload the following documents in eIRB:

• The approval letter from the external IRB showing that MUSC has been approved as a relying site
  • This document should be added in addition to the approval letters already uploaded in eIRB
• The approved/stamped Consent Form(s) if applicable
  • These documents should be uploaded as revised versions to the draft documents already reviewed.

The MUSC IRB will review the documents for completeness and to ensure that no changes have been made to the local context language without authorization. The MUSC IRB will then issue the Final Concurrence of Reliance Letter and the study team will enter the state of "Acknowledged". Only then can the study team begin enrolling. 

The IRB of record is responsible for providing the approval stamp for all documents approved by that IRB. The MUSC IRB watermark is not required on any document being reviewed by the external IRB.

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

The expiration date in eIRB will be set to match the external IRB's expiration date. 

Once the MUSC IRB has acknowledged your request for reliance and the external IRB has approved your study, the study team is responsible for submitting reportable events and amendments to both the external IRB and the MUSC IRB. Depending on the nature of the submission, the study team may need to submit to one IRB or both. 

Report to the External IRB:

• Any proposed changes in research;
• Unanticipated problems involving risks to participants;
• Non-compliance or protocol deviations.

Report to the MUSC IRB:

• Amendments involving 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 that affect local context, institutional policy, and/or state law requirements
  • Changes that require additional institutional approvals from one of the following committees:
    • Conflict of Interest Committee, Protocol Review Committee, Radiation Safey Committee, Institutional Biosafety Committee, or any other ancillary committees that require re-review
  • Changes to the study procedures or recruitment activities that were described in the initial application that require compliance with MUSC HRPP policies involving:
    • Students, trainees, and employees;
    • Persons with impaired decision-making capacity;
    • Non-English speaking subjects;
    • Children as subjects;
    • Prisoners as subjects.
• Status Updates for the following:
  • Annual status update with the external IRB's Continuing Review attached
  • Final closure report after the external IRB has closed the study

Report to Both the External IRB and the MUSC IRB:

• Complaints from a subject or other person regarding the research.