MUSC as the sIRB of Record

MUSC may serve as the Single IRB (sIRB) of record/Reviewing IRB/Lead IRB for a non-exempt multi-site study when the MUSC PI will either serve as the Lead Investigator or will serve as the Coordinating Center for the multi-site study. MUSC may also serve as the sIRB of record under other circumstances which would be determined on a case-by-case basis. 

When the MUSC IRB serves as the Reviewing IRB for external sites, the MUSC IRB must ensure the relying site investigators fulfill MUSC's requirements and are appropriately qualified and trained to participate in research. 

An external institution may rely on the MUSC IRB based on the following criteria:

• The institution has a valid FWA (Federalwide Assurance);
• The institution will be engaged in the research;
• The institution has the ability to perform post-approval monitoring of the research; and
• The institution is located in the United States.

When the lead study team (MUSC study team) asks MUSC IRB to serve as the Reviewing IRB for external sites, the study team must agree to take on several additional responsibilities. The MUSC study team will be responsible for the following:

• Collecting the required IRB information from external sites and investigators throughout the life of the study;
• Compiling the required information for the MUSC IRB;
• Making IRB submissions on behalf of the relying sites and investigators; and
• Communicating IRB decisions and approved documents back to the relying sites and investigators.

• The Lead PI should review the sIRB PI responsibilities when serving as the Lead PI for a study where MUSC is the IRB of record. Review of these responsibilities is required to make sure the PI is clear on the roles and responsibilities a study of this type requires. 

In order for MUSC to serve as the Reviewing IRB, the external institutions involved must be "engaged" in human subjects research. 

If you are unsure if any of the institutions are engaged in the research, please review the guidelines regarding Engagement of Institutions in Human Subjects Research. 

We have also created a helpful checklist to 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 survey to assist in managing the Reliance Requests. The Reliance Intake Form is required prior to submission of an eIRB application or before making any commitment that MUSC will serve as the IRB of record for a multi-site study. The MUSC IRB will review your single IRB request to determine whether we are willing to enter into the arrangement.

• Be prepared to provide the following information on the Reliance 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
  • Study wide protocol which must include the human subjects research activities which will be performed at MUSC and the external sites
  • Consent document for use at MUSC and the consent template document for use at the relying sites
  • Identify all sites that will be engaged in human subjects research and thus need IRB coverage
  • The grant deadline

The submitted form will be reviewed by the MUSC reliance team to determine if serving as the IRB of Record is appropriate. The study team will be provided with a Letter of Support as well as template language to include in your grant application. The template language will describe how MUSC IRB is prepared to serve as a sIRB. 

Submit a Reliance Intake Form

Collecting all the required information about multiple sites can be time and resource intensive. The study team needs to begin early in the process putting together a competent team of individuals who can handle the task. The study team should be prepared to:

• Make contact with the Principal Investigator and regulatory personnel at each relying site to ensure they are willing to participate and are able to rely on the sIRB. 
  • Please note: This letter is not the same as the formal IRB reliance agreements that may need to be established after the grant is awarded. 
• Prepare a communication plan (PDF) to include with the grant application (if NIH funded) or protocol.
  • The communication plan is a written document that defines the roles and responsibilities between the reviewing IRB and relying site. It spells out who communicates what, to whom, how, and when across the multi-site study. 
  • The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sits and sIRB will be handled. 
• Review Budget Requirements as there are additional IRB fees for MUSC serving as the IRB of Record for a milt-site trial. These fees must be included in the grant budget. Find more information about IRB fees. 

Once the MUSC IRB has agreed to serve as the IRB of Record and the grant has been funded, the overall study application can be submitted in eIRB. This application should not include any external investigators or relying site documents. Information on the relying sites will be added after the overall study has been approved. 

In order to submit a study where MUSC is serving as the Reviewing IRB, the application must contain the following:

• On the Study Identification IRB Review Request smartform, mark Yes for question 1.0 "Is this a request for a single IRB Review?"
• On the same smartform, mark No for question 2.0 "Is this a request for your local IRB to rely on another IRB?"
• The study wide protocol must include sections on how the study will be coordinated as a sIRB study, the communication plan for the sites, and how many sites will be involved. 
• The MUSC consent form must be converted to a relying site template
  • This document will contain placeholders for the relying site to update with their own information and local context language
• Advertisements or recruitment materials that will contain site-specific information must also be converted into templates for the relying sites to update.
• The Single IRB Relying Site Document Requirements smartform must be updated to show which attached study documents are Required, Optional, or Not Applicable for the remote sites to update with their local information
  • Typically, only the consent form template and any advertisement/recruitment material template would be marked as either Required or Optional, Study wide documents that are not updated, such as the protocol and questionnaires, would be marked Not Applicable.

The study application will be reviewed and approved as normal per the MUSC IRB review process.

Please note that you will not add the external sites until after you complete Steps 5 and 6 below. 

Once the overall study has been approved by the MUSC IRB, the MUSC study team must provide a list of all relying site names and contact information for the relying sites to the Reliance Manger/ Reliance Team. The list should ideally include the PI, study coordinator, and IRB/Regulatory personnel from each relying site. 

The Reliance Team will reach out to each site individually and provide the following documents required to establish the reliance arrangement:

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 Manger 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 official involved. The Reliance Manger 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. 
• The relying site will complete this form and it will be signed by the relying site PI and designated IRB official.

Study Approval Letter

• The overall study approval letter showing that the main MUSC IRB application has been reviewed and approved by the MUSC IRB. 

Study Protocol

• The MUSC IRB approved study wide protocol. This document should not be altered in any way by the relying site.

Consent Form Template

• The consent form template will be updated by the relying site to include any local language required by their institution. All local language that is added to the consent form must be clearly indicated on the local context form as well. 

Additional Documents

• Any advertisements or recruitment materials, including templates which may need to be updated with the relying site local language.

*Please note that many sites will also have their own local abbreviated approval process that must be completed prior to signing the reliance agreement (i.e. their own local IRB review). This may slow down the completion process depending on ancillary reviews, etc. 

In order for the relying site personnel to be added to the study, an "External Affiliate NetID" will need to be requested. MUSC has developed a secure process in which MUSC investigators can sponsor these "External Affiliate NetIDs" for external collaborators and community partners. This type of NetID is appropriate for any Non-MUSC research personnel working under the direction of a MUSC Principal Investigator who for study purposes, needs access to commonly used MUSC research systems. 

The MUSC study team will need to obtain these NetIDs for the relying site PI and one other relying site study team member. Typically, this other study team member is the study coordinator or regulatory coordinator for the study at the relying site. 

The request for an External Affiliate NetID can be made through the SPARCRequest system. The specific request can be found under SCTR Services in the services catalog and is titled "External Affiliate NetID Request". In addition, please complete the form linked to the request in SPARC.

There is no cost of background check required for the External Affiliate NetID to be processed. NetIDs will be issued by the SCTR SUCCESS Center and emailed directly to the affiliate within 2 business days. 

Relying Site locations, personnel, and documentation are not included in the initial study application and therefore must be added after IRB approval, through a separate request called Relying Site Documentation (RSD).

After the main study application has been reviewed and approved by the MUSC IRB, a tab labeled "Single IRB" will appear in the eIRB workspace on the main page of the study. This tab will allow the MUSC study team to add the external sites via the RSD. The MUSC researcher or study staff member with edit rights can add the external sites by choosing the site from a pre-populated list. If the site is not included in the pre-populated list, please contact the reliance team for assistance. 

Please note that the RSD cannot be submitted without first completing everything in steps 5 and 6. The study team should be prepared to provide the following:

• Relying site institution name
• Relying site study personnel (PI and one other study team member who have been granted external affiliate NetIDs)
• Fully executed Reliance Agreement
• Completed and signed Local Context Form
• Consent form template updated with all relying site required local language
• External Site HIPAA form (if the site is unable to combine it with the consent form or if MUSC is not the Privacy Office)
• Documentation of HIPAA approval
  • This written documentation is provided by the relying site Privacy Office indicating that the relying site has approved the HIPAA language. This is only required if MUSC is not the Privacy Office.

The MUSC IRB will review the RSD. Once approved, the MUSC study team should provide all study approvals to the relying sites. The relying sites should not begin any study procedures until approval has been issued by MUSC.

If the MUSC IRB determines that reliance is not appropriate, the non-affiliated investigators or external sites must obtain review from another IRB.