MUSC as the sIRB of Record

You may request that MUSC IRB provide review for all external sites. When you ask the MUSC IRB to provide IRB review for all external sites, the MUSC IRB has to ensure the investigators fulfill MUSC’s requirements and are appropriately qualified and trained to participate in the research.

If you ask MUSC IRB to review for external sites, you also agree to take on several additional responsibilities. The MUSC study team making the request is responsible for:

  • 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 sites and investigators
  • Communicating IRB decisions and approved documents back to the sites and investigators

Steps for Requesting MUSC IRB Review

Step 1: Submit a Reliance Intake Form (Required)

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 multi-site study. The MUSC IRB will review your single IRB request to determine whether we are willing to enter into the arrangement.

Submit a Reliance Intake Form

Many study teams are not fully prepared to handle the level of coordination and communication required when the MUSC IRB is being used for multiple sites, so the MUSC IRB requires that you complete the Intake form before making an offer to utilize the MUSC IRB for this purpose.

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 which must include the human subjects research activities which will be performed at MUSC and the external sites and template consent document(s), which will help facilitate the discussion.
  • Identify all sites that will be engaged in human subjects research and thus need IRB coverage
  • The grant deadline

In addition to completing the Intake form, review of the sIRB PI responsibilities when serving as the Lead PI for a study where MUSC is the IRB of record is required to make sure the PI is clear on the roles and responsibilities a study of this type requires.

Once MUSC IRB agrees to act as the sIRB, you will be provided 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.

It is best to contact the IRB Reliance Manager as soon as you determine the list of sites that will be involved in the study so that discussions can begin amongst the sites to determine if others are willing to cede review.

Step 2: Organize your submission and Team

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 all of the sites Principal Investigators should occur to ensure they are willing to participate but also that their institution is able to participate and rely on the sIRB. A letter of support should be obtained from the local IRB.

Prepare a communication plan to include with the grant application (if NIH funded) or protocol. This communication plan will describe the use of an sIRB that is selected to serve as the IRB of record for all study sites. The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.

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.

Review Budget Requirements as there are additional IRB fees for MUSC serving the as the IRB of Record for a multi-site trial. These fees must be included in the grant budget.  Find more information about IRB fees.

Step 3: Submit an eIRB application in two steps

a. eIRB application for the overall protocol/template and MUSC site

After consulting with the MUSC IRB and it has been determined that MUSC will serve as the IRB of Record, you can begin the submission process if your grant is funded. MUSC IRB strongly recommends that you add non-affiliated investigators or external sites via a stand-alone amendment (i.e. the only change is the addition of the non-affiliated investigators or sites) after initial review, not with the new study submission. Completion of the required agreements can take several weeks and may delay initial approvals or approvals of amendments that include additional changes.

A normal eIRB application should be submitted for review and approval with the lead study team making the following selections within eIRB:

  • On the Study Identification – IRB Review Request page, the request began by responding ‘Yes’ to the Central Review question.
  • Within the Remote Site Required Documents section, establish which attached study documents are required, optional or not applicable for the remote site locations to later upload for IRB approval.

b. Submitting the eIRB application for the external sites – See Step 6 below. You will not add the external sites until after you complete Steps 4 and 5.

Step 4: Complete the Reliance Agreements

When reliance is accepted, federal regulations require the relationship to be documented by a written agreement called a reliance agreement (also known as an Institutional Authorization Agreement). The reliance agreement documents the arrangement and also establishes expectations about communication, reporting, and procedures. Each participating site will need to establish a reliance agreement with the sIRB. Many peer institutions and many commercial IRBs have already signed a Master Reliance Agreement called the SMART IRB Agreement. Studies and institutions making use of this existing agreement will have a streamlined startup process. The MUSC 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 several weeks to complete due to the complexity and institutional officials involved. As such, it is best to contact the IRB Reliance Manager as soon as you determine the list of sites that will be involved in the study so that discussions can begin amongst the sites to determine if others are willing to cede review..

Step 5: Obtain External NetIDs for the External PI and Study Contact at Each Site

MUSC has developed a secure process in which MUSC investigators can sponsor “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 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 or 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.

Step 6: Add the External Sites via a Remote Site Document Amendment in eIRB

Once the main study is reviewed and approved, a Central IRB tab will appear in the eIRB workspace in eIRB. The Lead Site (researcher or study staff with edit rights) can add external (remote) sites by choosing the site from a pre-populated list of sites.

  • Be prepared to provide the following information:
  • Name of non-affiliated investigators and their associated institutions
  • Local Context Form
  • External Site Consent Form
  • External Site HIPAA form
  • Documentation of HIPAA approval (if MUSC is not the Privacy Office)

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