IRB Deferrals (Reliance Agreements)

Page Contents

1. Single IRB Mandate (sIRB)
2. Types of Reliance Agreements
3. How to request reliance on another IRB’s approval
4. How to request for the Georgia Tech IRB to serve as the relying IRB

When Georgia Institute of Technology investigators are conducting collaborative, non-exempt human subjects research (research requires Expedited or Full Board review), it may be appropriate to establish an IRB Authorization Agreement (IAA) allowing one institution to rely on IRB review conducted by the other institution. The Federal Regulations allow for institutions who have a Federal Wide Assurance (FWA) to rely on one another’s IRB approvals to streamline the review and approval process. 

Under certain scenarios, an IAA may not be needed as a memorandum of understanding (MOU) already exists between the Georgia Tech IRB and the other IRB (list of current MOUs can be found below).  Activities not eligible for an IAA are those that do not constitute human subjects research or are determined to be exempt. In those cases, the Georgia Tech IRB will conduct our own IRB review, if required. Additionally, the Georgia Tech IRB does not typically execute reliance agreements with international institutions. For questions or assistance with a reliance agreement, please contact IRBReliance@gatech.edu.

Single IRB Mandate (sIRB)

The single IRB (sIRB) mandate is an NIH policy that requires certain types of NIH-supported studies involving multiple sites where each site will conduct the same protocol involving non-exempt human subjects research to use a single IRB to accomplish IRB review and approval for all domestic participating sites.  It is the Georgia Tech IRB’s current policy to not serve as the sIRB until further notice.  It is Georgia Tech's current IRB policy to defer IRB review and administration to a commercial IRB to act as IRB of record to comply with the sIRB mandate when Georgia Tech is selected as the sIRB site.  This activity must be budgeted appropriately at the funding proposal stage.  The Georgia Tech IRB will enter into sIRB reliance agreements where the Georgia Tech IRB is relying on another sIRB.  The procedures for this can be found below.

Single IRB (sIRB) policy requirement of 45 CFR 46.114(b) of the 2018 Requirements goes into effect for ALL Federally Funded Human Subjects Research January 20, 2020.

The revised Common Rule (i.e., the 2018 Requirements) requires at 45 CFR 46.114(b) that all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States. Reliance on a single IRB of record in cooperative research is optional before January 20, 2020, even for research subject to the 2018 Requirements. Reliance on a single IRB of record in cooperative research is required beginning January 20, 2020, unless the study meets the criteria for an exception described in §46.114(b)(2) of the 2018 Requirements.

You may read more on this requirement here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html

Types of Reliance Agreements

1. SMART IRB
   • The Georgia Institute of Technology is a participating institution to the SMART IRB master reliance agreement. Using the SMART IRB agreement is the preferred method of reliance for all studies where Georgia Tech will rely on an external IRB or serve as the reviewing IRB.
     • When a study eligible for a reliance agreement involves a SMART IRB participating institution, a submission in our portal is needed from the Georgia Tech team to maintain records of active SMART IRB reliance agreements. The GT IRB uses the SMART IRB Letter of Acknowledgement to coordinate and document study-specific reliance arrangements under the SMART IRB master agreement.
2. IRB Authorization Agreements (IAA)
   • In cases where a collaborator is not at a participating institution to the SMART IRB master agreement, the Georgia Tech IRB may use our own template IRB Authorization Agreement or defer to the template agreement of the collaborating institution (pending acceptance by the Georgia Tech IRB).
3. Memorandum of Understanding (MOU)
   • The Georgia Tech IRB has a standing agreement with several IRBs, in which a separate agreement is not needed if the terms of the standing agreement is met. These terms can be found in our Policies and Procedures. The Georgia Tech IRB has a current agreement with the following IRBs:
     • Children’s Hospital of Atlanta
     • Emory University
     • St. Joseph’s Hospital
     • The University of Georgia

How to request reliance on another IRB’s approval

Submit a reliance agreement request in our submission portal. Details are provided below.

• Please Note: This shell submission is not being created for the purposes of approval, but rather, it is being created for the purposes of storing and maintaining a record of Georgia Tech's reliance upon the other institution

The shell protocol shall include:

1. Getting Started
   • A. Study title
     • The study title should lead with the name of the institution Georgia Tech plans on relying on (e.g. Emory -  Testing of Knee Exoskeleton).
2. Project Personnel
   • All Georgia Tech study personnel should be added to the study.
3. Basic Information
   • Project Type
     • Select Reliance Agreement/IRB Deferral Request
   • Class Project
     • Y/N answer
   • Study Sites
     • List Georgia Tech Sites
   • Collaboration Information
     • Name collaborators, institution and roles on the project
   • Study Dates
   • Funding
     • Upload any funding award document for the project
   • Studies involving DoD, Radiation, or Nanotechnology
4. IAA/Reliance Agreements
   • Reliance Agreement
     • Select the option that best describes reliance request
   • Reviewing IRB & IRB Contact Information
   • Protocol Description
     • A description of the project
   • Georgia Tech Engagement
     • Check Boxes that apply
     • Georgia Tech personnel's proposed role and involvement in the research, i.e. what research activities will Georgia Tech Personnel be engaged in?
   • IRB Approval
     • Upload IRB approval letter is GT is relying on another institution
   • Clinical Trial
     • IF this is a clinical trial, the Office of Regulatory Affairs will need to review, and a clinical trial may be needed in addition to a reliance agreement.
   • Study Documents
     • Copies of the approved protocol and consent forms from the other institution should be uploaded in this section. 

How to request for the Georgia Tech IRB to serve as the relying IRB

Submit a normal submission in our submission portal for review and approval. In the “Basic Information” section, select non-exempt research and the option “Study involving more than 1 site where Georgia Tech will serve as the IRB of Record”. A modification may be needed after the study is approved to finalize this process as an external IRB can only rely on our approved IRB submission. 

If this process is being initiated or continued after the study has been approved, then please submit a modification to list the institution that intends to rely on our approval, a description of how the institution and each or the external researchers are involved in the research (e.g., are they interacting with subjects, are they consenting subjects, are they participating in the implementation of any study related interventions, etc.).

For questions about IRB Authorization Agreements, please contact IRBReliance@gatech.edu.