Reliance Requests
Reliance Agreements
A Reliance Agreement, also known as an Individual Authorization Agreement, is a formal arrangement between the George Washington University (GW) and another institution engaged in human subjects research. This agreement allows one or more institutions to cede IRB review authority to another IRB. It outlines the responsibilities and communication protocols between the institution conducting the regulatory and ethical review and the institution(s) relying on this oversight. Participating institutions must hold a Federal Wide Assurance (FWA).
Benefits of Reliance Agreements
Reliance Agreements satisfy federal requirements and reduce the need for multiple IRB reviews while also safeguarding the rights and welfare of research participants. GW adheres to the single IRB mandate as prescribed by the revised Common Rule’s Cooperative Research provision. This rule applies to all U.S. sites involved in federally funded cooperative research projects involving multiple sites, with specific exceptions for tribal laws or federal mandates requiring multiple IRB reviews.
Single IRB Procedures
GW investigators seeking reliance for multi-site human research must submit a Reliance Request Form (docx). Each request is evaluated on a case-by-case basis considering factors such as the funding source, the number and location of participating sites, the level of risk to participants, and GW’s capability to provide sufficient oversight.
Steps for Starting a Reliance
If GW is the Reviewing IRB: Ensure the iRIS submission reflects all collaborating sites, their investigators, and the specific activities requiring GW IRB oversight. Relying institutions must also complete the Institutional Profile and Local Context Form (docx).
If GW is a Relying Institution: GW-consented participants must be consented with language that includes GW-required language as specified in the Consent Form Checklist (docx).
SMART IRB
GW uses the SMART IRB platform to streamline the execution of Reliance Agreements. This platform facilitates the handling of common challenges associated with multi-site research and offers flexibility in the size and scope of the collaboration. SMART IRB is not an IRB itself but serves as a master reliance agreement framework. If the collaborating institution has not joined the SMART IRB Agreement as a participating institution, notify the OHR for instructions.
Using SMART IRB
Request Access: Contact [email protected] if access is not granted promptly.
Start Reliance Request: The lead PI or designated submitter must Sign in to the SMART IRB online reliance system and submit a request. The PI will be asked to provide basic information about the research, list engaged sites, describe the activities at each site, and upload all relevant approved protocol documents (e.g. protocols, consents, surveys, and recruitment materials).
Please view this short Reliance Walkthrough Video for an overview of the process for PIs and Institutions.
Individual Investigator Agreements (IIAs)
An IIA provides a mechanism for institutions with an FWA to extend oversight to engaged collaborating individual investigators not affiliated with an FWA-holding institution. The process begins with the PI submitting a Reliance Request Form (docx). If the reliance is approved, the individual investigator will need to complete the Institutional Profile and Local Context Form (docx), a current CV, and CITI training certificates.