Reliance Agreements

• Definitions
• Policies and Requirements
• How to Request a Reliance Agreement
• Individual Investigator Agreements

Definitions:

• Reliance Agreement: A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.
• SMART IRB: The “SMART IRB” master reliance agreement was created in 2016 to harmonize and streamline the IRB review process for multisite studies. It enables reliance on a study-by-study basis, clearly defines roles and responsibilities of relying institutions and reviewing IRBs, and eliminates the need to sign reliance agreements for each study [e.g., a non-SMART IRB agreement]. 500+ institutions have already signed onto this agreement and are actively using it as the basis of reliance for multisite projects.

Policies and Requirements:

• The UMD IRB has adopted the Standard Operating Procedures of the SMART IRB initiative. SMART IRB Reliance Agreements will be utilized when engaging with institutions who also follow SMART IRB.
• SMART IRB Site: SMART IRB 
• UMD Reliance Agreement SOP - Policy 3.012
• NIH Policy: Effective January 25, 2018, the NIH requires use of a Single IRB [sIRB] for the review of NIH-funded multisite studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. This Policy applies to domestic sites only. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections. Under the policy, “multi-site” is defined as two or more sites. For more information: NOT-OD-16-094: Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
• Revised Common Rule: The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. Under the new Final Rule governing human subjects protections approved by the DHHS in January 2017, most U.S. government funded cooperative studies that meet the criteria for non-exempt “human subjects research”, and involve more than one site, will also require sIRB review.  This requirement is in effect as of January 20, 2020. For more information: Revised Common Rule | HHS.gov

How to Request a Reliance Agreement:

• If UMD is the Reviewing IRB, please complete this Roles and Responsibilities Form and send to RelianceAgreements@umd.edu.
• If UMD is the Relying IRB, please complete this Roles and Responsibilities Form and send to RelianceAgreements@umd.edu. 
• The UMD IRB reliance team will review the information provided in the reliance request email and will contact you with next steps/instructions. 
• UMD IRB Registration #: IRB00000474
• Federalwide Assurance (FWA) #: FWA00005856.

Individual Investigator Agreements:

Individual Investigator Agreements are used for researchers that will be engaged in human subject research that do not have an affiliated IRB or whose IRB does not have a Federalwide Assurance (FWA).  The Individual Investigator will be required to review:

• The Belmont Report
• The U. S. Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45CFR46.
• The FWA and the applicable Terms of the FWA for UMD.
• The relevant institutional policies and procedures for the protection of human subjects. 
• Documented completion of human subject research training. Please affiliate with UMD-College Park if taking CITI Training.

How to Request an Individual Investigator Agreement:

Please complete the Individual Investigator Agreement (IIA) for each investigator and the Roles and Responsibilities Form (R&R). Send the IIA and R&R documents to RelianceAgreements@umd.edu for processing and approval.