Reliance Agreements

UMD IRB Information

Name of Institution: University of Maryland, College Park
IRB Registration #: IRB00000474
Federalwide Assurance (FWA) #: FWA00005856
Point of Contact: Vidhi Rami - relianceagreements@umd.edu 

UMD Reliance Agreement SOP - Policy 3.012 

• Reliance Agreements
• Reliance Agreement Eligibility
• How to Request a Reliance Agreement
• Individual Investigator Agreements
• How to Request an Individual Investigator Agreement
• Exempt Study Collaborations

Reliance Agreements

A reliance agreement is a formal written document that allows one institution to rely on another institution's IRB for review, avoiding the need for duplicate reviews. 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 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.

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.

SMART IRB Site: https://smartirb.org/ 

Federal Policies and Requirements

• 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 

Reliance Agreement Eligibility

In order to be eligible for a reliance agreement, the following conditions must be met:

• Both collaborating institutions have an active Federalwide Assurance (FWA) number from DHHS.
• The Relying Institution is engaged in human subjects research (i.e. interacting with participants and/or their identifiable data). 
  • There are a few exceptions to this condition, for example, if the Relying Institution is the Prime Awardee on a Federal award. Please check in with the reliance agreement team for confirmation if the relying institution’s engagement is unclear.
• The study is approved by the Reviewing IRB and is non-exempt (i.e. an Expedited or Full Board project).

How to Request a Reliance Agreement

If UMD is the Reviewing IRB:

• If the project has been transitioned to Kuali IRB, please submit your request via Kuali IRB’s Reliance Agreement Form. More guidance is available here.
• If the project has NOT been transitioned to Kuali IRB and is still active on IRBNet, please email relianceagreements@umd.edu. In your email, please include the following information regarding the study collaboration:
  • The names of the external investigators and their institutional affiliations.
  • The roles and responsibilities of each external investigator. Please specify whether they will interact with participants and/or their identifiable data as part of their role.
  • Please include a statement indicating whether there are any conflicts of interest (COI) or financial COIs regarding this study collaboration.

If UMD is the Relying IRB:

• Please submit your request via Kuali IRB’s Reliance Agreement Form. More guidance is available here.

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

Complete the Individual Investigator Agreement (IIA) for each investigator and submit the request via Kuali IRB’s Reliance Agreement Form. More guidance is available here.

Exempt Study Collaborations

Reliance agreements for exempt studies are not required. Each institution will have its own set of requirements for exempt study collaborations. Find UMD IRB’s exempt collaboration guidelines below:

If UMD IRB is the Reviewing IRB:

• Non-UMD investigators may work on UMD IRB projects that are deemed Exempt; however, they must ensure that they have all the necessary approvals/permissions from their home institution in order to work on the study.

An external IRB served as the Reviewing IRB:

• UMD IRB is open to accepting an external IRB’s exemption. In some cases though, a Reviewing IRB may prohibit external institutions from ‘accepting’ their review. In this case, the external institution may need to conduct their own review of their role in the project. 
• In order to submit a request to UMD to accept an external exemption, please complete a Reliance Agreement Form on Kuali IRB. More guidance is available here.