A reliance agreement (i.e. IAA’s, IIA, etc.) is an agreement between two or more institutions that allows an institution’s IRB to rely on another, unrelated institution’s IRB for review of human subjects’ research. A reliance agreement comes in multiple formats, with the most common being Institutional Authorization Agreements (IAA), Memorandum of Understanding (MOU) and Master Reliance Agreement (MRA). An Investigator working at multiple institutions, each having their own IRB, may decide to have one IRB serve as the IRB of record for some or all participating sites. This practice is commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight. In this scenario, the UTMB IRB will either serve as the reviewing IRB (IRB of Record) or will cede oversight (rely) of the research activity to another equally qualified institution’s IRB. Each individual IRB will indicate which agreement format is appropriate for a specific study.
Submission Process
A member of the UTMB Study team submits the Reliance Agreement request through InfoED. It is recommended you contact the UTMB IRB Office for a consultation prior to submitting any documents via InfoED. Please email us at IRB@utmb.edu.
Agreement Types
IRB Authorization Agreement (IAA)
An IRB Authorization Agreement (IAA) is an agreement between UTMB and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, community organization, survey research organization) that receives funds from HHS must have an FWA. Entities use this agreement type to establish which institution will serve as the IRB-of-Record. Each institution’s Institutional Official or designee signs the IAA.
Individual Investigator Agreement (IIA)
An Individual Investigator Agreement (IIA) is an agreement between UTMB and an individual collaborator who is not affiliated with an institution with an FWA (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). This agreement outlines the responsibilities of the individual investigator for the protection of human subjects. The IIA is signed by the:
- Individual investigator
- UTMB Institutional Official or designee
Master Reliance Agreement
A Master Reliance Agreement (MRA) is utilized when multiple studies cede review to a specific external IRB. Master Agreements may be reciprocal in that signatory institutions can act as the site providing IRB review and oversight or the site relying. Master Reliance Agreements may be for a single protocol or a number of protocols that are negotiated on a case by case basis. The UTMB IRB currently has master agreements in place with the following external IRB’s:
- State of Texas Master IRB Reciprocity Agreement
- Smart IRB