» Reliance Agreements

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). 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 CU 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.

Note: Effective January 25, 2018, the National Institutes of Health mandated the use of single IRBs as a contingency for funding of multi-center studies.

Submission Process

A member of the Chapman University Study team submits the Reliance Agreement request through irb@chapman.edu.  You may submit any questions regarding the feasibility of the Chapman University serving as the IRB of record for a multi-site study, as well as any other queries to irb@chapman.edu.

Agreement Types

IRB Authorization Agreement (IAA)

An IRB Authorization Agreement (IAA) is an agreement between Chapman University 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, NGOs, 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 Chapman University 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
  • CU Principal Investigator (PI)
  • CU Institutional Official or designee

Memorandum of Understanding

We may draft a Memorandum of Understanding (MOU) to acknowledge an ongoing and strategic relationship between institutions. An MOU is intended to be a long-term agreement and/or to support a specific research study. The agreement generally describes a very broad concept of mutual understanding, goals, and plans shared by the parties.  It may also list areas of possible joint activities, without creating financial obligations or committing resources.

Resources

IRB Authorization Agreement - Where CU IRB will be in the IRB of record

IRB Authorization Agreement - Where CU IRB will NOT be the IRB of record

Individual Investigator Agreement (contact irb@chapman.edu to request the form)


Toggle Section