Single IRB Review
Note: This section applies only to multi-site or collaborative studies in which a single IRB will provide oversight for multiple sites/institutions. Multi-site and collaborative studies in which each institution will provide its own IRB review should follow the standard submission process.
Introduction
There are two complementary federal policies that require certain types of federally-funded research that involve multiple institutions to use one IRB to accomplish IRB review and approval for all of the institutions conducting the study/trial. The Single IRB (sIRB) Model allows multiple institutions that conduct the same protocol to cede to a single IRB for review.
Under this model, the IRB for each institution will serve in one of two roles: the Reviewing IRB or the Relying IRB. Whether GMU will serve as the Reviewing or Relying IRB depends on a number of factors, but every project involving human subjects research at GMU MUST be submitted to the IRB through RAMP prior to the start of research activities.
Eligibility for Single IRB Review
Whether a study is eligible for single IRB review depends on a number of factors, but we can provide some general guidance. You should always contact the IRB if you would like a more specific determination regarding your study.
Multi-site studies are generally eligible for single IRB review when:
- They have federal or state funding
- The sponsor requires single IRB review in order for GMU to be eligible to participate in the study
- There are other circumstances that warrant single IRB review – in this case, the study submission must include a justification for requesting single IRB review
Studies are ineligible for single IRB review when:
- They are determined to be outside the scope of IRB review (i.e., Not Human Subjects Research or Not Engaged)
- They are determined to be Exempt
- They involve international study sites
Agreement Types
IRB Authorization Agreement (IAA)
An IAA is an agreement between GMU 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) receiving funds from HHS must have an FWA. This agreement type is used to establish the IRB-of-Record (whether that’s GMU or the other institution) for non-Exempt research. The IAA is signed by the Institutional Officials or designee at each institution.
Individual Investigator Agreement (IIA)
An IIA is an agreement between GMU and an individual collaborator who is not affiliated with an FWA institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects in non-Exempt research. The IIA is signed by the Individual investigator and the GMU Institutional Official or designee.
Definitions
Collaborative or Cooperative Study: Research where multiple institutions or sites conduct the same research protocol, each completing specific procedures.
Engaged: In general, an institution is considered engaged in a human subjects research projects when its employees or agents: collect data about research subjects through interaction or intervention; access identifiable private information about the research subjects; secure informed consent from human subjects for the research. Please note that there are many specific exceptions to this. Please see DHHS Engagement Guidance for a more detailed overview of when institutions do and do not need to be considered engaged in human subjects research.
FWA (Federalwide Assurance): An assurance of compliance with the U.S. federal regulations for the protection of human subjects in research. A FWA is generally mandatory for institutions receiving federal funding for human subjects research and is approved by the Office for Human Research Protections (OHRP).
IAA (Institutional Review Board (IRB) Authorization Agreement): Agreement outlining the roles and responsibilities between institutions which enables IRB reliance.
IIA (Individual Investigator Agreement): Agreement defining the roles and responsibilities when an individual investigator relies on an external IRB.
Lead Site: The primary recipient of a federal grant OR the institution developing the protocol for non-funded research.
Multi-site research: means that the same research procedures or protocol are being conducted at one or more institutions. This typically involves a lead site that receives the grant or contract directly and then establishes subawards to other sites.
Reviewing IRB or sIRB: The IRB that is responsible for the review of the human subjects research on behalf of another institution or individual investigator. Also known as the IRB of Record.
Relying IRB: An IRB that cedes review to another IRB.
Same Protocol: Protocols addressing the same research questions and employing the same or similar methodologies to explore the same outcomes. Even if all sites are not conducting all study activities or if there are variations in procedures to adapt to local context, the activities are often still considered to be the “same protocol”.
SMARTIRB: An online platform which harmonizes and streamlines the reliance process for multi-site research. The SMART IRB platform eliminates the need for signed reliance agreements. For more information, please see https://smartirb.org/reliance/