Single IRB Reliance

If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead IRB for your study, or if you would like the UK IRB to defer review to another IRB, please complete the forms below and submit them to IRBReliance@uky.edu.

• IRB Reliance Request/Registration Form [PDF]

General inquiries/questions about IRB reliance and the University of Kentucky’s policies and procedures may also be submitted to: IRBReliance@uky.edu.

• Communication Plan Form [PDF]
• SAMPLE Individual Investigator Agreement [PDF]
• SAMPLE Individual Investigator Agreement for minors [PDF]
• SAMPLE IRB Authorization Agreement [PDF]

• IRB Reliance SOP [C1.0350] [PDF]
• NIH Single IRB Policy

• Lead PI Checklist [PDF]
• Relying Institution PI Checklist [PDF]
• Principal Investigator Responsibilities When Other Institutions Are Relying on the UK IRB [PDF]
• Principal Investigator Reliance Assurance Statement [D149.0000] [PDF]
• Off-Site Research: Letter of Support, Local Context, & Additional Requirements [HTML]
• OHRP's "Guidance on Engagement of Institutions in Human Subjects Research" [HTML]
• Sample Protocol for Reliance [PDF]
• Step-by-Step Guidance for University of Kentucky Investigators Requesting to Rely on an External IRB [PDF]
• Adding Non-UK Study Personnel [D163.0000] [PDF]

A single IRB is when one institution engaged in human subject research agrees to be the reviewing IRB for another institution for a cooperative study.  Single IRB is mandated when institutions located within the US are engaged in cooperative research conducted or supported by a Common Rule department or agency.  Generally, UK should be the IRB for any studies in which a UK investigator is the Principal Investigator. List of the common rule departments or agencies [HTML]

Studies that are not federally funded are reviewed on a case-by-case basis. 

Please contact UK’s Reliance Team if you want to use a single IRB for a non-funded study. 

Some of the items that are considered for non-federally funded studies include:

• Risk of the project,
• Sponsor’s requirement for single IRB,
• Accreditation status,

The number of sites and the research activities conducted for the project. 

Not all multi-site studies require a single IRB. Though there are exceptions, the following is less likely to require a single IRB:

• Exempt research,
• Research that is being conducted under research training awards,
• If a single IRB is unable to meet the needs of a specific population, especially if there are federal, tribal, or state laws surrounding research involving the population,
• If the research sites are only international.

• You want an external IRB to be the reviewing IRB,
• You want UK to serve as the reviewing IRB for a multi-site study,
• You are transferring your project to UK or want to work with your previous institution on a project,
• You or your colleagues are transferring to another institution and want to continue to work on the project,
• You have reliance questions about a project.

There are three criteria that must be met for single IRB to be mandated by the federal regulations (45 CFR 46.114) for a protocol: federal funding from one of twenty different federal depts/agencies, a non-Exempt protocol (i.e., an Expedited or Full-Board Review protocol), and engagement of human subject research by more than one institution.

A good rule of thumb is when the individual is consenting participants, intervening/interacting with participants, and/or viewing identifiable participant information (See UK’s guidance on Study Personnel for further information). If the engaged individual is an ‘agent’ of an institution, the institution is considered engaged. Agent is defined as the faculty, staff, or volunteers of a specific institution and UK Legal is often consulted to determine the status of a specific individual.

A PI requests the use of single IRB by completing a Reliance Request Form or contacting the Reliance Team inbox (irbreliance@uky.edu).

Yes, but different institutions have further criteria to determine if an IAA/Reliance Agreement is suitable for protocols that do not have a single IRB mandate. At UK, the type of review (i.e., Exempt, Expedited, Full-Board Review), the risk level of the protocol (minimal risk vs. greater than minimal risk), and the level of engagement by UK individuals is considered when determining if a protocol that does not meet the requirements for single IRB should have an exception be made.

Yes, UK can still collaborate on projects with other institutions even when a Reliance Agreement will not be signed. When other institutions are engaged in human subject research, but a Reliance Agreement is not signed, the non-UK individuals should seek IRB approval from their own IRB (known as local IRB approval).

UK’s ORI requires three documents when single IRB has been deemed mandatory or suitable: A completed IAA (signed by both institutions; the link provides an example of one type of IAA), a Communications Plan, and (if applicable) a Local Context Form.

Local Context is the Local Laws, Regulations, or Policies that may affect a multi-site study. At UK, it is provided by the Reliance Team when UK is ceding IRB Review and the Laws or Policies may impact the conduct of the study. The Reliance Team obtains the Local Context from other sites when UK is the Reviewing IRB. Examples include mandatory disease reporting, use of Short Forms, Age of Majority, and many others.

A Communications Plan is developed by the Reviewing IRB & Relying Site jointly to ensure everyone understands their communications responsibilities. UK’s Reliance Team completes the form and provides it to the HRPP staff at the other site for consideration and approval.

When research activities will occur at a site that is not owned or operated by UK and the other site is not engaged in human subject research. [HTML]

An IIA is required when an individual is engaged in human subject research, but does not have access to an IRB.

• IRB Authorization Agreement (IAA) – A legal document between two institutions that are engaged in human subject research wherein one institution (the Relying IRB) chooses to rely on the ethical and regulatory determinations made by the other institution’s IRB (Reviewing IRB). UK agrees to cover the activities of another institution.
• Individual Investigator Agreement (IIA) – A legal document between an individual who, generally, does not have access to an IRB, but who is engaged in human subject research alongside an institution with an IRB.
• Reviewing IRB – an IRB that reviews the ethical and regulatory aspects of a multi-site study for all participating sites.
• Relying IRB – an IRB that relies on another IRB for review of the ethical and regulatory aspects of a multi-site study.
• Reliance Agreement – synonymous with IAA.
• Single IRB – When an IRB reviews a protocol as a multi-site study on behalf of the other sites. An IAA/Reliance Agreement is used to document this arrangement. See the Code of Federal Regulations on Cooperative Research (45 CFR 46.114).