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Reliance Agreements

New Single IRB Requirement 

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Contact Rob Withrow at

rwithrow@utk.edu

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Guidance on Engagement of Institutions

Smart IRB

 

Cooperative Research

When multiple institutions are engaged in human subjects research (“cooperative research”), a formal relationship must be established between the two parties.  While there are a number of factors that may effect how that relationship is established and executed, a formal agreement is usually required.

Depending on the affiliation of the external investigator, different agreements will be used when the University of Tennessee, Knoxville is engaged in cooperative research.

Reliance Agreements are used when the external investigator is affiliated with an institution that holds its own Federalwide Assurance (FWA).  Usually this means that the investigator is affiliated with a hospital or university that is located in the United States of America and has its own IRB.

An Individual Investigator Agreement is utilized when University of Tennessee, Knoxville researchers are overseeing research that engages individuals who are not agents or employees of an institution with its own FWA.  These agreements are most commonly used when University of Tennessee, Knoxville researchers oversee research activities conducted by community members (e.g., “community engaged research”).  This agreement largely establishes that these researchers will adhere to the same policies and procedures that University of Tennessee, Knoxville researchers must follow.

 What if one investigator has affiliation with multiple institutions?

In cases where investigators hold affiliations with multiple institutions, the University of Tennessee, Knoxville’s IRB must determine whether the investigator is acting as an agent of another institution when conducting human subjects research. If this is found to be the case, an additional agreement will be required. To make this determination, the IRB considers whether the investigator is utilizing resources from another institution in their research. Such resources may include salary compensation for the researcher or research staff, use of physical space or equipment during research, and engaging additional personnel under their supervision. Please note that failure to disclose such affiliations may result in serious consequences for both the investigator and the participating institutions. We appreciate your cooperation in ensuring compliance with our policies and regulations.

What is a Reliance Agreement?

A Reliance Agreement is a document signed by two institutions that are engaged in human subjects research that permits one institution’s IRB to cede review to another institution’s IRB. This requires only one IRB to conduct a full review of a research project rather than both IRBs conducting a full review. An institution is considered to be engaged in the conduct of human subjects research if an employee or agent affiliated with that institution engages in any of the following:

  • Collecting data
  • Obtaining informed consent
  • Analyzing (or, in certain situations, accessing) identifiable data
  • Answering questions about the research for potential, current, or past participants
  • Acting as an extension of the Principal Investigator

A Reliance Agreement is the most common type of agreement that is established when organization’s engage in cooperative research.  This agreement is executed between two institutions that hold FWAs, meaning that each institution is located in the United States of America and has its own Institutional Review Board.  Most institutions will execute Reliance Agreements for research that is not being considered or approved under one of the categories of exempt review.  If the research is subject to the 2018 Common Rule or the Single IRB Review Mandate, then a Reliance Agreement is required.

Regardless of who acts as the reviewing IRB, the IRB ceding review still has responsibilities.  For this reason, the University of Tennessee, Knoxville requires that all requests for Reliance Agreements are registered through iMedris to allow for review of the protocol for compliance with state law (“local context review”) and other, required ancillary reviews such as Scientific Review by Department Review Chairs and Department Chairs.

The University of Tennessee, Knoxville utilizes different types of Reliance Agreements, depending on an institution’s membership in SMARTIRB.

The University of Tennessee, Knoxville is a member of the SMARTIRB, which allows for easier collaboration and more streamlined reliance agreement processing with other member institutions. SMARTIRB streamlines the reliance agreement process through the execution and agreement of a Common Master Agreement that most notably defines responsibilities and communication plans for IRBs engaged in cooperative research.

If an institution is not a member of SMARTIRB, the University of Tennessee, Knoxville will utilize a more defined communication plan to ensure all parties are appropriately aware of their responsibilities.

The University of Tennessee, Knoxville and the University of Tennessee Graduate School of Medicine have executed a Master Reliance Agreement that provides additional streamlining to the reliance agreement process.

The University of Tennessee, Knoxville IRB does not expect researchers to know whether a reliance agreement is required or which type of reliance agreement to use.  Instead, investigators are welcomed and encouraged to contact their HRPP liaison or visit virtual office hours for assistance in navigating the process.  Additionally, the University of Tennessee, Knoxville HRPP staff are happy to work directly with external IRBs to execute Reliance Agreements.

Federal Single IRB Requirement 

As of January 20, 2020, the Revised Common Rule (part 45 CFR 46.114) requires that all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States.

Similarly, the National Institutes of Health (NIH) requires the use of a single IRB of record for multi-site studies that are conducting the same protocol.

Even if your research is not subject to either one of these regulations, there may be instances in which a Reliance Agreement or Individual Investigator Agreement is needed for your research.

 Reliance Agreement Procedures

If you are not sure whether you need a reliance agreement for your study, please contact your College Liaison. If an agreement is needed, the next step is for you to submit a Reliance Agreement Form in iMedRIS.

If an investigator wishes to request an that the University of Tennessee, Knoxville act as the reviewing IRB for a study, they should submit their IRB application in iMedris as normal and answer “yes” on question 3 of application section (1200) Site Information.  The application will branch to a new question and the investigator should provide the following information:

  • The name of the research personnel not affiliated with the University of Tennessee, Knoxville
  • The professional affiliation of the research personnel not affiliated with the University of Tennessee, Knoxville
  • The duties that will be assigned to the research personnel not affiliated with the University of Tennessee Knoxville

If an institution other than the University of Tennessee, Knoxville will be reviewing the study or has already reviewed the study, follow these steps:

  • Create a New Project in iMedRIS
  • Select UTK Main Campus IRB Application
  • Complete the first three sections of the form
  • In section four of the form select the following option:
  • I am submitting my research in accord with an IRB Authorization Agreement. I am requesting to use an external IRB.
    • Please use this category even if your study has been granted an exemption by another IRB.
  • Complete the rest of the form, and attach the IRB approved research materials and approval letter as requested.
    • The University of Tennessee, Knoxville requires all requests for Reliance Agreements attach a copy of the application that has been most recently approved by the reviewing IRB.
    • The University of Tennessee, Knoxville requires all requests for Reliance Agreements attach a copy of the initial approval letter issued by the reviewing IRB. 

 What is an Individual Investigator Agreement (IIA)

An Individual Investigator Agreement is needed when an individual is engaged in the conduct of the research occurring at the University of Tennessee, Knoxville, but is not affiliated with the university or another institution that has an IRB (e.g., former student working with their faculty mentor, 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, the study Principal Investigator, the Principal Investigator’s Department Head, and the Institutional Official. If you have questions about whether an IIA is needed for your study, please contact your liaison.

If an investigator wishes to request an IIA for a study, they should submit their IRB application in iMedris as normal and answer “yes” on question 3 of application section (1200) Site Information.  The application will branch to a new question and the investigator should provide the following information:

  • The name of the research personnel not affiliated with the University of Tennessee, Knoxville
  • The professional affiliation of the research personnel not affiliated with the University of Tennessee, Knoxville
  • The duties that will be assigned to the research personnel not affiliated with the University of Tennessee Knoxville

 

Reliance Agreement FAQ

University of Tennessee, Knoxville IRB recognizes that some researchers may have affiliations with other institutions within the greater University of Tennessee system. For instance, many researchers hold dual affiliations with both the University of Tennessee, Knoxville and the University of Tennessee Graduate School of Medicine. In such cases, reliance agreements are required since both IRBs operate independently and hold separate FWAs. If you hold dual affiliation between the University of Tennessee, Knoxville and another component of the University of Tennessee system, please consult with the IRB prior to conducting human subjects research.

 

If an individual is only sharing IRB-approved recruitment materials (such as handing out a flyer or forwarding an email) and will not be involved in answering questions about the study or obtaining informed consent, they are not considered to be engaged in the research. In addition, if an individual is only receiving de-identified data and will not have a way to re-identify that data (e.g., through access to a code key or via indirect identifiers), they are also not considered to be engaged in research.

The reliance agreement outlines the responsibilities of the institution conducting the review and the institution relying on the reviewing IRB. For example, when the University of Tennessee, Knoxville IRB is ceding review to another IRB, we are still responsible for ensuring that our researchers have met the requirements for human subjects research training, reporting of potential conflicts of interest, and complying with applicable local laws. Therefore, even when the University of Tennessee, Knoxville IRB has ceded review to another IRB, submission to the University of Tennessee, Knoxville IRB is required so that we can maintain our responsibilities under the reliance agreement.

 

While many institutions will not sign Reliance Agreements for exempt studies, the University of Tennessee, Knoxville is happy to enter into Reliance Agreements for studies approved as exempt.  As with all reliance agreements, the IRB is happy to work directly with the reviewing institution to establish the next steps in the process.

 

While the IRB can provide benchmarks on review times, the time to execute a Reliance Agreement can be highly variable because of the inclusion of external institutions.

 

To determine whether a reliance agreement is needed, HRPP staff need to know the name of the external institution and affiliated researcher, the study procedures that will occur at each site, whether the external investigator is engaged in the research, whether the study has received funding, and the risk level of the research.

For studies that request the University of Tennessee, Knoxville cede IRB review to another institution, will consider the study as it relates to state regulations and University policies.  This is called “local context review.”  The study should also receive scientific review through signoff by the appropriate Department Review Chair and Department Chair.

 

A researcher is engaged in human subjects research when someone is engaged in any of the following:

  • Collecting data
  • Obtaining informed consent
  • Analyzing (or, in certain situations, accessing) identifiable data
  • Answering questions about the research for potential, current, or past participants
  • Acting as an extension of the Principal Investigator

For more information about how to determine if an individual is engaged in research see OHRP Guidance on Engagement of Institutions in Human Subjects Research.

 

Both the Institutional Official, or designee, from the relying institution and the reviewing institution must sign a Reliance Agreement. Individual Investigator Agreements must be signed by the Individual Investigator, the UT Principal Investigator, the UT Principal Investigator’s Department Head, and the UT Institutional Official.

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