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Reliance Agreements

New 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.

45 CFR 46.114 of the Revised Common Rule states:

(a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

(b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

(b)(2) The following research is not subject to this provision:

(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or

(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

(c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.

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.

Depending on the situation, the University of Tennessee, Knoxville Institutional Review Board (IRB) may either act as the reviewing IRB or to cede review to an external IRB.

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 research if an individual or individuals affiliated with that institution:

  • Recruit/Enroll participants
  • Answer questions about the study
  • Obtain informed consent
  • Collect data for the study
  • Have access to identifiable information from participants in the study

Note: 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.

Reliance Agreement Procedures

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

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

  1. Create a New Project in iMedRIS
    1. Select UTK Knoxville Main Campus IRB Application
  2. Complete the first three sections of the form
  3. In section four of the form select one of the options below, as applicable:
    1. I am submitting my research in accord with an IRB Authorization Agreement. I am requesting to use an external IRB.
    2. I am registering an Exempt study that will be or has been reviewed by an external IRB.

Note: Federal regulations do not require Reliance Agreements for Exempt studies, but the IRB still needs to collect information about that study so that we have a record of it.

  1. Complete the rest of the form, and attach the IRB approved research materials and approval letter as requested.

If the University of Tennessee, Knoxville IRB will be the IRB of record, the information needed for a reliance agreement determination will be collected in the IRB New Study Application. In this case, complete the New Study Application as usual, being sure to include detailed information about your collaborators and their role(s) on the project in application section (1200) Site Information.

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.

Reliance Agreement FAQ 

The HRPP staff need to know which investigators will be involved and what research activities will be occurring at each study site. If the study is funded, we will also need to review your funding proposal. If the study has already been reviewed by an external IRB, the HRPP staff will need to review the approved protocol and any other relevant study documents such as the study application, consent forms, and recruitment materials.

 

The HRPP recognizes that all research is important, and we want to facilitate a smooth and quick process for all investigators. At this time, the approximate timeline varies based on the PI’s depth of information provided and the response from the other institution. Once a Reliance Agreement Form has been submitted in iMedRIS, a HRPP staff member will review it within 5 business days. After that review, they will either ask for additional information from you or, if no additional information is needed, begin the process of executing the agreement. The time frame from submitting the Reliance Agreement form to a signed agreement is 1-4 weeks depending on the type of agreement.

 

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.

 

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

  • They participate in the consent process
  • They interact with participants as part of the research
  • They obtain or analyze personally identifiable subject data
  • The funding proposal states they are part of the research activities

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 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.