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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.

Reliance Agreements 

A Reliance Agreement, or IRB Authorization Agreement, is an agreement between two institutions that hold a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP). This agreement allows one institution’s IRB to rely on another for review of human subjects research. This type of agreement may be needed when collaborating with researchers external to UT, who are engaged in human subjects research. Institutions use this agreement to establish which institution will serve as the IRB of Record.

Individual Investigator Agreements 

In some types of collaborative research, an Individual Investigator Agreement, or Unaffiliated Investigator Agreement may be needed. This is an agreement between the University of Tennessee, Knoxville and an individual collaborator who is not affiliated with an institution with an Institutional Review Board (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, researcher at an institution without an IRB or Ethics Review Board). This agreement outlines the responsibilities of the individual investigator for the protection of human subjects and gives the UT Knoxville IRB oversight for this individual. The IIA is signed by the:

  • Individual investigator
  • UT Principal Investigator (PI)
  • UT Principal Investigator’s Department Head
  • UT Institutional Official

Submission Process 

If you believe you need a Reliance Agreement or Individual Investigator Agreement for your study, please start by submitting the Reliance Agreement Consultation Form. After the form has been submitted, the HRPP Liaison for your college will contact you to schedule a meeting. Once the appropriate documents and information are acquired, HRPP staff will determine whether an agreement is needed, and, if necessary, contact the other institution or individual investigator to execute the agreement.

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 Consultation Form has been submitted a HRPP staff member will contact you within 2 business days to follow up. From that consultation, they will either ask for additional information from you or contact the other institution to start the process of executing the agreement. The time frame from consultation 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.